# Official Journal C 258/2010

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2010.258.eng |
| --- | --- |
| Official Journal
  of the European Union | C 258 |
| | |
| English edition | Information and Notices | Volume 5324 September 2010 |

ISSN 1725-2423

doi:10.3000/17252423.C_2010.258.eng

Official Journal

of the European Union

C 258

English edition

Information and Notices

Volume 5324 September 2010

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2010/C 258/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010[Published pursuant to Article 13 or Article 38 of Regulation (CE) No 726/2004 of the European Parliament and of the Council] | 1 |
| 2010/C 258/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010[Decisions taken pursuant to Article 34 of Directive 2001/83/CE or Article 38 of Directive 2001/82/CE] | 32 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2010/C 258/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010[Published pursuant to Article 13 or Article 38 of Regulation (CE) No 726/2004 of the European Parliament and of the Council]

[Published pursuant to Article 13 or Article 38 of Regulation (CE) No 726/2004 of the European Parliament and of the Council]

1

2010/C 258/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010[Decisions taken pursuant to Article 34 of Directive 2001/83/CE or Article 38 of Directive 2001/82/CE]

[Decisions taken pursuant to Article 34 of Directive 2001/83/CE or Article 38 of Directive 2001/82/CE]

32

| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 24.9.2010 | EN | Official Journal of the European Union | C 258/1 |
| --- | --- | --- | --- |

24.9.2010

EN

Official Journal of the European Union

C 258/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010

[Published pursuant to Article 13 or Article 38 of Regulation (CE) No 726/2004 of the European Parliament and of the Council (1)]

(2010/C 258/01)

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 11.3.2010 | Revolade | Eltrombopag | GlaxoSmithKline Trading Services Limited
  6900 CorkAirport Business Park, Kinsale Road, Cork, Ireland | EU/1/10/612/001-006 | Film-coated tablet | B02BX05 | 15.3.2010 |
| 15.3.2010 | DuoCover | clopidogrel / acetylsalicylic acid | Bristol-MyersSquibbPharma EEIG
  Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/10/623/001-014 | Film-coated tablet | B01AC30 | 17.3.2010 |
| 15.3.2010 | DuoPlavin | clopidogrel / acetylsalicylic acid | Sanofi Pharma Bristol-Myers Squibb SNC
  174 Avenue de France, F-75013 Paris, France | EU/1/10/619/001-014 | Film-coated tablet | B01AC30 | 17.3.2010 |
| 15.3.2010 | ImmunoGam | Human Hepatitis B Immunoglobulin | Cangene Europe Limited
  Parkshot House, 5 Kew Road, Richmond, SurreyTW9 2PR, United Kingdom | EU/1/10/613/001-002 | Solution for injection | J06BB04 | 17.3.2010 |
| 15.3.2010 | Menveo | Meningococcal Group A, C, W135 and Y Conjugate Vaccine | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1 - Siena, Italia | EU/1/10/614/001 | Powder and solution for injection | Pending | 17.3.2010 |
| 15.3.2010 | Ristaben | sitagliptin | Merck Sharp & Dohme Ltd.
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621/001-018 | Film-coated tablet | A10BH01 | 17.3.2010 |
| 15.3.2010 | Ristfor | sitagliptin / metformin hydrochloride | Merck Sharp & Dohme Ltd.
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620/001-016 | Film-coated tablet | A10BD07 | 17.3.2010 |
| 15.3.2010 | Temozolomide HEXAL | temozolomide | HEXAL AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/10/616/001-024 | Capsule, hard | L01AX03 | 17.3.2010 |
| 15.3.2010 | Temozolomide Hospira | temozolomide | Hospira UK Ltd.
  Queensway, Royal Leamington Spa, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/615/001-024 | Capsule, hard | L01AX03 | 17.3.2010 |
| 15.3.2010 | Temozolomide Sandoz | temozolomide | Sandoz Pharmaceuticals GmbH
  Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | EU/1/10/617/001-024 | Capsule, hard | L01AX03 | 17.3.2010 |
| 15.3.2010 | Tepadina | Thiotepa | ADIENNE S.r.l.
  via Broseta, 64/B, 24128 Bergamo, Italia | EU/1/10/622/001-002 | powder for concentrate for solution for infusion | L01AC01 | 17.3.2010 |
| 23.3.2010 | Arepanrix | Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A) | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/10/624/001 | Suspension and emulsion for emulsion for injection | J07BB02 | 25.3.2010 |
| 6.4.2010 | Ribavirin BioPartners | Ribavirin | BioPartners GmbH
  Kaiserpassage 11 - D-72764 Reutlingen, Deutschland | EU/1/10/626/001-004 | Film-coated tablet | J05AB04 | 9.4.2010 |
| 19.4.2010 | Arzerra | Ofatumumab | Glaxo Group Ltd
  Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/10/625/001-002 | Concentrate for solution for infusion | L01XC10 | 21.4.2010 |
| 29.4.2010 | Raloxifene Teva | Raloxifene hydrochloride | Teva Pharma B.V.
  Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/10/627/001-003 | Film-coated tablet | G03XC01 | 3.5.2010 |
| 10.5.2010 | Docefrez | Docetaxel | Sun Pharmaceuticals Industries Europe B.V.
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/10/630/001-002 | Powder and solvent for concentrate for solution for infusion | L01CD02 | 12.5.2010 |
| 26.5.2010 | Prolia | denosumab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/10/618/001-004 | Solution for injection | M05BX04 | 28.5.2010 |
| 4.6.2010 | Tolura | telmisartan | KRKA, d.d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/10/632/001-021 | Tablet | C09CA07 | 8.6.2010 |
| 8.6.2010 | Humenza | Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A) | Sanofi Pasteur SA
  2, avenue Pont Pasteur, F-69007 Lyon, France | EU/1/10/629/001 | Suspension and emulsion for emulsion for injection | J07BB02 | 10.6.2010 |
| 8.6.2010 | Nivestim | Filgrastim | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/631/001-009 | Solution for injection or infusion | L03AA02 | 10.6.2010 |
| 10.6.2010 | Olanzapine Apotex | Olanzapine | Apotex Europe B.V.
  Darwingweg 20, 2333 CR Leiden, Nederland | EU/1/10/635/001-014 | Film-coated tablet
  Orodispersible tablet | N05AH03 | 14.6.2010 |
| 10.6.2010 | Ribavirin Three Rivers | Ribavirin | Three Rivers Global Pharma Limited
  20-22 Bedford Row, London WC1R4JS, United Kingdom | EU/1/10/634/001-004 | Capsule, hard | J05AB04 | 14.6.2010 |
| 10.6.2010 | Topotecan Hospira | Topotecan | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/10/633/001-002 | Concentrate for solution for infusion | L01XX17 | 14.6.2010 |
| 14.6.2010 | Votrient | Pazopanib hydrochloride | Glaxo Group Limited
  Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/10/628/001-004 | Film-coated tablet | L01XE11 | 16.6.2010 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

11.3.2010

Revolade

Eltrombopag

GlaxoSmithKline Trading Services Limited

6900 CorkAirport Business Park, Kinsale Road, Cork, Ireland

EU/1/10/612/001-006

Film-coated tablet

B02BX05

15.3.2010

15.3.2010

DuoCover

clopidogrel / acetylsalicylic acid

Bristol-MyersSquibbPharma EEIG

Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/10/623/001-014

Film-coated tablet

B01AC30

17.3.2010

15.3.2010

DuoPlavin

clopidogrel / acetylsalicylic acid

Sanofi Pharma Bristol-Myers Squibb SNC

174 Avenue de France, F-75013 Paris, France

EU/1/10/619/001-014

Film-coated tablet

B01AC30

17.3.2010

15.3.2010

ImmunoGam

Human Hepatitis B Immunoglobulin

Cangene Europe Limited

Parkshot House, 5 Kew Road, Richmond, SurreyTW9 2PR, United Kingdom

EU/1/10/613/001-002

Solution for injection

J06BB04

17.3.2010

15.3.2010

Menveo

Meningococcal Group A, C, W135 and Y Conjugate Vaccine

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1 - Siena, Italia

EU/1/10/614/001

Powder and solution for injection

Pending

17.3.2010

15.3.2010

Ristaben

sitagliptin

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/621/001-018

Film-coated tablet

A10BH01

17.3.2010

15.3.2010

Ristfor

sitagliptin / metformin hydrochloride

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/620/001-016

Film-coated tablet

A10BD07

17.3.2010

15.3.2010

Temozolomide HEXAL

temozolomide

HEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/10/616/001-024

Capsule, hard

L01AX03

17.3.2010

15.3.2010

Temozolomide Hospira

temozolomide

Hospira UK Ltd.

Queensway, Royal Leamington Spa, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/615/001-024

Capsule, hard

L01AX03

17.3.2010

15.3.2010

Temozolomide Sandoz

temozolomide

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland

EU/1/10/617/001-024

Capsule, hard

L01AX03

17.3.2010

15.3.2010

Tepadina

Thiotepa

ADIENNE S.r.l.

via Broseta, 64/B, 24128 Bergamo, Italia

EU/1/10/622/001-002

powder for concentrate for solution for infusion

L01AC01

17.3.2010

23.3.2010

Arepanrix

Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A)

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/10/624/001

Suspension and emulsion for emulsion for injection

J07BB02

25.3.2010

6.4.2010

Ribavirin BioPartners

Ribavirin

BioPartners GmbH

Kaiserpassage 11 - D-72764 Reutlingen, Deutschland

EU/1/10/626/001-004

Film-coated tablet

J05AB04

9.4.2010

19.4.2010

Arzerra

Ofatumumab

Glaxo Group Ltd

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/10/625/001-002

Concentrate for solution for infusion

L01XC10

21.4.2010

29.4.2010

Raloxifene Teva

Raloxifene hydrochloride

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/627/001-003

Film-coated tablet

G03XC01

3.5.2010

10.5.2010

Docefrez

Docetaxel

Sun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/10/630/001-002

Powder and solvent for concentrate for solution for infusion

L01CD02

12.5.2010

26.5.2010

Prolia

denosumab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618/001-004

Solution for injection

M05BX04

28.5.2010

4.6.2010

Tolura

telmisartan

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/10/632/001-021

Tablet

C09CA07

8.6.2010

8.6.2010

Humenza

Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (X-179A)

Sanofi Pasteur SA

2, avenue Pont Pasteur, F-69007 Lyon, France

EU/1/10/629/001

Suspension and emulsion for emulsion for injection

J07BB02

10.6.2010

8.6.2010

Nivestim

Filgrastim

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/631/001-009

Solution for injection or infusion

L03AA02

10.6.2010

10.6.2010

Olanzapine Apotex

Olanzapine

Apotex Europe B.V.

Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/10/635/001-014

Film-coated tablet

Orodispersible tablet

N05AH03

14.6.2010

10.6.2010

Ribavirin Three Rivers

Ribavirin

Three Rivers Global Pharma Limited

20-22 Bedford Row, London WC1R4JS, United Kingdom

EU/1/10/634/001-004

Capsule, hard

J05AB04

14.6.2010

10.6.2010

Topotecan Hospira

Topotecan

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/10/633/001-002

Concentrate for solution for infusion

L01XX17

14.6.2010

14.6.2010

Votrient

Pazopanib hydrochloride

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/10/628/001-004

Film-coated tablet

L01XE11

16.6.2010

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.4.2010 | Impulsor | Pierre Fabre Médicament
  45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France | | 12.4.2010 |
| 8.4.2010 | Milnacipran Pierre Fabre Medicament | Pierre Fabre Médicament
  45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France | | 12.4.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

8.4.2010

Impulsor

Pierre Fabre Médicament

45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France

12.4.2010

8.4.2010

Milnacipran Pierre Fabre Medicament

Pierre Fabre Médicament

45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France

12.4.2010

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 11.3.2010 | Cancidas | Merck Sharp & Dohme Ltd
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/01/196/001
  EU/1/01/196/003 | 15.3.2010 |
| 11.3.2010 | Dafiro | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/371/001-036 | 15.3.2010 |
| 11.3.2010 | Diacomit | Biocodex
  7 avenue Gallieni, 94250 Gentilly, France | EU/1/06/367/001-012 | 15.3.2010 |
| 11.3.2010 | Eporatio | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573/001-028 | 15.3.2010 |
| 11.3.2010 | Inovelon | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom | EU/1/06/378/001-016 | 15.3.2010 |
| 11.3.2010 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/494/003-004 | 15.3.2010 |
| 11.3.2010 | Zopya | Norpharm Regulatory Services Ltd
  26 Laurence Street, Drogheda, Co. Louth, Ireland | EU/1/09/562/001-009 | 15.3.2010 |
| 15.3.2010 | Abraxane | Abraxis BioScience Limited
  Rosanne House, Parkway, WelwynGarden City, Herts, AL8 6HG, United Kingdom | EU/1/07/428/001 | 17.3.2010 |
| 15.3.2010 | Aerinaze | SP Europe
  Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/07/399/001-006 | 17.3.2010 |
| 15.3.2010 | Afinitor | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/538/001-008 | 17.3.2010 |
| 15.3.2010 | Aldara | Meda AB
  Pipers väg 2A, Solna 170 73, Svërige | EU/1/98/080/002 | 17.3.2010 |
| 15.3.2010 | Altargo | Glaxo Group Limited
  Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/390/001-004 | 17.3.2010 |
| 15.3.2010 | Arcalyst | Regeneron UK Limited
  40 Bank Street, E14 5DS London, United Kingdom | EU/1/09/582/001 | 17.3.2010 |
| 15.3.2010 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430/001-002 | 19.3.2010 |
| 15.3.2010 | Avonex | Biogen Idec Ltd
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/97/033/002-004 | 17.3.2010 |
| 15.3.2010 | BeneFIX | Wyeth Europa Ltd.
  Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-007 | 17.3.2010 |
| 15.3.2010 | Biopoin | CT Arzneimittel GmbH
  Lengeder Straße 42a, D-13407 Berlin, Deutschland | EU/1/09/565/001-028 | 17.3.2010 |
| 15.3.2010 | Byetta | Eli Lilly Nederland B.V.
  Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/06/362/001-004 | 17.3.2010 |
| 15.3.2010 | Carbaglu | Orphan Europe
  Immeuble Le Wilson, 70 Avenue du General de Gaulle, 92800 Puteaux, France | EU/1/02/246/001-003 | 17.3.2010 |
| 15.3.2010 | Cayston | GileadSciencesInternational Limited
  Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543/001 | 17.3.2010 |
| 15.3.2010 | Clopidogrel DURA | Mylan dura GmbH
  Wittichstraße 6, D-64295 Darmstadt, Deutschland | EU/1/09/560/001-009 | 17.3.2010 |
| 15.3.2010 | Clopidogrel Hexal | Acino Pharma GmbH
  Am Windfeld 35, Miesbach 83714, Deutschland | EU/1/09/534/001-007 | 17.3.2010 |
| 15.3.2010 | Clopidogrel Teva Pharma | Teva Pharma B.V.
  Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/561/001-010 | 17.3.2010 |
| 15.3.2010 | Copalia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/372/001-036 | 17.3.2010 |
| 15.3.2010 | Cubicin | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/328/001-002 | 17.3.2010 |
| 15.3.2010 | Doribax | Janssen-Cilag International NV
  Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/467/001-002 | 17.3.2010 |
| 15.3.2010 | Duloxetine Boehringer Ingelheim | Boehringer Ingelheim International GmbH
  Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland | EU/1/08/471/001-012 | 17.3.2010 |
| 15.3.2010 | Dynastat | Pfizer Ltd
  Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/02/209/001-008 | 17.3.2010 |
| 15.3.2010 | Effentora | Cephalon Europe
  5 Rue Charles Martigny, Maisons-Alfort 94700, France | EU/1/08/441/001-010 | 22.3.2010 |
| 15.3.2010 | Elaprase | Shire Human Genetic Therapies AB
  Svärdvägen 11D, 182 33 Danderyd, Sverige | EU/1/06/365/001-003 | 17.3.2010 |
| 15.3.2010 | Eucreas | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/425/001-018 | 17.3.2010 |
| 15.3.2010 | Evoltra | Genzyme Europe BV
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/06/334/001-005 | 17.3.2010 |
| 15.3.2010 | Exjade | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/356/001-009 | 17.3.2010 |
| 15.3.2010 | Faslodex | AstraZenecaUK Limited
  Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom | EU/1/03/269/001 | 17.3.2010 |
| 15.3.2010 | Firazyr | Jerini AG
  Invalidenstr. 130, D-10115 Berlin, Deutschland | EU/1/08/461/001 | 17.3.2010 |
| 15.3.2010 | GONAL-f | Merck Serono Europe Ltd.
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/95/001/001
  EU/1/95/001/003-005
  EU/1/95/001/009
  EU/1/95/001/012
  EU/1/95/001/021-022
  EU/1/95/001/025-028
  EU/1/95/001/031-035 | 17.3.2010 |
| 15.3.2010 | Humira | Abbott Laboratories Limited
  Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/03/256/001-010 | 17.3.2010 |
| 15.3.2010 | Icandra | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/484/001-018 | 23.3.2010 |
| 15.3.2010 | IntronA | Schering Plough Europe
  Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/99/127/011-044 | 17.3.2010 |
| 15.3.2010 | Invirase | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026/001-002 | 17.3.2010 |
| 15.3.2010 | Iscover | Bristol-MyersSquibbPharma EEIG
  Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/98/070/012 | 17.3.2010 |
| 15.3.2010 | Kepivance | BiovitrumAB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/05/314/001 | 17.3.2010 |
| 15.3.2010 | Luveris | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/155/001-007 | 17.3.2010 |
| 15.3.2010 | Mircera | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/07/400/001-024 | 17.3.2010 |
| 15.3.2010 | M-M-RVAXPRO | Sanofi Pasteur MSD, SNC
  8, rue Jonas Salk, 69007 Lyon, France | EU/1/06/337/001-013 | 17.3.2010 |
| 15.3.2010 | Mozobil | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/09/537/001 | 19.3.2010 |
| 15.3.2010 | Neupro | Schwarz Pharma Ltd
  Shannon, Industrial Estate, Co. Clare, Ireland | EU/1/05/331/001-055 | 18.3.2010 |
| 15.3.2010 | Nimvastid | KRKA, d.d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/525/047-050 | 17.3.2010 |
| 15.3.2010 | Norvir | Abbott Laboratories Ltd
  Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | EU/1/96/016/001
  EU/1/96/016/003-004 | 17.3.2010 |
| 15.3.2010 | Ovitrelle | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/165/001-007 | 17.3.2010 |
| 15.3.2010 | Pergoveris | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/07/396/001-003 | 17.3.2010 |
| 15.3.2010 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC
  174 avenue de France - 75013 Paris, France | EU/1/98/069/012 | 17.3.2010 |
| 15.3.2010 | Prezista | Janssen-Cilag International NV
  Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/06/380/001-005 | 17.3.2010 |
| 15.3.2010 | Rapamune | Wyeth Europa Limited
  Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/01/171/007-010 | 17.3.2010 |
| 15.3.2010 | Remicade | Centocor B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-005 | 17.3.2010 |
| 15.3.2010 | Removab | Fresenius Biotech GmbH
  Am Haag 6-7, D-82166 Graefelfing, Deutschland | EU/1/09/512/001-002 | 17.3.2010 |
| 15.3.2010 | Revlimid | Celgene Europe Limited
  Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom | EU/1/07/391/001-004 | 17.3.2010 |
| 15.3.2010 | Reyataz | Bristol-MyersSquibbPharma EEIG
  Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267/001-010 | 17.3.2010 |
| 15.3.2010 | Sebivo | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/388/001-003 | 17.3.2010 |
| 15.3.2010 | Sebivo | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/388/001-003 | 17.3.2010 |
| 15.3.2010 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/494/001-002 | 17.3.2010 |
| 15.3.2010 | Sutent | Pfizer Ltd
  Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/06/347/001-008 | 17.3.2010 |
| 15.3.2010 | Tamiflu | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222/001-004 | 17.3.2010 |
| 15.3.2010 | Thalidomide Celgene | Celgene Europe Limited
  Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | EU/1/08/443/001 | 17.3.2010 |
| 15.3.2010 | Twinrix Adult | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/96/020/001-009 | 17.3.2010 |
| 15.3.2010 | Valtropin | BioPartners GmbH
  Kaiserpassage 11 - D-72764 Reutlingen, Deutschland | EU/1/06/335/001 | 17.3.2010 |
| 15.3.2010 | Vaniqa | Laboratorios Almirall, S.A.
  Ronda General Mitre, 151, 08022 Barcelona, España | EU/1/01/173/001-003 | 17.3.2010 |
| 15.3.2010 | Vantavo (ex Alendronate sodium and colecalciferol, MSD) | Merck Sharp & Dohme Ltd.
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572/001-009 | 17.3.2010 |
| 15.3.2010 | Vectibix | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/07/423/001-003 | 17.3.2010 |
| 15.3.2010 | Viread | Gilead Sciences International Limited
  Cambridge CB21 6GT United Kingdom | EU/1/01/200/001-002 | 18.3.2010 |
| 15.3.2010 | Zomarist | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/483/001-018 | 17.3.2010 |
| 15.3.2010 | Zylagren | KRKA, d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/558/001-010 | 17.3.2010 |
| 19.3.2010 | Clopidogrel ratiopharm GmbH | Acino Pharma GmbH
  Am Windfeld 35, 83714 Miesbach, Deutschland | EU/1/09/541/001-008 | 23.3.2010 |
| 19.3.2010 | Copalia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/372/001-036 | 23.3.2010 |
| 19.3.2010 | Dafiro | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/371/001-036 | 23.3.2010 |
| 19.3.2010 | Evoltra | Genzyme Europe BV
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/06/334/001-005 | 23.3.2010 |
| 19.3.2010 | Kineret | BiovitrumAB (publ)
  SE-112 76, Stockholm, Sverige | EU/1/02/203/001-003 | 23.3.2010 |
| 19.3.2010 | Renvela | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/09/521/001-007 | 23.3.2010 |
| 19.3.2010 | Ventavis | Bayer Schering Pharma AG
  Müllerstrasse 170-178, D-13342 Berlin, Deutschland | EU/1/03/255/001-008 | 23.3.2010 |
| 22.3.2010 | Fuzeon | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/252/001-003 | 24.3.2010 |
| 23.3.2010 | Abilify | Otsuka Pharmaceutical Europe Ltd
  Hunton House, HighbridgeBusinessPark, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom | EU/1/04/276/001-020
  EU/1/04/276/024-036 | 25.3.2010 |
| 23.3.2010 | Aerius | Schering Plough Europe
  Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/00/160/001-069 | 25.3.2010 |
| 23.3.2010 | Aloxi | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Republic of Ireland | EU/1/04/306/001 | 25.3.2010 |
| 23.3.2010 | Aranesp | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/01/185/001-022
  EU/1/01/185/031-099 | 25.3.2010 |
| 23.3.2010 | Axura | Merz Pharmaceuticals GmbH
  Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland | EU/1/02/218/001-003
  EU/1/02/218/007-010
  EU/1/02/218/012-016
  EU/1/02/218/023 | 25.3.2010 |
| 23.3.2010 | Azomyr | Schering Plough Europe
  Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/00/157/001-067 | 23.3.2010 |
| 23.3.2010 | Cetrotide | SERONO EUROPE LIMITED
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/99/100/001-003 | 25.3.2010 |
| 23.3.2010 | Cholestagel | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/03/268/001-004 | 25.3.2010 |
| 23.3.2010 | Clopidogrel Krka | KRKA, d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/556/001-011 | 25.3.2010 |
| 23.3.2010 | Clopidogrel ratiopharm | Acino Pharma GmbH
  Am Windfeld 35, 83714 Miesbach, Deutschland | EU/1/09/554/001-008 | 25.3.2010 |
| 23.3.2010 | Clopidogrel Sandoz | Acino Pharma GmbH
  Am Windfeld 35, 83714 Miesbach, Deutschland | EU/1/09/547/001-007 | 25.3.2010 |
| 23.3.2010 | Clopidogrel TAD | TAD Pharma GmbH
  Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland | EU/1/09/555/001-009 | 25.3.2010 |
| 23.3.2010 | Clopidogrel Teva | Teva Pharma B.V.
  Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/540/001-016 | 25.3.2010 |
| 23.3.2010 | Copalia HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/575/001-060 | 25.3.2010 |
| 23.3.2010 | Dafiro HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/574/001-060 | 25.3.2010 |
| 23.3.2010 | Enviage | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/406/001-020 | 25.3.2010 |
| 23.3.2010 | Exelon | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/066/001-026 | 25.3.2010 |
| 23.3.2010 | Exforge | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/370/001-036 | 25.3.2010 |
| 23.3.2010 | Humira | Abbott Laboratories Limited
  Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/03/256/001-010 | 25.3.2010 |
| 23.3.2010 | IDflu | Sanofi Pasteur SA
  2, avenue Pont Pasteur, F-69007 Lyon, France | EU/1/08/507/001-006 | 25.3.2010 |
| 23.3.2010 | Imprida | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/373/001-036 | 25.3.2010 |
| 23.3.2010 | Ixiaro | Intercell AG
  Campus Vienna Biocenter 3 A-1030 Wien, Österreich | EU/1/08/501/001-002 | 25.3.2010 |
| 23.3.2010 | Mabthera | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/98/067/001-002 | 25.3.2010 |
| 23.3.2010 | Mycophenolate mofetil Teva | Teva Pharma B.V.
  Computerweg 10, DR Utrecht 3542, Nederland | EU/1/07/439/001-004 | 25.3.2010 |
| 23.3.2010 | Myfenax | Teva Pharma B.V.
  Computerweg 10, DR Utrecht 3542, Nederland | EU/1/07/438/001-004 | 23.3.2010 |
| 23.3.2010 | Neoclarityn | Schering Plough Europe
  Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/00/161/001-067 | 23.3.2010 |
| 23.3.2010 | Norvir | Abbott Laboratories Ltd
  Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | EU/1/96/016/001
  EU/1/96/016/003-006 | 25.3.2010 |
| 23.3.2010 | Oslif Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | EU/1/09/586/001-010 | 25.3.2010 |
| 23.3.2010 | Prometax | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/092/001-026 | 25.3.2010 |
| 23.3.2010 | Revlimid | Celgene Europe Limited
  Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom | EU/1/07/391/001-004 | 25.3.2010 |
| 23.3.2010 | Riprazo | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/409/001-020 | 25.3.2010 |
| 23.3.2010 | Simponi | Centocor B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546/001-004 | 25.3.2010 |
| 23.3.2010 | Sprimeo | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/407/001-020 | 25.3.2010 |
| 23.3.2010 | Stalevo | Orion Corporation
  Orionintie 1, FIN-02200 Espoo, Suomi | EU/1/03/260/001-033 | 25.3.2010 |
| 23.3.2010 | Sutent | Pfizer Ltd
  Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/06/347/001-008 | 25.3.2010 |
| 23.3.2010 | Synagis | Abbott Laboratories Ltd
  Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | EU/1/99/117/001-002 | 23.3.2010 |
| 23.3.2010 | Tandemact | Takeda Global Research and Development Centre (Europe) Ltd.
  61 Aldwich, London WC2B 4AE, United Kingdom | EU/1/06/366/005-022 | 25.3.2010 |
| 23.3.2010 | Tasigna | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/422/001-004 | 25.3.2010 |
| 23.3.2010 | Thalidomide Celgene | Celgene Europe Limited
  Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | EU/1/08/443/001 | 25.3.2010 |
| 23.3.2010 | Visudyne | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/00/140/001 | 25.3.2010 |
| 23.3.2010 | Volibris | Glaxo Group Ltd
  Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/08/451/001-004 | 25.3.2010 |
| 23.3.2010 | Xeloda | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/163/001-002 | 25.3.2010 |
| 26.3.2010 | Adcirca | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA, Houten, Nederland | EU/1/08/476/005-006 | 30.3.2010 |
| 26.3.2010 | Avandamet | SmithKline Beecham Ltd.
  980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/03/258/001-022 | 30.3.2010 |
| 26.3.2010 | Avandia | SmithKline Beecham Ltd.
  980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/137/002-018 | 30.3.2010 |
| 26.3.2010 | Celsentri | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/418/001-010 | 29.3.2010 |
| 26.3.2010 | Celsentri | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/418/001-010 | 29.3.2010 |
| 26.3.2010 | Clopidogrel Qualimed | Qualimed
  117, Allée des Parcs, 69800 Saint Priest, France | EU/1/09/557/001-010 | 30.3.2010 |
| 26.3.2010 | Competact | Takeda Global Research and Development Centre (Europe) Ltd
  61 Aldwych, London WC2B 4AE, United Kingdom | EU/1/06/354/001-009 | 30.3.2010 |
| 26.3.2010 | Cubicin | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/328/001-002 | 30.3.2010 |
| 26.3.2010 | Ebixa | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/02/219/001-003
  EU/1/02/219/007-012
  EU/1/02/219/014-022
  EU/1/02/219/036 | 30.3.2010 |
| 26.3.2010 | Exforge HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/569/001-060 | 30.3.2010 |
| 26.3.2010 | Galvus | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/414/001-010
  EU/1/07/414/018 | 30.3.2010 |
| 26.3.2010 | Glivec | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/198/001-013 | 29.3.2010 |
| 26.3.2010 | Glivec | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/198/001-013 | 29.3.2010 |
| 26.3.2010 | Helixate NexGen | Bayer Schering Pharma AG
  13342 Berlin, Deutschland | EU/1/00/144/001-004 | 30.3.2010 |
| 26.3.2010 | Hirobriz Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | EU/1/09/594/001-010 | 30.3.2010 |
| 26.3.2010 | Ilaris | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/564/001-002 | 30.3.2010 |
| 26.3.2010 | Imprida HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/570/001-060 | 30.3.2010 |
| 26.3.2010 | InductOs | Wyeth Europa Ltd.
  Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/02/226/001 | 30.3.2010 |
| 26.3.2010 | Intanza | Sanofi Pasteur MSD SNC
  8, rue Jonas Salk, Lyon69007, France | EU/1/08/505/001-006 | 30.3.2010 |
| 26.3.2010 | IntronA | Schering Plough Europe
  Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/99/127/011-039
  EU/1/99/127/041-044 | 30.3.2010 |
| 26.3.2010 | Invega | Janssen-Cilag International NV
  Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/07/395/001-095 | 29.3.2010 |
| 26.3.2010 | Invirase | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026/001-002 | 30.3.2010 |
| 26.3.2010 | Isentress | Merck Sharp & Dohme Limited
  Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436/001-002 | 30.3.2010 |
| 26.3.2010 | Ivemend | Merck Sharp & Dohme Limited
  Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437/001 | 30.3.2010 |
| 26.3.2010 | Jalra | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/485/001-011 | 30.3.2010 |
| 26.3.2010 | Kogenate Bayer | Bayer Schering Pharma AG
  13342 Berlin, Deutschland | EU/1/00/143/001-011 | 30.3.2010 |
| 26.3.2010 | Onbrez Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/593/001-010 | 30.3.2010 |
| 26.3.2010 | Panretin | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | EU/1/00/149/001 | 30.3.2010 |
| 26.3.2010 | Rasilez HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/491/001-080 | 30.3.2010 |
| 26.3.2010 | Remicade | Centocor B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-005 | 30.3.2010 |
| 26.3.2010 | Sustiva | Bristol-MyersSquibbPharma EEIG
  Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110/001-005
  EU/1/99/110/008-010 | 30.3.2010 |
| 26.3.2010 | Temomedac | ALFRED E. TIEFENBACHER, (GmbH & Co. KG)
  Van-der-Smissen-Straße 1, Hamburg 22767, Deutschland | EU/1/09/605/001-012 | 30.3.2010 |
| 26.3.2010 | Tygacil | Wyeth Europa Ltd.
  Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/06/336/001 | 29.3.2010 |
| 26.3.2010 | Vistide | Gilead Sciences International Limited
  Cambridge, CB21 6GT, United Kingdom | EU/1/97/037/001 | 30.3.2010 |
| 26.3.2010 | Xagrid | ShirePharmaceuticalContracts Ltd
  Hampshire InternationalBusinessPark, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295/001 | 29.3.2010 |
| 26.3.2010 | Xiliarx | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/486/001-011 | 30.3.2010 |
| 30.3.2010 | Aclasta | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/308/001-002 | 1.4.2010 |
| 30.3.2010 | Actos | Takeda Global Research and Development Centre (Europe) Ltd
  61 Aldwych, London WC2B 4AE, United Kingdom | EU/1/00/150/001-024 | 1.4.2010 |
| 30.3.2010 | Afinitor | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/538/001-008 | 1.4.2010 |
| 30.3.2010 | Celvapan | Baxter AG
  Industriestraße 67, A-1221 Wien, Österreich | EU/1/08/506/001 | 1.4.2010 |
| 30.3.2010 | Clopidogrel Mylan | Mylan S.A.S
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/09/559/001-016 | 1.4.2010 |
| 30.3.2010 | Evicel | OMRIX biopharmaceuticals S.A. / N.V.
  200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België | EU/1/08/473/001-003 | 1.4.2010 |
| 30.3.2010 | Extavia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/454/001-002
  EU/1/08/454/005-007 | 1.4.2010 |
| 30.3.2010 | Glubrava | Takeda Global Research and Development Centre (Europe) Ltd
  61 Aldwych, London WC2B 4AE, United Kingdom | EU/1/07/421/001-009 | 1.4.2010 |
| 30.3.2010 | Glustin | Takeda Global Research and Development Centre (Europe) Ltd
  61 Aldwych, London WC2B 4AE, United Kingdom | EU/1/00/151/001-024 | 1.4.2010 |
| 30.3.2010 | INCRELEX | Ipsen Pharma
  65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/07/402/001 | 1.4.2010 |
| 30.3.2010 | Intelence | Janssen-Cilag International NV
  Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/468/001 | 1.4.2010 |
| 30.3.2010 | Kaletra | Abbott Laboratories Limited
  Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/01/172/004-007 | 31.3.2010 |
| 30.3.2010 | Levemir | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278/010-011 | 6.4.2010 |
| 30.3.2010 | Lucentis | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/374/001 | 1.4.2010 |
| 30.3.2010 | Rasilez | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/405/001-040 | 31.3.2010 |
| 30.3.2010 | RoActemra | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492/001-006 | 1.4.2010 |
| 30.3.2010 | Rotarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/05/330/001-011 | 1.4.2010 |
| 30.3.2010 | RotaTeq | Sanofi Pasteur MSD, SNC
  8, rue Jonas Salk, Lyon 69007, France | EU/1/06/348/001-002 | 1.4.2010 |
| 30.3.2010 | Xolair | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/319/001-010 | 31.3.2010 |
| 6.4.2010 | Retacrit | HOSPIRA Enterprises B.V.
  Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland | EU/1/07/431/001-025 | 14.4.2010 |
| 6.4.2010 | Silapo | STADA Arzneimittel AG
  Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland | EU/1/07/432/001-022 | 9.4.2010 |
| 9.4.2010 | Avaglim | SmithKline Beecham Ltd.
  980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/06/349/001-010 | 13.4.2010 |
| 9.4.2010 | Ketek | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92160 Antony, France | EU/1/01/191/001-005 | 13.4.2010 |
| 9.4.2010 | Viread | Gilead Sciences International Limited
  Cambridge CB21 6GT United Kingdom | EU/1/01/200/001-002 | 13.4.2010 |
| 15.4.2010 | Firdapse | EUSA Pharma SAS
  3 Allée des Séquoias, Limonest 69760, FRANCE | EU/1/09/601/001 | 20.4.2010 |
| 19.4.2010 | Ifirmasta | KRKA, d.d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/480/001-018 | 23.4.2010 |
| 22.4.2010 | Sildenafil Teva | Teva Pharma B.V.
  Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/584/001-018 | 26.4.2010 |
| 22.4.2010 | Tracleer | ActelionRegistration Ltd
  BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220/001-006 | 26.4.2010 |
| 27.4.2010 | Afinitor | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/538/001-008 | 29.4.2010 |
| 27.4.2010 | Aldara | Meda AB
  Pipers väg 2A, Solna 170 73, Svërige | EU/1/98/080/001-002 | 29.4.2010 |
| 27.4.2010 | Aldurazyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/03/253/001-003 | 29.4.2010 |
| 27.4.2010 | Altargo | Glaxo Group Limited
  Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/390/001-004 | 29.4.2010 |
| 27.4.2010 | Bridion | N.V. Organon
  Kloosterstraat 6, 5349 AB Oss, Nederland | EU/1/08/466/001-002 | 29.4.2010 |
| 27.4.2010 | Doribax | Janssen-Cilag International NV
  Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/467/001-002 | 29.4.2010 |
| 27.4.2010 | Exelon | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/066/001-026 | 29.4.2010 |
| 27.4.2010 | Focetria | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1 - Siena, Italia | EU/1/07/385/001-002
  EU/1/07/385/004 | 29.4.2010 |
| 27.4.2010 | Fuzeon | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/252/001-003 | 29.4.2010 |
| 27.4.2010 | Kinzalkomb | Bayer Schering Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/214/001-015 | 29.4.2010 |
| 27.4.2010 | MicardisPlus | Boehringer Ingelheim International GmbH
  Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland | EU/1/02/213/001-023 | 3.5.2010 |
| 27.4.2010 | Remicade | Centocor B.V.
  Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-005 | 29.4.2010 |
| 27.4.2010 | RoActemra | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492/001-006 | 29.4.2010 |
| 27.4.2010 | Tamiflu | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222/001-004 | 29.4.2010 |
| 27.4.2010 | Tarceva | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311/001-003 | 29.4.2010 |
| 27.4.2010 | Taxotere | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony Cedex, France | EU/1/95/002/001-005 | 29.4.2010 |
| 27.4.2010 | Tyverb | Glaxo Group Limited
  Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/440/001-002 | 29.4.2010 |
| 27.4.2010 | Velcade | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274/001-002 | 29.4.2010 |
| 27.4.2010 | Vimpat | UCB Pharma SA.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | EU/1/08/470/014-015 | 29.4.2010 |
| 29.4.2010 | Aclasta | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/308/001-002 | 3.5.2010 |
| 29.4.2010 | Arava | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/99/118/001-010 | 3.5.2010 |
| 29.4.2010 | Ceplene | EpiCept GmbH
  Goethestrasse 4, D-80336 München, Deutschland | EU/1/08/477/001 | 3.5.2010 |
| 29.4.2010 | Clopidogrel Winthrop | Sanofi-Aventis
  174, avenue de France, F-75013 Paris, France | EU/1/08/465/001-020 | 3.5.2010 |
| 29.4.2010 | Epivir | Glaxo Group Ltd.
  Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/96/015/001-005 | 4.5.2010 |
| 29.4.2010 | Focetria | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1 - Siena, Italia | EU/1/07/385/001-002
  EU/1/07/385/004 | 3.5.2010 |
| 29.4.2010 | Humira | Abbott Laboratories Limited
  Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/03/256/001-010 | 4.5.2010 |
| 29.4.2010 | Insulatard | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/233/001-017 | 3.5.2010 |
| 29.4.2010 | Intelence | Janssen-Cilag International NV
  Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/468/001 | 3.5.2010 |
| 29.4.2010 | Iscover | Bristol-MyersSquibbPharma EEIG
  Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/98/070/001a-001b
  EU/1/98/070/002a-002b
  EU/1/98/070/003a-003b
  EU/1/98/070/004a-004b
  EU/1/98/070/005a-005b
  EU/1/98/070/006a-006b
  EU/1/98/070/007a-007b
  EU/1/98/070/008-010
  EU/1/98/070/011a-011b
  EU/1/98/070/012 | 4.5.2010 |
| 29.4.2010 | Kepivance | BiovitrumAB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/05/314/001 | 3.5.2010 |
| 29.4.2010 | Lyrica | Pfizer Ltd
  Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/04/279/001-043 | 4.5.2010 |
| 29.4.2010 | Mircera | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/07/400/001-024 | 4.5.2010 |
| 29.4.2010 | NeoRecormon | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/97/031/019-046 | 4.5.2010 |
| 29.4.2010 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC
  174 avenue de France - 75013 Paris, France | EU/1/98/069/001a-001b
  EU/1/98/069/002a-002b
  EU/1/98/069/003a-003b
  EU/1/98/069/004a-004b
  EU/1/98/069/005a-005b
  EU/1/98/069/006a-006b
  EU/1/98/069/007a-007b
  EU/1/98/069/008-010
  EU/1/98/069/011a-011b
  EU/1/98/069/012 | 3.5.2010 |
| 29.4.2010 | PritorPlus | Bayer Schering Pharma AG
  13342 Berlin, Deutschland | EU/1/02/215/001-021 | 3.5.2010 |
| 29.4.2010 | Prometax | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/092/001-026 | 4.5.2010 |
| 29.4.2010 | Protaphane | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/234/001-017 | 3.5.2010 |
| 29.4.2010 | Tygacil | Wyeth Europa Ltd.
  Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/06/336/001 | 3.5.2010 |
| 29.4.2010 | Tyverb | Glaxo Group Limited
  Berkeley Avenue, Greenford, MiddlesexUB6 0NN, United Kingdom | EU/1/07/440/001-002 | 3.5.2010 |
| 29.4.2010 | Vectibix | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/07/423/001-003 | 3.5.2010 |
| 5.5.2010 | Aloxi | Helsinn Birex Pharmaceuticals Ltd
  Damastown, Mulhuddart, Dublin 15, Republic of Ireland | EU/1/04/306/001-003 | 7.5.2010 |
| 5.5.2010 | BeneFIX | Wyeth Europa Ltd.
  Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-007 | 7.5.2010 |
| 5.5.2010 | Bondenza | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/266/003-006 | 7.5.2010 |
| 5.5.2010 | Bonviva | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/265/003-006 | 7.5.2010 |
| 5.5.2010 | Celsentri | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/418/001-010 | 7.5.2010 |
| 5.5.2010 | Docetaxel Winthrop | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony Cedex, France | EU/1/07/384/001-005 | 7.5.2010 |
| 5.5.2010 | Enbrel | Wyeth Europa Limited
  Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-021 | 7.5.2010 |
| 5.5.2010 | Kiovig | Baxter AG
  Industriestraße 67, A - 1221 Wien, Österreich | EU/1/05/329/001-006 | 7.5.2010 |
| 5.5.2010 | Lantus | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/134/001-037 | 7.5.2010 |
| 5.5.2010 | Optisulin | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/133/001-032 | 7.5.2010 |
| 5.5.2010 | PegIntron | Schering Plough Europe
  Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/00/131/001-050 | 7.5.2010 |
| 5.5.2010 | Silgard | Merck Sharp & Dohme Ltd
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358/001-021 | 7.5.2010 |
| 5.5.2010 | Sprycel | Bristol-MyersSquibbPharma EEIG
  Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363/001-011 | 7.5.2010 |
| 5.5.2010 | Tyverb | Glaxo Group Limited
  Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/440/001-003 | 7.5.2010 |
| 5.5.2010 | ViraferonPeg | Schering Plough Europe
  Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/00/132/001-050 | 7.5.2010 |
| 5.5.2010 | Visudyne | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/00/140/001 | 7.5.2010 |
| 10.5.2010 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430/001-002 | 12.5.2010 |
| 10.5.2010 | Combivir | Glaxo Group Ltd.
  Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/98/058/001-002 | 12.5.2010 |
| 10.5.2010 | Infanrix hexa | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/00/152/001-020 | 12.5.2010 |
| 10.5.2010 | Optimark | Covidien Deutschland GmbH
  Gewerbepark 1, Neustadt/Donau 93333, Deutschland | EU/1/07/398/001-014 | 12.5.2010 |
| 10.5.2010 | Orgalutran | N.V. Organon
  P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland | EU/1/00/130/001-002 | 12.5.2010 |
| 10.5.2010 | Ranexa | Menarini International Operations Luxembourg S.A.
  1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | EU/1/08/462/001-012 | 12.5.2010 |
| 10.5.2010 | Tysabri | Elan Pharma International Ltd.
  Monksland, Athlone, County Westmeath, Ireland | EU/1/06/346/001 | 12.5.2010 |
| 10.5.2010 | Xeristar | Boehringer Ingelheim International GmbH
  Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland | EU/1/04/297/001-008 | 12.5.2010 |
| 10.5.2010 | Ziagen | Glaxo Group Ltd.
  Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom | EU/1/99/112/001-002 | 12.5.2010 |
| 12.5.2010 | Aclasta | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/308/001-002 | 18.5.2010 |
| 12.5.2010 | Gardasil | Sanofi Pasteur MSD, SNC
  8, rue Jonas Salk, 69007 Lyon, France | EU/1/06/357/001-021 | 18.5.2010 |
| 12.5.2010 | Kuvan | Merck KGaA
  Frankfurter Straße 250, 64293 Darmstadt, Deutschland | EU/1/08/481/001-003 | 18.5.2010 |
| 12.5.2010 | Olazax | GlenmarkPharmaceuticals s.r.o.
  City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | EU/1/09/597/001-005 | 18.5.2010 |
| 26.5.2010 | Avandia | SmithKline Beecham Ltd.
  980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/137/002-018 | 28.5.2010 |
| 26.5.2010 | Cyanokit | Merck Santé s.a.s.
  37, rue Saint-Romain, 69379 Lyon Cedex 08, France | EU/1/07/420/001 | 28.5.2010 |
| 26.5.2010 | Kivexa | Glaxo Group Ltd
  Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/04/298/001-003 | 28.5.2010 |
| 26.5.2010 | Myocet | Cephalon Europe
  5 Rue Charles Martigny, Maisons Alfort 94700, France | EU/1/00/141/001 | 28.5.2010 |
| 26.5.2010 | Olanzapine Glenmark | Glenmark Generics (Europe) Limited
  Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | EU/1/09/587/001-017 | 1.6.2010 |
| 26.5.2010 | Olanzapine Glenmark Europe | Glenmark Generics (Europe) Limited
  Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | EU/1/09/588/001-012 | 1.6.2010 |
| 26.5.2010 | Olazax Disperzi | GlenmarkPharmaceuticals s.r.o.
  City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | EU/1/09/592/001-005 | 28.5.2010 |
| 26.5.2010 | Prevenar | Wyeth-Lederle Vaccines S.A.
  Rue du Bosquet, 15 - 1348 Louvain-La-Neuve, Belgique | EU/1/00/167/001-008 | 28.5.2010 |
| 26.5.2010 | Telzir | Glaxo Group Ltd.
  Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom | EU/1/04/282/001-002 | 28.5.2010 |
| 26.5.2010 | Trizivir | Glaxo Group Ltd.
  Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/00/156/002-004 | 28.5.2010 |
| 26.5.2010 | Xagrid | ShirePharmaceuticalContracts Ltd
  Hampshire InternationalBusinessPark, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295/001 | 28.5.2010 |
| 2.6.2010 | Abraxane | Abraxis BioScience Limited
  Rosanne House, Parkway, WelwynGarden City, Herts, AL8 6HG, United Kingdom | EU/1/07/428/001 | 4.6.2010 |
| 2.6.2010 | Avastin | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300/001-002 | 7.6.2010 |
| 2.6.2010 | Bridion | N.V. Organon
  Kloosterstraat 6, 5349 AB Oss, Nederland | EU/1/08/466/001-002 | 4.6.2010 |
| 2.6.2010 | Celsentri | Pfizer Limited
  Ramsgate Road, Sandwich, KentCT13 9NJ, United Kingdom | EU/1/07/418/001-010 | 4.6.2010 |
| 2.6.2010 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/07/419/001-012 | 4.6.2010 |
| 2.6.2010 | Circadin | RAD Neurim Pharmaceuticals EEC Limited
  One Forbury Square, The Forbury, Reading, BerkshireRG1 3EB, United Kingdom | EU/1/07/392/001-002 | 7.6.2010 |
| 2.6.2010 | Erbitux | Merck KGaA
  Frankfurter Straße 250, 64271 Darmstadt, Deutschland | EU/1/04/281/001-005 | 7.6.2010 |
| 2.6.2010 | Fertavid | SP Europe
  Rue de Stalle, 73 B-1180 Bruxelles, Belgique | EU/1/09/510/001-019 | 4.6.2010 |
| 2.6.2010 | Humira | Abbott Laboratories Limited
  Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/03/256/001-010 | 7.6.2010 |
| 2.6.2010 | Intrinsa | Warner Chilcott Pharmaceuticals UK Ltd
  Whitehall Lane, Egham, SurreyTW20 9NW, United Kingdom | EU/1/06/352/001-003 | 4.6.2010 |
| 2.6.2010 | Prezista | Janssen-Cilag International NV
  Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/06/380/001-005 | 4.6.2010 |
| 2.6.2010 | Rasilez | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/405/001-040 | 4.6.2010 |
| 2.6.2010 | Rebif | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063/001-017 | 4.6.2010 |
| 2.6.2010 | Renagel | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/99/123/005-013 | 7.6.2010 |
| 2.6.2010 | Stalevo | Orion Corporation
  Orionintie 1, FIN-02200 Espoo, Suomi | EU/1/03/260/001-033 | 4.6.2010 |
| 2.6.2010 | Velcade | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274/001-002 | 4.6.2010 |
| 2.6.2010 | Vimpat | UCB Pharma SA.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | EU/1/08/470/001-017 | 7.6.2010 |
| 2.6.2010 | Zavesca | ActelionRegistration Ltd
  BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/238/001 | 4.6.2010 |
| 4.6.2010 | DepoCyte | Pacira Limited
  West Forest Gate, Wellington Road, Wokingham, Berkshire, RG40 2AQ, United Kingdom | EU/1/01/187/001 | 8.6.2010 |
| 4.6.2010 | Metalyse | Boehringer Ingelheim International GmbH
  Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland | EU/1/00/169/004-006 | 8.6.2010 |
| 4.6.2010 | Mircera | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/07/400/001-024 | 8.6.2010 |
| 4.6.2010 | Nymusa | CHIESI FARMACEUTICI SpA
  Via Palermo 26/A, I-43100 Parma, ITALIA | EU/1/09/528/001-002 | 8.6.2010 |
| 4.6.2010 | Rasilez HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/491/001-080 | 8.6.2010 |
| 4.6.2010 | RoActemra | Roche Registration Limited
  6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492/001-006 | 8.6.2010 |
| 4.6.2010 | Toviaz | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/07/386/001-018 | 8.6.2010 |
| 4.6.2010 | Zerit | Bristol-MyersSquibbPharma EEIG
  Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/96/009/001-009 | 8.6.2010 |
| 8.6.2010 | Lyrica | Pfizer Ltd
  Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/04/279/001-044 | 10.6.2010 |
| 10.6.2010 | Comtan | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/081/001-004 | 14.6.2010 |
| 10.6.2010 | Comtess | Orion Corporation
  Orionintie 1, FIN-02200 Espoo, Suomi | EU/1/98/082/001-003
  EU/1/98/082/005 | 14.6.2010 |
| 10.6.2010 | ellaOne | Laboratoire HRA Pharma
  15, rue Béranger, 75003 Paris, France | EU/1/09/522/001 | 14.6.2010 |
| 10.6.2010 | Mirapexin | Boehringer Ingelheim International GmbH
  Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/051/001-006
  EU/1/97/051/009-033 | 15.6.2010 |
| 10.6.2010 | Opgenra | Howmedica International S. de R. L.
  Raheen Business Park, Limerick, Ireland | EU/1/08/489/001-002 | 15.6.2010 |
| 10.6.2010 | Pergoveris | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/07/396/001-003 | 14.6.2010 |
| 10.6.2010 | Vasovist | TMC Pharma Services Ltd
  Eversley, Hampshire, RG27 0NT, United Kingdom | EU/1/05/313/001-009 | 14.6.2010 |
| 14.6.2010 | Lyrica | Pfizer Ltd
  Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/04/279/001-044 | 16.6.2010 |
| 14.6.2010 | Sifrol | Boehringer Ingelheim International GmbH
  Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050/001-006
  EU/1/97/050/009-033 | 17.6.2010 |
| 17.6.2010 | ATryn | GTC Biotherapeutics UK Limited
  10 Norwich Street, London EC4A 1BD, United Kingdom | EU/1/06/355/001-003 | 21.6.2010 |
| 17.6.2010 | Luveris | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/155/001-007 | 21.6.2010 |
| 17.6.2010 | Mirapexin | Boehringer Ingelheim International GmbH
  Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/051/001-006
  EU/1/97/051/009-033 | 21.6.2010 |
| 17.6.2010 | Onsenal | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/03/259/001-006 | 21.6.2010 |
| 17.6.2010 | Tyverb | Glaxo Group Limited
  Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/440/001-003 | 21.6.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

11.3.2010

Cancidas

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/01/196/001

EU/1/01/196/003

15.3.2010

11.3.2010

Dafiro

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/371/001-036

15.3.2010

11.3.2010

Diacomit

Biocodex

7 avenue Gallieni, 94250 Gentilly, France

EU/1/06/367/001-012

15.3.2010

11.3.2010

Eporatio

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/573/001-028

15.3.2010

11.3.2010

Inovelon

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom

EU/1/06/378/001-016

15.3.2010

11.3.2010

Stelara

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/494/003-004

15.3.2010

11.3.2010

Zopya

Norpharm Regulatory Services Ltd

26 Laurence Street, Drogheda, Co. Louth, Ireland

EU/1/09/562/001-009

15.3.2010

15.3.2010

Abraxane

Abraxis BioScience Limited

Rosanne House, Parkway, WelwynGarden City, Herts, AL8 6HG, United Kingdom

EU/1/07/428/001

17.3.2010

15.3.2010

Aerinaze

SP Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/07/399/001-006

17.3.2010

15.3.2010

Afinitor

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/538/001-008

17.3.2010

15.3.2010

Aldara

Meda AB

Pipers väg 2A, Solna 170 73, Svërige

EU/1/98/080/002

17.3.2010

15.3.2010

Altargo

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/390/001-004

17.3.2010

15.3.2010

Arcalyst

Regeneron UK Limited

40 Bank Street, E14 5DS London, United Kingdom

EU/1/09/582/001

17.3.2010

15.3.2010

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430/001-002

19.3.2010

15.3.2010

Avonex

Biogen Idec Ltd

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/97/033/002-004

17.3.2010

15.3.2010

BeneFIX

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-007

17.3.2010

15.3.2010

Biopoin

CT Arzneimittel GmbH

Lengeder Straße 42a, D-13407 Berlin, Deutschland

EU/1/09/565/001-028

17.3.2010

15.3.2010

Byetta

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/06/362/001-004

17.3.2010

15.3.2010

Carbaglu

Orphan Europe

Immeuble Le Wilson, 70 Avenue du General de Gaulle, 92800 Puteaux, France

EU/1/02/246/001-003

17.3.2010

15.3.2010

Cayston

GileadSciencesInternational Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543/001

17.3.2010

15.3.2010

Clopidogrel DURA

Mylan dura GmbH

Wittichstraße 6, D-64295 Darmstadt, Deutschland

EU/1/09/560/001-009

17.3.2010

15.3.2010

Clopidogrel Hexal

Acino Pharma GmbH

Am Windfeld 35, Miesbach 83714, Deutschland

EU/1/09/534/001-007

17.3.2010

15.3.2010

Clopidogrel Teva Pharma

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/561/001-010

17.3.2010

15.3.2010

Copalia

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/372/001-036

17.3.2010

15.3.2010

Cubicin

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/328/001-002

17.3.2010

15.3.2010

Doribax

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/467/001-002

17.3.2010

15.3.2010

Duloxetine Boehringer Ingelheim

Boehringer Ingelheim International GmbH

Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland

EU/1/08/471/001-012

17.3.2010

15.3.2010

Dynastat

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/02/209/001-008

17.3.2010

15.3.2010

Effentora

Cephalon Europe

5 Rue Charles Martigny, Maisons-Alfort 94700, France

EU/1/08/441/001-010

22.3.2010

15.3.2010

Elaprase

Shire Human Genetic Therapies AB

Svärdvägen 11D, 182 33 Danderyd, Sverige

EU/1/06/365/001-003

17.3.2010

15.3.2010

Eucreas

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/425/001-018

17.3.2010

15.3.2010

Evoltra

Genzyme Europe BV

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/06/334/001-005

17.3.2010

15.3.2010

Exjade

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/356/001-009

17.3.2010

15.3.2010

Faslodex

AstraZenecaUK Limited

Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom

EU/1/03/269/001

17.3.2010

15.3.2010

Firazyr

Jerini AG

Invalidenstr. 130, D-10115 Berlin, Deutschland

EU/1/08/461/001

17.3.2010

15.3.2010

GONAL-f

Merck Serono Europe Ltd.

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/95/001/001

EU/1/95/001/003-005

EU/1/95/001/009

EU/1/95/001/012

EU/1/95/001/021-022

EU/1/95/001/025-028

EU/1/95/001/031-035

17.3.2010

15.3.2010

Humira

Abbott Laboratories Limited

Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-010

17.3.2010

15.3.2010

Icandra

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/484/001-018

23.3.2010

15.3.2010

IntronA

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/99/127/011-044

17.3.2010

15.3.2010

Invirase

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/026/001-002

17.3.2010

15.3.2010

Iscover

Bristol-MyersSquibbPharma EEIG

Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/070/012

17.3.2010

15.3.2010

Kepivance

BiovitrumAB (publ)

SE-112 76 Stockholm, Sverige

EU/1/05/314/001

17.3.2010

15.3.2010

Luveris

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/155/001-007

17.3.2010

15.3.2010

Mircera

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/07/400/001-024

17.3.2010

15.3.2010

M-M-RVAXPRO

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/337/001-013

17.3.2010

15.3.2010

Mozobil

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/537/001

19.3.2010

15.3.2010

Neupro

Schwarz Pharma Ltd

Shannon, Industrial Estate, Co. Clare, Ireland

EU/1/05/331/001-055

18.3.2010

15.3.2010

Nimvastid

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/525/047-050

17.3.2010

15.3.2010

Norvir

Abbott Laboratories Ltd

Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

17.3.2010

15.3.2010

Ovitrelle

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/165/001-007

17.3.2010

15.3.2010

Pergoveris

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/07/396/001-003

17.3.2010

15.3.2010

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/98/069/012

17.3.2010

15.3.2010

Prezista

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/06/380/001-005

17.3.2010

15.3.2010

Rapamune

Wyeth Europa Limited

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/01/171/007-010

17.3.2010

15.3.2010

Remicade

Centocor B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

17.3.2010

15.3.2010

Removab

Fresenius Biotech GmbH

Am Haag 6-7, D-82166 Graefelfing, Deutschland

EU/1/09/512/001-002

17.3.2010

15.3.2010

Revlimid

Celgene Europe Limited

Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom

EU/1/07/391/001-004

17.3.2010

15.3.2010

Reyataz

Bristol-MyersSquibbPharma EEIG

Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267/001-010

17.3.2010

15.3.2010

Sebivo

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/388/001-003

17.3.2010

15.3.2010

Sebivo

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/388/001-003

17.3.2010

15.3.2010

Stelara

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/494/001-002

17.3.2010

15.3.2010

Sutent

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/06/347/001-008

17.3.2010

15.3.2010

Tamiflu

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/222/001-004

17.3.2010

15.3.2010

Thalidomide Celgene

Celgene Europe Limited

Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom

EU/1/08/443/001

17.3.2010

15.3.2010

Twinrix Adult

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/96/020/001-009

17.3.2010

15.3.2010

Valtropin

BioPartners GmbH

Kaiserpassage 11 - D-72764 Reutlingen, Deutschland

EU/1/06/335/001

17.3.2010

15.3.2010

Vaniqa

Laboratorios Almirall, S.A.

Ronda General Mitre, 151, 08022 Barcelona, España

EU/1/01/173/001-003

17.3.2010

15.3.2010

Vantavo (ex Alendronate sodium and colecalciferol, MSD)

Merck Sharp & Dohme Ltd.

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/09/572/001-009

17.3.2010

15.3.2010

Vectibix

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423/001-003

17.3.2010

15.3.2010

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-002

18.3.2010

15.3.2010

Zomarist

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/483/001-018

17.3.2010

15.3.2010

Zylagren

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/558/001-010

17.3.2010

19.3.2010

Clopidogrel ratiopharm GmbH

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/541/001-008

23.3.2010

19.3.2010

Copalia

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/372/001-036

23.3.2010

19.3.2010

Dafiro

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/371/001-036

23.3.2010

19.3.2010

Evoltra

Genzyme Europe BV

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/06/334/001-005

23.3.2010

19.3.2010

Kineret

BiovitrumAB (publ)

SE-112 76, Stockholm, Sverige

EU/1/02/203/001-003

23.3.2010

19.3.2010

Renvela

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/09/521/001-007

23.3.2010

19.3.2010

Ventavis

Bayer Schering Pharma AG

Müllerstrasse 170-178, D-13342 Berlin, Deutschland

EU/1/03/255/001-008

23.3.2010

22.3.2010

Fuzeon

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/03/252/001-003

24.3.2010

23.3.2010

Abilify

Otsuka Pharmaceutical Europe Ltd

Hunton House, HighbridgeBusinessPark, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

25.3.2010

23.3.2010

Aerius

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/160/001-069

25.3.2010

23.3.2010

Aloxi

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Republic of Ireland

EU/1/04/306/001

25.3.2010

23.3.2010

Aranesp

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185/001-022

EU/1/01/185/031-099

25.3.2010

23.3.2010

Axura

Merz Pharmaceuticals GmbH

Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland

EU/1/02/218/001-003

EU/1/02/218/007-010

EU/1/02/218/012-016

EU/1/02/218/023

25.3.2010

23.3.2010

Azomyr

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/157/001-067

23.3.2010

23.3.2010

Cetrotide

SERONO EUROPE LIMITED

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/99/100/001-003

25.3.2010

23.3.2010

Cholestagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/03/268/001-004

25.3.2010

23.3.2010

Clopidogrel Krka

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556/001-011

25.3.2010

23.3.2010

Clopidogrel ratiopharm

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/554/001-008

25.3.2010

23.3.2010

Clopidogrel Sandoz

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/547/001-007

25.3.2010

23.3.2010

Clopidogrel TAD

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland

EU/1/09/555/001-009

25.3.2010

23.3.2010

Clopidogrel Teva

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/540/001-016

25.3.2010

23.3.2010

Copalia HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/575/001-060

25.3.2010

23.3.2010

Dafiro HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/574/001-060

25.3.2010

23.3.2010

Enviage

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/406/001-020

25.3.2010

23.3.2010

Exelon

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/066/001-026

25.3.2010

23.3.2010

Exforge

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/370/001-036

25.3.2010

23.3.2010

Humira

Abbott Laboratories Limited

Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-010

25.3.2010

23.3.2010

IDflu

Sanofi Pasteur SA

2, avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507/001-006

25.3.2010

23.3.2010

Imprida

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/373/001-036

25.3.2010

23.3.2010

Ixiaro

Intercell AG

Campus Vienna Biocenter 3 A-1030 Wien, Österreich

EU/1/08/501/001-002

25.3.2010

23.3.2010

Mabthera

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/98/067/001-002

25.3.2010

23.3.2010

Mycophenolate mofetil Teva

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/439/001-004

25.3.2010

23.3.2010

Myfenax

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/07/438/001-004

23.3.2010

23.3.2010

Neoclarityn

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/161/001-067

23.3.2010

23.3.2010

Norvir

Abbott Laboratories Ltd

Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom

EU/1/96/016/001

EU/1/96/016/003-006

25.3.2010

23.3.2010

Oslif Breezhaler

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/09/586/001-010

25.3.2010

23.3.2010

Prometax

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/092/001-026

25.3.2010

23.3.2010

Revlimid

Celgene Europe Limited

Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom

EU/1/07/391/001-004

25.3.2010

23.3.2010

Riprazo

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/409/001-020

25.3.2010

23.3.2010

Simponi

Centocor B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546/001-004

25.3.2010

23.3.2010

Sprimeo

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/407/001-020

25.3.2010

23.3.2010

Stalevo

Orion Corporation

Orionintie 1, FIN-02200 Espoo, Suomi

EU/1/03/260/001-033

25.3.2010

23.3.2010

Sutent

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/06/347/001-008

25.3.2010

23.3.2010

Synagis

Abbott Laboratories Ltd

Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom

EU/1/99/117/001-002

23.3.2010

23.3.2010

Tandemact

Takeda Global Research and Development Centre (Europe) Ltd.

61 Aldwich, London WC2B 4AE, United Kingdom

EU/1/06/366/005-022

25.3.2010

23.3.2010

Tasigna

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/422/001-004

25.3.2010

23.3.2010

Thalidomide Celgene

Celgene Europe Limited

Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom

EU/1/08/443/001

25.3.2010

23.3.2010

Visudyne

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/00/140/001

25.3.2010

23.3.2010

Volibris

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/08/451/001-004

25.3.2010

23.3.2010

Xeloda

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/163/001-002

25.3.2010

26.3.2010

Adcirca

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA, Houten, Nederland

EU/1/08/476/005-006

30.3.2010

26.3.2010

Avandamet

SmithKline Beecham Ltd.

980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom

EU/1/03/258/001-022

30.3.2010

26.3.2010

Avandia

SmithKline Beecham Ltd.

980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom

EU/1/00/137/002-018

30.3.2010

26.3.2010

Celsentri

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/07/418/001-010

29.3.2010

26.3.2010

Celsentri

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/07/418/001-010

29.3.2010

26.3.2010

Clopidogrel Qualimed

Qualimed

117, Allée des Parcs, 69800 Saint Priest, France

EU/1/09/557/001-010

30.3.2010

26.3.2010

Competact

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/06/354/001-009

30.3.2010

26.3.2010

Cubicin

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/328/001-002

30.3.2010

26.3.2010

Ebixa

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/02/219/001-003

EU/1/02/219/007-012

EU/1/02/219/014-022

EU/1/02/219/036

30.3.2010

26.3.2010

Exforge HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/569/001-060

30.3.2010

26.3.2010

Galvus

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/414/001-010

EU/1/07/414/018

30.3.2010

26.3.2010

Glivec

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/198/001-013

29.3.2010

26.3.2010

Glivec

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/198/001-013

29.3.2010

26.3.2010

Helixate NexGen

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/00/144/001-004

30.3.2010

26.3.2010

Hirobriz Breezhaler

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/09/594/001-010

30.3.2010

26.3.2010

Ilaris

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/564/001-002

30.3.2010

26.3.2010

Imprida HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/570/001-060

30.3.2010

26.3.2010

InductOs

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/02/226/001

30.3.2010

26.3.2010

Intanza

Sanofi Pasteur MSD SNC

8, rue Jonas Salk, Lyon69007, France

EU/1/08/505/001-006

30.3.2010

26.3.2010

IntronA

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/99/127/011-039

EU/1/99/127/041-044

30.3.2010

26.3.2010

Invega

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/07/395/001-095

29.3.2010

26.3.2010

Invirase

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/026/001-002

30.3.2010

26.3.2010

Isentress

Merck Sharp & Dohme Limited

Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/436/001-002

30.3.2010

26.3.2010

Ivemend

Merck Sharp & Dohme Limited

Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/437/001

30.3.2010

26.3.2010

Jalra

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/485/001-011

30.3.2010

26.3.2010

Kogenate Bayer

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/00/143/001-011

30.3.2010

26.3.2010

Onbrez Breezhaler

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/593/001-010

30.3.2010

26.3.2010

Panretin

Eisai Limited

European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom

EU/1/00/149/001

30.3.2010

26.3.2010

Rasilez HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491/001-080

30.3.2010

26.3.2010

Remicade

Centocor B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

30.3.2010

26.3.2010

Sustiva

Bristol-MyersSquibbPharma EEIG

Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/99/110/001-005

EU/1/99/110/008-010

30.3.2010

26.3.2010

Temomedac

ALFRED E. TIEFENBACHER, (GmbH & Co. KG)

Van-der-Smissen-Straße 1, Hamburg 22767, Deutschland

EU/1/09/605/001-012

30.3.2010

26.3.2010

Tygacil

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/06/336/001

29.3.2010

26.3.2010

Vistide

Gilead Sciences International Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/97/037/001

30.3.2010

26.3.2010

Xagrid

ShirePharmaceuticalContracts Ltd

Hampshire InternationalBusinessPark, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295/001

29.3.2010

26.3.2010

Xiliarx

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/486/001-011

30.3.2010

30.3.2010

Aclasta

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/308/001-002

1.4.2010

30.3.2010

Actos

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/00/150/001-024

1.4.2010

30.3.2010

Afinitor

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/538/001-008

1.4.2010

30.3.2010

Celvapan

Baxter AG

Industriestraße 67, A-1221 Wien, Österreich

EU/1/08/506/001

1.4.2010

30.3.2010

Clopidogrel Mylan

Mylan S.A.S

117 allée des Parcs, 69800 Saint Priest, France

EU/1/09/559/001-016

1.4.2010

30.3.2010

Evicel

OMRIX biopharmaceuticals S.A. / N.V.

200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België

EU/1/08/473/001-003

1.4.2010

30.3.2010

Extavia

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/454/001-002

EU/1/08/454/005-007

1.4.2010

30.3.2010

Glubrava

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/07/421/001-009

1.4.2010

30.3.2010

Glustin

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/00/151/001-024

1.4.2010

30.3.2010

INCRELEX

Ipsen Pharma

65, quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402/001

1.4.2010

30.3.2010

Intelence

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

1.4.2010

30.3.2010

Kaletra

Abbott Laboratories Limited

Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/01/172/004-007

31.3.2010

30.3.2010

Levemir

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278/010-011

6.4.2010

30.3.2010

Lucentis

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/374/001

1.4.2010

30.3.2010

Rasilez

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405/001-040

31.3.2010

30.3.2010

RoActemra

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/08/492/001-006

1.4.2010

30.3.2010

Rotarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/05/330/001-011

1.4.2010

30.3.2010

RotaTeq

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

1.4.2010

30.3.2010

Xolair

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/319/001-010

31.3.2010

6.4.2010

Retacrit

HOSPIRA Enterprises B.V.

Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland

EU/1/07/431/001-025

14.4.2010

6.4.2010

Silapo

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland

EU/1/07/432/001-022

9.4.2010

9.4.2010

Avaglim

SmithKline Beecham Ltd.

980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom

EU/1/06/349/001-010

13.4.2010

9.4.2010

Ketek

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92160 Antony, France

EU/1/01/191/001-005

13.4.2010

9.4.2010

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-002

13.4.2010

15.4.2010

Firdapse

EUSA Pharma SAS

3 Allée des Séquoias, Limonest 69760, FRANCE

EU/1/09/601/001

20.4.2010

19.4.2010

Ifirmasta

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480/001-018

23.4.2010

22.4.2010

Sildenafil Teva

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/584/001-018

26.4.2010

22.4.2010

Tracleer

ActelionRegistration Ltd

BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220/001-006

26.4.2010

27.4.2010

Afinitor

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/538/001-008

29.4.2010

27.4.2010

Aldara

Meda AB

Pipers väg 2A, Solna 170 73, Svërige

EU/1/98/080/001-002

29.4.2010

27.4.2010

Aldurazyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/03/253/001-003

29.4.2010

27.4.2010

Altargo

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/390/001-004

29.4.2010

27.4.2010

Bridion

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/08/466/001-002

29.4.2010

27.4.2010

Doribax

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/467/001-002

29.4.2010

27.4.2010

Exelon

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/066/001-026

29.4.2010

27.4.2010

Focetria

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1 - Siena, Italia

EU/1/07/385/001-002

EU/1/07/385/004

29.4.2010

27.4.2010

Fuzeon

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/03/252/001-003

29.4.2010

27.4.2010

Kinzalkomb

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214/001-015

29.4.2010

27.4.2010

MicardisPlus

Boehringer Ingelheim International GmbH

Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland

EU/1/02/213/001-023

3.5.2010

27.4.2010

Remicade

Centocor B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

29.4.2010

27.4.2010

RoActemra

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/08/492/001-006

29.4.2010

27.4.2010

Tamiflu

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/222/001-004

29.4.2010

27.4.2010

Tarceva

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311/001-003

29.4.2010

27.4.2010

Taxotere

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony Cedex, France

EU/1/95/002/001-005

29.4.2010

27.4.2010

Tyverb

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/440/001-002

29.4.2010

27.4.2010

Velcade

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-002

29.4.2010

27.4.2010

Vimpat

UCB Pharma SA.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

EU/1/08/470/014-015

29.4.2010

29.4.2010

Aclasta

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/308/001-002

3.5.2010

29.4.2010

Arava

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118/001-010

3.5.2010

29.4.2010

Ceplene

EpiCept GmbH

Goethestrasse 4, D-80336 München, Deutschland

EU/1/08/477/001

3.5.2010

29.4.2010

Clopidogrel Winthrop

Sanofi-Aventis

174, avenue de France, F-75013 Paris, France

EU/1/08/465/001-020

3.5.2010

29.4.2010

Epivir

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/96/015/001-005

4.5.2010

29.4.2010

Focetria

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1 - Siena, Italia

EU/1/07/385/001-002

EU/1/07/385/004

3.5.2010

29.4.2010

Humira

Abbott Laboratories Limited

Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-010

4.5.2010

29.4.2010

Insulatard

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233/001-017

3.5.2010

29.4.2010

Intelence

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

3.5.2010

29.4.2010

Iscover

Bristol-MyersSquibbPharma EEIG

Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/070/001a-001b

EU/1/98/070/002a-002b

EU/1/98/070/003a-003b

EU/1/98/070/004a-004b

EU/1/98/070/005a-005b

EU/1/98/070/006a-006b

EU/1/98/070/007a-007b

EU/1/98/070/008-010

EU/1/98/070/011a-011b

EU/1/98/070/012

4.5.2010

29.4.2010

Kepivance

BiovitrumAB (publ)

SE-112 76 Stockholm, Sverige

EU/1/05/314/001

3.5.2010

29.4.2010

Lyrica

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/04/279/001-043

4.5.2010

29.4.2010

Mircera

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/07/400/001-024

4.5.2010

29.4.2010

NeoRecormon

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/97/031/019-046

4.5.2010

29.4.2010

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/98/069/001a-001b

EU/1/98/069/002a-002b

EU/1/98/069/003a-003b

EU/1/98/069/004a-004b

EU/1/98/069/005a-005b

EU/1/98/069/006a-006b

EU/1/98/069/007a-007b

EU/1/98/069/008-010

EU/1/98/069/011a-011b

EU/1/98/069/012

3.5.2010

29.4.2010

PritorPlus

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/02/215/001-021

3.5.2010

29.4.2010

Prometax

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/092/001-026

4.5.2010

29.4.2010

Protaphane

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234/001-017

3.5.2010

29.4.2010

Tygacil

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/06/336/001

3.5.2010

29.4.2010

Tyverb

Glaxo Group Limited

Berkeley Avenue, Greenford, MiddlesexUB6 0NN, United Kingdom

EU/1/07/440/001-002

3.5.2010

29.4.2010

Vectibix

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423/001-003

3.5.2010

5.5.2010

Aloxi

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Republic of Ireland

EU/1/04/306/001-003

7.5.2010

5.5.2010

BeneFIX

Wyeth Europa Ltd.

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-007

7.5.2010

5.5.2010

Bondenza

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/03/266/003-006

7.5.2010

5.5.2010

Bonviva

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/03/265/003-006

7.5.2010

5.5.2010

Celsentri

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/07/418/001-010

7.5.2010

5.5.2010

Docetaxel Winthrop

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony Cedex, France

EU/1/07/384/001-005

7.5.2010

5.5.2010

Enbrel

Wyeth Europa Limited

Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/126/001-021

7.5.2010

5.5.2010

Kiovig

Baxter AG

Industriestraße 67, A - 1221 Wien, Österreich

EU/1/05/329/001-006

7.5.2010

5.5.2010

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134/001-037

7.5.2010

5.5.2010

Optisulin

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133/001-032

7.5.2010

5.5.2010

PegIntron

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/131/001-050

7.5.2010

5.5.2010

Silgard

Merck Sharp & Dohme Ltd

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358/001-021

7.5.2010

5.5.2010

Sprycel

Bristol-MyersSquibbPharma EEIG

Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/363/001-011

7.5.2010

5.5.2010

Tyverb

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/440/001-003

7.5.2010

5.5.2010

ViraferonPeg

Schering Plough Europe

Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/00/132/001-050

7.5.2010

5.5.2010

Visudyne

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/00/140/001

7.5.2010

10.5.2010

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430/001-002

12.5.2010

10.5.2010

Combivir

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/98/058/001-002

12.5.2010

10.5.2010

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/00/152/001-020

12.5.2010

10.5.2010

Optimark

Covidien Deutschland GmbH

Gewerbepark 1, Neustadt/Donau 93333, Deutschland

EU/1/07/398/001-014

12.5.2010

10.5.2010

Orgalutran

N.V. Organon

P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland

EU/1/00/130/001-002

12.5.2010

10.5.2010

Ranexa

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/462/001-012

12.5.2010

10.5.2010

Tysabri

Elan Pharma International Ltd.

Monksland, Athlone, County Westmeath, Ireland

EU/1/06/346/001

12.5.2010

10.5.2010

Xeristar

Boehringer Ingelheim International GmbH

Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland

EU/1/04/297/001-008

12.5.2010

10.5.2010

Ziagen

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom

EU/1/99/112/001-002

12.5.2010

12.5.2010

Aclasta

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/308/001-002

18.5.2010

12.5.2010

Gardasil

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/357/001-021

18.5.2010

12.5.2010

Kuvan

Merck KGaA

Frankfurter Straße 250, 64293 Darmstadt, Deutschland

EU/1/08/481/001-003

18.5.2010

12.5.2010

Olazax

GlenmarkPharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/597/001-005

18.5.2010

26.5.2010

Avandia

SmithKline Beecham Ltd.

980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom

EU/1/00/137/002-018

28.5.2010

26.5.2010

Cyanokit

Merck Santé s.a.s.

37, rue Saint-Romain, 69379 Lyon Cedex 08, France

EU/1/07/420/001

28.5.2010

26.5.2010

Kivexa

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/04/298/001-003

28.5.2010

26.5.2010

Myocet

Cephalon Europe

5 Rue Charles Martigny, Maisons Alfort 94700, France

EU/1/00/141/001

28.5.2010

26.5.2010

Olanzapine Glenmark

Glenmark Generics (Europe) Limited

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom

EU/1/09/587/001-017

1.6.2010

26.5.2010

Olanzapine Glenmark Europe

Glenmark Generics (Europe) Limited

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom

EU/1/09/588/001-012

1.6.2010

26.5.2010

Olazax Disperzi

GlenmarkPharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika

EU/1/09/592/001-005

28.5.2010

26.5.2010

Prevenar

Wyeth-Lederle Vaccines S.A.

Rue du Bosquet, 15 - 1348 Louvain-La-Neuve, Belgique

EU/1/00/167/001-008

28.5.2010

26.5.2010

Telzir

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom

EU/1/04/282/001-002

28.5.2010

26.5.2010

Trizivir

Glaxo Group Ltd.

Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/00/156/002-004

28.5.2010

26.5.2010

Xagrid

ShirePharmaceuticalContracts Ltd

Hampshire InternationalBusinessPark, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295/001

28.5.2010

2.6.2010

Abraxane

Abraxis BioScience Limited

Rosanne House, Parkway, WelwynGarden City, Herts, AL8 6HG, United Kingdom

EU/1/07/428/001

4.6.2010

2.6.2010

Avastin

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

7.6.2010

2.6.2010

Bridion

N.V. Organon

Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/08/466/001-002

4.6.2010

2.6.2010

Celsentri

Pfizer Limited

Ramsgate Road, Sandwich, KentCT13 9NJ, United Kingdom

EU/1/07/418/001-010

4.6.2010

2.6.2010

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419/001-012

4.6.2010

2.6.2010

Circadin

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury, Reading, BerkshireRG1 3EB, United Kingdom

EU/1/07/392/001-002

7.6.2010

2.6.2010

Erbitux

Merck KGaA

Frankfurter Straße 250, 64271 Darmstadt, Deutschland

EU/1/04/281/001-005

7.6.2010

2.6.2010

Fertavid

SP Europe

Rue de Stalle, 73 B-1180 Bruxelles, Belgique

EU/1/09/510/001-019

4.6.2010

2.6.2010

Humira

Abbott Laboratories Limited

Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-010

7.6.2010

2.6.2010

Intrinsa

Warner Chilcott Pharmaceuticals UK Ltd

Whitehall Lane, Egham, SurreyTW20 9NW, United Kingdom

EU/1/06/352/001-003

4.6.2010

2.6.2010

Prezista

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/06/380/001-005

4.6.2010

2.6.2010

Rasilez

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405/001-040

4.6.2010

2.6.2010

Rebif

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/98/063/001-017

4.6.2010

2.6.2010

Renagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/123/005-013

7.6.2010

2.6.2010

Stalevo

Orion Corporation

Orionintie 1, FIN-02200 Espoo, Suomi

EU/1/03/260/001-033

4.6.2010

2.6.2010

Velcade

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-002

4.6.2010

2.6.2010

Vimpat

UCB Pharma SA.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

EU/1/08/470/001-017

7.6.2010

2.6.2010

Zavesca

ActelionRegistration Ltd

BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/238/001

4.6.2010

4.6.2010

DepoCyte

Pacira Limited

West Forest Gate, Wellington Road, Wokingham, Berkshire, RG40 2AQ, United Kingdom

EU/1/01/187/001

8.6.2010

4.6.2010

Metalyse

Boehringer Ingelheim International GmbH

Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland

EU/1/00/169/004-006

8.6.2010

4.6.2010

Mircera

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/07/400/001-024

8.6.2010

4.6.2010

Nymusa

CHIESI FARMACEUTICI SpA

Via Palermo 26/A, I-43100 Parma, ITALIA

EU/1/09/528/001-002

8.6.2010

4.6.2010

Rasilez HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491/001-080

8.6.2010

4.6.2010

RoActemra

Roche Registration Limited

6 Falcon Way, ShirePark, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/08/492/001-006

8.6.2010

4.6.2010

Toviaz

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/07/386/001-018

8.6.2010

4.6.2010

Zerit

Bristol-MyersSquibbPharma EEIG

Uxbridge BusinessPark, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/96/009/001-009

8.6.2010

8.6.2010

Lyrica

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/04/279/001-044

10.6.2010

10.6.2010

Comtan

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/081/001-004

14.6.2010

10.6.2010

Comtess

Orion Corporation

Orionintie 1, FIN-02200 Espoo, Suomi

EU/1/98/082/001-003

EU/1/98/082/005

14.6.2010

10.6.2010

ellaOne

Laboratoire HRA Pharma

15, rue Béranger, 75003 Paris, France

EU/1/09/522/001

14.6.2010

10.6.2010

Mirapexin

Boehringer Ingelheim International GmbH

Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/051/001-006

EU/1/97/051/009-033

15.6.2010

10.6.2010

Opgenra

Howmedica International S. de R. L.

Raheen Business Park, Limerick, Ireland

EU/1/08/489/001-002

15.6.2010

10.6.2010

Pergoveris

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/07/396/001-003

14.6.2010

10.6.2010

Vasovist

TMC Pharma Services Ltd

Eversley, Hampshire, RG27 0NT, United Kingdom

EU/1/05/313/001-009

14.6.2010

14.6.2010

Lyrica

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/04/279/001-044

16.6.2010

14.6.2010

Sifrol

Boehringer Ingelheim International GmbH

Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/050/001-006

EU/1/97/050/009-033

17.6.2010

17.6.2010

ATryn

GTC Biotherapeutics UK Limited

10 Norwich Street, London EC4A 1BD, United Kingdom

EU/1/06/355/001-003

21.6.2010

17.6.2010

Luveris

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/00/155/001-007

21.6.2010

17.6.2010

Mirapexin

Boehringer Ingelheim International GmbH

Binger Strasse 173- D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/051/001-006

EU/1/97/051/009-033

21.6.2010

17.6.2010

Onsenal

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/03/259/001-006

21.6.2010

17.6.2010

Tyverb

Glaxo Group Limited

Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/440/001-003

21.6.2010

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 29.4.2010 | Agenerase | Glaxo Group Limited
  Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/00/148/001-004 | 5.5.2010 |
| 26.5.2010 | Duloxetine Boehringer Ingelheim | Boehringer Ingelheim International GmbH
  Binger Strasse 173 - D-55216 Ingelheim am Rhein, Deutschland | EU/1/08/471/003-005
  EU/1/08/471/011-012 | 28.5.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

29.4.2010

Agenerase

Glaxo Group Limited

Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/00/148/001-004

5.5.2010

26.5.2010

Duloxetine Boehringer Ingelheim

Boehringer Ingelheim International GmbH

Binger Strasse 173 - D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/471/003-005

EU/1/08/471/011-012

28.5.2010

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 15.3.2010 | Aivlosin | ECO Animal Health Ltd
  78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | EU/2/04/044/001-002 | 17.3.2010 |
| 15.3.2010 | Draxxin | Pfizer Ltd
  Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/03/041/004 | 17.3.2010 |
| 15.3.2010 | Incurin | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/00/018/001 | 17.3.2010 |
| 15.3.2010 | Masivet | AB Science S.A.
  3 avenue George V, 75008 Paris, France | EU/2/08/087/001-002 | 17.3.2010 |
| 15.3.2010 | Meloxivet | Janssen Pharmaceutica N.V.
  Turnhoutseweg 30, B-2340 Beerse, België | EU/2/07/077/001-005 | 17.3.2010 |
| 15.3.2010 | SevoFlo | Abbott Laboratories Limited
  Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM | EU/2/02/035/007 | 17.3.2010 |
| 16.3.2010 | Rabigen SAG2 | VIRBAC S.A.
  1ère Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/00/021/001-002 | 19.3.2010 |
| 22.3.2010 | Purevax FeLV | Merial
  29 Avenue Tony Garnier, 69007 Lyon, France | EU/2/00/019/005-007 | 24.3.2010 |
| 23.3.2010 | Ibraxion | Merial
  29 Avenue Tony Garnier, 69007 Lyon, France | EU/2/99/017/001-006 | 23.3.2010 |
| 23.3.2010 | Loxicom | Norbrook Laboratories Limited
  Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | EU/2/08/090/001-009 | 25.3.2010 |
| 26.3.2010 | Meloxidyl | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/06/070/001-007 | 30.3.2010 |
| 30.3.2010 | Acticam | Omnipharm Ltd
  Suite 3, 24 High Street, Ruddington, Nottingham, NG11 6EA, United Kingdom | EU/2/08/088/001-004 | 1.4.2010 |
| 9.4.2010 | Slentrol | Pfizer Ltd
  Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/07/071/001-003 | 13.4.2010 |
| 27.4.2010 | Vaxxitek HVT+ IBD | Merial
  29 Avenue Tony Garnier, 69007 Lyon, France | EU/2/02/032/001-002 | 29.4.2010 |
| 29.4.2010 | Trocoxil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent, CT13 9NJ United Kingdom | EU/2/08/084/001-005 | 4.5.2010 |
| 26.5.2010 | Ibaflin | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/00/022/001a-001b
  EU/2/00/022/002a-002b
  EU/2/00/022/003a-003b
  EU/2/00/022/004a-004b
  EU/2/00/022/005-017 | 28.5.2010 |
| 26.5.2010 | Naxcel | Pfizer Ltd
  Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/05/053/001-003 | 28.5.2010 |
| 2.6.2010 | Metacam | Boehringer Ingelheim Vetmedica GmbH
  55216 Ingelheim am Rhein, Deutschland | EU/2/97/004/026
  EU/2/97/004/033-034 | 4.6.2010 |
| 10.6.2010 | Flexicam | Dechra Veterinary Products A/S
  Mekuvej 9, 7171 Uldum, Danmark | EU/2/06/058/001-004 | 14.6.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

15.3.2010

Aivlosin

ECO Animal Health Ltd

78 Coombe Road New Malden Surrey KT3 4QS United Kingdom

EU/2/04/044/001-002

17.3.2010

15.3.2010

Draxxin

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/03/041/004

17.3.2010

15.3.2010

Incurin

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/00/018/001

17.3.2010

15.3.2010

Masivet

AB Science S.A.

3 avenue George V, 75008 Paris, France

EU/2/08/087/001-002

17.3.2010

15.3.2010

Meloxivet

Janssen Pharmaceutica N.V.

Turnhoutseweg 30, B-2340 Beerse, België

EU/2/07/077/001-005

17.3.2010

15.3.2010

SevoFlo

Abbott Laboratories Limited

Abbott House, VanwallBusinessPark, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM

EU/2/02/035/007

17.3.2010

16.3.2010

Rabigen SAG2

VIRBAC S.A.

1ère Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/00/021/001-002

19.3.2010

22.3.2010

Purevax FeLV

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/00/019/005-007

24.3.2010

23.3.2010

Ibraxion

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/99/017/001-006

23.3.2010

23.3.2010

Loxicom

Norbrook Laboratories Limited

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090/001-009

25.3.2010

26.3.2010

Meloxidyl

CEVA SANTE ANIMALE

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/06/070/001-007

30.3.2010

30.3.2010

Acticam

Omnipharm Ltd

Suite 3, 24 High Street, Ruddington, Nottingham, NG11 6EA, United Kingdom

EU/2/08/088/001-004

1.4.2010

9.4.2010

Slentrol

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/07/071/001-003

13.4.2010

27.4.2010

Vaxxitek HVT+ IBD

Merial

29 Avenue Tony Garnier, 69007 Lyon, France

EU/2/02/032/001-002

29.4.2010

29.4.2010

Trocoxil

Pfizer Limited

Ramsgate Road, Sandwich, Kent, CT13 9NJ United Kingdom

EU/2/08/084/001-005

4.5.2010

26.5.2010

Ibaflin

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/00/022/001a-001b

EU/2/00/022/002a-002b

EU/2/00/022/003a-003b

EU/2/00/022/004a-004b

EU/2/00/022/005-017

28.5.2010

26.5.2010

Naxcel

Pfizer Ltd

Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/05/053/001-003

28.5.2010

2.6.2010

Metacam

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/026

EU/2/97/004/033-034

4.6.2010

10.6.2010

Flexicam

Dechra Veterinary Products A/S

Mekuvej 9, 7171 Uldum, Danmark

EU/2/06/058/001-004

14.6.2010

—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 14.6.2010 | Pruban | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/00/024/001 | 16.6.2010 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

14.6.2010

Pruban

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/00/024/001

16.6.2010

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4H

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

| 24.9.2010 | EN | Official Journal of the European Union | C 258/32 |
| --- | --- | --- | --- |

24.9.2010

EN

Official Journal of the European Union

C 258/32

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2010 to 30 June 2010

[Decisions taken pursuant to Article 34 of Directive 2001/83/CE (1) or Article 38 of Directive 2001/82/CE (2)]

(2010/C 258/02)

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | MemberState concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 2.6.2010 | Clopidogrel Orion | See annex I | See annex I | 3.6.2010 |
| 10.6.2010 | Colistin sulfate | See annex II | See annex II | 11.6.2010 |
| 19.4.2010 | Diovan (1219) | See annex III | See annex III | 20.4.2010 |
| 15.3.2010 | Lescol | See annex IV | See annex IV | 17.3.2010 |
| 19.4.2010 | Diovan (1220) | See annex V | See annex V | 20.4.2010 |
| 10.6.2010 | Losec and associated names | See annex VI | See annex VI | 14.6.2010 |
| 15.4.2010 | Protium and associated names | See annex VII | See annex VII | 16.4.2010 |
| 26.3.2010 | Cevazuril 50 mg/ml oral suspension for piglets | See annex VIII | See annex VIII | 30.3.2010 |
| 30.3.2010 | Pantoprazole Bluefish | See annex IX | See annex IX | 31.3.2010 |
| 30.3.2010 | Pantoprazole Olinka (1169) | See annex X | See annex X | 31.3.2010 |
| 30.3.2010 | Pantoprazole Olinka (1170) | See annex XI | See annex XI | 31.3.2010 |
| 26.5.2010 | Valproate-ratiopharm chrono 300/500 mg Retardtabletten | See annex XII | See annex XII | 27.5.2010 |
| 4.6.2010 | Clopidogrel Teva and associated names | See annex XIII | See annex XIII | 7.6.2010 |
| 14.6.2010 | Doxycycline hyclate | See annex XIV | See annex XIV | 15.6.2010 |
| 10.6.2010 | Opgenra | Howmedica International S. de R. L., RaheenBusinessPark, Limerick, Ireland | This Decision is addressed to the Member States | 14.6.2010 |
| 10.5.2010 | Tysabri | Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland | This Decision is addressed to the Member States | 11.5.2010 |
| 10.5.2010 | Ranexa | Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | This Decision is addressed to the Member States | 12.5.2010 |
| 11.3.2010 | Revolade | GlaxoSmithKline Trading Services Limited, 6900 CorkAirportBusinessPark, Kinsale Road, Cork, Ireland | This Decision is addressed to the Member States | 12.3.2010 |
| 11.3.2010 | Stelara | Janssen-Cilag International NV, Turnhoutseweg, 30 - 2340 Beerse - België | This Decision is addressed to the Member States | 12.3.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

MemberState concerned

Date of notification

2.6.2010

Clopidogrel Orion

See annex I

See annex I

3.6.2010

10.6.2010

Colistin sulfate

See annex II

See annex II

11.6.2010

19.4.2010

Diovan (1219)

See annex III

See annex III

20.4.2010

15.3.2010

Lescol

See annex IV

See annex IV

17.3.2010

19.4.2010

Diovan (1220)

See annex V

See annex V

20.4.2010

10.6.2010

Losec and associated names

See annex VI

See annex VI

14.6.2010

15.4.2010

Protium and associated names

See annex VII

See annex VII

16.4.2010

26.3.2010

Cevazuril 50 mg/ml oral suspension for piglets

See annex VIII

See annex VIII

30.3.2010

30.3.2010

Pantoprazole Bluefish

See annex IX

See annex IX

31.3.2010

30.3.2010

Pantoprazole Olinka (1169)

See annex X

See annex X

31.3.2010

30.3.2010

Pantoprazole Olinka (1170)

See annex XI

See annex XI

31.3.2010

26.5.2010

Valproate-ratiopharm chrono 300/500 mg Retardtabletten

See annex XII

See annex XII

27.5.2010

4.6.2010

Clopidogrel Teva and associated names

See annex XIII

See annex XIII

7.6.2010

14.6.2010

Doxycycline hyclate

See annex XIV

See annex XIV

15.6.2010

10.6.2010

Opgenra

Howmedica International S. de R. L., RaheenBusinessPark, Limerick, Ireland

This Decision is addressed to the Member States

14.6.2010

10.5.2010

Tysabri

Elan Pharma International Ltd., Monksland, Athlone, County Westmeath, Ireland

This Decision is addressed to the Member States

11.5.2010

10.5.2010

Ranexa

Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

This Decision is addressed to the Member States

12.5.2010

11.3.2010

Revolade

GlaxoSmithKline Trading Services Limited, 6900 CorkAirportBusinessPark, Kinsale Road, Cork, Ireland

This Decision is addressed to the Member States

12.3.2010

11.3.2010

Stelara

Janssen-Cilag International NV, Turnhoutseweg, 30 - 2340 Beerse - België

This Decision is addressed to the Member States

12.3.2010

—   Refusal of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | MemberState concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 27.4.2010 | Vasotop | See annex XV | See annex XV | 28.4.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

MemberState concerned

Date of notification

27.4.2010

Vasotop

See annex XV

See annex XV

28.4.2010

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | MemberState concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 3.3.2010 | Sibutramine | See annex XVI | See annex XVI | 4.3.2010 |
| 14.6.2010 | Dextropropoxyphene | See annex XVII | See annex XVII | 15.6.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

MemberState concerned

Date of notification

3.3.2010

Sibutramine

See annex XVI

See annex XVI

4.3.2010

14.6.2010

Dextropropoxyphene

See annex XVII

See annex XVII

15.6.2010

—   Revocation of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | MemberState concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 14.6.2010 | Dextropropoxyphene | See annex XVIII | See annex XVIII | 15.6.2010 |
| 14.6.2010 | benfluorex | See annex XIX | See annex XIX | 15.6.2010 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

MemberState concerned

Date of notification

14.6.2010

Dextropropoxyphene

See annex XVIII

See annex XVIII

15.6.2010

14.6.2010

benfluorex

See annex XIX

See annex XIX

15.6.2010

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| MemberState EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Czech Republic | Orion Corporation
  Orionintie 1, FI-02200 Espoo
  Finland | Clopidogrel Orion | 75 mg | Film-coated tablet | Oral use |
| Denmark | Orion Corporation
  Orionintie 1, FI-02200 Espoo
  Finland | Clopidogrel Orion | 75 mg | Film-coated tablet | Oral use |
| Finland | Orion Corporation
  Orionintie 1, FI-02200 Espoo
  Finland | Clopidogrel Orion | 75 mg | Film-coated tablet | Oral use |
| Germany | Orion Corporation
  Orionintie 1, FI-02200 Espoo
  Finland | Clopidogrel Orion | 75 mg | Film-coated tablet | Oral use |
| Latvia | Orion Corporation
  Orionintie 1, FI-02200 Espoo
  Finland | Clopidogrel Orion | 75 mg | Film-coated tablet | Oral use |
| Lithuania | Orion Corporation
  Orionintie 1, FI-02200 Espoo
  Finland | Clopidogrel Orion | 75 mg | Film-coated tablet | Oral use |
| Norway | Orion Corporation
  Orionintie 1, FI-02200 Espoo
  Finland | Clopidogrel Orion | 75 mg | Film-coated tablet | Oral use |
| Slovak Republic | Orion Corporation
  Orionintie 1, FI-02200 Espoo
  Finland | Clopidogrel Orion | 75 mg | Film-coated tablet | Oral use |
| Sweden | Orion Corporation
  Orionintie 1, FI-02200 Espoo
  Finland | Clopidogrel Orion | 75 mg | Film-coated tablet | Oral use |

MemberState EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Czech Republic

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

Clopidogrel Orion

75 mg

Film-coated tablet

Oral use

Denmark

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

Clopidogrel Orion

75 mg

Film-coated tablet

Oral use

Finland

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

Clopidogrel Orion

75 mg

Film-coated tablet

Oral use

Germany

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

Clopidogrel Orion

75 mg

Film-coated tablet

Oral use

Latvia

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

Clopidogrel Orion

75 mg

Film-coated tablet

Oral use

Lithuania

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

Clopidogrel Orion

75 mg

Film-coated tablet

Oral use

Norway

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

Clopidogrel Orion

75 mg

Film-coated tablet

Oral use

Slovak Republic

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

Clopidogrel Orion

75 mg

Film-coated tablet

Oral use

Sweden

Orion Corporation

Orionintie 1, FI-02200 Espoo

Finland

Clopidogrel Orion

75 mg

Film-coated tablet

Oral use

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, WITHDRAWAL PERIOD AND APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member state/EEA | Applicant/Marketing Authorisation Holder | Product name | INN | Strength | Pharmaceutical form | Animal species | Frequency and route of administration | Recommended dose | Withdrawal period(s) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | Colivet 2 000 000 IU/ml, Konzentrat für eine orale Lösung für Schweine und Geflügel | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Pigs
  Poultry | For three consecutive days in drinking water | Pigs: 100 000 IU/kg bw/day in two equally divided doses per day
  Poultry: 75 000 IU/kg bw/day | Pigs: meat: 1 day
  Broilers and laying hens: 1 day
  Other poultry: 7 days
  Eggs: Zero days |
| Belgium | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Calves, Lambs: meat and offals 7 days.
  Pigs: meat and offals 1 day.
  Broiler and laying, hens: 1 day.
  Eggs: Zero days.
  Other Poultry: meat and offals - 7 days.
  Eggs: Zero days |
| Bulgaria | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | Colivet oral solution | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Poutry | Orally: 3 days | Pigs: 100 000 IU/kg b.w./day
  Poultry: 75 000 IU/kg/b.w./day | Meat: 1 days
  Eggs: Zero days |
| Bulgaria | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Calves, Lambs: meat and offals 7 days.
  Pigs: meat and offals 1 day.
  Broiler and laying, hens: 1 day.
  Eggs: Zero days.
  Other poultry: meat and offals: 7 days.
  Eggs: Zero days |
| Cyprus | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | COLIVET 2 000 000 IU/ml | Colistin sulfate | 2 MIU/ml | Oral Solution | Pigs
  Birds | Pigs: 100 000 IU/kg/day
  Poultry: 75 000 IU/kg/day | Pigs: 0,50 ml of product per 10 kg of body weight per day for 3 consecutive days
  Poultry: 37,5 ml of product per tonne of body weight per day for 3 consecutive days. | Meat and offal:
  Pigs: 1 day
  Broilers and laying hens: 1 day
  Other poultry: 7 days
  Eggs: Zero days |
| Czech Republic | Ceva Animal Health Slovakia s.r.o.
  Račianska 77
  831 02 Bratislava
  SLOVAK REPUBLIC | Colivet Sol. | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Chicken (broilers) | Daily.Orally | Broilers: 75 000 IU colistin per kg of bodyweight (i.e. 0,37 ml of product per 10 kg of bodyweight per day for 3-5 days via drinking water)
  Pigs: 50 000 IU colistin per kg of bodyweight per 12 hrs (i.e. 0,25 ml of product per 10 kg of bodyweight per 12 hrs for 3-5 days via drinking water or milk replacement). | Meat and offal:
  Pigs and chicken broilers: 2 days.
  Do not use in laying hens producing eggs for human consumption. |
| Denmark | Ceva Animal Health A/S
  Andkærvej 19
  7100 Vejle
  DENMARK | Colivet | Colistin sulfate | 2 MIU/ml | Oral Solution | Pigs | Daily.Orally | 100 000 IU colistin / kg body weight daily for 3-5 days. | 1 day |
| Denmark | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Meat and offal: 7 days
  Eggs: Zero days |
| France | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | COLISTINE CEVA 2 MUI/ml concentré pour solution buvable pour porcins et volailles | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Poultry | 3 days | Pigs: 100 000 IU of colistin per kg body weight per day for 3 consecutive days by oral route, i.e. 0,50 ml of product per 10 kg of body weight per day for 3 consecutive days.
  Poultry: 75 000 IU of colistin per kg body weight per day for 3 consecutive days by oral route, i.e. 37,5 ml of product per tonne of body weight per day for 3 consecutive days. | Meat and offals:
  Pigs: 1 day
  Chickens and egg laying hens: 1 day
  Other poultry: 7 days
  Eggs: Zero days |
| France | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | COLIVET SOLUTION | Colistin sulfate | 2 MIU/ml | Oral solution | Calves
  Lambs
  Pigs
  Poultry | 3 days | Calves, Lambs, Porcine: 100 000 UI/kg/day
  Poultry: 75 000 UI/kg/day | Meat and offals:
  Calves and lambs: 7 days
  Porcine: 1 day
  Chicken and egg-laying hens: 1 day
  Other birds: 7 days
  Eggs: Zero days |
| France | Coophavet S.A.S
  Saint Herblion, B.P. 70089
  44153 Ancenis Cedex
  FRANCE | COFACOLI SOLUTION | Colistin sulfate | 2 MIU/ml | Oral solution | Calves
  Lambs
  Pigs
  Poultry | 3 days | Calves, Lambs, Porcine: 100 000 UI/kg/day
  Poultry: 75 000 UI/kg/day | Meat and offals: 7 days.
  Eggs: Zero days |
| France | Franvet
  Zone industrielle d'Etriche
  Route d'Avire, BP 103
  49500 Segré Cedex
  FRANCE | MILICOLI | Colistin sulfate | 2 MIU/ml | Oral solution | Calves
  Lambs
  Pigs
  Poultry | 3 days | Calves, Lambs, Porcine: 100 000 UI/kg/day
  Poultry: 75 000 UI/kg/day | Meat and offals:Porcine, calves, chicken: 1 day
  Lamb and poultry other than chicken: 7 days
  Eggs: Zero days |
| France | Laboratoires Biové
  3 rue de Lorraine
  62510 Arques
  FRANCE | ACTI COLI 2 MUI/ML | Colistin sulfate | 2 MIU/ml | Oral solution | Calves
  Lambs
  Pigs
  Poultry | 3 days | Calves, Lambs, Porcine: 100 000 UI/kg/day
  Poultry: 75 000 UI/kg/day | Meat and offals:
  Pigs: 0 days
  Chicken: 1 day
  Other poultry: 7 days
  Calves: 2 days
  Lamb: 7 days
  Eggs: Zero days |
| France | Laprovet
  2 Chemin de la Milletière
  B.P. 67562
  37075 Tours Cedex 2
  FRANCE | COLISTINE SOLUTION E.A.F. | Colistin sulfate | 2 MIU/ml | Oral solution | Calves
  Lambs
  Pigs
  Poultry | 3 days | Calves, Lambs, Porcine: 100 000 UI/kg/day
  Poultry: 75 000 UI/kg/day | Meat and offals: 7 days.
  Eggs: Zero days |
| France | Sogeval
  Zone Industrielle des Touches
  200, avenue de Mayenne
  B.P. 2227
  53022 Laval Cedex 9
  FRANCE | SOGECOLI 2 millions UI/ml solution buvable | Colistin sulfate | 2 MIU/ml | Oral solution | Calves
  Lambs
  Pigs
  Poultry | 3 days | Calves, Lambs, Porcine: 100 000 UI/kg/day
  Poultry: 75 000 UI/kg/day | Meat and offals:
  Pigs: 0 day
  Chicken: 1 day
  Other poultry: 7 days.
  Calves: 2 days.
  Lamb: 7 days
  Eggs: Zero days |
| France | Virbac S.A.
  1ere Avenue 2065 M LID
  B.P. 27
  06516 Carros Cedex
  FRANCE | COLISTINE SULFATE 2 MUI/ml buvable virbac | Colistin sulfate | 2 MIU/ml | Oral solution | Calves
  Lambs
  Pigs
  Poultry | 3 days | Calves, Lambs, Porcine: 100 000 UI/kg/day
  Poultry: 75 000 UI/kg/day | Meat and offals: 7 days.
  Eggs: Zero days |
| Germany | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | Coliplus | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Meat and offal: 7 days
  Eggs: Zero days |
| Greece | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | Colivet | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Pigs
  Poultry | Drinking water/per day | Pigs: 100 000 IU/Kg BW x 3 days
  Poultry:75 000 IU/Kg BW X 3 days | Pigs: 1 day
  Broilers and laying hens: 1 day
  Other poultry: 7 days
  Eggs: Zero days |
| Greece | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLISTIN 2 000 000 IU/ML/DIVASA-FARMANIC | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Meat and offal: 7 days
  Eggs: Zero days |
| Hungary | Divasa-Farmavic S.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Meat and offal: 7 days
  Eggs: Zero days. |
| Hungary | Coophavet S.A.S
  Saint Herblion, B.P. 70089
  44153 Ancenis Cedex
  FRANCE | Cofacoli oral solution | Colistin sulfate | 2 MIU/ml | Oral solution | Cattle (suckling calf)
  Pig
  Chicken | Calf, Pig: 0,25 ml product/10 kg bw twice daily for 3-4 days
  Chicken, Laying hen: 37,5 ml product/ton of living weight dissolved in drinking water for 3 days. | Calf, Pig: 50 000 IU/kg bw
  Broiler chicken, laying hen: 75 000 IU/kg bw/day. | Calf: 3 days
  Pig: 2 days
  Chicken and laying hen: 2 days
  Eggs: Zero days. |
| Ireland | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | COLISCOUR 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Pigs
  Poultry | Daily for three consecutive days. Administration is by the oral route via drinking water. | Pigs: 100 000 IU of colistin per kg body weight per day i.e. 0,50 ml of product per 10 kg of body weight per day
  Poultry: 75 000 IU of colistin per kg body weight per day i.e. 37,5 ml of product per tonne of body weight per day | Pigs: Meat and offal: 1 day
  Broilers and laying hens: Meat and offal: 1 day
  Other poultry: Meat and offal: 7 days.
  Eggs: Zero days. |
| Italy | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Calves, Lambs: Meat and offals: 7 days.
  Pigs: Meat and offals: 1 day.
  Broiler and laying, hens: 1 day.
  Eggs: Zero days.
  Other Poultry: meat and offals: 7 days.
  Eggs: Zero days |
| Latvia | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | Colivet oral solution | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Poultry | Oral use. Administration vis drinking water or milk or direct application by mouth. Twice a day for 3 to 5 consecutive days. | Chicken: 75 000 IU colistin per kg per day (0,37 ml of Colivet per 10 kg twice a day)
  Pig: 50 000 IU of colistin per kg twice a day(0,25 ml Colivet per 10 kg twice a day). | Edible tissues: 1 day
  Eggs: 1 day |
| Lithuania | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | COLIVET SOLUTION, geriamasis tirpalas | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Poultry | With drinking water or milk powder.
  Orally via drinking water. | Pigs: 50 000 IU/kg of body weight, i.e. 0,25 ml Colivet Solution per 10 kg of body weight twice daily for 3-5 consecutive days.
  Poultry: 75 000 IU/kg of body weight per day, i.e. approximately 0,37 ml of Colivet Solution per 10 kg of body weight per day for 3-5 consecutive days. | Meat: 1 day.
  Poultry: meat and eggs: 1 day |
| Lithuania | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | Colistop, geriamasis tirpalas | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Poultry (broilers chickens) | For oral administration, usually via drinking water.
  For 3 consecutive days. | Pigs: 102500 IU/kg BW every 12 hours, for 3 days (equivalent to 0,5 ml of Colistop Solution/10 kg BW every 12 hours, for 3 consecutive days).
  Broilers chickens: 123 000 IU/kg BW/day, for 3 days (equivalent to 0,06 ml of Colistop Solution/kg BW/day, for 3 consecutive days) | Fattening pigs: 2 days.
  Broilers chickens: 7 days |
| Lithuania | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Calves, Lambs: Meat and offals: 7 days.
  Pigs: Meat and offals: 1 day.
  Broiler and laying, hens: 1 day.
  Eggs: Zero days.
  Other Poultry: Meat and offals: 7 days.
  Eggs: Zero days |
| Poland | Ceva Santé Animale
  Zone Industrielle La Ballastiere
  B.P. 126
  33500 Libourne
  FRANCE | Colivet solution | Colistin sulfate | 2 MIU/ml | oral solution | Pig
  Chickens | Administration via drinking water or milk. For 3-5 days | Chickens: 75 000 I.U. colistin/1 kg b.w./day for 3 - 5 days, (0,37 ml of product/10 kg b.w.twice daily for 3 - 5 days
  Pigs: 50 000 I.U. colistin/1 kg b.w./day for 3 - 5 days, (0,25 ml of product/10 kg b.w. twice daily for 3 - 5 days. | Meat and offal: 1 day
  Eggs: 1 day |
| Poland | DIVASA - FARMAVIC, S.A.
  Ctra. Sant Hipòlit, km 71
  08503 GURB - VIC
  (Barcelona)
  Spain | Coliplus 2 000 000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens | Colistin (as colistin sulfate) | 2 MIU/ml | Concentrate for oral solution for use in drinking water | Cattle (calves), sheep (lambs), swine and chickens | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Meat and offal: 7 days
  Eggs: Zero days
  Not permitted for use in animals producing milk for human consumption |
| Portugal | Ceva Saúde Animal - Produtos Farmacêuticos e Farmacológicos, Lda
  Rua Doutor António Loureiro Borges, 9/9A - 9°A
  Miraflores
  1495-131 Algés
  PORTUGAL | Colivet 2 000 000 UI/ml, concentrate for oral solution for pigs and birds | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Pigs
  Domestic birds | 3 days | Swine: 100 000 UI/kg BW/day
  Birds: 75 000 UI/kg BW/day | Meat and offal:
  Pigs: 1 day
  Broilers and laying hens: 1 day,
  Other birds: 7 days,
  Eggs: Zero days |
| Portugal | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Calves, Lambs: Meat and offals: 7 days.
  Pigs: Meat and offals: 1 day.
  Broiler and laying, hens: 1 day.
  Eggs: Zero days.
  Other Poultry: Meat and offals: 7 days.
  Eggs: Zero days |
| Romania | CENAVISA, S.A.
  Camí Pedra Estela S/N
  43205 Reus
  SPAIN | ENTEROBAS SOLUCION | Colistin sulfate | 2 MIU/ml | oral solution | Calves
  Pigs
  Poultry | Oral administration (drinking water or as milk replacer) treatment: 4-5 days | Calves and Pigs: 100 000 UI/kg b.w/day equivalent to 0,5 ml/10 kg b.w./day
  Poultry: 100 000 UI/kg b.w./day equivalent to 0,5 ml/litre drinking water/day | Meat: calves - 2 days
  Pigs: 5 days
  Poultry: 3 days
  Eggs: do not use in animals from which eggs are produced for human consumption |
| Romania | CEVA SANTE ANIMALE ROMANIA SRL
  5 Chindiei, sector 4
  040185 Bucharest
  ROMANIA | COLIVET SOLUTION | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Poultry | Oral administration (drinking water) treatment: 3 consecutive days | Pigs: 100 000 I.U. of colistin (as sulfate) /1kg b.w. in two equally divided doses/day, i.e. 0,5 ml of product per 10 kg of body weight in two equally divided doses/day Poultry: 75 000 I.U. of colistin (as sulfate) /1kg b.w. per day, i.e. 37,5 ml of product per 1 tone of body weight/day | Meat and offal: pigs 1 day
  Broilers and layers: 1 day
  Eggs: Zero days |
| Romania | Divasa-Farmavic S.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Meat and offal: 7 day
  Eggs: Zero days |
| Romania | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS SOLUTION | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs,
  Broilers | Oral administration (drinking water) treatment: 3 days | Poultry: 0,03 ml/kg b.w/day
  Pigs: 0,5 ml/10 kg b.w. every 12 hours | Meat: 9 days |
| Romania | Franvet
  Zone industrielle d'Etriche
  Route d'Avire, BP 103
  49500 Segré Cedex
  FRANCE | MILICOLI | Colistin sulfate | 2 MIU/ml | Oral solution | Calves
  Lambs
  Pigs
  Poultry | Oral administration (drinking water or milk replacer) treatment: 3 - 4 days | Calves, Pigs and Lambs: 50 000 I.U./kg b.w. or 0,25 ml of product/10 kg b.w Poultry: 75 000 I.U./kg/day or 0,25 ml/1 litre water | Meat and offal: 7 days
  Eggs: Zero days |
| Romania | S.C. CRIDA PHARM S.R.L.
  Str. Stadionului nr. 1
  Oltenita
  ROMANIA | COLICRID | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Poultry | Oral administration (drinking water) treatment: 3 - 5 days | Pigs: 100 000 I.U. of colistin sulfate/1kg b.w./day, i.e. 0,05 ml of product/kg of body weight/day Poultry: 100 000 I.U. of colistin sulfate/1kg b.w./day, i.e. 0,05 ml of product/kg of body weight/day | Meat: pigs: 7 days
  Poultry: 3 days |
| Romania | Sogeval
  Zone Industrielle des Touches
  200, avenue de Mayenne
  B.P. 2227
  53022 Laval Cedex 9
  FRANCE | SOGECOLI | Colistin sulfate | 2 MIU/ml | Oral solution | Calves
  Lambs
  Poultry | Oral administration treatment: 3 - 4 days | Calves, Lamb: 50 000 I.U./kg b.w. or 0,25 ml/10 kg b.w. twice a day, morning and evening Poultry: 75 000 I.U./ kg b.w. daily or 0,25 ml/1 litre water | Meat: 7 days |
| Slovak Republic | Ceva Animal Health Slovakia, spol. s.r.o.
  Račianska 77
  831 02 Bratislava
  SLOVAK REPUBLIC | COLIVET sol. ad us.vet. | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs,
  Chickens | 3 - 5 days in drinking water, milk or direct administration | Pigs: 50 000 IU colistine sulfate/kg b.w. (0,25 ml product/10 kg b.w.) (2 times).
  Chickens: 75 000 IU colistine sulfate/kg b.w. (0,37 ml product/10 kg b.w. | Meat: 1 day.
  Eggs: 1 day. |
| Slovak Republic | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml koncentrát na perorálny roztok na použitie v pitnej vode pre hovädzí dobytok, ovce, ošípané a kurčatá | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Calves, Lambs: Meat and offals: 7 days.
  Pigs: Meat and offals: 1 day.
  Broiler and laying, hens: 1 day.
  Eggs: Zero days.
  Other Poultry: Meat and offals: Zero days. |
| Spain | CEVA SALUD ANIMAL, S.A.
  Carabela La Niña no 12 5a planta
  08017 Barcelona
  SPAIN | COLIVET 2 000 000 UI/ML | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Birds | 3 days. Orally | Pigs: 100 000 UI/Kgbw
  Birds: 75 000 UI/Kg bw | 1 day |
| Spain | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS SOLUCION | Colistin sulfate | 2 MIU/ml | Oral solution | Pigs
  Birds (Chicken) | 3 days. Orally | Pigs: 102 500 UI/Kg bw/12 hours
  Birds: 123 000 UI/Kg bw/12 hours | Pigs: 2 days
  Birds: 7 days |
| Spain | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLISTINA DIVASA 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Meat: 7 days
  Eggs: Zero days |
| The Netherlands | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Meat: 7 days
  Eggs: Zero days. |
| United Kingdom | Ceva Animal Health Ltd
  90 The Broadway
  Chesham
  Buckinghamshire
  HP5 1EG
  UNITED KINGDOM | Colibird | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Poultry | For three consecutive days in drinking water | 75 000 IU/kg bw/day | Meat: 7 days.
  Eggs: Zero days. |
| United Kingdom | Ceva Animal Health Ltd
  90 The Broadway
  Chesham
  Buckinghamshire
  HP5 1EG
  UNITED KINGDOM | Coliscour, oral solution of colistin sulphate 2 MIU/ml | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Pigs | Twice daily for five consecutive days (via drinking water or direct oral administration) | 50 000 IU/kg bw given twice daily | Meat and offal: 1 day |
| United Kingdom | Divasa-FarmavicS.A.
  Ctra San Hipolito km 71
  08503 Gurb-Vic (Barcelona)
  SPAIN | Coliplus 2 000 000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens | Colistin sulfate | 2 MIU/ml | Concentrate for oral solution | Calves
  Lambs
  Pigs
  Poultry | Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water. | Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.
  Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days. | Meat: 7 days
  Eggs: Zero days. |

Member state/EEA

Applicant/Marketing Authorisation Holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Frequency and route of administration

Recommended dose

Withdrawal period(s)

Austria

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

Colivet 2 000 000 IU/ml, Konzentrat für eine orale Lösung für Schweine und Geflügel

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Pigs

Poultry

For three consecutive days in drinking water

Pigs: 100 000 IU/kg bw/day in two equally divided doses per day

Poultry: 75 000 IU/kg bw/day

Pigs: meat: 1 day

Broilers and laying hens: 1 day

Other poultry: 7 days

Eggs: Zero days

Belgium

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Calves, Lambs: meat and offals 7 days.

Pigs: meat and offals 1 day.

Broiler and laying, hens: 1 day.

Eggs: Zero days.

Other Poultry: meat and offals - 7 days.

Eggs: Zero days

Bulgaria

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

Colivet oral solution

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Poutry

Orally: 3 days

Pigs: 100 000 IU/kg b.w./day

Poultry: 75 000 IU/kg/b.w./day

Meat: 1 days

Eggs: Zero days

Bulgaria

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Calves, Lambs: meat and offals 7 days.

Pigs: meat and offals 1 day.

Broiler and laying, hens: 1 day.

Eggs: Zero days.

Other poultry: meat and offals: 7 days.

Eggs: Zero days

Cyprus

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

COLIVET 2 000 000 IU/ml

Colistin sulfate

2 MIU/ml

Oral Solution

Pigs

Birds

Pigs: 100 000 IU/kg/day

Poultry: 75 000 IU/kg/day

Pigs: 0,50 ml of product per 10 kg of body weight per day for 3 consecutive days

Poultry: 37,5 ml of product per tonne of body weight per day for 3 consecutive days.

Meat and offal:

Pigs: 1 day

Broilers and laying hens: 1 day

Other poultry: 7 days

Eggs: Zero days

Czech Republic

Ceva Animal Health Slovakia s.r.o.

Račianska 77

831 02 Bratislava

SLOVAK REPUBLIC

Colivet Sol.

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Chicken (broilers)

Daily.Orally

Broilers: 75 000 IU colistin per kg of bodyweight (i.e. 0,37 ml of product per 10 kg of bodyweight per day for 3-5 days via drinking water)

Pigs: 50 000 IU colistin per kg of bodyweight per 12 hrs (i.e. 0,25 ml of product per 10 kg of bodyweight per 12 hrs for 3-5 days via drinking water or milk replacement).

Meat and offal:

Pigs and chicken broilers: 2 days.

Do not use in laying hens producing eggs for human consumption.

Denmark

Ceva Animal Health A/S

Andkærvej 19

7100 Vejle

DENMARK

Colivet

Colistin sulfate

2 MIU/ml

Oral Solution

Pigs

Daily.Orally

100 000 IU colistin / kg body weight daily for 3-5 days.

1 day

Denmark

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Meat and offal: 7 days

Eggs: Zero days

France

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

COLISTINE CEVA 2 MUI/ml concentré pour solution buvable pour porcins et volailles

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Poultry

3 days

Pigs: 100 000 IU of colistin per kg body weight per day for 3 consecutive days by oral route, i.e. 0,50 ml of product per 10 kg of body weight per day for 3 consecutive days.

Poultry: 75 000 IU of colistin per kg body weight per day for 3 consecutive days by oral route, i.e. 37,5 ml of product per tonne of body weight per day for 3 consecutive days.

Meat and offals:

Pigs: 1 day

Chickens and egg laying hens: 1 day

Other poultry: 7 days

Eggs: Zero days

France

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

COLIVET SOLUTION

Colistin sulfate

2 MIU/ml

Oral solution

Calves

Lambs

Pigs

Poultry

3 days

Calves, Lambs, Porcine: 100 000 UI/kg/day

Poultry: 75 000 UI/kg/day

Meat and offals:

Calves and lambs: 7 days

Porcine: 1 day

Chicken and egg-laying hens: 1 day

Other birds: 7 days

Eggs: Zero days

France

Coophavet S.A.S

Saint Herblion, B.P. 70089

44153 Ancenis Cedex

FRANCE

COFACOLI SOLUTION

Colistin sulfate

2 MIU/ml

Oral solution

Calves

Lambs

Pigs

Poultry

3 days

Calves, Lambs, Porcine: 100 000 UI/kg/day

Poultry: 75 000 UI/kg/day

Meat and offals: 7 days.

Eggs: Zero days

France

Franvet

Zone industrielle d'Etriche

Route d'Avire, BP 103

49500 Segré Cedex

FRANCE

MILICOLI

Colistin sulfate

2 MIU/ml

Oral solution

Calves

Lambs

Pigs

Poultry

3 days

Calves, Lambs, Porcine: 100 000 UI/kg/day

Poultry: 75 000 UI/kg/day

Meat and offals:Porcine, calves, chicken: 1 day

Lamb and poultry other than chicken: 7 days

Eggs: Zero days

France

Laboratoires Biové

3 rue de Lorraine

62510 Arques

FRANCE

ACTI COLI 2 MUI/ML

Colistin sulfate

2 MIU/ml

Oral solution

Calves

Lambs

Pigs

Poultry

3 days

Calves, Lambs, Porcine: 100 000 UI/kg/day

Poultry: 75 000 UI/kg/day

Meat and offals:

Pigs: 0 days

Chicken: 1 day

Other poultry: 7 days

Calves: 2 days

Lamb: 7 days

Eggs: Zero days

France

Laprovet

2 Chemin de la Milletière

B.P. 67562

37075 Tours Cedex 2

FRANCE

COLISTINE SOLUTION E.A.F.

Colistin sulfate

2 MIU/ml

Oral solution

Calves

Lambs

Pigs

Poultry

3 days

Calves, Lambs, Porcine: 100 000 UI/kg/day

Poultry: 75 000 UI/kg/day

Meat and offals: 7 days.

Eggs: Zero days

France

Sogeval

Zone Industrielle des Touches

200, avenue de Mayenne

B.P. 2227

53022 Laval Cedex 9

FRANCE

SOGECOLI 2 millions UI/ml solution buvable

Colistin sulfate

2 MIU/ml

Oral solution

Calves

Lambs

Pigs

Poultry

3 days

Calves, Lambs, Porcine: 100 000 UI/kg/day

Poultry: 75 000 UI/kg/day

Meat and offals:

Pigs: 0 day

Chicken: 1 day

Other poultry: 7 days.

Calves: 2 days.

Lamb: 7 days

Eggs: Zero days

France

Virbac S.A.

1ere Avenue 2065 M LID

B.P. 27

06516 Carros Cedex

FRANCE

COLISTINE SULFATE 2 MUI/ml buvable virbac

Colistin sulfate

2 MIU/ml

Oral solution

Calves

Lambs

Pigs

Poultry

3 days

Calves, Lambs, Porcine: 100 000 UI/kg/day

Poultry: 75 000 UI/kg/day

Meat and offals: 7 days.

Eggs: Zero days

Germany

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

Coliplus

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Meat and offal: 7 days

Eggs: Zero days

Greece

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

Colivet

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Pigs

Poultry

Drinking water/per day

Pigs: 100 000 IU/Kg BW x 3 days

Poultry:75 000 IU/Kg BW X 3 days

Pigs: 1 day

Broilers and laying hens: 1 day

Other poultry: 7 days

Eggs: Zero days

Greece

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLISTIN 2 000 000 IU/ML/DIVASA-FARMANIC

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Meat and offal: 7 days

Eggs: Zero days

Hungary

Divasa-Farmavic S.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Meat and offal: 7 days

Eggs: Zero days.

Hungary

Coophavet S.A.S

Saint Herblion, B.P. 70089

44153 Ancenis Cedex

FRANCE

Cofacoli oral solution

Colistin sulfate

2 MIU/ml

Oral solution

Cattle (suckling calf)

Pig

Chicken

Calf, Pig: 0,25 ml product/10 kg bw twice daily for 3-4 days

Chicken, Laying hen: 37,5 ml product/ton of living weight dissolved in drinking water for 3 days.

Calf, Pig: 50 000 IU/kg bw

Broiler chicken, laying hen: 75 000 IU/kg bw/day.

Calf: 3 days

Pig: 2 days

Chicken and laying hen: 2 days

Eggs: Zero days.

Ireland

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

COLISCOUR 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Pigs

Poultry

Daily for three consecutive days. Administration is by the oral route via drinking water.

Pigs: 100 000 IU of colistin per kg body weight per day i.e. 0,50 ml of product per 10 kg of body weight per day

Poultry: 75 000 IU of colistin per kg body weight per day i.e. 37,5 ml of product per tonne of body weight per day

Pigs: Meat and offal: 1 day

Broilers and laying hens: Meat and offal: 1 day

Other poultry: Meat and offal: 7 days.

Eggs: Zero days.

Italy

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Calves, Lambs: Meat and offals: 7 days.

Pigs: Meat and offals: 1 day.

Broiler and laying, hens: 1 day.

Eggs: Zero days.

Other Poultry: meat and offals: 7 days.

Eggs: Zero days

Latvia

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

Colivet oral solution

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Poultry

Oral use. Administration vis drinking water or milk or direct application by mouth. Twice a day for 3 to 5 consecutive days.

Chicken: 75 000 IU colistin per kg per day (0,37 ml of Colivet per 10 kg twice a day)

Pig: 50 000 IU of colistin per kg twice a day(0,25 ml Colivet per 10 kg twice a day).

Edible tissues: 1 day

Eggs: 1 day

Lithuania

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

COLIVET SOLUTION, geriamasis tirpalas

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Poultry

With drinking water or milk powder.

Orally via drinking water.

Pigs: 50 000 IU/kg of body weight, i.e. 0,25 ml Colivet Solution per 10 kg of body weight twice daily for 3-5 consecutive days.

Poultry: 75 000 IU/kg of body weight per day, i.e. approximately 0,37 ml of Colivet Solution per 10 kg of body weight per day for 3-5 consecutive days.

Meat: 1 day.

Poultry: meat and eggs: 1 day

Lithuania

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

Colistop, geriamasis tirpalas

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Poultry (broilers chickens)

For oral administration, usually via drinking water.

For 3 consecutive days.

Pigs: 102500 IU/kg BW every 12 hours, for 3 days (equivalent to 0,5 ml of Colistop Solution/10 kg BW every 12 hours, for 3 consecutive days).

Broilers chickens: 123 000 IU/kg BW/day, for 3 days (equivalent to 0,06 ml of Colistop Solution/kg BW/day, for 3 consecutive days)

Fattening pigs: 2 days.

Broilers chickens: 7 days

Lithuania

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Calves, Lambs: Meat and offals: 7 days.

Pigs: Meat and offals: 1 day.

Broiler and laying, hens: 1 day.

Eggs: Zero days.

Other Poultry: Meat and offals: 7 days.

Eggs: Zero days

Poland

Ceva Santé Animale

Zone Industrielle La Ballastiere

B.P. 126

33500 Libourne

FRANCE

Colivet solution

Colistin sulfate

2 MIU/ml

oral solution

Pig

Chickens

Administration via drinking water or milk. For 3-5 days

Chickens: 75 000 I.U. colistin/1 kg b.w./day for 3 - 5 days, (0,37 ml of product/10 kg b.w.twice daily for 3 - 5 days

Pigs: 50 000 I.U. colistin/1 kg b.w./day for 3 - 5 days, (0,25 ml of product/10 kg b.w. twice daily for 3 - 5 days.

Meat and offal: 1 day

Eggs: 1 day

Poland

DIVASA - FARMAVIC, S.A.

Ctra. Sant Hipòlit, km 71

08503 GURB - VIC

(Barcelona)

Spain

Coliplus 2 000 000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens

Colistin (as colistin sulfate)

2 MIU/ml

Concentrate for oral solution for use in drinking water

Cattle (calves), sheep (lambs), swine and chickens

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Meat and offal: 7 days

Eggs: Zero days

Not permitted for use in animals producing milk for human consumption

Portugal

Ceva Saúde Animal - Produtos Farmacêuticos e Farmacológicos, Lda

Rua Doutor António Loureiro Borges, 9/9A - 9°A

Miraflores

1495-131 Algés

PORTUGAL

Colivet 2 000 000 UI/ml, concentrate for oral solution for pigs and birds

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Pigs

Domestic birds

3 days

Swine: 100 000 UI/kg BW/day

Birds: 75 000 UI/kg BW/day

Meat and offal:

Pigs: 1 day

Broilers and laying hens: 1 day,

Other birds: 7 days,

Eggs: Zero days

Portugal

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Calves, Lambs: Meat and offals: 7 days.

Pigs: Meat and offals: 1 day.

Broiler and laying, hens: 1 day.

Eggs: Zero days.

Other Poultry: Meat and offals: 7 days.

Eggs: Zero days

Romania

CENAVISA, S.A.

Camí Pedra Estela S/N

43205 Reus

SPAIN

ENTEROBAS SOLUCION

Colistin sulfate

2 MIU/ml

oral solution

Calves

Pigs

Poultry

Oral administration (drinking water or as milk replacer) treatment: 4-5 days

Calves and Pigs: 100 000 UI/kg b.w/day equivalent to 0,5 ml/10 kg b.w./day

Poultry: 100 000 UI/kg b.w./day equivalent to 0,5 ml/litre drinking water/day

Meat: calves - 2 days

Pigs: 5 days

Poultry: 3 days

Eggs: do not use in animals from which eggs are produced for human consumption

Romania

CEVA SANTE ANIMALE ROMANIA SRL

5 Chindiei, sector 4

040185 Bucharest

ROMANIA

COLIVET SOLUTION

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Poultry

Oral administration (drinking water) treatment: 3 consecutive days

Pigs: 100 000 I.U. of colistin (as sulfate) /1kg b.w. in two equally divided doses/day, i.e. 0,5 ml of product per 10 kg of body weight in two equally divided doses/day Poultry: 75 000 I.U. of colistin (as sulfate) /1kg b.w. per day, i.e. 37,5 ml of product per 1 tone of body weight/day

Meat and offal: pigs 1 day

Broilers and layers: 1 day

Eggs: Zero days

Romania

Divasa-Farmavic S.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Meat and offal: 7 day

Eggs: Zero days

Romania

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS SOLUTION

Colistin sulfate

2 MIU/ml

Oral solution

Pigs,

Broilers

Oral administration (drinking water) treatment: 3 days

Poultry: 0,03 ml/kg b.w/day

Pigs: 0,5 ml/10 kg b.w. every 12 hours

Meat: 9 days

Romania

Franvet

Zone industrielle d'Etriche

Route d'Avire, BP 103

49500 Segré Cedex

FRANCE

MILICOLI

Colistin sulfate

2 MIU/ml

Oral solution

Calves

Lambs

Pigs

Poultry

Oral administration (drinking water or milk replacer) treatment: 3 - 4 days

Calves, Pigs and Lambs: 50 000 I.U./kg b.w. or 0,25 ml of product/10 kg b.w Poultry: 75 000 I.U./kg/day or 0,25 ml/1 litre water

Meat and offal: 7 days

Eggs: Zero days

Romania

S.C. CRIDA PHARM S.R.L.

Str. Stadionului nr. 1

Oltenita

ROMANIA

COLICRID

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Poultry

Oral administration (drinking water) treatment: 3 - 5 days

Pigs: 100 000 I.U. of colistin sulfate/1kg b.w./day, i.e. 0,05 ml of product/kg of body weight/day Poultry: 100 000 I.U. of colistin sulfate/1kg b.w./day, i.e. 0,05 ml of product/kg of body weight/day

Meat: pigs: 7 days

Poultry: 3 days

Romania

Sogeval

Zone Industrielle des Touches

200, avenue de Mayenne

B.P. 2227

53022 Laval Cedex 9

FRANCE

SOGECOLI

Colistin sulfate

2 MIU/ml

Oral solution

Calves

Lambs

Poultry

Oral administration treatment: 3 - 4 days

Calves, Lamb: 50 000 I.U./kg b.w. or 0,25 ml/10 kg b.w. twice a day, morning and evening Poultry: 75 000 I.U./ kg b.w. daily or 0,25 ml/1 litre water

Meat: 7 days

Slovak Republic

Ceva Animal Health Slovakia, spol. s.r.o.

Račianska 77

831 02 Bratislava

SLOVAK REPUBLIC

COLIVET sol. ad us.vet.

Colistin sulfate

2 MIU/ml

Oral solution

Pigs,

Chickens

3 - 5 days in drinking water, milk or direct administration

Pigs: 50 000 IU colistine sulfate/kg b.w. (0,25 ml product/10 kg b.w.) (2 times).

Chickens: 75 000 IU colistine sulfate/kg b.w. (0,37 ml product/10 kg b.w.

Meat: 1 day.

Eggs: 1 day.

Slovak Republic

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml koncentrát na perorálny roztok na použitie v pitnej vode pre hovädzí dobytok, ovce, ošípané a kurčatá

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Calves, Lambs: Meat and offals: 7 days.

Pigs: Meat and offals: 1 day.

Broiler and laying, hens: 1 day.

Eggs: Zero days.

Other Poultry: Meat and offals: Zero days.

Spain

CEVA SALUD ANIMAL, S.A.

Carabela La Niña no 12 5a planta

08017 Barcelona

SPAIN

COLIVET 2 000 000 UI/ML

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Birds

3 days. Orally

Pigs: 100 000 UI/Kgbw

Birds: 75 000 UI/Kg bw

1 day

Spain

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS SOLUCION

Colistin sulfate

2 MIU/ml

Oral solution

Pigs

Birds (Chicken)

3 days. Orally

Pigs: 102 500 UI/Kg bw/12 hours

Birds: 123 000 UI/Kg bw/12 hours

Pigs: 2 days

Birds: 7 days

Spain

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLISTINA DIVASA 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Meat: 7 days

Eggs: Zero days

The Netherlands

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

COLIPLUS 2 000 000 IU/ml concentrate for oral solution for use in drinking water for cattle, sheep, swine and chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Meat: 7 days

Eggs: Zero days.

United Kingdom

Ceva Animal Health Ltd

90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

UNITED KINGDOM

Colibird

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Poultry

For three consecutive days in drinking water

75 000 IU/kg bw/day

Meat: 7 days.

Eggs: Zero days.

United Kingdom

Ceva Animal Health Ltd

90 The Broadway

Chesham

Buckinghamshire

HP5 1EG

UNITED KINGDOM

Coliscour, oral solution of colistin sulphate 2 MIU/ml

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Pigs

Twice daily for five consecutive days (via drinking water or direct oral administration)

50 000 IU/kg bw given twice daily

Meat and offal: 1 day

United Kingdom

Divasa-FarmavicS.A.

Ctra San Hipolito km 71

08503 Gurb-Vic (Barcelona)

SPAIN

Coliplus 2 000 000 IU/ml Concentrate for Oral Solution for use in drinking water for Cattle, Sheep, Swine and Chickens

Colistin sulfate

2 MIU/ml

Concentrate for oral solution

Calves

Lambs

Pigs

Poultry

Calves, Lambs, Pigs, Poultry: for three consecutive days in drinking water.

Calves and Lambs: 100 000 IU of colistin / kg bw/day divided in two identical doses, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Pigs: 100 000 IU of colistin / kg bw/day, i.e. 0,50 ml of product/10 kg bw/day for 3 consecutive days.

Poultry: 75 000 IU of colistin / kg bw/day, i.e. 37,5 ml of product/1 tone bw/day for 3 consecutive days.

Meat: 7 days

Eggs: Zero days.

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Diovan 40 mg Filmtabletten | 40 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Angiosan 40 mg Filmtabletten | 40 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Diovan 80 mg Filmtabletten | 80 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Angiosan 80 mg Filmtabletten | 80 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Diovan 160 mg Filmtabletten | 160 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Angiosan 160 mg Filmtabletten | 160 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Diovan 320 mg Filmtabletten | 320 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Angiosan 320 mg Filmtabletten | 320 mg | film-coated tablets | Oral Use |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40, bus 1
  B–1800 Vilvoorde
  (Tel: +32-2-246 16 11) | Diovane 40 mg | 40 mg | film-coated tablets | Oral Use |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40, bus 1
  B–1800 Vilvoorde
  (Tel: +32-2-246 16 11) | Diovane 80 mg | 80 mg | film-coated tablets | Oral Use |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40, bus 1
  B–1800 Vilvoorde
  (Tel: +32-2-246 16 11) | Diovane 160 mg | 160 mg | film-coated tablets | Oral Use |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40, bus 1
  B–1800 Vilvoorde
  (Tel: +32-2-246 16 11) | Diovane 320 mg | 320 mg | film-coated tablets | Oral Use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Cyprus | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Cyprus | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Cyprus | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Cyprus | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Czech Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  (Tel +420-2–2577 51 11) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Czech Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  (Tel +420-2–2577 51 11) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan | 40 mg | film-coated tablets | Oral Use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan | 80 mg | film-coated tablets | Oral Use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan | 160 mg | film-coated tablets | Oral Use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan | 320 mg | film-coated tablets | Oral Use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| France | Novartis Pharma S.A.S.
  2 and 4, rue Lionel Terray
  92500 RUEIL-MALMAISON
  France
  (Tel: +33-1–5547 60 00) | Tareg 40 mg | 40 mg | film-coated tablets | Oral Use |
| France | Novartis Pharma S.A.S.
  2 and 4, rue Lionel Terray
  92500 RUEIL-MALMAISON
  France
  (Tel: +33-1–5547 60 00) | Tareg 80 mg | 80 mg | film-coated tablets | Oral Use |
| France | Novartis Pharma S.A.S.
  2 and 4, rue Lionel Terray
  92500 RUEIL-MALMAISON
  France
  (Tel: +33-1–5547 60 00) | Tareg 160 mg | 160 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Cordinate 40 mg | 40 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Provas 40 mg | 40 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Cordinate 80 mg | 80 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Provas 80 mg | 80 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 160 mg protect | 160 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Cordinate 160 mg | 160 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Provas 160 mg | 160 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 320 mg forte | 320 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Cordinate 320 mg | 320 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Provas 320 mg | 320 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Dalzad 40 mg | 40 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Dalzad 80 mg | 80 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Dalzad 160 mg | 160 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Dalzad 320 mg | 320 mg | film-coated tablets | Oral Use |
| Hungary | Novartis Hungaria Kft.
  Bartók Béla út 43-47
  H–1114 Budapest
  (Tel: +36-1-457 65 00) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Hungary | Novartis Hungaria Kft.
  Bartók Béla út 43-47
  H–1114 Budapest
  (Tel: +36-1-457 65 00) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Hungary | Novartis Hungaria Kft.
  Bartók Béla út 43-47
  H–1114 Budapest
  (Tel: +36-1-457 65 00) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Hungary | Novartis Hungaria Kft.
  Bartók Béla út 43-47
  H–1114 Budapest
  (Tel: +36-1-457 65 00) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Ireland | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Ireland | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Ireland | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Ireland | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Tareg 40 mg | 40 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Rixil 40 mg | 40 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Tareg 80 mg | 80 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Rixil 80 mg | 80 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Tareg 160 mg | 160 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Rixil 160 mg | 160 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Tareg 320 mg | 320 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Rixil 320 mg | 320 mg | film-coated tablets | Oral Use |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 80 mg plėvele dengtos tabletės | 80 mg | film-coated tablets | Oral Use |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 160 mg plėvele dengtos tabletės | 160 mg | film-coated tablets | Oral Use |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 320 mg plėvele dengtos tabletės | 320 mg | film-coated tablets | Oral Use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Malta | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Malta | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Malta | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Malta | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Netherlands | Novartis Pharma B.V.
  Postbus 241
  NL–6824 DP Arnhem
  (Tel: + 31-26-378 21 00) | Diovan 40 | 40 mg | film-coated tablets | Oral Use |
| Netherlands | Novartis Pharma B.V.
  Postbus 241
  NL–6800 LZ Arnhem
  (Tel: + 31-26-378 21 00) | Diovan 80 | 80 mg | film-coated tablets | Oral Use |
| Netherlands | Novartis Pharma B.V.
  Postbus 241
  NL–6824 DP Arnhem
  (Tel: + 31-26-378 21 00) | Diovan 160 | 160 mg | film-coated tablets | Oral Use |
| Netherlands | Novartis Pharma B.V.
  Postbus 241
  NL–6824 DP Arnhem
  (Tel: + 31-26-378 21 00) | Diovan 320 | 320 mg | film-coated tablets | Oral Use |
| Norway | Novartis Norge AS
  Brynsalléen 4
  Postboks 237 Økern
  NO–0510 Oslo
  (Tel: +47–2305 20 00) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Norway | Novartis Norge AS
  Brynsalléen 4
  Postboks 237 Økern
  NO–0510 Oslo
  (Tel: +47–2305 20 00) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Norway | Novartis Norge AS
  Brynsalléen 4
  Postboks 237 Økern
  NO–0510 Oslo
  (Tel: +47–2305 20 00) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Norway | Novartis Norge AS
  Brynsalléen 4
  Postboks 237 Økern
  NO–0510 Oslo
  (Tel: +47–2305 20 00) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan | 40 mg | film-coated tablets | Oral Use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan | 80 mg | film-coated tablets | Oral Use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan | 160 mg | film-coated tablets | Oral Use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan | 320 mg | film-coated tablets | Oral Use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Diovan | 40 mg | film-coated tablets | Oral Use |
| Portugal | Laboratório Normal-Produtos Farmacêuticos, Lda
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Tareg | 40 mg | film-coated tablets | Oral Use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Diovan | 80 mg | film-coated tablets | Oral Use |
| Portugal | Laboratório Normal-Produtos Farmacêuticos, Lda
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Tareg | 80 mg | film-coated tablets | Oral Use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Diovan | 160 mg | film-coated tablets | Oral Use |
| Portugal | Laboratório Normal-Produtos Farmacêuticos, Lda
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Tareg | 160 mg | film-coated tablets | Oral Use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Diovan | 320 mg | film-coated tablets | Oral Use |
| Romania | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 40 mg,
  film coated tablets | 40 mg | film-coated tablets | Oral Use |
| Romania | Novartis
  Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 80 mg, film coated tablets | 80 mg | film-coated tablets | Oral Use |
| Romania | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 160 mg, film coated tablets | 160 mg | film-coated tablets | Oral Use |
| Slovak Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  Czech Republic
  (Tel +420-2–2577 51 11) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Slovak Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  Czech Republic
  (Tel +420-2–2577 51 11) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Slovak Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  Czech Republic
  (Tel +420-2–2577 51 11) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Slovak Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  Czech Republic
  (Tel +420-2–2577 51 11) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 40 mg filmsko obložene tablete | 40 mg | film-coated tablets | Oral Use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 80 mg filmsko obložene tablete | 80 mg | film-coated tablets | Oral Use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 160 mg filmsko obložene tablete | 160 mg | film-coated tablets | Oral Use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 320 mg filmsko obložene tablete | 320 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Diován Cardio 40 mg comprimidos recubiertos con película | 40 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Kalpress Cardio 40 mg comprimidos recubiertos con película | 40 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Miten Cardio 40 mg comprimidos recubiertos con película | 40 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Diován 80 mg comprimidos recubiertos con película | 80 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Kalpress 80 mg comprimidos recubiertos con película | 80 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Miten 80 mg comprimidos recubiertos con película | 80 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Diován 160 mg comprimidos recubiertos con película | 160 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Kalpress 160 mg comprimidos recubiertos con película | 160 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Miten 160 mg comprimidos recubiertos con película | 160 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Diován 320 mg comprimidos recubiertos con película | 320 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Kalpress 320 mg comprimidos recubiertos con película | 320 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Miten 320 mg comprimidos recubiertos con película | 320 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Diovan | 40 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Angiosan | 40 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Valsartan Novartis | 40 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Diovan | 80 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Angiosan | 80 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Valsartan Novartis | 80 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Diovan | 160 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Angiosan | 160 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Valsartan Novartis | 160 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Diovan | 320 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Angiosan | 320 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Valsartan Novartis | 320 mg | film-coated tablets | Oral Use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Diovan 40 mg Filmtabletten

40 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Angiosan 40 mg Filmtabletten

40 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Diovan 80 mg Filmtabletten

80 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Angiosan 80 mg Filmtabletten

80 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Diovan 160 mg Filmtabletten

160 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Angiosan 160 mg Filmtabletten

160 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Diovan 320 mg Filmtabletten

320 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Angiosan 320 mg Filmtabletten

320 mg

film-coated tablets

Oral Use

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B–1800 Vilvoorde

(Tel: +32-2-246 16 11)

Diovane 40 mg

40 mg

film-coated tablets

Oral Use

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B–1800 Vilvoorde

(Tel: +32-2-246 16 11)

Diovane 80 mg

80 mg

film-coated tablets

Oral Use

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B–1800 Vilvoorde

(Tel: +32-2-246 16 11)

Diovane 160 mg

160 mg

film-coated tablets

Oral Use

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B–1800 Vilvoorde

(Tel: +32-2-246 16 11)

Diovane 320 mg

320 mg

film-coated tablets

Oral Use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Cyprus

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Cyprus

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Cyprus

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Cyprus

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Czech Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

(Tel +420-2–2577 51 11)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Czech Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

(Tel +420-2–2577 51 11)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan

40 mg

film-coated tablets

Oral Use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan

80 mg

film-coated tablets

Oral Use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan

160 mg

film-coated tablets

Oral Use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan

320 mg

film-coated tablets

Oral Use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

France

Novartis Pharma S.A.S.

2 and 4, rue Lionel Terray

92500 RUEIL-MALMAISON

France

(Tel: +33-1–5547 60 00)

Tareg 40 mg

40 mg

film-coated tablets

Oral Use

France

Novartis Pharma S.A.S.

2 and 4, rue Lionel Terray

92500 RUEIL-MALMAISON

France

(Tel: +33-1–5547 60 00)

Tareg 80 mg

80 mg

film-coated tablets

Oral Use

France

Novartis Pharma S.A.S.

2 and 4, rue Lionel Terray

92500 RUEIL-MALMAISON

France

(Tel: +33-1–5547 60 00)

Tareg 160 mg

160 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Cordinate 40 mg

40 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Provas 40 mg

40 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Cordinate 80 mg

80 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Provas 80 mg

80 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 160 mg protect

160 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Cordinate 160 mg

160 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Provas 160 mg

160 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 320 mg forte

320 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Cordinate 320 mg

320 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Provas 320 mg

320 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Dalzad 40 mg

40 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Dalzad 80 mg

80 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Dalzad 160 mg

160 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Dalzad 320 mg

320 mg

film-coated tablets

Oral Use

Hungary

Novartis Hungaria Kft.

Bartók Béla út 43-47

H–1114 Budapest

(Tel: +36-1-457 65 00)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Hungary

Novartis Hungaria Kft.

Bartók Béla út 43-47

H–1114 Budapest

(Tel: +36-1-457 65 00)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Hungary

Novartis Hungaria Kft.

Bartók Béla út 43-47

H–1114 Budapest

(Tel: +36-1-457 65 00)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Hungary

Novartis Hungaria Kft.

Bartók Béla út 43-47

H–1114 Budapest

(Tel: +36-1-457 65 00)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Ireland

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Ireland

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Ireland

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Ireland

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Tareg 40 mg

40 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Rixil 40 mg

40 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Tareg 80 mg

80 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Rixil 80 mg

80 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Tareg 160 mg

160 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Rixil 160 mg

160 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Tareg 320 mg

320 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Rixil 320 mg

320 mg

film-coated tablets

Oral Use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 80 mg plėvele dengtos tabletės

80 mg

film-coated tablets

Oral Use

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 160 mg plėvele dengtos tabletės

160 mg

film-coated tablets

Oral Use

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 320 mg plėvele dengtos tabletės

320 mg

film-coated tablets

Oral Use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Malta

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Malta

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Malta

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Malta

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Netherlands

Novartis Pharma B.V.

Postbus 241

NL–6824 DP Arnhem

(Tel: + 31-26-378 21 00)

Diovan 40

40 mg

film-coated tablets

Oral Use

Netherlands

Novartis Pharma B.V.

Postbus 241

NL–6800 LZ Arnhem

(Tel: + 31-26-378 21 00)

Diovan 80

80 mg

film-coated tablets

Oral Use

Netherlands

Novartis Pharma B.V.

Postbus 241

NL–6824 DP Arnhem

(Tel: + 31-26-378 21 00)

Diovan 160

160 mg

film-coated tablets

Oral Use

Netherlands

Novartis Pharma B.V.

Postbus 241

NL–6824 DP Arnhem

(Tel: + 31-26-378 21 00)

Diovan 320

320 mg

film-coated tablets

Oral Use

Norway

Novartis Norge AS

Brynsalléen 4

Postboks 237 Økern

NO–0510 Oslo

(Tel: +47–2305 20 00)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Norway

Novartis Norge AS

Brynsalléen 4

Postboks 237 Økern

NO–0510 Oslo

(Tel: +47–2305 20 00)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Norway

Novartis Norge AS

Brynsalléen 4

Postboks 237 Økern

NO–0510 Oslo

(Tel: +47–2305 20 00)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Norway

Novartis Norge AS

Brynsalléen 4

Postboks 237 Økern

NO–0510 Oslo

(Tel: +47–2305 20 00)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Poland

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan

40 mg

film-coated tablets

Oral Use

Poland

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan

80 mg

film-coated tablets

Oral Use

Poland

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan

160 mg

film-coated tablets

Oral Use

Poland

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan

320 mg

film-coated tablets

Oral Use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Diovan

40 mg

film-coated tablets

Oral Use

Portugal

Laboratório Normal-Produtos Farmacêuticos, Lda

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Tareg

40 mg

film-coated tablets

Oral Use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Diovan

80 mg

film-coated tablets

Oral Use

Portugal

Laboratório Normal-Produtos Farmacêuticos, Lda

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Tareg

80 mg

film-coated tablets

Oral Use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Diovan

160 mg

film-coated tablets

Oral Use

Portugal

Laboratório Normal-Produtos Farmacêuticos, Lda

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Tareg

160 mg

film-coated tablets

Oral Use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Diovan

320 mg

film-coated tablets

Oral Use

Romania

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 40 mg,

film coated tablets

40 mg

film-coated tablets

Oral Use

Romania

Novartis

Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 80 mg, film coated tablets

80 mg

film-coated tablets

Oral Use

Romania

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 160 mg, film coated tablets

160 mg

film-coated tablets

Oral Use

Slovak Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

Czech Republic

(Tel +420-2–2577 51 11)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Slovak Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

Czech Republic

(Tel +420-2–2577 51 11)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Slovak Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

Czech Republic

(Tel +420-2–2577 51 11)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Slovak Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

Czech Republic

(Tel +420-2–2577 51 11)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 40 mg filmsko obložene tablete

40 mg

film-coated tablets

Oral Use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 80 mg filmsko obložene tablete

80 mg

film-coated tablets

Oral Use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 160 mg filmsko obložene tablete

160 mg

film-coated tablets

Oral Use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 320 mg filmsko obložene tablete

320 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Diován Cardio 40 mg comprimidos recubiertos con película

40 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Kalpress Cardio 40 mg comprimidos recubiertos con película

40 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Miten Cardio 40 mg comprimidos recubiertos con película

40 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Diován 80 mg comprimidos recubiertos con película

80 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Kalpress 80 mg comprimidos recubiertos con película

80 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Miten 80 mg comprimidos recubiertos con película

80 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Diován 160 mg comprimidos recubiertos con película

160 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Kalpress 160 mg comprimidos recubiertos con película

160 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Miten 160 mg comprimidos recubiertos con película

160 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Diován 320 mg comprimidos recubiertos con película

320 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Kalpress 320 mg comprimidos recubiertos con película

320 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Miten 320 mg comprimidos recubiertos con película

320 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Diovan

40 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Angiosan

40 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Valsartan Novartis

40 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Diovan

80 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Angiosan

80 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Valsartan Novartis

80 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Diovan

160 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Angiosan

160 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Valsartan Novartis

160 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Diovan

320 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Angiosan

320 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Valsartan Novartis

320 mg

film-coated tablets

Oral Use

United Kingdom

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

United Kingdom

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

United Kingdom

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

United Kingdom

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH, Brunner Strasse 59
  1235 Wien,
  Austria | Lescol 20 mg - Kapseln | 20 mg | Capsule, hard | Oral use |
| Austria | Novartis Pharma GmbH, Brunner Strasse 59
  1235 Wien,
  Austria | Lescol 40 mg - Kapseln | 40 mg | Capsule, hard | Oral use |
| Austria | Novartis Pharma GmbH, Brunner Strasse 59
  1235 Wien,
  Austria | Fluvastatin ‘Novartis’ 20 mg-Kapseln | 20 mg | Capsule, hard | Oral use |
| Austria | Novartis Pharma GmbH, Brunner Strasse 59
  1235 Wien,
  Austria | Fluvastatin ‘Novartis’ 40 mg-Kapseln | 40 mg | Capsule, hard | Oral use |
| Austria | Novartis Pharma GmbH, Brunner Strasse 59
  1235 Wien,
  Austria | Lescol MR 80 mg – Filmtabletten | 80 mg | Film-coated tablet | Oral use |
| Austria | Novartis Pharma GmbH, Brunner Strasse 59
  1235 Wien,
  Austria | Fluvastatin ‘Novartis’ MR 80 mg – Filmtabletten | 80 mg | Film-coated tablet | Oral use |
| Belgium | Novartis Pharma N.V.
  Medialaan, 40 bus 1,
  1800 Vilvoorde,
  Belgium | Lescol 20 mg, hard capsules | 20 mg | Capsule, hard | Oral use |
| Belgium | Novartis Pharma N.V.
  Medialaan, 40 bus 1,
  1800 Vilvoorde,
  Belgium | Lescol 40, hard capsules | 40 mg | Capsule, hard | Oral use |
| Belgium | Novartis Pharma N.V.
  Medialaan, 40 bus 1,
  1800 Vilvoorde,
  Belgium | Lescol Exel 80 mg prolonged-release tablet | 80 mg | Prolonged-release tablet | Oral use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25,
  90429 Nuremberg,
  Germany | Lescol caps. 40 mg | 40 mg | Capsule, hard | Oral use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25,
  90429 Nuremberg,
  Germany | Lescol XL prolonged release tablet 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Cyprus | Demetriades & Papaellinas Ltd.,
  Kasou 21, 1086 Nicosia,
  Cyprus | Lescol Capsule, 20mg | 20 mg | Capsule, hard | Oral use |
| Cyprus | Demetriades & Papaellinas Ltd.,
  Kasou 21, 1086 Nicosia,
  Cyprus | Lescol Capsule, 40mg | 40 mg | Capsule, hard | Oral use |
| Cyprus | Demetriades & Papaellinas Ltd.,
  Kasou 21, 1086 Nicosia,
  Cyprus | Lescol XL Prolonged release tablet 80mg | 80 mg | Film-coated tablet | Oral use |
| Czech Republic | Novartis, s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 - Nusle,
  Czech Republic | Lescol 20 mg | 20 mg | Capsule, hard | Oral use |
| Czech Republic | Novartis, s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 - Nusle,
  Czech Republic | Lescol 40 mg | 40 mg | Capsule, hard | Oral use |
| Czech Republic | Novartis, s.r.o.
  Na Pankráci 1724/129
  140 00 Praha 4 - Nusle,
  Czech Republic | Lescol XL | 80 mg | Film-coated tablet | Oral use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172,
  2100 København Ø,
  Denmark | Lescol | 20 mg | Capsule, hard | Oral use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172,
  2100 København Ø,
  Denmark | Lescol | 40 mg | Capsule, hard | Oral use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172
  2100 Kopenhagen Ø,
  Denmark | Lescol Depot | 80 mg | Prolonged-release tablet | Oral use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland | Lescol 40 mg | 40 mg | Capsule | Oral use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland | Lescol XL | 80 mg | Prolonged-release tablet | Oral use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FI–02130 Espoo
  Finland | Lescol 20 mg | 20 mg | Capsule, hard | Oral use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FI–02130 Espoo
  Finland | Lescol 40 mg | 40 mg | Capsule, hard | Oral use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FI–02130 Espoo
  Finland | Lescol Depot 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| France | Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,
  France | LESCOL 20 mg | 20 mg | Capsule, hard | Oral use |
| France | Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,
  France | LESCOL 40 mg | 40 mg | Capsule, hard | Oral use |
| France | Pierre FABRE MEDICAMENT
  45, place Abel Gance
  92100 Boulogne,
  France | Fractal 20 mg | 20 mg | Capsule, hard | Oral use |
| France | Pierre FABRE MEDICAMENT
  45, place Abel Gance
  92100 Boulogne,
  France | Fractal 40 mg | 40 mg | Capsule, hard | Oral use |
| France | Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,
  France | Lescol LP 80 mg | 80 mg | Film-coated, modified-release tablet | Oral use |
| France | Pierre FABRE MEDICAMENT
  45, place Abel Gance
  92100 Boulogne
  France | Fractal LP 80 mg | 80 mg | Film-coated, modified-release tablet | Oral use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg,
  Germany | Locol 20 mg Hartkapsel | 20 mg | Capsules, hard | Oral use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg,
  Germany | Locol 40 mg Hartkapsel | 40 mg | Capsules, hard | Oral use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg,
  Germany | Cranoc 20 mg Hartkapsel | 20 mg | Capsules, hard | Oral use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg,
  Germany | Cranoc 40 mg Hartkapsel | 40 mg | Capsules, hard | Oral use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg,
  Germany | Locol 80 mg Retardtabletten | 80 mg | Prolonged-release tablet | Oral use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  90429 Nürnberg,
  Germany | Cranoc 80mg
  Retardtabletten | 80 mg | Prolonged-release tablet | Oral use |
| Germany | Grünwalder Gesundheitsproducte GmbH
  Ruhlandstrasse 5, 83646 Bad Töltz,
  Germany | Fluvastatin-Novartis 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km), Metamorphosis
  GR-144 51 Athens
  Greece | Lescol® Capsule, hard 20mg | 20 mg | Capsule, hard | Oral use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens,
  Greece | Lescol® Capsule, hard 40mg | 40 mg | Capsule, hard | Oral use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens,
  Greece | Lescol®XL Prolonged-release tablet 80mg | 80 mg | Prolonged release tablet | Oral use |
| Hungary | Novartis Hungária Kft. Pharma
  Bartók Béla út 43-47, 5th Floor,
  1114 Budapest,
  Hungary | Lescol 40 mg hard caps | 40 mg | Capsule, hard | Oral use |
| Hungary | Novartis Hungária Kft. Pharma
  Bartók Béla út 43-47, 5th Floor,
  1114 Budapest,
  Hungary | Lescol XL 80 mg retard tablet | 80 mg | Prolonged-release tablet | Oral use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172,
  2100 København Ø,
  Denmark | Lescol 20 mg hard caps | 20 mg | Capsule, hard | Oral use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172,
  2100 København Ø,
  Denmark | Lescol 40 mg hard caps | 40 mg | Capsule, hard | Oral use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172,
  2100 København Ø,
  Denmark | Lescol Depot 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Ireland | Novartis Pharmaceuticals UK Limited
  Frimley Business Park,
  Frimley, Camberley, Surrey GU16 7SR,
  United Kingdom | Lescol 20mg Capsules | 20 mg | Capsule, hard | Oral use |
| Ireland | Novartis Pharmaceuticals UK Limited
  Frimley Business Park,
  Frimley, Camberley, Surrey GU16 7SR,
  United Kingdom | Lescol 40mg Capsules | 40 mg | Capsule, hard | Oral use |
| Ireland | Novartis Pharmaceuticals UK Limited
  Frimley Business Park,
  Frimley, Camberley, Surrey GU16 7SR,
  United Kingdom | Lescol XL 80mg prolonged release tablets | 80 mg | Prolonged release tablet | Oral use |
| Italy | Novartis Farma S.p.A.
  Largo Boccioni, 1,
  21040 Origgio (VA),
  Italy | Lescol | 20 mg | Capsule, hard | Oral use |
| Italy | Novartis Farma S.p.A.
  Largo Boccioni, 1,
  21040 Origgio (VA),
  Italy | Lescol | 40 mg | Capsule, hard | Oral use |
| Italy | ITALFARMACO S.p.A.
  Viale Fulvio Testi, 330
  20126 Milano
  Italy | Lipaxan | 20 mg | Capsule, hard | Oral use |
| Italy | ITALFARMACO S.p.A.
  Viale Fulvio Testi, 330
  20126 Milano
  Italy | Lipaxan | 40 mg | Capsule, hard | Oral use |
| Italy | UCB PHARMA S.p.A
  Via Gadames, 57
  20151 Milano
  Italy | Primesin | 20 mg | Capsule, hard | Oral use |
| Italy | UCB PHARMA S.p.A
  Via Gadames, 57
  20151 Milano
  Italy | Primesin | 40 mg | Capsule, hard | Oral use |
| Italy | SANDOZ S.p.A
  Address: Largo Umberto Boccioni 1
  I–21040 Origgio / VA
  Italy | FLUVASTATINA Sandoz | 20 mg | Capsule, hard | Oral use |
| Italy | SANDOZ S.p.A
  Address: Largo Umberto Boccioni 1
  I–21040 Origgio / VA
  Italy | FLUVASTATINA Sandoz 40 mg hard capsules | 40 mg | Capsule, hard | Oral use |
| Italy | Novartis Farma S.p.A.
  Largo Boccioni, 1,
  21040 Origgio (VA),
  Italy | Lescol 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Italy | ITALFARMACO S.p.A.
  Viale Fulvio Testi, 330
  20126 Milano
  Italy | Lipaxan 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Italy | UCB PHARMA S.p.A
  Via Gadames, 57
  20151 Milano
  Italy | Primesin 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland | Lescol XL 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo,
  Finland | Lescol XL | 80 mg | Prolonged-release tablet | Oral use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg,
  Germany | Locol 20 mg hard caps | 20 mg | Capsules, hard | Oral use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg,
  Germany | Locol 40 mg hard caps | 40 mg | Capsules, hard | Oral use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg,
  Germany | Locol 80 mg Retard tablet | 80 mg | Prolonged-release tablet | Oral use |
| Malta | Novartis Pharmaceuticals UK Limited
  Frimley Business Park,
  Frimley, Camberley, Surrey GU16 7SR,
  United Kingdom | Lescol | 20 mg | Capsule, hard | Oral use |
| Malta | Novartis Pharmaceuticals UK Limited
  Frimley Business Park,
  Frimley, Camberley, Surrey GU16 7SR,
  United Kingdom | Lescol | 40 mg | Capsule, hard | Oral use |
| Malta | Novartis Pharmaceuticals UK Limited
  Frimley Business Park,
  Frimley, Camberley, Surrey GU16 7SR,
  United Kingdom | Lescol XL | 80 mg | Film-coated tablet | Oral use |
| Norway | Novartis Norge AS,
  Postboks 237 Økern, 0510 Oslo,
  Norway | LESCOL | 20 mg | Capsule, hard | Oral use |
| Norway | Novartis Norge AS,
  Postboks 237 Økern, 0510 Oslo,
  Norway | LESCOL | 40 mg | Capsule, hard | Oral use |
| Norway | Novartis Norge AS,
  Postboks 237 Økern, 0510 Oslo,
  Norway | LESCOL DEPOT 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Netherlands | Novartis Pharma B.V.
  P.O. Box 241
  6800 LZ Arnhem
  The Netherlands | Lescol 20 mg, capsules | 20 mg | Capsule, hard | Oral use |
| Netherlands | Novartis Pharma B.V.
  Raapopseweg 1,
  6824 DP Arnhem,
  The Netherlands | Lescol 40 mg, capsules | 40 mg | Capsule, hard | Oral use |
| Netherlands | Novartis Pharma B.V.
  Raapopseweg 1,
  6824 DP Arnhem,
  The Netherlands | Lescol XL 80, tablet | 80 mg | Film-coated tablet | Oral use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25,
  D–90429Nürnberg,
  Germany | Lescol | 20 mg | Capsule, hard | Oral use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25,
  D–90429 Nürnberg,
  Germany | Lescol | 40 mg | Capsule, hard | Oral use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25,
  D–90429 Nürnberg,
  Germany | Lescol XL | 80 mg | Prolonged-release tablet | Oral use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edif. 8, Quinta de Beloura 2710-444, Sintra,
  Portugal | Lescol | 20 mg | Capsule, hard | Oral use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edif. 8, Quinta de Beloura 2710-444, Sintra,
  Portugal | Lescol | 40 mg | Capsule, hard | Oral use |
| Portugal | Bialport – Produtos Farmacêuticos, S.A.
  À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado
  Portugal | Cardiol 20 | 20 mg | Capsule, hard | Oral use |
| Portugal | Bialport – Produtos Farmacêuticos, S.A.
  À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado
  Portugal | Cardiol 40 | 40 mg | Capsule, hard | Oral use |
| Portugal | Laboratório Normal - Produtos Farmacêuticos, S.A.
  Rua do Centro empresarial, Edifício 8,
  Quinta da Beloura
  2710-444 Sintra
  Portugal | Canef | 20 mg | Capsule, hard | Oral use |
| Portugal | Laboratório Normal - Produtos Farmacêuticos, S.A.
  Rua do Centro empresarial, Edifício 8,
  Quinta da Beloura
  2710-444 Sintra
  Portugal | Canef | 40 mg | Capsule, hard | Oral use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edif. 8,
  Quinta de Beloura 2710-444, Sintra,
  Portugal | Lescol XL | 80 mg | Prolonged-release tablet | Oral use |
| Portugal | Bialport – Produtos Farmacêuticos, S.A.
  À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado
  Portugal | Cardiol XL | 80 mg | Prolonged-release tablet | Oral use |
| Portugal | Laboratório Normal - Produtos Farmacêuticos, S.A.
  Rua do Centro empresarial, Edifício 8,
  Quinta da Beloura
  2710-444 Sintra
  Portugal | Canef 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Romania | NOVARTIS PHARMA GmbH
  Roonstrasse 25, D–90429 Nürnberg,
  Germany | LESCOL 20 mg | 20 mg | Capsule, hard | Oral use |
| Romania | NOVARTIS PHARMA GmbH
  Roonstrasse 25, D–90429 Nürnberg,
  Germany | LESCOL 40 mg | 40 mg | Capsule, hard | Oral use |
| Romania | NOVARTIS PHARMA GmbH
  Roonstrasse 25, D–90429 Nürnberg,
  Germany | LESCOL XL | 80 mg | Prolonged-release tablet | Oral use |
| Slovak Republic | Novartis, s.r.o.
  U Nákladového nádraží 10,
  13000 Prague 3,
  Czech Republic | Lescol 20 mg | 20 mg | Capsule, hard | Oral use |
| Slovak Republic | Novartis, s.r.o.
  U Nákladového nádraží 10,
  13000 Prague 3,
  Czech Republic | Lescol 40 mg | 40 mg | Capsule, hard | Oral use |
| Slovak Republic | Novartis, s.r.o.
  U Nákladového nádraží 10,
  13000 Prague 3,
  Czech Republic | Lescol XL 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25, D–90429 Nürnberg,
  Germany | Lescol 40 mg trde kapsule | 40 mg | Capsule, hard | Oral use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25, D–90429 Nürnberg,
  Germany | Lescol XL 80 mg tablete s podaljšanim sproščanjem | 80 mg | Prolonged-release tablet | Oral use |
| Spain | Novartis Farmacéutica S.A.
  Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
  Spain | Lescol 20 mg caps | 20 mg | Capsule, hard | Oral use |
| Spain | Novartis Farmacéutica S.A.
  Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
  Spain | Lescol 40 mg caps | 40 mg | Capsule, hard | Oral use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona,
  Spain | Liposit 20 mg caps | 20 mg | Capsule, hard | Oral use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona,
  Spain | Liposit 40 mg caps | 40 mg | Capsule, hard | Oral use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona,
  Spain | Vaditon 20 mg caps | 20 mg | Capsule, hard | Oral use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona,
  Spain | Vaditon 40 mg caps | 40 mg | Capsule, hard | Oral use |
| Spain | Novartis Farmacéutica, S.A.
  Av. Diagonal, 507
  08029 Barcelona,
  Spain | Digaril 20 mg caps | 20 mg | Capsule, hard | Oral use |
| Spain | Novartis Farmacéutica, S.A.
  Av. Diagonal, 507
  08029 Barcelona,
  Spain | Digaril 40 mg caps | 40 mg | Capsule, hard | Oral use |
| Spain | GRÜNENTHAL PHARMA, S.A.
  Doctor Zamenhof no 36
  28027 Madrid,
  Spain | Lymetel 20 mg caps | 20 mg | Capsule, hard | Oral use |
| Spain | GRÜNENTHAL PHARMA, S.A.
  Doctor Zamenhof no 36
  28027 Madrid,
  Spain | Lymetel 40 mg caps | 40 mg | Capsule, hard | Oral use |
| Spain | Novartis Farmacéutica S.A.
  Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,
  Spain | Lescol prolib 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  Spain | Liposit Prolib 80 | 80 mg | Prolonged-release tablet | Oral use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  Spain | Vaditon Prolib 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Spain | Novartis Farmacéutica, S.A.
  Av. Diagonal, 507
  08029 Barcelona
  Spain | Digaril Prolib 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Spain | Laboratorios Andrómaco, S.A.
  Doctor Zamenhof no 36
  28027 Madrid
  Spain | Lymetel Prolib 80 mg | 80 mg | Prolonged-release tablet | Oral use |
| Sweden | Novartis Sverige AB
  Box 1150,
  18311 Täby,
  Sweden | Lescol | 20 mg | Capsule, hard | Oral use |
| Sweden | Novartis Sverige AB
  Box 1150,
  18311 Täby,
  Sweden | Lescol | 40 mg | Capsule, hard | Oral use |
| Sweden | Novartis Sverige AB
  Box 1150,
  18311 Täby,
  Sweden | Lescol Depot | 80 mg | Prolonged-release tablet | Oral use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  (Trading as Sandoz Pharmaceuticals)
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | LESCOL CAPSULES 20MG | 20 mg | Capsule, hard | Oral use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  (Trading as Sandoz Pharmaceuticals)
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | LESCOL CAPSULES 40MG | 40 mg | Capsule, hard | Oral use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  (Trading as Sandoz Pharmaceuticals)
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom | LESCOLXL 80 mg Prolonged Release Tablets | 80 mg | Prolonged-release tablet | Oral use |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Novartis Pharma GmbH, Brunner Strasse 59

1235 Wien,

Austria

Lescol 20 mg - Kapseln

20 mg

Capsule, hard

Oral use

Austria

Novartis Pharma GmbH, Brunner Strasse 59

1235 Wien,

Austria

Lescol 40 mg - Kapseln

40 mg

Capsule, hard

Oral use

Austria

Novartis Pharma GmbH, Brunner Strasse 59

1235 Wien,

Austria

Fluvastatin ‘Novartis’ 20 mg-Kapseln

20 mg

Capsule, hard

Oral use

Austria

Novartis Pharma GmbH, Brunner Strasse 59

1235 Wien,

Austria

Fluvastatin ‘Novartis’ 40 mg-Kapseln

40 mg

Capsule, hard

Oral use

Austria

Novartis Pharma GmbH, Brunner Strasse 59

1235 Wien,

Austria

Lescol MR 80 mg – Filmtabletten

80 mg

Film-coated tablet

Oral use

Austria

Novartis Pharma GmbH, Brunner Strasse 59

1235 Wien,

Austria

Fluvastatin ‘Novartis’ MR 80 mg – Filmtabletten

80 mg

Film-coated tablet

Oral use

Belgium

Novartis Pharma N.V.

Medialaan, 40 bus 1,

1800 Vilvoorde,

Belgium

Lescol 20 mg, hard capsules

20 mg

Capsule, hard

Oral use

Belgium

Novartis Pharma N.V.

Medialaan, 40 bus 1,

1800 Vilvoorde,

Belgium

Lescol 40, hard capsules

40 mg

Capsule, hard

Oral use

Belgium

Novartis Pharma N.V.

Medialaan, 40 bus 1,

1800 Vilvoorde,

Belgium

Lescol Exel 80 mg prolonged-release tablet

80 mg

Prolonged-release tablet

Oral use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25,

90429 Nuremberg,

Germany

Lescol caps. 40 mg

40 mg

Capsule, hard

Oral use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25,

90429 Nuremberg,

Germany

Lescol XL prolonged release tablet 80 mg

80 mg

Prolonged-release tablet

Oral use

Cyprus

Demetriades & Papaellinas Ltd.,

Kasou 21, 1086 Nicosia,

Cyprus

Lescol Capsule, 20mg

20 mg

Capsule, hard

Oral use

Cyprus

Demetriades & Papaellinas Ltd.,

Kasou 21, 1086 Nicosia,

Cyprus

Lescol Capsule, 40mg

40 mg

Capsule, hard

Oral use

Cyprus

Demetriades & Papaellinas Ltd.,

Kasou 21, 1086 Nicosia,

Cyprus

Lescol XL Prolonged release tablet 80mg

80 mg

Film-coated tablet

Oral use

Czech Republic

Novartis, s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle,

Czech Republic

Lescol 20 mg

20 mg

Capsule, hard

Oral use

Czech Republic

Novartis, s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle,

Czech Republic

Lescol 40 mg

40 mg

Capsule, hard

Oral use

Czech Republic

Novartis, s.r.o.

Na Pankráci 1724/129

140 00 Praha 4 - Nusle,

Czech Republic

Lescol XL

80 mg

Film-coated tablet

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172,

2100 København Ø,

Denmark

Lescol

20 mg

Capsule, hard

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172,

2100 København Ø,

Denmark

Lescol

40 mg

Capsule, hard

Oral use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø,

Denmark

Lescol Depot

80 mg

Prolonged-release tablet

Oral use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

Lescol 40 mg

40 mg

Capsule

Oral use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

Lescol XL

80 mg

Prolonged-release tablet

Oral use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FI–02130 Espoo

Finland

Lescol 20 mg

20 mg

Capsule, hard

Oral use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FI–02130 Espoo

Finland

Lescol 40 mg

40 mg

Capsule, hard

Oral use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FI–02130 Espoo

Finland

Lescol Depot 80 mg

80 mg

Prolonged-release tablet

Oral use

France

Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,

France

LESCOL 20 mg

20 mg

Capsule, hard

Oral use

France

Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,

France

LESCOL 40 mg

40 mg

Capsule, hard

Oral use

France

Pierre FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne,

France

Fractal 20 mg

20 mg

Capsule, hard

Oral use

France

Pierre FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne,

France

Fractal 40 mg

40 mg

Capsule, hard

Oral use

France

Novartis Pharma S.A.S. 2 & 4, rue Lionel Terray, 92500 Rueil Malmaison Cédex,

France

Lescol LP 80 mg

80 mg

Film-coated, modified-release tablet

Oral use

France

Pierre FABRE MEDICAMENT

45, place Abel Gance

92100 Boulogne

France

Fractal LP 80 mg

80 mg

Film-coated, modified-release tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg,

Germany

Locol 20 mg Hartkapsel

20 mg

Capsules, hard

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg,

Germany

Locol 40 mg Hartkapsel

40 mg

Capsules, hard

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg,

Germany

Cranoc 20 mg Hartkapsel

20 mg

Capsules, hard

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg,

Germany

Cranoc 40 mg Hartkapsel

40 mg

Capsules, hard

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg,

Germany

Locol 80 mg Retardtabletten

80 mg

Prolonged-release tablet

Oral use

Germany

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg,

Germany

Cranoc 80mg

Retardtabletten

80 mg

Prolonged-release tablet

Oral use

Germany

Grünwalder Gesundheitsproducte GmbH

Ruhlandstrasse 5, 83646 Bad Töltz,

Germany

Fluvastatin-Novartis 80 mg

80 mg

Prolonged-release tablet

Oral use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km), Metamorphosis

GR-144 51 Athens

Greece

Lescol® Capsule, hard 20mg

20 mg

Capsule, hard

Oral use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens,

Greece

Lescol® Capsule, hard 40mg

40 mg

Capsule, hard

Oral use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens,

Greece

Lescol®XL Prolonged-release tablet 80mg

80 mg

Prolonged release tablet

Oral use

Hungary

Novartis Hungária Kft. Pharma

Bartók Béla út 43-47, 5th Floor,

1114 Budapest,

Hungary

Lescol 40 mg hard caps

40 mg

Capsule, hard

Oral use

Hungary

Novartis Hungária Kft. Pharma

Bartók Béla út 43-47, 5th Floor,

1114 Budapest,

Hungary

Lescol XL 80 mg retard tablet

80 mg

Prolonged-release tablet

Oral use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172,

2100 København Ø,

Denmark

Lescol 20 mg hard caps

20 mg

Capsule, hard

Oral use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172,

2100 København Ø,

Denmark

Lescol 40 mg hard caps

40 mg

Capsule, hard

Oral use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172,

2100 København Ø,

Denmark

Lescol Depot 80 mg

80 mg

Prolonged-release tablet

Oral use

Ireland

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley, Camberley, Surrey GU16 7SR,

United Kingdom

Lescol 20mg Capsules

20 mg

Capsule, hard

Oral use

Ireland

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley, Camberley, Surrey GU16 7SR,

United Kingdom

Lescol 40mg Capsules

40 mg

Capsule, hard

Oral use

Ireland

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley, Camberley, Surrey GU16 7SR,

United Kingdom

Lescol XL 80mg prolonged release tablets

80 mg

Prolonged release tablet

Oral use

Italy

Novartis Farma S.p.A.

Largo Boccioni, 1,

21040 Origgio (VA),

Italy

Lescol

20 mg

Capsule, hard

Oral use

Italy

Novartis Farma S.p.A.

Largo Boccioni, 1,

21040 Origgio (VA),

Italy

Lescol

40 mg

Capsule, hard

Oral use

Italy

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italy

Lipaxan

20 mg

Capsule, hard

Oral use

Italy

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italy

Lipaxan

40 mg

Capsule, hard

Oral use

Italy

UCB PHARMA S.p.A

Via Gadames, 57

20151 Milano

Italy

Primesin

20 mg

Capsule, hard

Oral use

Italy

UCB PHARMA S.p.A

Via Gadames, 57

20151 Milano

Italy

Primesin

40 mg

Capsule, hard

Oral use

Italy

SANDOZ S.p.A

Address: Largo Umberto Boccioni 1

I–21040 Origgio / VA

Italy

FLUVASTATINA Sandoz

20 mg

Capsule, hard

Oral use

Italy

SANDOZ S.p.A

Address: Largo Umberto Boccioni 1

I–21040 Origgio / VA

Italy

FLUVASTATINA Sandoz 40 mg hard capsules

40 mg

Capsule, hard

Oral use

Italy

Novartis Farma S.p.A.

Largo Boccioni, 1,

21040 Origgio (VA),

Italy

Lescol 80 mg

80 mg

Prolonged-release tablet

Oral use

Italy

ITALFARMACO S.p.A.

Viale Fulvio Testi, 330

20126 Milano

Italy

Lipaxan 80 mg

80 mg

Prolonged-release tablet

Oral use

Italy

UCB PHARMA S.p.A

Via Gadames, 57

20151 Milano

Italy

Primesin 80 mg

80 mg

Prolonged-release tablet

Oral use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

Lescol XL 80 mg

80 mg

Prolonged-release tablet

Oral use

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo,

Finland

Lescol XL

80 mg

Prolonged-release tablet

Oral use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg,

Germany

Locol 20 mg hard caps

20 mg

Capsules, hard

Oral use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg,

Germany

Locol 40 mg hard caps

40 mg

Capsules, hard

Oral use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg,

Germany

Locol 80 mg Retard tablet

80 mg

Prolonged-release tablet

Oral use

Malta

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley, Camberley, Surrey GU16 7SR,

United Kingdom

Lescol

20 mg

Capsule, hard

Oral use

Malta

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley, Camberley, Surrey GU16 7SR,

United Kingdom

Lescol

40 mg

Capsule, hard

Oral use

Malta

Novartis Pharmaceuticals UK Limited

Frimley Business Park,

Frimley, Camberley, Surrey GU16 7SR,

United Kingdom

Lescol XL

80 mg

Film-coated tablet

Oral use

Norway

Novartis Norge AS,

Postboks 237 Økern, 0510 Oslo,

Norway

LESCOL

20 mg

Capsule, hard

Oral use

Norway

Novartis Norge AS,

Postboks 237 Økern, 0510 Oslo,

Norway

LESCOL

40 mg

Capsule, hard

Oral use

Norway

Novartis Norge AS,

Postboks 237 Økern, 0510 Oslo,

Norway

LESCOL DEPOT 80 mg

80 mg

Prolonged-release tablet

Oral use

Netherlands

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

The Netherlands

Lescol 20 mg, capsules

20 mg

Capsule, hard

Oral use

Netherlands

Novartis Pharma B.V.

Raapopseweg 1,

6824 DP Arnhem,

The Netherlands

Lescol 40 mg, capsules

40 mg

Capsule, hard

Oral use

Netherlands

Novartis Pharma B.V.

Raapopseweg 1,

6824 DP Arnhem,

The Netherlands

Lescol XL 80, tablet

80 mg

Film-coated tablet

Oral use

Poland

Novartis Pharma GmbH

Roonstrasse 25,

D–90429Nürnberg,

Germany

Lescol

20 mg

Capsule, hard

Oral use

Poland

Novartis Pharma GmbH

Roonstrasse 25,

D–90429 Nürnberg,

Germany

Lescol

40 mg

Capsule, hard

Oral use

Poland

Novartis Pharma GmbH

Roonstrasse 25,

D–90429 Nürnberg,

Germany

Lescol XL

80 mg

Prolonged-release tablet

Oral use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edif. 8, Quinta de Beloura 2710-444, Sintra,

Portugal

Lescol

20 mg

Capsule, hard

Oral use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edif. 8, Quinta de Beloura 2710-444, Sintra,

Portugal

Lescol

40 mg

Capsule, hard

Oral use

Portugal

Bialport – Produtos Farmacêuticos, S.A.

À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado

Portugal

Cardiol 20

20 mg

Capsule, hard

Oral use

Portugal

Bialport – Produtos Farmacêuticos, S.A.

À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado

Portugal

Cardiol 40

40 mg

Capsule, hard

Oral use

Portugal

Laboratório Normal - Produtos Farmacêuticos, S.A.

Rua do Centro empresarial, Edifício 8,

Quinta da Beloura

2710-444 Sintra

Portugal

Canef

20 mg

Capsule, hard

Oral use

Portugal

Laboratório Normal - Produtos Farmacêuticos, S.A.

Rua do Centro empresarial, Edifício 8,

Quinta da Beloura

2710-444 Sintra

Portugal

Canef

40 mg

Capsule, hard

Oral use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edif. 8,

Quinta de Beloura 2710-444, Sintra,

Portugal

Lescol XL

80 mg

Prolonged-release tablet

Oral use

Portugal

Bialport – Produtos Farmacêuticos, S.A.

À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado

Portugal

Cardiol XL

80 mg

Prolonged-release tablet

Oral use

Portugal

Laboratório Normal - Produtos Farmacêuticos, S.A.

Rua do Centro empresarial, Edifício 8,

Quinta da Beloura

2710-444 Sintra

Portugal

Canef 80 mg

80 mg

Prolonged-release tablet

Oral use

Romania

NOVARTIS PHARMA GmbH

Roonstrasse 25, D–90429 Nürnberg,

Germany

LESCOL 20 mg

20 mg

Capsule, hard

Oral use

Romania

NOVARTIS PHARMA GmbH

Roonstrasse 25, D–90429 Nürnberg,

Germany

LESCOL 40 mg

40 mg

Capsule, hard

Oral use

Romania

NOVARTIS PHARMA GmbH

Roonstrasse 25, D–90429 Nürnberg,

Germany

LESCOL XL

80 mg

Prolonged-release tablet

Oral use

Slovak Republic

Novartis, s.r.o.

U Nákladového nádraží 10,

13000 Prague 3,

Czech Republic

Lescol 20 mg

20 mg

Capsule, hard

Oral use

Slovak Republic

Novartis, s.r.o.

U Nákladového nádraží 10,

13000 Prague 3,

Czech Republic

Lescol 40 mg

40 mg

Capsule, hard

Oral use

Slovak Republic

Novartis, s.r.o.

U Nákladového nádraží 10,

13000 Prague 3,

Czech Republic

Lescol XL 80 mg

80 mg

Prolonged-release tablet

Oral use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25, D–90429 Nürnberg,

Germany

Lescol 40 mg trde kapsule

40 mg

Capsule, hard

Oral use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25, D–90429 Nürnberg,

Germany

Lescol XL 80 mg tablete s podaljšanim sproščanjem

80 mg

Prolonged-release tablet

Oral use

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,

Spain

Lescol 20 mg caps

20 mg

Capsule, hard

Oral use

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,

Spain

Lescol 40 mg caps

40 mg

Capsule, hard

Oral use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona,

Spain

Liposit 20 mg caps

20 mg

Capsule, hard

Oral use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona,

Spain

Liposit 40 mg caps

40 mg

Capsule, hard

Oral use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona,

Spain

Vaditon 20 mg caps

20 mg

Capsule, hard

Oral use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona,

Spain

Vaditon 40 mg caps

40 mg

Capsule, hard

Oral use

Spain

Novartis Farmacéutica, S.A.

Av. Diagonal, 507

08029 Barcelona,

Spain

Digaril 20 mg caps

20 mg

Capsule, hard

Oral use

Spain

Novartis Farmacéutica, S.A.

Av. Diagonal, 507

08029 Barcelona,

Spain

Digaril 40 mg caps

40 mg

Capsule, hard

Oral use

Spain

GRÜNENTHAL PHARMA, S.A.

Doctor Zamenhof no 36

28027 Madrid,

Spain

Lymetel 20 mg caps

20 mg

Capsule, hard

Oral use

Spain

GRÜNENTHAL PHARMA, S.A.

Doctor Zamenhof no 36

28027 Madrid,

Spain

Lymetel 40 mg caps

40 mg

Capsule, hard

Oral use

Spain

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanas, N° 764, 08013, Barcelona,

Spain

Lescol prolib 80 mg

80 mg

Prolonged-release tablet

Oral use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Liposit Prolib 80

80 mg

Prolonged-release tablet

Oral use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Vaditon Prolib 80 mg

80 mg

Prolonged-release tablet

Oral use

Spain

Novartis Farmacéutica, S.A.

Av. Diagonal, 507

08029 Barcelona

Spain

Digaril Prolib 80 mg

80 mg

Prolonged-release tablet

Oral use

Spain

Laboratorios Andrómaco, S.A.

Doctor Zamenhof no 36

28027 Madrid

Spain

Lymetel Prolib 80 mg

80 mg

Prolonged-release tablet

Oral use

Sweden

Novartis Sverige AB

Box 1150,

18311 Täby,

Sweden

Lescol

20 mg

Capsule, hard

Oral use

Sweden

Novartis Sverige AB

Box 1150,

18311 Täby,

Sweden

Lescol

40 mg

Capsule, hard

Oral use

Sweden

Novartis Sverige AB

Box 1150,

18311 Täby,

Sweden

Lescol Depot

80 mg

Prolonged-release tablet

Oral use

United Kingdom

Novartis Pharmaceuticals UK Ltd

(Trading as Sandoz Pharmaceuticals)

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

LESCOL CAPSULES 20MG

20 mg

Capsule, hard

Oral use

United Kingdom

Novartis Pharmaceuticals UK Ltd

(Trading as Sandoz Pharmaceuticals)

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

LESCOL CAPSULES 40MG

40 mg

Capsule, hard

Oral use

United Kingdom

Novartis Pharmaceuticals UK Ltd

(Trading as Sandoz Pharmaceuticals)

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

LESCOLXL 80 mg Prolonged Release Tablets

80 mg

Prolonged-release tablet

Oral use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Diovan 40 mg Filmtabletten | 40 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Angiosan 40 mg Filmtabletten | 40 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Diovan 80 mg Filmtabletten | 80 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Angiosan 80 mg Filmtabletten | 80 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Diovan 160 mg Filmtabletten | 160 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Angiosan 160 mg Filmtabletten | 160 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Diovan 320 mg Filmtabletten | 320 mg | film-coated tablets | Oral Use |
| Austria | Novartis Pharma GmbH
  Stella-Klein-Löw-Weg 17
  A–1020 Wien
  (Tel: + 43-1–8665 70) | Angiosan 320 mg Filmtabletten | 320 mg | film-coated tablets | Oral Use |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40, bus 1
  B–1800 Vilvoorde
  (Tel: +32-2-246 16 11) | Diovane 40 mg | 40 mg | film-coated tablets | Oral Use |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40, bus 1
  B–1800 Vilvoorde
  (Tel: +32-2-246 16 11) | Diovane 80 mg | 80 mg | film-coated tablets | Oral Use |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40, bus 1
  B–1800 Vilvoorde
  (Tel: +32-2-246 16 11) | Diovane 160 mg | 160 mg | film-coated tablets | Oral Use |
| Belgium | N.V. Novartis Pharma S.A.
  Medialaan 40, bus 1
  B–1800 Vilvoorde
  (Tel: +32-2-246 16 11) | Diovane 320 mg | 320 mg | film-coated tablets | Oral Use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Bulgaria | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Cyprus | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Cyprus | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Cyprus | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Cyprus | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Czech Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  (Tel +420-2–2577 51 11) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Czech Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  (Tel +420-2–2577 51 11) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Denmark | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  (Tel: +45-39-16 84 00) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan | 40 mg | film-coated tablets | Oral Use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan | 80 mg | film-coated tablets | Oral Use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan | 160 mg | film-coated tablets | Oral Use |
| Estonia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan | 320 mg | film-coated tablets | Oral Use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Finland | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  (Tel: + 358-9–6133 22 11) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| France | Novartis Pharma S.A.S.
  2 and 4, rue Lionel Terray
  92500 RUEIL-MALMAISON
  (Tel: +33-1–5547 60 00) | Tareg 40 mg | 40 mg | film-coated tablets | Oral Use |
| France | Novartis Pharma S.A.S.
  2 and 4, rue Lionel Terray
  92500 RUEIL-MALMAISON
  (Tel: +33-1–5547 60 00) | Tareg 80 mg | 80 mg | film-coated tablets | Oral Use |
| France | Novartis Pharma S.A.S.
  2 and 4, rue Lionel Terray
  92500 RUEIL-MALMAISON
  (Tel: +33-1–5547 60 00) | Tareg 160 mg | 160 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Cordinate 40 mg | 40 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Provas 40 mg | 40 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Cordinate 80 mg | 80 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Provas 80 mg | 80 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 160 mg protect | 160 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Cordinate 160 mg | 160 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Provas 160 mg | 160 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Diovan 320 mg forte | 320 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Cordinate 320 mg | 320 mg | film-coated tablets | Oral Use |
| Germany | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  (Tel: +49-911-273-0) | Provas 320 mg | 320 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Dalzad 40 mg | 40 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Dalzad 80 mg | 80 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Dalzad 160 mg | 160 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Greece | Novartis (Hellas) S.A.C.I.
  National Road No. 1 (12th Km)
  Metamorphosis
  GR-144 51 Athens
  (Tel: +30-210-281 17 12) | Dalzad 320 mg | 320 mg | film-coated tablets | Oral Use |
| Hungary | Novartis Hungaria Kft.
  Bartók Béla út 43-47
  H–1114 Budapest
  (Tel: +36-1-457 65 00) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Hungary | Novartis Hungaria Kft.
  Bartók Béla út 43-47
  H–1114 Budapest
  (Tel: +36-1-457 65 00) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Hungary | Novartis Hungaria Kft.
  Bartók Béla út 43-47
  H–1114 Budapest
  (Tel: +36-1-457 65 00) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Hungary | Novartis Hungaria Kft.
  Bartók Béla út 43-47
  H–1114 Budapest
  (Tel: +36-1-457 65 00) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  Denmark
  (Tel: +45-39-16 84 00) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  Denmark
  (Tel: +45-39-16 84 00) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  Denmark
  (Tel: +45-39-16 84 00) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Iceland | Novartis Healthcare A/S
  Lyngbyvej 172
  DK–2100 København Ø
  Denmark
  (Tel: +45-39-16 84 00) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Ireland | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Ireland | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Ireland | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Ireland | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Tareg 40 mg | 40 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Rixil 40 mg | 40 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Tareg 80 mg | 80 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Rixil 80 mg | 80 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Tareg 160 mg | 160 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Rixil 160 mg | 160 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Tareg 320 mg | 320 mg | film-coated tablets | Oral Use |
| Italy | Novartis Farma S.p.A.
  Largo Umberto Boccioni 1
  I–21040 Origgio
  (Tel: + 39-02–96542214) | Rixil 320 mg | 320 mg | film-coated tablets | Oral Use |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Latvia | Novartis Finland OY
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan 80 mg plėvele dengtos tabletės | 80 mg | film-coated tablets | Oral Use |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan 160 mg plėvele dengtos tabletės | 160 mg | film-coated tablets | Oral Use |
| Lithuania | Novartis Finland Oy
  Metsänneidonkuja 10
  FIN–02130 Espoo
  Finland
  (Tel: + 358-9–6133 22 11) | Diovan 320 mg plėvele dengtos tabletės | 320 mg | film-coated tablets | Oral Use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Luxembourg | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Malta | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Malta | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Malta | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Malta | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  United Kingdom
  (Tel: +44–1276-69 22 55) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Netherlands | Novartis Pharma B.V.
  Postbus 241
  NL–6824 DP Arnhem
  (Tel: + 31-26-378 21 00) | Diovan 40 | 40 mg | film-coated tablets | Oral Use |
| Netherlands | Novartis Pharma B.V.
  Postbus 241
  NL–6800 LZ Arnhem
  (Tel: + 31-26-378 21 00) | Diovan 80 | 80 mg | film-coated tablets | Oral Use |
| Netherlands | Novartis Pharma B.V.
  Postbus 241
  NL–6824 DP Arnhem
  (Tel: + 31-26-378 21 00) | Diovan 160 | 160 mg | film-coated tablets | Oral Use |
| Netherlands | Novartis Pharma B.V.
  Postbus 241
  NL–6824 DP Arnhem
  (Tel: + 31-26-378 21 00) | Diovan 320 | 320 mg | film-coated tablets | Oral Use |
| Norway | Novartis Norge AS
  Brynsalléen 4
  Postboks 237 Økern
  NO–0510 Oslo
  (Tel: +47–2305 20 00) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Norway | Novartis Norge AS
  Brynsalléen 4
  Postboks 237 Økern
  NO–0510 Oslo
  (Tel: +47–2305 20 00) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Norway | Novartis Norge AS
  Brynsalléen 4
  Postboks 237 Økern
  NO–0510 Oslo
  (Tel: +47–2305 20 00) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Norway | Novartis Norge AS
  Brynsalléen 4
  Postboks 237 Økern
  NO–0510 Oslo
  (Tel: +47–2305 20 00) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan | 40 mg | film-coated tablets | Oral Use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan | 80 mg | film-coated tablets | Oral Use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan | 160 mg | film-coated tablets | Oral Use |
| Poland | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan | 320 mg | film-coated tablets | Oral Use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Diovan | 40 mg | film-coated tablets | Oral Use |
| Portugal | Laboratório Normal-Produtos Farmacêuticos, Lda
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Tareg | 40 mg | film-coated tablets | Oral Use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Diovan | 80 mg | film-coated tablets | Oral Use |
| Portugal | Laboratório Normal-Produtos Farmacêuticos, Lda
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Tareg | 80 mg | film-coated tablets | Oral Use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Diovan | 160 mg | film-coated tablets | Oral Use |
| Portugal | Laboratório Normal-Produtos Farmacêuticos, Lda
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Tareg | 160 mg | film-coated tablets | Oral Use |
| Portugal | Novartis Farma - Produtos Farmacêuticos S.A.
  Rua do Centro Empresarial, Edificio 8
  Quinta da Beloura
  P–2710-444 Sintra
  (Tel: +351 21000 86 00) | Diovan | 320 mg | film-coated tablets | Oral Use |
| Romania | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 40 mg,
  film coated tablets | 40 mg | film-coated tablets | Oral Use |
| Romania | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 80 mg, film coated tablets | 80 mg | film-coated tablets | Oral Use |
| Romania | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 160 mg, film coated tablets | 160 mg | film-coated tablets | Oral Use |
| Slovak Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  Czech Republic
  (Tel +420-2–2577 51 11) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| Slovak Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  Czech Republic
  (Tel +420-2–2577 51 11) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| Slovak Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  Czech Republic
  (Tel +420-2–2577 51 11) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| Slovak Republic | NOVARTIS s.r.o. Pharma
  Nagano III.
  U Nákladového nádraží 10
  130 00 Praha 3
  Czech Republic
  (Tel +420-2–2577 51 11) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 40 mg filmsko obložene tablete | 40 mg | film-coated tablets | Oral Use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 80 mg filmsko obložene tablete | 80 mg | film-coated tablets | Oral Use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 160 mg filmsko obložene tablete | 160 mg | film-coated tablets | Oral Use |
| Slovenia | Novartis Pharma GmbH
  Roonstrasse 25
  D–90429 Nürnberg
  Germany
  (Tel: +49-911-273-0) | Diovan 320 mg filmsko obložene tablete | 320 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Diován Cardio 40 mg comprimidos recubiertos con película | 40 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Kalpress Cardio 40 mg comprimidos recubiertos con película | 40 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Miten Cardio 40 mg comprimidos recubiertos con película | 40 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Diován 80 mg comprimidos recubiertos con película | 80 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Kalpress 80 mg comprimidos recubiertos con película | 80 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Miten 80 mg comprimidos recubiertos con película | 80 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Diován 160 mg comprimidos recubiertos con película | 160 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Kalpress 160 mg comprimidos recubiertos con película | 160 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Miten 160 mg comprimidos recubiertos con película | 160 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Diován 320 mg comprimidos recubiertos con película | 320 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Kalpress 320 mg comprimidos recubiertos con película | 320 mg | film-coated tablets | Oral Use |
| Spain | Novartis Farmacéutica, S.A.
  Gran Via de les Corts Catalanes, 764
  08013 Barcelona
  (Tel: +34-93-306 42 00) | Miten 320 mg comprimidos recubiertos con película | 320 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Diovan | 40 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Angiosan | 40 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Valsartan Novartis | 40 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Diovan | 80 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Angiosan | 80 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Valsartan Novartis | 80 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Diovan | 160 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Angiosan | 160 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Valsartan Novartis | 160 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Diovan | 320 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Angiosan | 320 mg | film-coated tablets | Oral Use |
| Sweden | Novartis Sverige AB
  Kemistvägen 1B
  P.O. Box 1150
  SE-183 11 Täby
  (Tel: + 46-8-732 32 00) | Valsartan Novartis | 320 mg | film-coated tablets | Oral Use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  (Tel: +44–1276-69 22 55) | Diovan 40 mg | 40 mg | film-coated tablets | Oral Use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  (Tel: +44–1276-69 22 55) | Diovan 80 mg | 80 mg | film-coated tablets | Oral Use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  (Tel: +44–1276-69 22 55) | Diovan 160 mg | 160 mg | film-coated tablets | Oral Use |
| United Kingdom | Novartis Pharmaceuticals UK Ltd
  FrimleyBusinessPark
  Frimley, Camberley
  Surrey GU16 7SR
  (Tel: +44–1276-69 22 55) | Diovan 320 mg | 320 mg | film-coated tablets | Oral Use |

Member State EU/EEA

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical Form

Route of administration

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Diovan 40 mg Filmtabletten

40 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Angiosan 40 mg Filmtabletten

40 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Diovan 80 mg Filmtabletten

80 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Angiosan 80 mg Filmtabletten

80 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Diovan 160 mg Filmtabletten

160 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Angiosan 160 mg Filmtabletten

160 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Diovan 320 mg Filmtabletten

320 mg

film-coated tablets

Oral Use

Austria

Novartis Pharma GmbH

Stella-Klein-Löw-Weg 17

A–1020 Wien

(Tel: + 43-1–8665 70)

Angiosan 320 mg Filmtabletten

320 mg

film-coated tablets

Oral Use

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B–1800 Vilvoorde

(Tel: +32-2-246 16 11)

Diovane 40 mg

40 mg

film-coated tablets

Oral Use

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B–1800 Vilvoorde

(Tel: +32-2-246 16 11)

Diovane 80 mg

80 mg

film-coated tablets

Oral Use

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B–1800 Vilvoorde

(Tel: +32-2-246 16 11)

Diovane 160 mg

160 mg

film-coated tablets

Oral Use

Belgium

N.V. Novartis Pharma S.A.

Medialaan 40, bus 1

B–1800 Vilvoorde

(Tel: +32-2-246 16 11)

Diovane 320 mg

320 mg

film-coated tablets

Oral Use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Bulgaria

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Cyprus

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Cyprus

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Cyprus

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Cyprus

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Czech Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

(Tel +420-2–2577 51 11)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Czech Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

(Tel +420-2–2577 51 11)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Denmark

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

(Tel: +45-39-16 84 00)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan

40 mg

film-coated tablets

Oral Use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan

80 mg

film-coated tablets

Oral Use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan

160 mg

film-coated tablets

Oral Use

Estonia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan

320 mg

film-coated tablets

Oral Use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Finland

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

(Tel: + 358-9–6133 22 11)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

France

Novartis Pharma S.A.S.

2 and 4, rue Lionel Terray

92500 RUEIL-MALMAISON

(Tel: +33-1–5547 60 00)

Tareg 40 mg

40 mg

film-coated tablets

Oral Use

France

Novartis Pharma S.A.S.

2 and 4, rue Lionel Terray

92500 RUEIL-MALMAISON

(Tel: +33-1–5547 60 00)

Tareg 80 mg

80 mg

film-coated tablets

Oral Use

France

Novartis Pharma S.A.S.

2 and 4, rue Lionel Terray

92500 RUEIL-MALMAISON

(Tel: +33-1–5547 60 00)

Tareg 160 mg

160 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Cordinate 40 mg

40 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Provas 40 mg

40 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Cordinate 80 mg

80 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Provas 80 mg

80 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 160 mg protect

160 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Cordinate 160 mg

160 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Provas 160 mg

160 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Diovan 320 mg forte

320 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Cordinate 320 mg

320 mg

film-coated tablets

Oral Use

Germany

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

(Tel: +49-911-273-0)

Provas 320 mg

320 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Dalzad 40 mg

40 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Dalzad 80 mg

80 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Dalzad 160 mg

160 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Greece

Novartis (Hellas) S.A.C.I.

National Road No. 1 (12th Km)

Metamorphosis

GR-144 51 Athens

(Tel: +30-210-281 17 12)

Dalzad 320 mg

320 mg

film-coated tablets

Oral Use

Hungary

Novartis Hungaria Kft.

Bartók Béla út 43-47

H–1114 Budapest

(Tel: +36-1-457 65 00)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Hungary

Novartis Hungaria Kft.

Bartók Béla út 43-47

H–1114 Budapest

(Tel: +36-1-457 65 00)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Hungary

Novartis Hungaria Kft.

Bartók Béla út 43-47

H–1114 Budapest

(Tel: +36-1-457 65 00)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Hungary

Novartis Hungaria Kft.

Bartók Béla út 43-47

H–1114 Budapest

(Tel: +36-1-457 65 00)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

Denmark

(Tel: +45-39-16 84 00)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

Denmark

(Tel: +45-39-16 84 00)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

Denmark

(Tel: +45-39-16 84 00)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Iceland

Novartis Healthcare A/S

Lyngbyvej 172

DK–2100 København Ø

Denmark

(Tel: +45-39-16 84 00)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Ireland

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Ireland

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Ireland

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Ireland

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Tareg 40 mg

40 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Rixil 40 mg

40 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Tareg 80 mg

80 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Rixil 80 mg

80 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Tareg 160 mg

160 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Rixil 160 mg

160 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Tareg 320 mg

320 mg

film-coated tablets

Oral Use

Italy

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I–21040 Origgio

(Tel: + 39-02–96542214)

Rixil 320 mg

320 mg

film-coated tablets

Oral Use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Latvia

Novartis Finland OY

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan 80 mg plėvele dengtos tabletės

80 mg

film-coated tablets

Oral Use

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan 160 mg plėvele dengtos tabletės

160 mg

film-coated tablets

Oral Use

Lithuania

Novartis Finland Oy

Metsänneidonkuja 10

FIN–02130 Espoo

Finland

(Tel: + 358-9–6133 22 11)

Diovan 320 mg plėvele dengtos tabletės

320 mg

film-coated tablets

Oral Use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Luxembourg

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Malta

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Malta

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Malta

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Malta

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

United Kingdom

(Tel: +44–1276-69 22 55)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Netherlands

Novartis Pharma B.V.

Postbus 241

NL–6824 DP Arnhem

(Tel: + 31-26-378 21 00)

Diovan 40

40 mg

film-coated tablets

Oral Use

Netherlands

Novartis Pharma B.V.

Postbus 241

NL–6800 LZ Arnhem

(Tel: + 31-26-378 21 00)

Diovan 80

80 mg

film-coated tablets

Oral Use

Netherlands

Novartis Pharma B.V.

Postbus 241

NL–6824 DP Arnhem

(Tel: + 31-26-378 21 00)

Diovan 160

160 mg

film-coated tablets

Oral Use

Netherlands

Novartis Pharma B.V.

Postbus 241

NL–6824 DP Arnhem

(Tel: + 31-26-378 21 00)

Diovan 320

320 mg

film-coated tablets

Oral Use

Norway

Novartis Norge AS

Brynsalléen 4

Postboks 237 Økern

NO–0510 Oslo

(Tel: +47–2305 20 00)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Norway

Novartis Norge AS

Brynsalléen 4

Postboks 237 Økern

NO–0510 Oslo

(Tel: +47–2305 20 00)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Norway

Novartis Norge AS

Brynsalléen 4

Postboks 237 Økern

NO–0510 Oslo

(Tel: +47–2305 20 00)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Norway

Novartis Norge AS

Brynsalléen 4

Postboks 237 Økern

NO–0510 Oslo

(Tel: +47–2305 20 00)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Poland

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan

40 mg

film-coated tablets

Oral Use

Poland

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan

80 mg

film-coated tablets

Oral Use

Poland

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan

160 mg

film-coated tablets

Oral Use

Poland

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan

320 mg

film-coated tablets

Oral Use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Diovan

40 mg

film-coated tablets

Oral Use

Portugal

Laboratório Normal-Produtos Farmacêuticos, Lda

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Tareg

40 mg

film-coated tablets

Oral Use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Diovan

80 mg

film-coated tablets

Oral Use

Portugal

Laboratório Normal-Produtos Farmacêuticos, Lda

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Tareg

80 mg

film-coated tablets

Oral Use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Diovan

160 mg

film-coated tablets

Oral Use

Portugal

Laboratório Normal-Produtos Farmacêuticos, Lda

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Tareg

160 mg

film-coated tablets

Oral Use

Portugal

Novartis Farma - Produtos Farmacêuticos S.A.

Rua do Centro Empresarial, Edificio 8

Quinta da Beloura

P–2710-444 Sintra

(Tel: +351 21000 86 00)

Diovan

320 mg

film-coated tablets

Oral Use

Romania

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 40 mg,

film coated tablets

40 mg

film-coated tablets

Oral Use

Romania

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 80 mg, film coated tablets

80 mg

film-coated tablets

Oral Use

Romania

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 160 mg, film coated tablets

160 mg

film-coated tablets

Oral Use

Slovak Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

Czech Republic

(Tel +420-2–2577 51 11)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

Slovak Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

Czech Republic

(Tel +420-2–2577 51 11)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

Slovak Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

Czech Republic

(Tel +420-2–2577 51 11)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

Slovak Republic

NOVARTIS s.r.o. Pharma

Nagano III.

U Nákladového nádraží 10

130 00 Praha 3

Czech Republic

(Tel +420-2–2577 51 11)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 40 mg filmsko obložene tablete

40 mg

film-coated tablets

Oral Use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 80 mg filmsko obložene tablete

80 mg

film-coated tablets

Oral Use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 160 mg filmsko obložene tablete

160 mg

film-coated tablets

Oral Use

Slovenia

Novartis Pharma GmbH

Roonstrasse 25

D–90429 Nürnberg

Germany

(Tel: +49-911-273-0)

Diovan 320 mg filmsko obložene tablete

320 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Diován Cardio 40 mg comprimidos recubiertos con película

40 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Kalpress Cardio 40 mg comprimidos recubiertos con película

40 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Miten Cardio 40 mg comprimidos recubiertos con película

40 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Diován 80 mg comprimidos recubiertos con película

80 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Kalpress 80 mg comprimidos recubiertos con película

80 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Miten 80 mg comprimidos recubiertos con película

80 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Diován 160 mg comprimidos recubiertos con película

160 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Kalpress 160 mg comprimidos recubiertos con película

160 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Miten 160 mg comprimidos recubiertos con película

160 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Diován 320 mg comprimidos recubiertos con película

320 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Kalpress 320 mg comprimidos recubiertos con película

320 mg

film-coated tablets

Oral Use

Spain

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

(Tel: +34-93-306 42 00)

Miten 320 mg comprimidos recubiertos con película

320 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Diovan

40 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Angiosan

40 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Valsartan Novartis

40 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Diovan

80 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Angiosan

80 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Valsartan Novartis

80 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Diovan

160 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Angiosan

160 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Valsartan Novartis

160 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Diovan

320 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Angiosan

320 mg

film-coated tablets

Oral Use

Sweden

Novartis Sverige AB

Kemistvägen 1B

P.O. Box 1150

SE-183 11 Täby

(Tel: + 46-8-732 32 00)

Valsartan Novartis

320 mg

film-coated tablets

Oral Use

United Kingdom

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

(Tel: +44–1276-69 22 55)

Diovan 40 mg

40 mg

film-coated tablets

Oral Use

United Kingdom

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

(Tel: +44–1276-69 22 55)

Diovan 80 mg

80 mg

film-coated tablets

Oral Use

United Kingdom

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

(Tel: +44–1276-69 22 55)

Diovan 160 mg

160 mg

film-coated tablets

Oral Use

United Kingdom

Novartis Pharmaceuticals UK Ltd

FrimleyBusinessPark

Frimley, Camberley

Surrey GU16 7SR

(Tel: +44–1276-69 22 55)

Diovan 320 mg

320 mg

film-coated tablets

Oral Use

---

ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | (Invented) name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | Losec 10mg – Kapseln | 10 mg | capsule, hard | Oral use | |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | Losec 20mg – Kapseln | 20 mg | capsule, hard | Oral use | |
| Austria | AstraZeneca Österreich GmbH,
  Schwarzenbergplatz 7,
  A-1037 Wien
  Austria | Losec 40 mg -Trockenstechampulle mit Lösungsmittel | 40 mg | Powder for solution for injection | Intravenous use | 40 mg |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec 40mg Forte, harde maagsapresistente capsules | 40 mg | Hard Gastroresistant capsules | Oral use | |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec 40 mg, poeder voor oplossing voor intraveneuze infusie | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec-Mups 10mg, 10 mg, maagsapresistente tabletten | 10 mg | Gastroresistant tablets | Oral use | |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec-Mups 20mg, 20 mg, maagsapresistente tabletten | 20 mg | Gastroresistant tablets | Oral use | |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec-Mups 40mg, 40 mg, maagsapresistente tabletten | 40 mg | Gastroresistant tablets | Oral use | |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussel
  Belgium | Omeprazole AstraZeneca 20mg, harde maagsapresistente capsules | 20 mg | Hard Gastroresistant capsules | Oral use | |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussel
  Belgium | Omeprazole AstraZeneca 40mg Forte, harde maagsapresistente capsules | 40 mg | Hard Gastroresistant capsules | Oral use | |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Omeprazole AstraZeneca 40mg, poeder voor oplossing voor intraveneuze infusie | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Logastric 10mg, maagsapresistente capsules | 10 mg | Hard Gastroresistant capsules | Oral use | |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Logastric 20mg, maagsapresistente capsules | 20 mg | Hard Gastroresistant capsules | Oral use | |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Logastric 40mg Forte, maagsapresistente capsules | 40 mg | Hard Gastroresistant capsules | Oral use | |
| Belgium | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Logastric-Mups 40mg, 40 mg, maagsapresistente tabletten | 40 mg | Gastroresistant tablets | Oral use | |
| Cyprus | AstraZeneca AB,
  151 85 Södertälje
  Sweden | Losec Mups | 10mg | Gastro-resistant tablets | Oral use | |
| Cyprus | AstraZeneca AB,
  151 85 Södertälje
  Sweden | Losec Mups | 20mg | Gastro-resistant tablets | Oral use | |
| Czech Republic | AstraZeneca UK Ltd., Silk Road Business Park, SK10 2NA Macclesfield, Cheshire, United Kingdom | LOSEC 20 mg | 20 mg | Gastro-resistant capsule, hard | Oral use | |
| Czech Republic | AstraZeneca UK Ltd., Silk Road Business Park, SK10 2NA Macclesfield, Cheshire, United Kingdom | LOSEC 40 mg | 40 mg | Powder for solution for infusion | Intravenous use | |
| Denmark | AstraZeneca A/S
  Roskildevej 22
  2620 Albertslund
  Denmark | Losec | 10 mg | Gastroresistant tablets | Oral use | |
| Denmark | AstraZeneca A/S
  Roskildevej 22
  2620 Albertslund
  Denmark | Losec | 20 mg | Gastroresistant tablets | Oral use | |
| Denmark | AstraZeneca A/S
  Roskildevej 22
  2620 Albertslund
  Denmark | Losec | 40 mg | Gastroresistant tablets | Oral use | |
| Denmark | AstraZeneca A/S
  Roskildevej 22
  2620 Albertslund
  Denmark | Losec | 40 mg/ml | Powder and Solvens for solution for injection | Intravenous use | 40 mg |
| Denmark | AstraZeneca A/S
  Roskildevej 22
  2620 Albertslund
  Denmark | Losec | 40 mg/ml | Powder for solution for infusion | Intravenous use | 40 mg |
| Estonia | AstraZeneca AB,
  S-151 85 Södertälje Sweden | Losec MUPS | 20 mg | Gastroresistant tablets | Oral use | |
| Estonia | AstraZeneca AB,
  S-151 85 Södertälje Sweden | Losec 40 MG | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Finland | AstraZeneca Oy
  Luomanportti 3
  FI-02200 Espoo
  Finland | Losec Mups 10 mg enterotabletti | 10 mg | Gastroresistant tablet | Oral use | |
| Finland | AstraZeneca Oy
  Luomanportti 3
  FI-02200 Espoo
  Finland | Losec Mups 20 mg enterotabletti | 20 mg | Gastroresistant tablet | Oral use | |
| Finland | AstraZeneca Oy
  Luomanportti 3
  FI-02200 Espoo
  Finland | Losec Mups 40 mg enterotabletti | 40 mg | Gastroresistant tablet | Oral use | |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | MOPRAL® 20 mg microgranules gastrorésistants en gélule | 20 mg | Capsules | Oral use | |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | MOPRAL® 10 mg microgranules gastrorésistants en gélule | 10 mg | Capsules | Oral use | |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | ZOLTUM® 20 mg microgranules gastrorésistants en gélule | 20 mg | Capsules | Oral use | |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | ZOLTUM® 10 mg microgranules gastrorésistants en gélule | 10 mg | Capsules | Oral use | |
| France | AstraZeneca
  1, Place Renault
  92844 RUEIL-MALMAISON Cedex
  France | MOPRAL 40 mg, lyophilisat pour perfusion (IV). | 40 mg | Lyophylizat for perfusion | Intravenous use | 40 mg |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | Antra pro infusione | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | Antra MUPS 10 mg | 10 mg | Gastro-resistant tablets | Oral use | |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | Antra MUPS 20 mg | 20 mg | Gastro-resistant tablets | Oral use | |
| Germany | AstraZeneca GmbH
  22876 Wedel
  Germany | Antra MUPS 40 mg | 40 mg | Gastro-resistant tablets | Oral use | |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi Athens
  Greece | Losec®, Γαστροανθεκτικό καψάκιο σκληρό 10 mg/CAP | 10 mg | Gastro-resistant capsules, hard | Oral use | |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi Athens
  Greece | Losec®, Γαστροανθεκτικό καψάκιο σκληρό 20 mg/CAP | 20 mg | Gastro-resistant capsules, hard | Oral use | |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi Athens
  Greece | Losec®, Γαστροανθεκτικό καψάκιο σκληρό 40 mg/CAP | 40 mg | Gastro-resistant capsules, hard | Oral use | |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi Athens
  Greece | Losec MUPS®, Γαστροανθεκτικό δισκίο 10 mg/TAB | 10 mg | Gastro-resistant tablets | Oral use | |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi Athens
  Greece | Losec MUPS®, Γαστροανθεκτικό δισκίο 20 mg/TAB | 20 m | Gastro-resistant tablets | Oral use | |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi Athens
  Greece | Losec MUPS®, Γαστροανθεκτικό δισκίο 40 mg/TAB | 40 mg | Gastro-resistant tablets | Oral use | |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi Athens
  Greece | Losec®, Ενέσιμο λυόφιλο 40 mg/VIAL | 40 mg | Powder and solvent for solution for injection | Intravenous use | 40 mg |
| Greece | AstraZeneca S.A.
  4 Theotokopoulou & Astronafton str
  151 25 Maroussi Athens
  Greece | Losec®, Ενέσιμο λυόφιλο για ενδοφλέβια έγχυση 40 mg/VIAL | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Hungary | AstraZeneca Kft.
  H-2045 Törökbálint, Park u. 3.
  Hungary | Losec 10 mg kapszula | 10 mg | Capsule, hard | Oral use | |
| Hungary | AstraZeneca Kft.
  H-2045 Törökbálint, Park u. 3.
  Hungary | Losec 20 mg kapszulaz | 20 mg | Capsule, hard | Oral use | |
| Hungary | AstraZeneca Kft.
  H-2045 Törökbálint, Park u. 3.
  Hungary | Losec 40 mg por infúzióhoz | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Iceland | AstraZeneca A/S
  Roskildevej 22
  DK-2620 Albertslund
  Denmark | Losec | 10 mg | Gastroresistant tablets | Oral use | |
| Iceland | AstraZeneca A/S
  Roskildevej 22
  DK-2620 Albertslund
  Denmark | Losec | 20 mg | Gastroresistant tablets | Oral use | |
| Iceland | AstraZeneca A/S
  Roskildevej 22
  DK-2620 Albertslund
  Denmark | Losec | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec MUPS Tablets 10mg | 10mg | Gastro-resistant, film-coated tablet | Oral use | |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec MUPS Tablets 20mg | 20mg | Gastro-resistant, film-coated tablet | Oral use | |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec MUPS Tablets 40mg | 40mg | Gastro-resistant, film-coated tablet | Oral use | |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec Losec 40mg Powder for Solution for Infusion | 40mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Ireland | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec IV 40mg Powder and Solvent for Solution for Injection | 40mg | Powder and solvent for solution for injection | Intravenous use | 40 mg |
| Italy | AstraZeneca S.p.A.
  Via F. Sforza
  Palazzo Volta
  20080 Basiglio (MI)
  Italy | Antra 10 mg capsule rigide a rilascio modificato | 10 mg | Hard modified release capsules | Oral use | |
| Italy | AstraZeneca S.p.A.
  Via F. Sforza
  Palazzo Volta
  20080 Basiglio (MI)
  Italy | Antra 20 mg capsule rigide a rilascio modificato | 20 mg | Hard modified release capsules | Oral use | |
| Italy | AstraZeneca S.p.A.
  Via F. Sforza
  Palazzo Volta
  20080 Basiglio (MI)
  Italy | Antra 40 mg capsule rigide a rilascio modificato | 40 mg | Hard modified release capsules | Oral use | |
| Italy | AstraZeneca S.p.A.
  Via F. Sforza
  Palazzo Volta
  20080 Basiglio (MI)
  Italy | Antra 40 mg polvere per soluzione per infusione | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Italy | AstraZeneca AB,
  S-151 85 Södertälje
  Sweden | Losec 10 mg capsule rigide a rilascio modificato | 10 mg | Hard modified release capsules | Oral use | |
| Italy | AstraZeneca AB,
  S-151 85 Södertälje
  Sweden | Losec 20 mg capsule rigide a rilascio modificato | 20 mg | Hard modified release capsules | Oral use | |
| Italy | AstraZeneca AB,
  S-151 85 Södertälje
  Sweden | Losec 40 mg capsule rigide a rilascio modificato | 40 mg | Hard modified release capsules | Oral use | |
| Italy | AstraZeneca AB,
  S-151 85 Södertälje
  Sweden | Losec 40 mg polvere per soluzione per infusione | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Italy | Bracco S.p.A.
  Via E. Folli 50
  20134 Milano
  Italy | Mepral 10 mg capsule rigide a rilascio modificato | 10 mg | Hard modified release capsules | Oral use | |
| Italy | Bracco S.p.A.
  Via E. Folli 50
  20134 Milano
  Italy | Mepral 20 mg capsule rigide a rilascio modificato | 20 mg | Hard modified release capsules | Oral use | |
| Italy | Bracco S.p.A.
  Via E. Folli 50
  20134 Milano
  Italy | Mepral 40 mg capsule rigide a rilascio modificato | 40 mg | Hard modified release capsules | Oral use | |
| Italy | Bracco S.p.A.
  Via E. Folli 50
  20134 Milano
  Italy | Mepral 40 mg polvere per soluzione per infusione | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Italy | Malesci Istituto Farmacobiologico S.p.A.
  Via Lungo l'Ema 7
  50015 Bagno a Ripoli (FI)
  Italy | Omeprazen 10 mg capsule rigide a rilascio modificato | 10 mg | Hard modified release capsules | Oral use | |
| Italy | Malesci Istituto Farmacobiologico S.p.A.
  Via Lungo l'Ema 7
  50015 Bagno a Ripoli (FI)
  Italy | Omeprazen 20 mg capsule rigide a rilascio modificato | 20 mg | Hard modified release capsules | Oral use | |
| Italy | Malesci Istituto Farmacobiologico S.p.A.
  Via Lungo l'Ema 7
  50015 Bagno a Ripoli (FI)
  Italy | Omeprazen 40 mg capsule rigide a rilascio modificato | 40 mg | Hard modified release capsules | Oral use | |
| Italy | Malesci Istituto Farmacobiologico S.p.A.
  Via Lungo l'Ema 7
  50015 Bagno a Ripoli (FI)
  Italy | Omeprazen 40 mg polvere per soluzione per infusione | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Latvia | AstraZeneca AB,
  S-151 85 Södertälje Sweden | Losec 40 mg pulveris infūziju šķīduma pagatavošanai | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec Forte Gelules 40mg | 40 mg | Hard gastroresis-tant capsules | Oral use | |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec poudre pour perfusion 40 mg | 40 mg | Powder for solution for intravenous infusion | Intravenous use | 40 mg |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec-Mups 10mg | 10 mg | Gastroresistant tablets | Oral use | |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec-Mups 20mg | 20 mg | Gastroresistant tablets | Oral use | |
| Luxembourg | NV AstraZeneca SA
  Egide Van Ophemstraat 110
  1180 Brussels
  Belgium | Losec-Mups 40mg | 40 mg | Gastroresistant tablets | Oral use | |
| Malta | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec MUPS Tablets 10mg | 10mg | Gastro-resistant, film-coated tablet | Oral use | |
| Malta | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec MUPS Tablets 20mg | 20mg | Gastro-resistant, film-coated tablet | Oral use | |
| Netherlands | AstraZeneca BV
  Postbus 599
  2700 AN, Zoetermeer
  The Netherlands | Losec 10 | 10 mg | Gstroresistant capsules | Oral use | |
| Netherlands | AstraZeneca BV
  Postbus 599
  2700 AN, Zoetermeer
  The Netherlands | Losec 20 | 20 mg | Gastroresistant capsules | Oral use | |
| Netherlands | AstraZeneca BV
  Postbus 599
  2700 AN, Zoetermeer
  The Netherlands | Losec 40 | 40 mg | Gastroresistant capsules | Oral use | |
| Netherlands | AstraZeneca BV
  Postbus 599
  2700 AN, Zoetermeer
  The Netherlands | Losec | 40 mg | Powder and solvent for solution for injection | Intravenous use | 40 mg |
| Netherlands | AstraZeneca BV
  Postbus 599
  2700 AN, Zoetermeer
  The Netherlands | Losec Infuus | 40 mg | Powder for solution for intravenous infusion | Intravenous use | 40 mg |
| Netherlands | AstraZeneca BV
  Postbus 599
  2700 AN, Zoetermeer
  The Netherlands | Losec MUPS 10 | 10 mg | Gastroresistant tablets | Oral use | |
| Netherlands | AstraZeneca BV
  Postbus 599
  2700 AN, Zoetermeer
  The Netherlands | Losec MUPS 20 | 20 mg | Gastroresistant tablets | Oral use | |
| Netherlands | AstraZeneca BV
  Postbus 599
  2700 AN, Zoetermeer
  The Netherlands | Losec MUPS 40 | 40 mg | Gastroresistant tablets | Oral use | |
| Norway | AstraZeneca AS,
  Postboks 200 Vinderen, 0319 OSLO
  Norway | Losec® MUPS® | 10 mg | Gastroresistant tablets | Oral use | |
| Norway | AstraZeneca AS,
  Postboks 200 Vinderen, 0319 OSLO
  Norway | Losec® MUPS® | 20 mg | Gastroresistant tablets | Oral use | |
| Norway | AstraZeneca AS,
  Postboks 200 Vinderen, 0319 OSLO
  Norway | Losec® | 40mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Poland | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec 10 | 10mg | Capsules | Oral use | |
| Poland | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec | 20mg | Capsules | Oral use | |
| Poland | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec | 40mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Valejas
  2745-663 Barcarena
  Portugal | Losec | 20 mg | Gastroresistant capsules | Oral use | |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Valejas
  2745-663 Barcarena
  Portugal | Losec | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Portugal | AstraZeneca Produtos Farmacêuticos, Lda.
  Rua Humberto Madeira, n.o 7, Valejas
  2745-663 Barcarena
  Portugal | Losec | 40 mg | Powder and solvent for injectable solution | Intravenous use | 40 mg |
| Romania | AstraZeneca AB,
  S-151 85 Södertälje
  Sweden | Losec MUPS 10 mg coprimate filmate gastrorezistente | 10 mg | Film-coated gastroresistant tablets | Oral use | |
| Romania | AstraZeneca AB,
  S-151 85 Södertälje
  Sweden | Losec MUPS 20 mg
  comprimate filmate gastrorezistene | 20mg | Film-coated gastroresistant tablets | Oral use | |
| Romania | AstraZeneca AB,
  S-151 85 Södertälje
  Sweden | Losec 40mg liofilizat pentru solutie perfuzabila | 40mg | Lyophilisate for solution for infusion | Intravenous use | 40 mg |
| Slovak Republic | AstraZeneca AB,
  S-151 85 Södertälje
  Sweden | Losec® | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| Spain | Laboratorio Tau, S.A.
  C/Serrano Galvache, 56 Edificio Roble
  28033 Madrid
  Spain | LOSEC infusión i.v. | 40 mg | Powder for infusion | Intravenous use | 40 mg |
| Spain | Laboratorio Tau, S.A.
  C/Serrano Galvache, 56 Edificio Roble
  28033 Madrid
  Spain | LOSEC cápsulas 20 mg | 20 mg | Capsules, hard | Oral use | |
| Sweden | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec | 10 mg | Gastro-resistant tablets | Oral use | |
| Sweden | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec | 20 mg | Gastro-resistant tablets | Oral use | |
| Sweden | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec | 40 mg | Gastro-resistant tablets | Oral use | |
| Sweden | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec | 40 mg | Powder for solution for injection | Intravenous use | 40 mg |
| Sweden | AstraZeneca AB
  S-151 85 Södertälje
  Sweden | Losec | 40 mg | Powder for solution for infusion | Intravenous use | 40 mg |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec MUPS Tablets 10mg | 10mg | Film-coated Tablet | Oral use | |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec MUPS Tablets 20mg | 20mg | Film-coated Tablet | Oral use | |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec MUPS Tablets 40mg | 40mg | Film-coated Tablet | Oral use | |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec Capsules 10mg | 10mg | Hard gelatin capsules | Oral use | |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec Capsules 20mg | 20mg | Hard gelatin capsules | Oral use | |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec Capsules 40mg | 40mg | Hard gelatine capsules | Oral use | |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec Infusion 40mg | 40mg | Powder for solution for infusion | Intravenous use | 40 mg |
| United Kingdom | AstraZeneca UK Limited
  600 Capability Green
  Luton LU1 3LU
  United Kingdom | Losec IV Injection 40mg | 40mg | Powder and solvent for solution for injection | Intravenous use | 40 mg |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

Losec 10mg – Kapseln

10 mg

capsule, hard

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

Losec 20mg – Kapseln

20 mg

capsule, hard

Oral use

Austria

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7,

A-1037 Wien

Austria

Losec 40 mg -Trockenstechampulle mit Lösungsmittel

40 mg

Powder for solution for injection

Intravenous use

40 mg

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec 40mg Forte, harde maagsapresistente capsules

40 mg

Hard Gastroresistant capsules

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec 40 mg, poeder voor oplossing voor intraveneuze infusie

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec-Mups 10mg, 10 mg, maagsapresistente tabletten

10 mg

Gastroresistant tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec-Mups 20mg, 20 mg, maagsapresistente tabletten

20 mg

Gastroresistant tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec-Mups 40mg, 40 mg, maagsapresistente tabletten

40 mg

Gastroresistant tablets

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel

Belgium

Omeprazole AstraZeneca 20mg, harde maagsapresistente capsules

20 mg

Hard Gastroresistant capsules

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel

Belgium

Omeprazole AstraZeneca 40mg Forte, harde maagsapresistente capsules

40 mg

Hard Gastroresistant capsules

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Omeprazole AstraZeneca 40mg, poeder voor oplossing voor intraveneuze infusie

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Logastric 10mg, maagsapresistente capsules

10 mg

Hard Gastroresistant capsules

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Logastric 20mg, maagsapresistente capsules

20 mg

Hard Gastroresistant capsules

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Logastric 40mg Forte, maagsapresistente capsules

40 mg

Hard Gastroresistant capsules

Oral use

Belgium

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Logastric-Mups 40mg, 40 mg, maagsapresistente tabletten

40 mg

Gastroresistant tablets

Oral use

Cyprus

AstraZeneca AB,

151 85 Södertälje

Sweden

Losec Mups

10mg

Gastro-resistant tablets

Oral use

Cyprus

AstraZeneca AB,

151 85 Södertälje

Sweden

Losec Mups

20mg

Gastro-resistant tablets

Oral use

Czech Republic

AstraZeneca UK Ltd., Silk Road Business Park, SK10 2NA Macclesfield, Cheshire, United Kingdom

LOSEC 20 mg

20 mg

Gastro-resistant capsule, hard

Oral use

Czech Republic

AstraZeneca UK Ltd., Silk Road Business Park, SK10 2NA Macclesfield, Cheshire, United Kingdom

LOSEC 40 mg

40 mg

Powder for solution for infusion

Intravenous use

Denmark

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Losec

10 mg

Gastroresistant tablets

Oral use

Denmark

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Losec

20 mg

Gastroresistant tablets

Oral use

Denmark

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Losec

40 mg

Gastroresistant tablets

Oral use

Denmark

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Losec

40 mg/ml

Powder and Solvens for solution for injection

Intravenous use

40 mg

Denmark

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Losec

40 mg/ml

Powder for solution for infusion

Intravenous use

40 mg

Estonia

AstraZeneca AB,

S-151 85 Södertälje Sweden

Losec MUPS

20 mg

Gastroresistant tablets

Oral use

Estonia

AstraZeneca AB,

S-151 85 Södertälje Sweden

Losec 40 MG

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Finland

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Losec Mups 10 mg enterotabletti

10 mg

Gastroresistant tablet

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Losec Mups 20 mg enterotabletti

20 mg

Gastroresistant tablet

Oral use

Finland

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Losec Mups 40 mg enterotabletti

40 mg

Gastroresistant tablet

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

MOPRAL® 20 mg microgranules gastrorésistants en gélule

20 mg

Capsules

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

MOPRAL® 10 mg microgranules gastrorésistants en gélule

10 mg

Capsules

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

ZOLTUM® 20 mg microgranules gastrorésistants en gélule

20 mg

Capsules

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

ZOLTUM® 10 mg microgranules gastrorésistants en gélule

10 mg

Capsules

Oral use

France

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cedex

France

MOPRAL 40 mg, lyophilisat pour perfusion (IV).

40 mg

Lyophylizat for perfusion

Intravenous use

40 mg

Germany

AstraZeneca GmbH

22876 Wedel

Germany

Antra pro infusione

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Germany

AstraZeneca GmbH

22876 Wedel

Germany

Antra MUPS 10 mg

10 mg

Gastro-resistant tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

Antra MUPS 20 mg

20 mg

Gastro-resistant tablets

Oral use

Germany

AstraZeneca GmbH

22876 Wedel

Germany

Antra MUPS 40 mg

40 mg

Gastro-resistant tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi Athens

Greece

Losec®, Γαστροανθεκτικό καψάκιο σκληρό 10 mg/CAP

10 mg

Gastro-resistant capsules, hard

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi Athens

Greece

Losec®, Γαστροανθεκτικό καψάκιο σκληρό 20 mg/CAP

20 mg

Gastro-resistant capsules, hard

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi Athens

Greece

Losec®, Γαστροανθεκτικό καψάκιο σκληρό 40 mg/CAP

40 mg

Gastro-resistant capsules, hard

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi Athens

Greece

Losec MUPS®, Γαστροανθεκτικό δισκίο 10 mg/TAB

10 mg

Gastro-resistant tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi Athens

Greece

Losec MUPS®, Γαστροανθεκτικό δισκίο 20 mg/TAB

20 m

Gastro-resistant tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi Athens

Greece

Losec MUPS®, Γαστροανθεκτικό δισκίο 40 mg/TAB

40 mg

Gastro-resistant tablets

Oral use

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi Athens

Greece

Losec®, Ενέσιμο λυόφιλο 40 mg/VIAL

40 mg

Powder and solvent for solution for injection

Intravenous use

40 mg

Greece

AstraZeneca S.A.

4 Theotokopoulou & Astronafton str

151 25 Maroussi Athens

Greece

Losec®, Ενέσιμο λυόφιλο για ενδοφλέβια έγχυση 40 mg/VIAL

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Hungary

AstraZeneca Kft.

H-2045 Törökbálint, Park u. 3.

Hungary

Losec 10 mg kapszula

10 mg

Capsule, hard

Oral use

Hungary

AstraZeneca Kft.

H-2045 Törökbálint, Park u. 3.

Hungary

Losec 20 mg kapszulaz

20 mg

Capsule, hard

Oral use

Hungary

AstraZeneca Kft.

H-2045 Törökbálint, Park u. 3.

Hungary

Losec 40 mg por infúzióhoz

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Iceland

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund

Denmark

Losec

10 mg

Gastroresistant tablets

Oral use

Iceland

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund

Denmark

Losec

20 mg

Gastroresistant tablets

Oral use

Iceland

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund

Denmark

Losec

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec MUPS Tablets 10mg

10mg

Gastro-resistant, film-coated tablet

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec MUPS Tablets 20mg

20mg

Gastro-resistant, film-coated tablet

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec MUPS Tablets 40mg

40mg

Gastro-resistant, film-coated tablet

Oral use

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec Losec 40mg Powder for Solution for Infusion

40mg

Powder for solution for infusion

Intravenous use

40 mg

Ireland

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec IV 40mg Powder and Solvent for Solution for Injection

40mg

Powder and solvent for solution for injection

Intravenous use

40 mg

Italy

AstraZeneca S.p.A.

Via F. Sforza

Palazzo Volta

20080 Basiglio (MI)

Italy

Antra 10 mg capsule rigide a rilascio modificato

10 mg

Hard modified release capsules

Oral use

Italy

AstraZeneca S.p.A.

Via F. Sforza

Palazzo Volta

20080 Basiglio (MI)

Italy

Antra 20 mg capsule rigide a rilascio modificato

20 mg

Hard modified release capsules

Oral use

Italy

AstraZeneca S.p.A.

Via F. Sforza

Palazzo Volta

20080 Basiglio (MI)

Italy

Antra 40 mg capsule rigide a rilascio modificato

40 mg

Hard modified release capsules

Oral use

Italy

AstraZeneca S.p.A.

Via F. Sforza

Palazzo Volta

20080 Basiglio (MI)

Italy

Antra 40 mg polvere per soluzione per infusione

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Italy

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Losec 10 mg capsule rigide a rilascio modificato

10 mg

Hard modified release capsules

Oral use

Italy

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Losec 20 mg capsule rigide a rilascio modificato

20 mg

Hard modified release capsules

Oral use

Italy

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Losec 40 mg capsule rigide a rilascio modificato

40 mg

Hard modified release capsules

Oral use

Italy

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Losec 40 mg polvere per soluzione per infusione

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Italy

Bracco S.p.A.

Via E. Folli 50

20134 Milano

Italy

Mepral 10 mg capsule rigide a rilascio modificato

10 mg

Hard modified release capsules

Oral use

Italy

Bracco S.p.A.

Via E. Folli 50

20134 Milano

Italy

Mepral 20 mg capsule rigide a rilascio modificato

20 mg

Hard modified release capsules

Oral use

Italy

Bracco S.p.A.

Via E. Folli 50

20134 Milano

Italy

Mepral 40 mg capsule rigide a rilascio modificato

40 mg

Hard modified release capsules

Oral use

Italy

Bracco S.p.A.

Via E. Folli 50

20134 Milano

Italy

Mepral 40 mg polvere per soluzione per infusione

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Italy

Malesci Istituto Farmacobiologico S.p.A.

Via Lungo l'Ema 7

50015 Bagno a Ripoli (FI)

Italy

Omeprazen 10 mg capsule rigide a rilascio modificato

10 mg

Hard modified release capsules

Oral use

Italy

Malesci Istituto Farmacobiologico S.p.A.

Via Lungo l'Ema 7

50015 Bagno a Ripoli (FI)

Italy

Omeprazen 20 mg capsule rigide a rilascio modificato

20 mg

Hard modified release capsules

Oral use

Italy

Malesci Istituto Farmacobiologico S.p.A.

Via Lungo l'Ema 7

50015 Bagno a Ripoli (FI)

Italy

Omeprazen 40 mg capsule rigide a rilascio modificato

40 mg

Hard modified release capsules

Oral use

Italy

Malesci Istituto Farmacobiologico S.p.A.

Via Lungo l'Ema 7

50015 Bagno a Ripoli (FI)

Italy

Omeprazen 40 mg polvere per soluzione per infusione

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Latvia

AstraZeneca AB,

S-151 85 Södertälje Sweden

Losec 40 mg pulveris infūziju šķīduma pagatavošanai

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec Forte Gelules 40mg

40 mg

Hard gastroresis-tant capsules

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec poudre pour perfusion 40 mg

40 mg

Powder for solution for intravenous infusion

Intravenous use

40 mg

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec-Mups 10mg

10 mg

Gastroresistant tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec-Mups 20mg

20 mg

Gastroresistant tablets

Oral use

Luxembourg

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussels

Belgium

Losec-Mups 40mg

40 mg

Gastroresistant tablets

Oral use

Malta

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec MUPS Tablets 10mg

10mg

Gastro-resistant, film-coated tablet

Oral use

Malta

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec MUPS Tablets 20mg

20mg

Gastro-resistant, film-coated tablet

Oral use

Netherlands

AstraZeneca BV

Postbus 599

2700 AN, Zoetermeer

The Netherlands

Losec 10

10 mg

Gstroresistant capsules

Oral use

Netherlands

AstraZeneca BV

Postbus 599

2700 AN, Zoetermeer

The Netherlands

Losec 20

20 mg

Gastroresistant capsules

Oral use

Netherlands

AstraZeneca BV

Postbus 599

2700 AN, Zoetermeer

The Netherlands

Losec 40

40 mg

Gastroresistant capsules

Oral use

Netherlands

AstraZeneca BV

Postbus 599

2700 AN, Zoetermeer

The Netherlands

Losec

40 mg

Powder and solvent for solution for injection

Intravenous use

40 mg

Netherlands

AstraZeneca BV

Postbus 599

2700 AN, Zoetermeer

The Netherlands

Losec Infuus

40 mg

Powder for solution for intravenous infusion

Intravenous use

40 mg

Netherlands

AstraZeneca BV

Postbus 599

2700 AN, Zoetermeer

The Netherlands

Losec MUPS 10

10 mg

Gastroresistant tablets

Oral use

Netherlands

AstraZeneca BV

Postbus 599

2700 AN, Zoetermeer

The Netherlands

Losec MUPS 20

20 mg

Gastroresistant tablets

Oral use

Netherlands

AstraZeneca BV

Postbus 599

2700 AN, Zoetermeer

The Netherlands

Losec MUPS 40

40 mg

Gastroresistant tablets

Oral use

Norway

AstraZeneca AS,

Postboks 200 Vinderen, 0319 OSLO

Norway

Losec® MUPS®

10 mg

Gastroresistant tablets

Oral use

Norway

AstraZeneca AS,

Postboks 200 Vinderen, 0319 OSLO

Norway

Losec® MUPS®

20 mg

Gastroresistant tablets

Oral use

Norway

AstraZeneca AS,

Postboks 200 Vinderen, 0319 OSLO

Norway

Losec®

40mg

Powder for solution for infusion

Intravenous use

40 mg

Poland

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec 10

10mg

Capsules

Oral use

Poland

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec

20mg

Capsules

Oral use

Poland

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec

40mg

Powder for solution for infusion

Intravenous use

40 mg

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Valejas

2745-663 Barcarena

Portugal

Losec

20 mg

Gastroresistant capsules

Oral use

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Valejas

2745-663 Barcarena

Portugal

Losec

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Portugal

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Valejas

2745-663 Barcarena

Portugal

Losec

40 mg

Powder and solvent for injectable solution

Intravenous use

40 mg

Romania

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Losec MUPS 10 mg coprimate filmate gastrorezistente

10 mg

Film-coated gastroresistant tablets

Oral use

Romania

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Losec MUPS 20 mg

comprimate filmate gastrorezistene

20mg

Film-coated gastroresistant tablets

Oral use

Romania

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Losec 40mg liofilizat pentru solutie perfuzabila

40mg

Lyophilisate for solution for infusion

Intravenous use

40 mg

Slovak Republic

AstraZeneca AB,

S-151 85 Södertälje

Sweden

Losec®

40 mg

Powder for solution for infusion

Intravenous use

40 mg

Spain

Laboratorio Tau, S.A.

C/Serrano Galvache, 56 Edificio Roble

28033 Madrid

Spain

LOSEC infusión i.v.

40 mg

Powder for infusion

Intravenous use

40 mg

Spain

Laboratorio Tau, S.A.

C/Serrano Galvache, 56 Edificio Roble

28033 Madrid

Spain

LOSEC cápsulas 20 mg

20 mg

Capsules, hard

Oral use

Sweden

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec

10 mg

Gastro-resistant tablets

Oral use

Sweden

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec

20 mg

Gastro-resistant tablets

Oral use

Sweden

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec

40 mg

Gastro-resistant tablets

Oral use

Sweden

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec

40 mg

Powder for solution for injection

Intravenous use

40 mg

Sweden

AstraZeneca AB

S-151 85 Södertälje

Sweden

Losec

40 mg

Powder for solution for infusion

Intravenous use

40 mg

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec MUPS Tablets 10mg

10mg

Film-coated Tablet

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec MUPS Tablets 20mg

20mg

Film-coated Tablet

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec MUPS Tablets 40mg

40mg

Film-coated Tablet

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec Capsules 10mg

10mg

Hard gelatin capsules

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec Capsules 20mg

20mg

Hard gelatin capsules

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec Capsules 40mg

40mg

Hard gelatine capsules

Oral use

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec Infusion 40mg

40mg

Powder for solution for infusion

Intravenous use

40 mg

United Kingdom

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Losec IV Injection 40mg

40mg

Powder and solvent for solution for injection

Intravenous use

40 mg

---

ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | (Invented) name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Nycomed Pharma GmbH
  Euro Plaza Gebäude F Technologiestrasse 5
  1120 Vienna
  Austria | Pantoloc 20 mg -Filmtabletten | 20 mg | Gastro-resistant tablet | oral use | |
| Austria | Nycomed Pharma GmbH
  Euro Plaza Gebäude F Technologiestrasse 5
  1120 Vienna
  Austria | Pantoloc 40 mg -Filmtabletten | 40 mg | Gastro-resistant tablet | oral use | |
| Austria | Nycomed Pharma GmbH
  Euro Plaza Gebäude F Technologiestrasse 5
  1120 Vienna
  Austria | Pantoloc 40 mg -Trockenstech-
  ampulle | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Austria | Nycomed Austria GmbH
  St. Peter Strasse 25
  4020 Linz
  Austria | Zurcal 20 mg -Filmtabletten | 20 mg | Gastro-resistant tablet | oral use | |
| Austria | Nycomed Austria GmbH
  St. Peter Strasse 25
  4020 Linz
  Austria | Zurcal 40 mg -Filmtabletten | 40 mg | Gastro-resistant tablet | oral use | |
| Austria | Nycomed Austria GmbH
  St. Peter Strasse 25
  4020 Linz
  Austria | Zurcal 40 mg -Trockenstech-
  ampulle | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Belgium | Nycomed Belgium SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Pantozol | 40 mg | Gastro-resistant tablet | oral use | |
| Belgium | Nycomed Belgium
  SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Pantozol | 20 mg | Gastro-resistant tablet | oral use | |
| Belgium | Nycomed Belgium
  SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Pantozol IV | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Belgium | Nycomed Belgium SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Zurcale | 40 mg | Gastro-resistant tablet | oral use | |
| Belgium | Nycomed Belgium SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Zurcale 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Belgium | Nycomed Belgium SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Zurcale IV | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Bulgaria | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc | 20 mg | Gastro-resistant tablet | oral use | |
| Bulgaria | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc | 40 mg | Gastro-resistant tablet | oral use | |
| Cyprus | Mundipharma Pharmaceuticals Ltd.
  Othellos str. 13
  Dhali Industrial Zone
  1685 Nicosia
  Cyprus | Controloc | 20 mg | Gastro-resistant tablet | oral use | |
| Cyprus | Mundipharma Pharmaceuticals Ltd.
  Othellos str. 13
  Dhali Industrial Zone
  1685 Nicosia
  Cyprus | Controloc | 40 mg | Gastro-resistant tablet | oral use | |
| Cyprus | Mundipharma Pharmaceuticals Ltd.
  Othellos str. 13
  Dhali Industrial Zone
  1685 Nicosia
  Cyprus | Controloc i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Czech Republic | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Controloc 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Czech Republic | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Controloc 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Czech Republic | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Controloc i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Denmark | Nycomed Denmark ApS
  Langebjerg 1
  4000 Roskilde
  Denmark | Pantoloc | 20 mg | Gastro-resistant tablet | oral use | |
| Denmark | Nycomed Denmark ApS
  Langebjerg 1
  4000 Roskilde
  Denmark | Pantoloc | 40 mg | Gastro-resistant tablet | oral use | |
| Denmark | Nycomed Denmark ApS
  Langebjerg 1
  4000 Roskilde
  Denmark | Pantoloc | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Estonia | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Controloc 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Estonia | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Controloc 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Finland | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Somac 20 mg enterotabletti | 20 mg | Gastro-resistant tablet | oral use | |
| Finland | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Somac 40 mg enterotabletti | 40 mg | Gastro-resistant tablet | oral use | |
| Finland | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Somac 40 mg injektiokuiva-aine, liuosta varten | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Eupantol 20 mg,
  comprimé gastro-
  résistant | 20 mg | Gastro-resistant tablet | oral use | |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Eupantol 40 mg,
  comprimé gastro-
  résistant | 40 mg | Gastro-resistant tablet | oral use | |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Eupantol 40 mg poudre pour solution injectable IV | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Inipomp 20 mg,
  comprimé gastro-
  résistant | 20 mg | Gastro-resistant tablet | oral use | |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Inipomp 40 mg,
  comprimé gastro-
  résistant | 40 mg | Gastro-resistant tablet | oral use | |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Inipomp 40 mg; poudre pour IV | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Pantec 20 mg, comprimé gastro-
  résistant | 20 mg | Gastro-resistant tablet | oral use | |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Pantec 40 mg,
  comprimé gastro-
  résistant | 40 mg | Gastro-resistant tablet | oral use | |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Pantipp 20 mg,
  comprimé gastro-
  résistant | 20 mg | Gastro-resistant tablet | oral use | |
| France | Nycomed France
  13, rue Watt
  75013 Paris
  France | Pantipp 40 mg,
  comprimé gastro-
  résistant | 40 mg | Gastro-resistant tablet | oral use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantoprazol NYC 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantoprazol NYC 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantoloc i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantoprazol 20 mg Byk | 20 mg | Gastro-resistant tablet | oral use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantoprazol-Byk i.v. | 40 mg | Powder for solution for injection | intravenous use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantozol 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantozol 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantozol i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | PantoLomberg
  20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantoprazole Lomberg 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Rifun 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Germany | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Rifun 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Germany | Byk Tosse Arzneimittel GmbH, Moltkestr. 4
  78467 Constance
  Germany | Zurcal S 20 mg magensaftresistente Tabletten | 20 mg | Gastro-resistant tablet | oral use | |
| Germany | Byk Tosse Arzneimittel GmbH,
  Moltkestr. 4
  78467 Constance
  Germany | Zurcal S 40 mg magensaftresistente Tabletten | 40 mg | Gastro-resistant tablet | oral use | |
| Greece | Sanofi-Aventis Greece
  348, Syngrou Avenue
  Building A
  176 74 Kallithea
  Greece | Controloc 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Greece | Sanofi-Aventis Greece
  348, Syngrou Avenue
  Building A
  176 74 Kallithea
  Greece | Controloc | 40 mg | Gastro-resistant tablet | oral use | |
| Greece | Sanofi-Aventis Greece
  348, Syngrou Avenue
  Building A
  176 74 Kallithea
  Greece | Controloc i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Greece | Nycomed Hellas S.A.
  196, Kifissias Ave.
  152 31 Chalandri
  Athens
  Greece | Zurcazol 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Greece | Nycomed Hellas S.A.
  196, Kifissias Ave.
  152 31 Chalandri
  Athens
  Greece | Zurcazol | 40 mg | Gastro-resistant tablet | oral use | |
| Greece | Nycomed Hellas S.A.
  196, Kifissias Ave.
  152 31 Chalandri
  Athens
  Greece | Zurcazol i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Hungary | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Controloc 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Hungary | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Hungary | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Ireland | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Protium | 40 mg | Gastro-resistant tablet | oral use | |
| Ireland | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Protium 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Ireland | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Protium i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Italy | Nycomed Italia S.r.l
  via Libero Temolo 4
  20126 Milan
  Italy | Pantecta | 40 mg | Gastro-resistant tablet | oral use | |
| Italy | Nycomed Italia S.r.l
  via Libero Temolo 4
  20126 Milan
  Italy | Pantecta | 20 mg | Gastro-resistant tablet | oral use | |
| Italy | Almirall S.p.A
  via Messina, 38 Torre C
  20154 Milan
  Italy | Pantopan | 40 mg | Gastro-resistant tablet | oral use | |
| Italy | Almirall S.p.A
  via Messina, 38 Torre C
  20154 Milan
  Italy | Pantopan | 20 mg | Gastro-resistant tablet | oral use | |
| Italy | Nycomed S.p.A.
  Via Temolo 4
  20126 Milan
  Italy | Pantorc | 40 mg | Gastro-resistant tablet | oral use | |
| Italy | Nycomed S.p.A.
  Via Temolo 4
  20126 Milan
  Italy | Pantorc | 20 mg | Gastro-resistant tablet | oral use | |
| Italy | Nycomed S.p.A.
  Via Temolo 4
  20126 Milan
  Italy | Pantorc. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Italy | Recordati Industria Chimica e Farmaceutica S.p.A
  Via M. Civitali 1
  20148 Milan
  Italy | Peptazol | 40 mg | Gastro-resistant tablet | oral use | |
| Italy | Recordati Industria Chimica e Farmaceutica S.p.A
  Via M. Civitali 1
  20148 Milan
  Italy | Peptazol | 20 mg | Gastro-resistant tablet | oral use | |
| Latvia | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Latvia | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Lithuania | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Controloc | 20 mg | Gastro-resistant tablet | oral use | |
| Lithuania | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Controloc | 40 mg | Gastro-resistant tablet | oral use | |
| Luxembourg | Nycomed Belgium SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Panto-Byk-20 | 20 mg | Gastro-resistant tablet | oral use | |
| Luxembourg | Nycomed Belgium SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Panto-Byk-40 | 40 mg | Gastro-resistant tablet | oral use | |
| Luxembourg | Nycomed Belgium
  SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Panto-Byk-IV | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Luxembourg | Nycomed Belgium SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Pantozol-20 | 20 mg | Gastro-resistant tablet | oral use | |
| Luxembourg | Nycomed Belgium SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Pantozol 40 | 40 mg | Gastro-resistant tablet | oral use | |
| Luxembourg | Nycomed Belgium SCA/CVA
  Gentsesteenweg 615
  1080 Brussels
  Belgium | Pantozol-IV | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Netherlands | Nycomed bv
  Jupiterstraat 250
  2132 HK Hoofddorp
  Netherlands | Pantozol 20 | 20 mg | Gastro-resistant tablet | oral use | |
| Netherlands | Nycomed bv
  Jupiterstraat 250
  2132 HK Hoofddorp
  Netherlands | Pantozol 40 | 40 mg | Gastro-resistant tablet | oral use | |
| Netherlands | Nycomed bv
  Jupiterstraat 250
  2132 HK Hoofddorp
  Netherlands | Pantozol i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Netherlands | Nycomed bv
  Jupiterstraat 250
  2132 HK Hoofddorp
  Netherlands | Pantoprazol Nycomed 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Norway | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Somac | 20 mg | Gastro-resistant tablet | oral use | |
| Norway | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Somac | 40 mg | Gastro-resistant tablet | oral use | |
| Norway | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Somac | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Poland | Nycomed Pharma Sp.z o.o.
  Al. Jerozolimskie 146A
  02-305 Warsaw
  Poland | Controloc 20 | 20 mg | Gastro-resistant tablet | oral use | |
| Poland | Nycomed Pharma Sp.z o.o.
  Al. Jerozolimskie 146A
  02-305 Warsaw
  Poland | Controloc 40 | 40 mg | Gastro-resistant tablet | oral use | |
| Poland | Nycomed Pharma Sp.z o.o.
  Al. Jerozolimskie 146A
  02-305 Warsaw
  Poland | Controloc | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Portugal | Laboratórios Delta, Lda.
  Rua Direita, 148
  Massamá
  2745-751 QUELUZ
  Portugal | Apton 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Portugal | Laboratórios Delta, Lda.
  Rua Direita, 148
  Massamá
  2745-751 QUELUZ
  Portugal | Apton | 20 mg | Gastro-resistant tablet | oral use | |
| Portugal | Nycomed Portugal
  Produtos Farmaceuticos, Lda.
  Quinta da Fonte Edificio
  Gil Eanes Paço D'Arcos
  2770-192 Paço D'Arcos
  Portugal | Pantoc 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Portugal | Nycomed Portugal - Produtos Farmacêuticos, Lda.
  Quinta da Fonte Edificio
  Gil Eanes Paço D'Arcos
  2770-192 Paço D'Arcos
  Portugal | Pantoc | 20 mg | Gastro-resistant tablet | oral use | |
| Portugal | Nycomed Portugal - Produtos Farmacêuticos, Lda.
  Quinta da Fonte Edificio
  Gil Eanes Paço D'Arcos
  2770-192 Paço D'Arcos
  Portugal | Pantoc IV | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Portugal | Nycomed Portugal - Produtos Farmacêuticos, Lda.
  Quinta da Fonte Edificio
  Gil Eanes Paço D'Arcos
  2770-192 Paço D'Arcos
  Portugal | Zurcal | 20 mg | Gastro-resistant tablet | oral use | |
| Portugal | Nycomed Portugal
  Produtos Farmaceuticos, Lda.
  Quinta da Fonte Edificio
  Gil Eanes Paço D'Arcos
  2770-192 Paço D'Arcos
  Portugal | Zurcal 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Portugal | Nycomed Portugal - Produtos Farmacêuticos, Lda.
  Quinta da Fonte Edificio
  Gil Eanes Paço D'Arcos
  2770-192 Paço D'Arcos
  Portugal | Pantoprazole ALTANA 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Portugal | Nycomed Portugal - Produtos Farmacêuticos, Lda.
  Quinta da Fonte Edificio
  Gil Eanes Paço D'Arcos
  2770-192 Paço D'Arcos
  Portugal | Pantoprazole ALTANA 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Romania | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Controloc 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| Romania | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstance
  Germany | Controloc 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Romania | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstance
  Germany | Controloc i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Slovak Republic | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc 20 mg gastrorezistentné tablety | 20 mg | Gastro-resistant tablet | oral use | |
| Slovak Republic | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| Slovak Republic | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Slovenia | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc 20 mg gastrorezistentne tablete | 20 mg | Gastro-resistant tablet | oral use | |
| Slovenia | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc 40 mg gastrorezistentne tablete | 40 mg | Gastro-resistant tablet | oral use | |
| Slovenia | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Controloc 40 mg prašek za raztopino za injiciranje | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Spain | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Anagastra 20 mg Blister | 20 mg | Gastro-resistant tablet | oral use | |
| Spain | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Anagastra 40 mg blister | 40 mg | Gastro-resistant tablet | oral use | |
| Spain | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Anagastra 40 mg polvo para solución inyectable I.V. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| Spain | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantecta 20 mg comprimidos gastrorresistentes Blister | 20 mg | Gastro-resistant tablet | oral use | |
| Spain | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Pantecta 40 mg Blister | 40 mg | Gastro-resistant tablet | oral use | |
| Spain | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Constance
  Germany | Ulcotenal 20 mg comprimidos gastrorresistentes Blister | 20 mg | Gastro-resistant tablet | oral use | |
| Spain | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstanz
  Germany | Ulcotenal 40 mg Blister | 40 mg | Gastro-resistant tablet | oral use | |
| Sweden | Nycomed AB
  Box 27264
  102 53 Stockholm
  Sweden | Pantoloc | 20 mg | Gastro-resistant tablet | oral use | |
| Sweden | Nycomed AB
  Box 27264
  102 53 Stockholm
  Sweden | Pantoloc | 40 mg | Gastro-resistant tablet | oral use | |
| Sweden | Nycomed AB
  Box 27264
  102 53 Stockholm
  Sweden | Pantoloc | 40 mg | Powder for solution for injection | intravenous use | 40 mg |
| United Kingdom | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstance
  Germany | Protium 20 mg | 20 mg | Gastro-resistant tablet | oral use | |
| United Kingdom | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstance
  Germany | Protium 40 mg | 40 mg | Gastro-resistant tablet | oral use | |
| United Kingdom | Nycomed GmbH
  Byk-Gulden-Str.2
  78467 Konstance
  Germany | Protium i.v. | 40 mg | Powder for solution for injection | intravenous use | 40 mg |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

Nycomed Pharma GmbH

Euro Plaza Gebäude F Technologiestrasse 5

1120 Vienna

Austria

Pantoloc 20 mg -Filmtabletten

20 mg

Gastro-resistant tablet

oral use

Austria

Nycomed Pharma GmbH

Euro Plaza Gebäude F Technologiestrasse 5

1120 Vienna

Austria

Pantoloc 40 mg -Filmtabletten

40 mg

Gastro-resistant tablet

oral use

Austria

Nycomed Pharma GmbH

Euro Plaza Gebäude F Technologiestrasse 5

1120 Vienna

Austria

Pantoloc 40 mg -Trockenstech-

ampulle

40 mg

Powder for solution for injection

intravenous use

40 mg

Austria

Nycomed Austria GmbH

St. Peter Strasse 25

4020 Linz

Austria

Zurcal 20 mg -Filmtabletten

20 mg

Gastro-resistant tablet

oral use

Austria

Nycomed Austria GmbH

St. Peter Strasse 25

4020 Linz

Austria

Zurcal 40 mg -Filmtabletten

40 mg

Gastro-resistant tablet

oral use

Austria

Nycomed Austria GmbH

St. Peter Strasse 25

4020 Linz

Austria

Zurcal 40 mg -Trockenstech-

ampulle

40 mg

Powder for solution for injection

intravenous use

40 mg

Belgium

Nycomed Belgium SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Pantozol

40 mg

Gastro-resistant tablet

oral use

Belgium

Nycomed Belgium

SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Pantozol

20 mg

Gastro-resistant tablet

oral use

Belgium

Nycomed Belgium

SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Pantozol IV

40 mg

Powder for solution for injection

intravenous use

40 mg

Belgium

Nycomed Belgium SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Zurcale

40 mg

Gastro-resistant tablet

oral use

Belgium

Nycomed Belgium SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Zurcale 20 mg

20 mg

Gastro-resistant tablet

oral use

Belgium

Nycomed Belgium SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Zurcale IV

40 mg

Powder for solution for injection

intravenous use

40 mg

Bulgaria

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc

20 mg

Gastro-resistant tablet

oral use

Bulgaria

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc

40 mg

Gastro-resistant tablet

oral use

Cyprus

Mundipharma Pharmaceuticals Ltd.

Othellos str. 13

Dhali Industrial Zone

1685 Nicosia

Cyprus

Controloc

20 mg

Gastro-resistant tablet

oral use

Cyprus

Mundipharma Pharmaceuticals Ltd.

Othellos str. 13

Dhali Industrial Zone

1685 Nicosia

Cyprus

Controloc

40 mg

Gastro-resistant tablet

oral use

Cyprus

Mundipharma Pharmaceuticals Ltd.

Othellos str. 13

Dhali Industrial Zone

1685 Nicosia

Cyprus

Controloc i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Czech Republic

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Controloc 20 mg

20 mg

Gastro-resistant tablet

oral use

Czech Republic

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Controloc 40 mg

40 mg

Gastro-resistant tablet

oral use

Czech Republic

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Controloc i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Denmark

Nycomed Denmark ApS

Langebjerg 1

4000 Roskilde

Denmark

Pantoloc

20 mg

Gastro-resistant tablet

oral use

Denmark

Nycomed Denmark ApS

Langebjerg 1

4000 Roskilde

Denmark

Pantoloc

40 mg

Gastro-resistant tablet

oral use

Denmark

Nycomed Denmark ApS

Langebjerg 1

4000 Roskilde

Denmark

Pantoloc

40 mg

Powder for solution for injection

intravenous use

40 mg

Estonia

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Controloc 20 mg

20 mg

Gastro-resistant tablet

oral use

Estonia

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Controloc 40 mg

40 mg

Gastro-resistant tablet

oral use

Finland

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Somac 20 mg enterotabletti

20 mg

Gastro-resistant tablet

oral use

Finland

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Somac 40 mg enterotabletti

40 mg

Gastro-resistant tablet

oral use

Finland

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Somac 40 mg injektiokuiva-aine, liuosta varten

40 mg

Powder for solution for injection

intravenous use

40 mg

France

Nycomed France

13, rue Watt

75013 Paris

France

Eupantol 20 mg,

comprimé gastro-

résistant

20 mg

Gastro-resistant tablet

oral use

France

Nycomed France

13, rue Watt

75013 Paris

France

Eupantol 40 mg,

comprimé gastro-

résistant

40 mg

Gastro-resistant tablet

oral use

France

Nycomed France

13, rue Watt

75013 Paris

France

Eupantol 40 mg poudre pour solution injectable IV

40 mg

Powder for solution for injection

intravenous use

40 mg

France

Nycomed France

13, rue Watt

75013 Paris

France

Inipomp 20 mg,

comprimé gastro-

résistant

20 mg

Gastro-resistant tablet

oral use

France

Nycomed France

13, rue Watt

75013 Paris

France

Inipomp 40 mg,

comprimé gastro-

résistant

40 mg

Gastro-resistant tablet

oral use

France

Nycomed France

13, rue Watt

75013 Paris

France

Inipomp 40 mg; poudre pour IV

40 mg

Powder for solution for injection

intravenous use

40 mg

France

Nycomed France

13, rue Watt

75013 Paris

France

Pantec 20 mg, comprimé gastro-

résistant

20 mg

Gastro-resistant tablet

oral use

France

Nycomed France

13, rue Watt

75013 Paris

France

Pantec 40 mg,

comprimé gastro-

résistant

40 mg

Gastro-resistant tablet

oral use

France

Nycomed France

13, rue Watt

75013 Paris

France

Pantipp 20 mg,

comprimé gastro-

résistant

20 mg

Gastro-resistant tablet

oral use

France

Nycomed France

13, rue Watt

75013 Paris

France

Pantipp 40 mg,

comprimé gastro-

résistant

40 mg

Gastro-resistant tablet

oral use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantoprazol NYC 20 mg

20 mg

Gastro-resistant tablet

oral use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantoprazol NYC 40 mg

40 mg

Gastro-resistant tablet

oral use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantoloc i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantoprazol 20 mg Byk

20 mg

Gastro-resistant tablet

oral use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantoprazol-Byk i.v.

40 mg

Powder for solution for injection

intravenous use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantozol 20 mg

20 mg

Gastro-resistant tablet

oral use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantozol 40 mg

40 mg

Gastro-resistant tablet

oral use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantozol i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

PantoLomberg

20 mg

20 mg

Gastro-resistant tablet

oral use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantoprazole Lomberg 20 mg

20 mg

Gastro-resistant tablet

oral use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Rifun 20 mg

20 mg

Gastro-resistant tablet

oral use

Germany

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Rifun 40 mg

40 mg

Gastro-resistant tablet

oral use

Germany

Byk Tosse Arzneimittel GmbH, Moltkestr. 4

78467 Constance

Germany

Zurcal S 20 mg magensaftresistente Tabletten

20 mg

Gastro-resistant tablet

oral use

Germany

Byk Tosse Arzneimittel GmbH,

Moltkestr. 4

78467 Constance

Germany

Zurcal S 40 mg magensaftresistente Tabletten

40 mg

Gastro-resistant tablet

oral use

Greece

Sanofi-Aventis Greece

348, Syngrou Avenue

Building A

176 74 Kallithea

Greece

Controloc 20 mg

20 mg

Gastro-resistant tablet

oral use

Greece

Sanofi-Aventis Greece

348, Syngrou Avenue

Building A

176 74 Kallithea

Greece

Controloc

40 mg

Gastro-resistant tablet

oral use

Greece

Sanofi-Aventis Greece

348, Syngrou Avenue

Building A

176 74 Kallithea

Greece

Controloc i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Greece

Nycomed Hellas S.A.

196, Kifissias Ave.

152 31 Chalandri

Athens

Greece

Zurcazol 20 mg

20 mg

Gastro-resistant tablet

oral use

Greece

Nycomed Hellas S.A.

196, Kifissias Ave.

152 31 Chalandri

Athens

Greece

Zurcazol

40 mg

Gastro-resistant tablet

oral use

Greece

Nycomed Hellas S.A.

196, Kifissias Ave.

152 31 Chalandri

Athens

Greece

Zurcazol i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Hungary

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Controloc 20 mg

20 mg

Gastro-resistant tablet

oral use

Hungary

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc 40 mg

40 mg

Gastro-resistant tablet

oral use

Hungary

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Ireland

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Protium

40 mg

Gastro-resistant tablet

oral use

Ireland

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Protium 20 mg

20 mg

Gastro-resistant tablet

oral use

Ireland

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Protium i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Italy

Nycomed Italia S.r.l

via Libero Temolo 4

20126 Milan

Italy

Pantecta

40 mg

Gastro-resistant tablet

oral use

Italy

Nycomed Italia S.r.l

via Libero Temolo 4

20126 Milan

Italy

Pantecta

20 mg

Gastro-resistant tablet

oral use

Italy

Almirall S.p.A

via Messina, 38 Torre C

20154 Milan

Italy

Pantopan

40 mg

Gastro-resistant tablet

oral use

Italy

Almirall S.p.A

via Messina, 38 Torre C

20154 Milan

Italy

Pantopan

20 mg

Gastro-resistant tablet

oral use

Italy

Nycomed S.p.A.

Via Temolo 4

20126 Milan

Italy

Pantorc

40 mg

Gastro-resistant tablet

oral use

Italy

Nycomed S.p.A.

Via Temolo 4

20126 Milan

Italy

Pantorc

20 mg

Gastro-resistant tablet

oral use

Italy

Nycomed S.p.A.

Via Temolo 4

20126 Milan

Italy

Pantorc.

40 mg

Powder for solution for injection

intravenous use

40 mg

Italy

Recordati Industria Chimica e Farmaceutica S.p.A

Via M. Civitali 1

20148 Milan

Italy

Peptazol

40 mg

Gastro-resistant tablet

oral use

Italy

Recordati Industria Chimica e Farmaceutica S.p.A

Via M. Civitali 1

20148 Milan

Italy

Peptazol

20 mg

Gastro-resistant tablet

oral use

Latvia

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc 20 mg

20 mg

Gastro-resistant tablet

oral use

Latvia

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc 40 mg

40 mg

Gastro-resistant tablet

oral use

Lithuania

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Controloc

20 mg

Gastro-resistant tablet

oral use

Lithuania

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Controloc

40 mg

Gastro-resistant tablet

oral use

Luxembourg

Nycomed Belgium SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Panto-Byk-20

20 mg

Gastro-resistant tablet

oral use

Luxembourg

Nycomed Belgium SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Panto-Byk-40

40 mg

Gastro-resistant tablet

oral use

Luxembourg

Nycomed Belgium

SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Panto-Byk-IV

40 mg

Powder for solution for injection

intravenous use

40 mg

Luxembourg

Nycomed Belgium SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Pantozol-20

20 mg

Gastro-resistant tablet

oral use

Luxembourg

Nycomed Belgium SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Pantozol 40

40 mg

Gastro-resistant tablet

oral use

Luxembourg

Nycomed Belgium SCA/CVA

Gentsesteenweg 615

1080 Brussels

Belgium

Pantozol-IV

40 mg

Powder for solution for injection

intravenous use

40 mg

Netherlands

Nycomed bv

Jupiterstraat 250

2132 HK Hoofddorp

Netherlands

Pantozol 20

20 mg

Gastro-resistant tablet

oral use

Netherlands

Nycomed bv

Jupiterstraat 250

2132 HK Hoofddorp

Netherlands

Pantozol 40

40 mg

Gastro-resistant tablet

oral use

Netherlands

Nycomed bv

Jupiterstraat 250

2132 HK Hoofddorp

Netherlands

Pantozol i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Netherlands

Nycomed bv

Jupiterstraat 250

2132 HK Hoofddorp

Netherlands

Pantoprazol Nycomed 40 mg

40 mg

Gastro-resistant tablet

oral use

Norway

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Somac

20 mg

Gastro-resistant tablet

oral use

Norway

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Somac

40 mg

Gastro-resistant tablet

oral use

Norway

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Somac

40 mg

Powder for solution for injection

intravenous use

40 mg

Poland

Nycomed Pharma Sp.z o.o.

Al. Jerozolimskie 146A

02-305 Warsaw

Poland

Controloc 20

20 mg

Gastro-resistant tablet

oral use

Poland

Nycomed Pharma Sp.z o.o.

Al. Jerozolimskie 146A

02-305 Warsaw

Poland

Controloc 40

40 mg

Gastro-resistant tablet

oral use

Poland

Nycomed Pharma Sp.z o.o.

Al. Jerozolimskie 146A

02-305 Warsaw

Poland

Controloc

40 mg

Powder for solution for injection

intravenous use

40 mg

Portugal

Laboratórios Delta, Lda.

Rua Direita, 148

Massamá

2745-751 QUELUZ

Portugal

Apton 40 mg

40 mg

Gastro-resistant tablet

oral use

Portugal

Laboratórios Delta, Lda.

Rua Direita, 148

Massamá

2745-751 QUELUZ

Portugal

Apton

20 mg

Gastro-resistant tablet

oral use

Portugal

Nycomed Portugal

Produtos Farmaceuticos, Lda.

Quinta da Fonte Edificio

Gil Eanes Paço D'Arcos

2770-192 Paço D'Arcos

Portugal

Pantoc 40 mg

40 mg

Gastro-resistant tablet

oral use

Portugal

Nycomed Portugal - Produtos Farmacêuticos, Lda.

Quinta da Fonte Edificio

Gil Eanes Paço D'Arcos

2770-192 Paço D'Arcos

Portugal

Pantoc

20 mg

Gastro-resistant tablet

oral use

Portugal

Nycomed Portugal - Produtos Farmacêuticos, Lda.

Quinta da Fonte Edificio

Gil Eanes Paço D'Arcos

2770-192 Paço D'Arcos

Portugal

Pantoc IV

40 mg

Powder for solution for injection

intravenous use

40 mg

Portugal

Nycomed Portugal - Produtos Farmacêuticos, Lda.

Quinta da Fonte Edificio

Gil Eanes Paço D'Arcos

2770-192 Paço D'Arcos

Portugal

Zurcal

20 mg

Gastro-resistant tablet

oral use

Portugal

Nycomed Portugal

Produtos Farmaceuticos, Lda.

Quinta da Fonte Edificio

Gil Eanes Paço D'Arcos

2770-192 Paço D'Arcos

Portugal

Zurcal 40 mg

40 mg

Gastro-resistant tablet

oral use

Portugal

Nycomed Portugal - Produtos Farmacêuticos, Lda.

Quinta da Fonte Edificio

Gil Eanes Paço D'Arcos

2770-192 Paço D'Arcos

Portugal

Pantoprazole ALTANA 20 mg

20 mg

Gastro-resistant tablet

oral use

Portugal

Nycomed Portugal - Produtos Farmacêuticos, Lda.

Quinta da Fonte Edificio

Gil Eanes Paço D'Arcos

2770-192 Paço D'Arcos

Portugal

Pantoprazole ALTANA 40 mg

40 mg

Gastro-resistant tablet

oral use

Romania

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Controloc 20 mg

20 mg

Gastro-resistant tablet

oral use

Romania

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstance

Germany

Controloc 40 mg

40 mg

Gastro-resistant tablet

oral use

Romania

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstance

Germany

Controloc i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Slovak Republic

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc 20 mg gastrorezistentné tablety

20 mg

Gastro-resistant tablet

oral use

Slovak Republic

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc 40 mg

40 mg

Gastro-resistant tablet

oral use

Slovak Republic

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

Slovenia

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc 20 mg gastrorezistentne tablete

20 mg

Gastro-resistant tablet

oral use

Slovenia

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc 40 mg gastrorezistentne tablete

40 mg

Gastro-resistant tablet

oral use

Slovenia

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Controloc 40 mg prašek za raztopino za injiciranje

40 mg

Powder for solution for injection

intravenous use

40 mg

Spain

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Anagastra 20 mg Blister

20 mg

Gastro-resistant tablet

oral use

Spain

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Anagastra 40 mg blister

40 mg

Gastro-resistant tablet

oral use

Spain

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Anagastra 40 mg polvo para solución inyectable I.V.

40 mg

Powder for solution for injection

intravenous use

40 mg

Spain

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantecta 20 mg comprimidos gastrorresistentes Blister

20 mg

Gastro-resistant tablet

oral use

Spain

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Pantecta 40 mg Blister

40 mg

Gastro-resistant tablet

oral use

Spain

Nycomed GmbH

Byk-Gulden-Str.2

78467 Constance

Germany

Ulcotenal 20 mg comprimidos gastrorresistentes Blister

20 mg

Gastro-resistant tablet

oral use

Spain

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstanz

Germany

Ulcotenal 40 mg Blister

40 mg

Gastro-resistant tablet

oral use

Sweden

Nycomed AB

Box 27264

102 53 Stockholm

Sweden

Pantoloc

20 mg

Gastro-resistant tablet

oral use

Sweden

Nycomed AB

Box 27264

102 53 Stockholm

Sweden

Pantoloc

40 mg

Gastro-resistant tablet

oral use

Sweden

Nycomed AB

Box 27264

102 53 Stockholm

Sweden

Pantoloc

40 mg

Powder for solution for injection

intravenous use

40 mg

United Kingdom

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstance

Germany

Protium 20 mg

20 mg

Gastro-resistant tablet

oral use

United Kingdom

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstance

Germany

Protium 40 mg

40 mg

Gastro-resistant tablet

oral use

United Kingdom

Nycomed GmbH

Byk-Gulden-Str.2

78467 Konstance

Germany

Protium i.v.

40 mg

Powder for solution for injection

intravenous use

40 mg

---

ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Applicant/Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, Suspension zum Eingeben für Ferkel | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Belgium | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, orale suspensie voor biggen | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Bulgaria | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | СЕВАЗУРИЛ 50 мг/мл, суспензия за перорално прилагане при прасета | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Cyprus | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, πόσιμο εναιώρημα για χοιρίδια | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Czech Republic | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml,
  Perorální suspense pro selata | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Denmark | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | Cevazuril 50mg/ml, oral suspension til spædgrise | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Estonia | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE Bristol
  UK | CEVAZURIL 50 mg/ml, Suukaudne suspension jaoks põrsad | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| France | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, suspension buvable pour porcelets (1) | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Germany | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, Suspension zum Eingeben für Ferkel | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Greece | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, πόσιμο εναιώρημα για χοιρίδια | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Hungary | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, belsőleges szuszpenzió malacoknak | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Ireland | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, oral suspension for piglets | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Italy | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, sospensione orale per suinetti | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Latvia | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, Suspensija iekšķīgai lietošanai dēļ sivēni | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Lithuania | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, Geriamoji suspensija dèl paršeliai | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Luxembourg | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, suspension buvable pour porcelets (1) | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Malta | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml Suspensjoni orali għal ħnienes | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| The Netherlands | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, orale suspensie voor biggen | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Poland | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, zawiesina doustna dla prosiąt | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Portugal | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, suspensão oral para leitões | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight. |
| Romania | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, Suspensie orală pentru purceii | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight. |
| Slovakia | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, Perorálna suspenzia pre prasiatka | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight. |
| Spain | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, Suspensión Oral para lechones | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight. |
| United Kingdom | Ceva Santé Animale
  Z.I. La Ballastière
  33500 Libourne
  FRANCE | CEVAZURIL 50 mg/ml, oral suspension for piglets | Oral suspension | 50 mg toltrazuril/ml | Piglets | Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight. |

Member State

Applicant/Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Austria

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, Suspension zum Eingeben für Ferkel

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Belgium

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, orale suspensie voor biggen

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Bulgaria

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

СЕВАЗУРИЛ 50 мг/мл, суспензия за перорално прилагане при прасета

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Cyprus

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, πόσιμο εναιώρημα για χοιρίδια

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Czech Republic

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml,

Perorální suspense pro selata

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Denmark

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

Cevazuril 50mg/ml, oral suspension til spædgrise

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Estonia

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE Bristol

UK

CEVAZURIL 50 mg/ml, Suukaudne suspension jaoks põrsad

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

France

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, suspension buvable pour porcelets (1)

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Germany

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, Suspension zum Eingeben für Ferkel

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Greece

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, πόσιμο εναιώρημα για χοιρίδια

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Hungary

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, belsőleges szuszpenzió malacoknak

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Ireland

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, oral suspension for piglets

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Italy

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, sospensione orale per suinetti

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Latvia

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, Suspensija iekšķīgai lietošanai dēļ sivēni

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Lithuania

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, Geriamoji suspensija dèl paršeliai

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Luxembourg

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, suspension buvable pour porcelets (1)

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Malta

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml Suspensjoni orali għal ħnienes

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

The Netherlands

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, orale suspensie voor biggen

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Poland

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, zawiesina doustna dla prosiąt

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Portugal

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, suspensão oral para leitões

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0,4 ml oral suspension per kg body weight.

Romania

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, Suspensie orală pentru purceii

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.

Slovakia

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, Perorálna suspenzia pre prasiatka

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.

Spain

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, Suspensión Oral para lechones

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.

United Kingdom

Ceva Santé Animale

Z.I. La Ballastière

33500 Libourne

FRANCE

CEVAZURIL 50 mg/ml, oral suspension for piglets

Oral suspension

50 mg toltrazuril/ml

Piglets

Individual animal treatment. Each piglet to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight.

---

(1)  Marketing Authorisation granted

---

ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

| Member State EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazol
  Bluefish 20 mg/40 mg magensaftresistente
  Tabletten | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Denmark | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Finland | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish
  20 mg/40 mg enterotabletia/entero-tabletter | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| France | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish 20 mg/40 mg comprimé gastro-
  resistant | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Germany | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish
  20 mg/40 mg magensaftresistente
  tabletten | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Hungary | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish
  20 mg/40 mg bélben oldódó tabletta | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Ireland | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish
  20 mg/40 mg gastro-resistant tablet | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Italy | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazolo Bluefish | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Netherlands | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazol Bluefish
  20 mg/40 mg maagsapresistente-tabletten | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Norway | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazol Bluefish enterotabletter | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Poland | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Portugal | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Spain | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish
  20 mg/40 mg comprimidos gastro-resistentes | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |
| Sweden | Bluefish Pharmaceuticals AB
  Torsgatan 11
  SE-111 23 Stockholm
  Sweden | Pantoprazole Bluefish | 20 mg and 40 mg | Gastro-resistant tablet | Oral use |

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazol

Bluefish 20 mg/40 mg magensaftresistente

Tabletten

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Denmark

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Finland

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish

20 mg/40 mg enterotabletia/entero-tabletter

20 mg and 40 mg

Gastro-resistant tablet

Oral use

France

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish 20 mg/40 mg comprimé gastro-

resistant

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Germany

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish

20 mg/40 mg magensaftresistente

tabletten

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Hungary

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish

20 mg/40 mg bélben oldódó tabletta

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Ireland

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish

20 mg/40 mg gastro-resistant tablet

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Italy

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazolo Bluefish

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Netherlands

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazol Bluefish

20 mg/40 mg maagsapresistente-tabletten

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Norway

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazol Bluefish enterotabletter

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Poland

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Portugal

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Spain

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish

20 mg/40 mg comprimidos gastro-resistentes

20 mg and 40 mg

Gastro-resistant tablet

Oral use

Sweden

Bluefish Pharmaceuticals AB

Torsgatan 11

SE-111 23 Stockholm

Sweden

Pantoprazole Bluefish

20 mg and 40 mg

Gastro-resistant tablet

Oral use

---

ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

| Member State EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Czech Republic | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 20 mg Gastro-resistant tablets | 20 mg | Gastro-resistant tablet | Oral use |
| Czech Republic | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 40 mg Gastro-resistant tablets | 40 mg | Gastro-resistant tablet | Oral use |
| Germany | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 20 mg Gastro-resistant tablets | 20 mg | Gastro-resistant tablet | Oral use |
| Germany | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 40 mg Gastro-resistant tablets | 40 mg | Gastro-resistant tablet | Oral use |
| Poland | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole Olinka | 20 mg | Gastro-resistant tablet | Oral use |
| Poland | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole Olinka | 40 mg | Gastro-resistant tablet | Oral use |
| Slovak Republic | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole Olinka 20 mg Gastrorezistentne tablety | 20 mg | Gastro-resistant tablet | Oral use |
| Slovak Republic | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole Olinka 40 mg Gastrorezistentne tablety | 40 mg | Gastro-resistant tablet | Oral use |
| United Kingdom | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 20 mg Gastro-resistant tablets | 20 mg | Gastro-resistant tablet | Oral use |
| United Kingdom | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 40 mg Gastro-resistant tablets | 40 mg | Gastro-resistant tablet | Oral use |

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Czech Republic

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 20 mg Gastro-resistant tablets

20 mg

Gastro-resistant tablet

Oral use

Czech Republic

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 40 mg Gastro-resistant tablets

40 mg

Gastro-resistant tablet

Oral use

Germany

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 20 mg Gastro-resistant tablets

20 mg

Gastro-resistant tablet

Oral use

Germany

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 40 mg Gastro-resistant tablets

40 mg

Gastro-resistant tablet

Oral use

Poland

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole Olinka

20 mg

Gastro-resistant tablet

Oral use

Poland

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole Olinka

40 mg

Gastro-resistant tablet

Oral use

Slovak Republic

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole Olinka 20 mg Gastrorezistentne tablety

20 mg

Gastro-resistant tablet

Oral use

Slovak Republic

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole Olinka 40 mg Gastrorezistentne tablety

40 mg

Gastro-resistant tablet

Oral use

United Kingdom

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 20 mg Gastro-resistant tablets

20 mg

Gastro-resistant tablet

Oral use

United Kingdom

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 40 mg Gastro-resistant tablets

40 mg

Gastro-resistant tablet

Oral use

---

ANNEX XI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES

| Member State EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Germany | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 20 mg Volkspharma Gastro-resistant tablets | 20 mg | Gastro-resistant tablet | Oral use |
| Germany | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 40 mg Volkspharma Gastro-resistant tablets | 40 mg | Gastro-resistant tablet | Oral use |
| Poland | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole Phargem | 20 mg | Gastro-resistant tablet | Oral use |
| Poland | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole Phargem | 40 mg | Gastro-resistant tablet | Oral use |
| United Kingdom | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 20 mg Gastro-resistant tablets | 20 mg | Gastro-resistant tablet | Oral use |
| United Kingdom | Olinka (UK) Limited
  38/40 Chamberlayne Road
  London, United Kingdom
  NW10 3JE | Pantoprazole 40 mg Gastro-resistant tablets | 40 mg | Gastro-resistant tablet | Oral use |

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Germany

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 20 mg Volkspharma Gastro-resistant tablets

20 mg

Gastro-resistant tablet

Oral use

Germany

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 40 mg Volkspharma Gastro-resistant tablets

40 mg

Gastro-resistant tablet

Oral use

Poland

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole Phargem

20 mg

Gastro-resistant tablet

Oral use

Poland

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole Phargem

40 mg

Gastro-resistant tablet

Oral use

United Kingdom

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 20 mg Gastro-resistant tablets

20 mg

Gastro-resistant tablet

Oral use

United Kingdom

Olinka (UK) Limited

38/40 Chamberlayne Road

London, United Kingdom

NW10 3JE

Pantoprazole 40 mg Gastro-resistant tablets

40 mg

Gastro-resistant tablet

Oral use

---

ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)

| Member State (EU/EEA) | Marketing Authorisation Holder | Product Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Czech Republic | Ratiopharm GmbH
  Graf Arco Strasse 3
  89079
  Ulm, Germany | Valproat-Ratiopharm Chrono 300 mg | 300 mg | Prolonged-release tablet | Oral use |
| Czech Republic | Ratiopharm GmbH
  Graf Arco Strasse 3
  89079
  Ulm, Germany | Valproat-Ratiopharm Chrono 500 mg | 500 mg | Prolonged-release tablet | Oral use |
| Germany | Ratiopharm GmbH
  Graf Arco Strasse 3
  89079
  Ulm, Germany | Valproinsäure-ratiopharm chrono 300 mg Retardtabletten | 300 mg | Prolonged-release tablet | Oral use |
| Germany | Ratiopharm GmbH
  Graf Arco Strasse 3
  89079
  Ulm, Germany | Valproinsäure-ratiopharm chrono 500 mg Retardtabletten | 500 mg | Prolonged-release tablet | Oral use |
| Italy | Ratiopharm GmbH
  Graf Arco Strasse 3
  89079
  Ulm, Germany | Acido valproico E sodio Valproato Ratiopharm | 300 mg | Prolonged-release tablet | Oral use |
| Italy | Ratiopharm GmbH
  Graf Arco Strasse 3
  89079
  Ulm, Germany | Acido valproico E sodio Valproato Ratiopharm | 500 mg | Prolonged-release tablet | Oral use |
| Luxembourg | Ratiopharm GmbH
  Postfach 3380
  89070 Ulm, Germany | Valproinsäure Ratiopharm Chrono | 300 mg | Prolonged-release tablet | Oral use |
| Luxembourg | Ratiopharm GmbH
  Postfach 3380
  89070 Ulm
  Germany | Valproinsäure Ratiopharm Chrono | 500 mg | Prolonged-release tablet | Oral use |
| The Netherlands | Ratiopharm Nederland B.V.
  Florapark 4
  2012HK Haarlem
  The Netherlands | Natriumvalproaat ratiopharm chrono 300 mg | 300 mg | Prolonged-release tablet | Oral use |
| The Netherlands | Ratiopharm Nederland B.V.
  Florapark 4
  2012HK Haarlem
  The Netherlands | Natriumvalproaat ratiopharm chrono 500 mg | 500 mg | Prolonged-release tablet | Oral use |
| Poland | Ratiopharm GmbH
  Graf-Arco-Strasse 3
  89079 Ulm
  Germany | Valpro-ratiopharm Chrono 300 mg | 199,8 mg + 87 mg | Prolonged-release tablet | Oral use |
| Poland | Ratiopharm GmbH
  Graf-Arco-Strasse 3
  89079 Ulm
  Germany | Valpro-ratiopharm Chrono 500 mg | 333 mg + 145 mg | Prolonged-release tablet | Oral use |
| Portugal | Ratiopharm – Comércio e Indústria de Produtos Farmacêuticos, Lda.
  Rua Quinta do Pinheiro – Edifício Tejo 6° Piso
  Carnaxide
  P-2790-143 | Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada | 300 mg | Prolonged-release tablet | Oral use |
| Portugal | Ratiopharm – Comércio e Indústria de Produtos
  Farmacêuticos, Lda.
  Rua Quinta do Pinheiro – Edifício Tejo 6° Piso
  Carnaxide P-2790-143
  Portugal | Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada | 500 mg | Prolonged-release tablet | Oral use |
| Slovakia | Ratiopharm GmbH
  Graf-Arco-Strasse 3
  89079 Ulm
  Germany | Valpro ratiopharm Chrono | 500 mg | Prolonged-release tablet | Oral use |
| United Kingdom | Ratiopharm GmbH
  Graf-Arco-Strasse 3
  89079 Ulm
  Germany | Valprotek CR 300 mg (prolonged release) tablets | 300 mg | Prolonged-release tablet | Oral use |
| United Kingdom | Ratiopharm GmbH
  Graf-Arco-Strasse 3
  89079 Ulm
  Germany | Valprotek CR 500 mg (prolonged release) tablets | 500 mg | Prolonged-release tablet | Oral use |

Member State (EU/EEA)

Marketing Authorisation Holder

Product Name

Strength

Pharmaceutical Form

Route of administration

Czech Republic

Ratiopharm GmbH

Graf Arco Strasse 3

89079

Ulm, Germany

Valproat-Ratiopharm Chrono 300 mg

300 mg

Prolonged-release tablet

Oral use

Czech Republic

Ratiopharm GmbH

Graf Arco Strasse 3

89079

Ulm, Germany

Valproat-Ratiopharm Chrono 500 mg

500 mg

Prolonged-release tablet

Oral use

Germany

Ratiopharm GmbH

Graf Arco Strasse 3

89079

Ulm, Germany

Valproinsäure-ratiopharm chrono 300 mg Retardtabletten

300 mg

Prolonged-release tablet

Oral use

Germany

Ratiopharm GmbH

Graf Arco Strasse 3

89079

Ulm, Germany

Valproinsäure-ratiopharm chrono 500 mg Retardtabletten

500 mg

Prolonged-release tablet

Oral use

Italy

Ratiopharm GmbH

Graf Arco Strasse 3

89079

Ulm, Germany

Acido valproico E sodio Valproato Ratiopharm

300 mg

Prolonged-release tablet

Oral use

Italy

Ratiopharm GmbH

Graf Arco Strasse 3

89079

Ulm, Germany

Acido valproico E sodio Valproato Ratiopharm

500 mg

Prolonged-release tablet

Oral use

Luxembourg

Ratiopharm GmbH

Postfach 3380

89070 Ulm, Germany

Valproinsäure Ratiopharm Chrono

300 mg

Prolonged-release tablet

Oral use

Luxembourg

Ratiopharm GmbH

Postfach 3380

89070 Ulm

Germany

Valproinsäure Ratiopharm Chrono

500 mg

Prolonged-release tablet

Oral use

The Netherlands

Ratiopharm Nederland B.V.

Florapark 4

2012HK Haarlem

The Netherlands

Natriumvalproaat ratiopharm chrono 300 mg

300 mg

Prolonged-release tablet

Oral use

The Netherlands

Ratiopharm Nederland B.V.

Florapark 4

2012HK Haarlem

The Netherlands

Natriumvalproaat ratiopharm chrono 500 mg

500 mg

Prolonged-release tablet

Oral use

Poland

Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Valpro-ratiopharm Chrono 300 mg

199,8 mg + 87 mg

Prolonged-release tablet

Oral use

Poland

Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Valpro-ratiopharm Chrono 500 mg

333 mg + 145 mg

Prolonged-release tablet

Oral use

Portugal

Ratiopharm – Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro – Edifício Tejo 6° Piso

Carnaxide

P-2790-143

Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada

300 mg

Prolonged-release tablet

Oral use

Portugal

Ratiopharm – Comércio e Indústria de Produtos

Farmacêuticos, Lda.

Rua Quinta do Pinheiro – Edifício Tejo 6° Piso

Carnaxide P-2790-143

Portugal

Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada

500 mg

Prolonged-release tablet

Oral use

Slovakia

Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Valpro ratiopharm Chrono

500 mg

Prolonged-release tablet

Oral use

United Kingdom

Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Valprotek CR 300 mg (prolonged release) tablets

300 mg

Prolonged-release tablet

Oral use

United Kingdom

Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Valprotek CR 500 mg (prolonged release) tablets

500 mg

Prolonged-release tablet

Oral use

---

ANNEX XIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State EU/EEA | Applicant company name, address | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | TEVA Pharma B.V.
  Computerweg 10,
  3542 DR Utrecht
  The Netherlands | Clopidogrel Teva 75 mg Filmtabletten | 75 mg | Film-coated tablet | Oral Use |
| Belgium | TEVA Pharma B.V.
  Computerweg10,
  3542DR Utrecht
  The Netherlands | Clopidogrel 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Bulgaria | TEVA Pharma B.V.,
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Clopix 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Cyprus | TEVA Pharma BV
  Computerweg 10,
  3542 DR Utrecht
  The Netherlands | Clopidogrel 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Czech Republic | Teva Pharmaceuticals CR, s.r.o.,
  Radlická 3185/1c,
  150 00 Praha 5,
  Czech Republic | Teclop 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Denmark | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | Clopix | 75 mg | Film-coated tablet | Oral Use |
| Estonia | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | Clopidogrel Dr. Reddy's 75 mg | 75 mg | Film-coated tablet | Oral Use |
| Finland | Teva Sweden AB
  Jarnvägsgatan 11
  Box 1070
  25110 Helsingborg
  Sweden | Tevaplat 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| France | TEVA Classics
  Immeuble Palatin 1
  1 cours du Triangle
  92836 PARISLA DEFENSE
  FRANCE | Clopidogrel TEVA CLASSICS 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Germany | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley,
  East Yorkshire, HU17 0LD
  United Kingdom | Clopidogrel 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Greece | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | Clopidogrel 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Hungary | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | ALVADAVIX 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Ireland | TEVA Generics B.V.
  Computerweg 10, 3542DR Utrecht
  The Netherlands | Clopidogrel 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Italy | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | Clopidogrel 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Latvia | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | Clopidogrel Dr. Reddy's 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Lithuania | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | Clopidogrel Dr. Reddy's 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Luxembourg | Teva Pharma BV
  Computerweg 10
  NL- 3542 DR Utrecht
  The Netherlands | Clopidophar | 75 mg | Film-coated tablet | Oral Use |
| The Netherlands | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | Clopidogrel 75 mg filmomhulde tabletten | 75 mg | Film-coated tablet | Oral Use |
| Norway | Teva Sweden AB
  Järnvägsgatan 11, Box 1070
  251 10 Helsingborg | Tevaplat 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Poland | Teva Pharma B.V.
  Computerweg 10, 3542 DR Utrecht
  The Netherlands | Clopidogrel Teva Pharma | 75 mg | Film-coated tablet | Oral Use |
| Romania | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | XOVAL 75 mg comprimate filmate | 75 mg | Film-coated tablet | Oral Use |
| Slovak Republic | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | Clopidogrel 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Spain | TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133,
  Edificio Britania 4oIzq.
  28003 MADRID,
  Spain | Clopidogrel TEVAGEN 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |
| Sweden | Dr. Reddy's Laboratories (UK) Ltd.
  6 Riverview Road, Beverley, East Yorkshire, HU17 0LD
  United Kingdom | Clopidogrel Reddy's | 75 mg | Film-coated tablet | Oral Use |
| United Kingdom | Teva Pharma BV.
  Computerweg 10,
  Utrecht NL–3542DR
  Netherlands | Clopidogrel 75 mg film-coated tablets | 75 mg | Film-coated tablet | Oral Use |

Member State EU/EEA

Applicant company name, address

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

TEVA Pharma B.V.

Computerweg 10,

3542 DR Utrecht

The Netherlands

Clopidogrel Teva 75 mg Filmtabletten

75 mg

Film-coated tablet

Oral Use

Belgium

TEVA Pharma B.V.

Computerweg10,

3542DR Utrecht

The Netherlands

Clopidogrel 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Bulgaria

TEVA Pharma B.V.,

Computerweg 10

3542 DR Utrecht

The Netherlands

Clopix 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Cyprus

TEVA Pharma BV

Computerweg 10,

3542 DR Utrecht

The Netherlands

Clopidogrel 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Czech Republic

Teva Pharmaceuticals CR, s.r.o.,

Radlická 3185/1c,

150 00 Praha 5,

Czech Republic

Teclop 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Denmark

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

Clopix

75 mg

Film-coated tablet

Oral Use

Estonia

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

Clopidogrel Dr. Reddy's 75 mg

75 mg

Film-coated tablet

Oral Use

Finland

Teva Sweden AB

Jarnvägsgatan 11

Box 1070

25110 Helsingborg

Sweden

Tevaplat 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

France

TEVA Classics

Immeuble Palatin 1

1 cours du Triangle

92836 PARISLA DEFENSE

FRANCE

Clopidogrel TEVA CLASSICS 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Germany

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley,

East Yorkshire, HU17 0LD

United Kingdom

Clopidogrel 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Greece

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

Clopidogrel 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Hungary

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

ALVADAVIX 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Ireland

TEVA Generics B.V.

Computerweg 10, 3542DR Utrecht

The Netherlands

Clopidogrel 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Italy

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

Clopidogrel 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Latvia

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

Clopidogrel Dr. Reddy's 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Lithuania

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

Clopidogrel Dr. Reddy's 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Luxembourg

Teva Pharma BV

Computerweg 10

NL- 3542 DR Utrecht

The Netherlands

Clopidophar

75 mg

Film-coated tablet

Oral Use

The Netherlands

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

Clopidogrel 75 mg filmomhulde tabletten

75 mg

Film-coated tablet

Oral Use

Norway

Teva Sweden AB

Järnvägsgatan 11, Box 1070

251 10 Helsingborg

Tevaplat 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Poland

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht

The Netherlands

Clopidogrel Teva Pharma

75 mg

Film-coated tablet

Oral Use

Romania

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

XOVAL 75 mg comprimate filmate

75 mg

Film-coated tablet

Oral Use

Slovak Republic

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

Clopidogrel 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Spain

TEVA GENERICOS ESPAÑOLA, S.L. Guzmán el Bueno 133,

Edificio Britania 4oIzq.

28003 MADRID,

Spain

Clopidogrel TEVAGEN 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

Sweden

Dr. Reddy's Laboratories (UK) Ltd.

6 Riverview Road, Beverley, East Yorkshire, HU17 0LD

United Kingdom

Clopidogrel Reddy's

75 mg

Film-coated tablet

Oral Use

United Kingdom

Teva Pharma BV.

Computerweg 10,

Utrecht NL–3542DR

Netherlands

Clopidogrel 75 mg film-coated tablets

75 mg

Film-coated tablet

Oral Use

---

ANNEX XIV

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, INDICATIONS/WITHDRAWAL PERIODS AND APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member state/EEA | Applicant/Marketing Authorisation Holder | Product name | INN | Strength | Pharmaceutical form | Animal species | Frequency and route of administration | Recommended dose | Withdrawal period(s)/Indications |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Chevita Tierarzneimittel
  Gesellschaft
  m.b.H. Kaplanstraße 10 AT
  4600 Wels
  AUSTRIA | Doxymax 500 mg/g - Pulver zur Herstellung einer Lösung zum Einnehmen für Schweine und Hühner | Doxycycline hyclate | 500 mg/g | Oral powder | Pigs,
  Chicken (broiler) | Chicken:
  3-5 days, oral via drinking water | Chicken: 25mg doxycyclin hyclat/kg BW/day = 1g powder/20 kg/day | Meat and offal: Chicken (Broiler) 5 days,
  Eggs: not for use in laying hen
  Indications: infection of respiratory tract caused by Mycoplasma spp. (M.gallisepticum, Escherichia coli, Septicamia caused by Pasteurella multocida |
| Belgium | DOPHARMA B.V.
  Zalmweg 24,
  P.O. BOX 205
  4940 AE Raamsdonksveer
  THE NETHERLANDS | Doxycycline 50 % Dopharma | Doxycycline hyclate | 500 mg/g | Water soluble powder | Calves, porcine, poultry | Poultry:
  50mg/kg/day | 3-5 days 500 g/1 000 L drinking water | Meat and offal: 6 days
  Indications: infections by micro-organisms in respiratory or gastro-intestinal system |
| Belgium | VIRBAC S.A.
  1ère avenue - 2065 m - L.I.D.
  06516 CARROS
  FRANCE | Pulmodox 50 % | Doxycycline hyclate | 500 mg/g | Water soluble powder | Calves, porcine, poultry | Poultry: 50 mg/kg/day | 3-5 days 500 g/1 000 L drinking water | Meat and offal: 6 days
  Indications: infections by micro-organisms in respiratory or gastro-intestinal system |
| Belgium | Eurovet Animal Health B.V.
  Handelsveg 25
  PO Box 179
  5530 AD Bladel
  THE NETHERLANDS | Soludox 50 % | Doxycycline hyclate | 500mg/g | Water soluble powder | Porcine, poultry | Poultry:
  10-20mg/kg/day | 3-4 days 100-200 g/1 000 L drinkwater | Meat and offal:
  3 days/10mg/kg
  12 days/20mg/kg
  Indications: respiratory diseases |
| Belgium | Eurovet Animal Health B.V.
  Handelsveg 25
  PO Box 179
  5530 AD Bladel
  THE NETHERLANDS | Soludox 15 % ad. us. vet.. | Doxycycline hyclate | 150mg/g | Water soluble powder | Porcine, calves, poultry, fancy birds, pigeons | Poultry:
  10-20mg/kg/day | 3-5 days 500 g/1 000 L drinkwater | Meat and offal:
  7 days
  Indications: respiratory diseases caused by germs |
| Belgium | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen
  BELGIUM | Hydrodoxx 500 mg/g water-soluble powder | Doxycycline hyclate | 500mg/g doxycycline hyclate | Powder for oral solution | Chickens (broilers) & Pigs (fattening pigs) | Oral (drinking water) | 20 mg doxycycline (hyclate)/kg x 3-5 days | Meat and offal:
  Chickens: 6 days
  Do not use in laying birds producing eggs for human consumption
  Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum. |
| Bulgaria | Farma Sis OOD
  4 San Stefano Str.
  Dobrich
  BULGARIA | Doxinyl
  10 % Oral Suspension | Doxycycline hyclate | 100mg/ml | Oral Suspension | Poultry | Via drinking water | 50 -100 ml Doxinyl 10 % in 100 l drinking water per day
  (50-100 mg Doxycycline in 1 l drinking water) 3-5 days | Meat - 5 days |
| Bulgaria | Farma Sis OOD
  4 San Stefano Str.
  Dobrich
  BULGARIA | Cyvadox 10 % | Doxycycline hyclate | 100mg/ml | Oral Suspension | Poultry | Via drinking water | 0,5-1 ml in 1 l drinking water per day \3-5 days\ 50-100 mg Doxycycline | Meat - 7 days |
| Bulgaria | DOPHARMA B.V.
  Zalmweg 24,
  P.O. BOX 205
  4940 AE Raamsdonksveer
  THE NETHERLANDS | Doxycycline 50 %
  w.s.p. | Doxycycline hyclate | 500mg/g | Water soluble powder | Poultry | Via drinking water | 500g Doxycycline 50 % w.s.p. in 100 l drinking water/3-5 days/ | Meat - 4 days |
| Bulgaria | Farmavet OOD
  40 Otec Paisij Str.
  Shumen
  BULGARIA | Doxycycline 20 %
  Pulvis solubilis | Doxycycline hyclate | 200mg/g | Water soluble powder | Poultry | Via drinking water | 50g Doxycycline 20 % in 100l drinking water/3-5 days/ | Meat - 7 days |
| Bulgaria | Interchemie Werken
  De Adelaar BV
  Hosterweg 26a
  5811 Ccastenray
  THE NETHERLANDS | Doxy – WS | Doxycycline hyclate | 200mg/g | Water soluble powder | Poultry | Via drinking water | 1kg Doxy-WS in 2 000-4 000 l drinking water | Meat - 7 days |
| Bulgaria | Ceva Sante Animale France
  La Balastiere
  33501 Libourne Cedex
  FRANCE | Doxyvit 50 %
  WSP | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry | Via drinking water | 2-3g Doxyvit 50 % WSP in 10 l. Drinking water - 5 days/equivalent to 100-150 mg Doxycycline in 1l water | Meat - 7 days |
| Bulgaria | Ceva Sante Animale France
  La Balastiere
  33501 Libourne Cedex
  FRANCE | Doxyvit 100 | Doxycycline hyclate | 100 mg/g | Water soluble powder | Poultry | Via drinking water | 10 mg Doxyvit per kg body weight per day | Meat - 7 days |
| Bulgaria | Vetpartners OOD
  Ivan Asen Str.
  4270 Parvomaj
  BULGARIA | Polidoxichem 500/WSP | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry | Via drinking water | 50-100 mg Doxycycline in 1l drinking water/3-5 days/ equivalent to 0,1-0,2g Polidoxichem 500 WSP in 1l drinking water per day | Meat - 7 days |
| Bulgaria | Biovet AD
  39 Petar Rakov Str.
  4550 Peshtera
  BULGARIA | Vibravet 10 %
  Water soluble premix | Doxycycline hyclate | 100 mg/g | Water soluble powder | Poultry | Via drinking water | 1g Vibravet 10 % in 1l drinking water /=67-100 mg Doxycycline/per day. 5 days | Meat - 7 days |
| Cyprus | PREMIER SHUKUROGLOU LTD | HIPRADOXI -S | Doxycycline hyclate | 100 mg | Oral solution | Pigs, Chicken (broiler) | By oral route, via drinking water | Broilers: 50-100 mg doxycycline hyclaye/L water for 3-5 days | Broilers: meat: 5 days Pigs: meat:6 days |
| Czech republic | Industria Italiana Integratori TREI S.p.A.
  Viale Corassori 62
  41100 Modena
  ITALY | DOXIPAN 20 | Doxycycline hyclate | 20 g/100 g | Powder for oral solution | Chicken-broiler, turkey | Administer orally via drinking water for 5 days. | Broiler:
  5-7,5 g of product/10 l drinking water
  turkey:
  10 – 20 mg doxycycline/kg bodyweight | Chicken broiler: Meat and offal: 5 days.
  Turkey: meat and offal: 10 days
  Indications:
  Chicken broilers: Chronic respiratory diseases and associated infections.
  Turkeys: Diseases caused G+ and G- micro-organisms and mycoplasmas, especially respiratory and articular syndrome caused by mycoplasmas and/or staphylococcus. |
| Czech republic | Pharmagal s.r.o.,
  Murgašova 5,
  949 01 Nitra,
  SLOVAK REPUBLIC | DOXYGAL | Doxycycline hyclate | 50 mg/1 g | Powder for oral solution | Poultry | Administer orally via drinking water for 3-5 days. | Therapeutically- preventive: 50 mg doxycycline/1 l drinking water
  Therapeutically: 100 mg doxycycline/1 l drinking water | Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption.
  Indications: Used for the treatment of the secondary bacterial infections following to viral origin diseases. Poultry: CRD (mycoplasmosis), colibacillosis |
| Czech republic | Lavet Pharmaceuticals Ltd.,
  1161 Budapest Ottó u. 14,
  HUNGARY | DOXYVIT 40 % | Doxycicline hyclate | 40g/100g | Powder for oral solution | Chicken-broiler, turkey | Administer orally via drinking water for 3-5 days. | 1.Continuous therapy:
  1,0g DOXYVIT 40 % per 3-6 L of drinking water
  2.Pulse therapy:
  10-20 mg doxycycline / kg b.w., intervals 4-8 hours. | Chicken broiler, turkey: Meat and offal: 4 days. Not permitted for use in laying hens from which eggs are produced for human consumption.
  Indications:
  Treatment and prevention of respiratory, intestinal and systemic infections caused by microorganisms susceptible to doxycycline in broilers and turkeys. Chronic respiratory disease (Mycoplasma gallisepticum, Escherichia coli) Aerosaculitis (Mycoplasma meleagridis) Infectious synovitis (Mycoplasma synoviae) Fowl cholera (Pasterella multocida) Bordetella turkey infections (Bordetella avium) Infectious coryza (Haemophilus paragallinarum) Colibacillosis (Eschrichia coli) Necrotic enteritidis (Clostridium perfringens) Chlamydiosis (Chlamydia psittaci) |
| Czech republic | Laboratorios Karizoo S.A
  Polígono Industrial La Borda
  Mas Pujades
  11-12
  08140 Caldes de Montbui
  Barcelona
  SPAIN | KARIDOX 100 mg/ml | Doxycycline hyclate | 100 mg/1 ml | Oral solution | Chicken-broiler | Administer orally via drinking water for 3-5 days. | 10-20 mg doxycycline/kg bodyweight/day (i.e.. 0,5-1,0 ml of product/l of drinking water/day). | Chickens(broilers): Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption
  Indications: Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms susceptible to doxycycline. |
| Czech republic | Tekro, spol. s.r.o.,
  Višňová 2/484,
  140 00 Praha 4,
  CZECH REPUBLIC | MEDITEK DOX 100 | Doxycycline hyclate | 100g/kg | Powder for oral solution | Broiler | Administer orally via drinking water for 3-5 days. | 10 mg Doxycycline hyclate/1kg bodyweight (1,0 kg of product / 1 000 l drinking water) | Chickens (broilers): Meat and offal: 7 days
  Indications: Prevention and treatment of infection disease of the respiratory and gastrointestinal tract in pigs and broilers caused by the pathogens susceptible to doxycycline. It is efficient on the several bacteria resistant to first generation tetracyclines. |
| Czech republic | CHEMO IBERICA, S.A. Gran Via Carlos III, 98 7a Edificio Trade
  08028 Barcelona SPAIN | ORIDOX 100 mg/ml, perorální roztok pro podání v pitné vodě pro brojlery a prasata | Doxycycline hyclate | 100 mg/1ml | Oral solution | Chicken-broiler | Administer orally via drinking water for 3-5 days. | 10-20 mg doxycycline/kg bodyweight/day (i.e.. 0,5-1,0 ml of product/ldrinking water/day | Chickens (broilers): Meat and offal: 7 days.
  Eggs: Not permitted for use in laying hens from which eggs are produced for human consumption
  Indications: Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms susceptible to doxycycline. |
| Czech republic | VIRBAC S.A.
  1ère avenue - 2065 m - L.I.D.
  06516 CARROS
  FRANCE | Pulmodox O.S.P. 5 % | Doxycycline hyclate | 0,05 g/1g | Powder for oral solution | Poultry | Administer orally via drinking water for 3-5 days. | Poultry till 2 weeks: 1 g of the product per L of drinking water and day
  Poultry over 2 weeks: 2 g of the product per L of drinking water and day
  Duration of the treatment: 3 - 5 days. | Chicken (broilers): Meat and offal: 4 days, Not permitted for use in laying hens from which eggs are produced for human consumption.
  Indications:
  Treatment of respiratory infections caused by the pathogens susceptible to doxycycline and chickens (broilers). |
| Czech republic | KELA Laboratoria n.v.
  Industrial Zone
  De Kluis
  St. Lenaartseweg 48
  2320 Hoogstraten
  BELGIUM | Respidox 5 % | Doxycycline hyclate | 50 mg / 1 g | Powder for oral solution | Poultry | Administer orally via drinking water for 3 days. | 2 g of product/l drinking water | Poultry: Meat and offal: 7 days
  Not permitted for use in laying hens from which eggs are produced for human consumption.
  Indications: Treatment of the infections caused by the microrganisms susceptible to doxycycline.
  Poultry: CRD, colibacillosis, inflammation of nasal mucosa, synovitis, salmonelosis, fowl cholera, chlamydiosis |
| Czech republic | COOPHAVET
  Saint Herblon
  44150 Ancenis
  FRANCE | RONAXAN P.S. 5 % | Doxycycline hyclate | 50 mg / 1 g | Powder for oral solution | Chickens | Administer orally via drinking water for 5 days. | 10 mg doxycycline / kg bodyweight. / day (i.e.. 1 g of product/5 kg bodyweight.) | Chicken (broilers): Meat and offal: 4 days,
  Not permitted for use in laying hens from which eggs are produced for human consumption.
  Indications: Treatment of respiratory infections caused by the pathogens susceptible to doxycycline in chickens (broilers). |
| Czech republic | LABORATORIOS CALIER, S.A.
  BARCELONÉS, 26
  08520 Les Franqueses del Valles
  SPAIN | Doxycycline Calier 500 mg/g | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry
  Pigs | Oral
  3-5 days | 20 mg/kg/day | 6 days
  Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum |
| Czech republic | Ceva Animal Health Slovakia spol. s.r.o.
  Račianska 77
  831 02 Bratislava
  SLOVENIA | DOXYVIT 100 | Doxycycline hydrocloride | 100 g/1 000 g | Powder for oral solution | Poultry (chicken, turkey, goose) | Administer orally via drinking water for 5 days. | 10 mg doxycycline/kg bodyweight per day, i.e. 0,1 g DOXYVIT 100 / kg bodyweight | Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption.
  Indications: Treatment and prevention of respiratory, intestinal and systemic infections caused by micro-organisms susceptible to doxycycline in hens, turkeys and gouses: chronical respiratory disease (Mycoplasma gallisepticum, Escherichia coli), aerosaculitis (Mycoplasma meleagridis), synovitis (Mycoplasma synoviae), fowl cholera (Pasteurella mul tocida), bordetela turkey infections (Bordetella avium), infectious coryza (Haemophilus paragallinarum), colibacillosis (Esccherichia coli), necrotic enteritis (Clostridium perfringens), chlamydiosis (Chlamydia psittaci), prevention in stress conditions (vaccination, changes in housing, transportation) |
| Denmark | Laborartorios Karizoo
  S.A. Pol.Ind. La Borda c/Mas Pujades 11-12
  Caldes de Montbui 08140
  SPAIN | Karidox | Doxycycline hyclate | 10 % | Oral solution | Chickens, swine | Orally (drinking water) for 3 to 5 days | In chickens: 10-20 mg doxycycline hyclate per kg bodyweight per day for 3 to 5 days (i.e. 0.5-1.0 ml product/litre water/day) | Chickens for slaughter: 7 days Eggs: May not be administered to egg laying poultry if the eggs are intended for human use.
  Indications:Prevention and treatment of CRD and mycoplasmosis caused by microorgansisms sensitive to doxycycline. |
| Denmark | CHEMO IBERICA, S.A.
  Gran Via Carlos III, 98 7a

  Edificio Trade
  08028 Barcelona
  SPAIN | Oridox | Doxycycline hyclate | 10 % | Oral solution | Chickens, swine | Orally (drinking water) for 3 to 5 days | In chickens: 10-20 mg doxycycline hyclate per kg bodyweight per day for 3 to 5 days (i.e. 0.5-1.0 ml product/litre water/day) | Chickens for slaughter: 7 days Eggs: May not be administered to egg laying poultry if the eggs are intended for human use.
  Indications: Prevention and treatment of CRD and mycoplasmosis caused by microorgansisms sensitive to doxycycline. |
| Denmark | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen
  BELGIUM | HydroDoxx | Doxycycline hyclate | 500 mg/g doxycycline hyclate | Powder for oral solution | Chickens (broilers) & Pigs (fattening pigs) | Oral (drinking water) | 20 mg doxycycline (hyclate)/kg x 3-5 days | Meat and offal:
  Chickens: 6 days
  Do not use in laying birds producing eggs for human consumption
  Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum. |
| Estonia | Laboratorios Hipra S.A.
  Avda La Selva 135
  17170 Amer (Girona)
  SPAIN | Hipradoxi-S | Doxycycline hyclate | 100 mg/ml | Concentrate for oral solution | chicken (broilers) | oral use via drinking water. | 50 ... 100 mg doxycycline/litre water | Meat and offal:
  5 days. Not authorised for use in laying birds producing eggs for human consumption.
  Indications: Colibacillosis, C.R.D. and associated infections. |
| Estonia | Laboratorios Hipra S.A.
  Avda La Selva 135
  17170 Amer (Girona)
  SPAIN | Hipradoxi-P | Doxycycline hyclate | 100 mg/g | powder for oral solution | chicken (broilers) | oral use via drinking water. | 20 mg doxycycline/kg bw/day | Meat and offal:
  5 days. Not authorised for use in laying birds producing eggs for human consumption.
  Indications: Colibacillosis, C.R.D. and associated infections. |
| Estonia | Maxx Pharma OÜ
  Kaluri tee 5
  Haabneeme
  74001 Viimsi
  Harjumaa
  ESTONIA | Doxyprim 40 % | Doxycycline hyclate | 400 mg/g | powder for oral solution | chicken, turkeys | oral use via drinking water. | 10 ... 20 mg/kg bw/day 5 days | Meat and offal:
  4 days. Not authorised for use in laying birds producing eggs for human consumption.
  Indications: For the treatment of respiratory, intestinal and systemic infections caused by doxycycline-sensitive organisms. |
| Estonia | Zoovetvaru
  uusaru 5
  76505 Saue
  Harjumaa
  ESTONIA | Doxycin | Doxycycline hyclate | 200 mg/g | powder for oral solution | chicken (broilers) | for oral administaration, via drinking water. | 10 mg doxycycline/kg bw/day 3-5 days | Meat and offal:
  6 days. Do not use in laying birds producing eggs for human consumption.
  Indications: For the treatment of infections of the respiratory system and alimentary tract caused by microorganisms sensitive to doxycycline, including mycoplasmas, bordeteliosis, chlamydiosis, pasteurellosis anaerobic infections, salmonellosis, staphylococcosis, colibacillosis. |
| Estonia | Dutch Farm Veterinary Pharmaceuticals B.V.
  Veemweg 1
  3771 MT Barnevald
  THE NETHERLANDS | Dutch Farm Doxycycline 20 % WSP | Doxycycline hyclate | 200 mg/g | powder for oral solution | poultry | for oral administration, via drinking water. | 15 mg Doxycycline hyclate/kg bw/day 3-5 days. | Meat and offal:
  7 days. Do not use in laying birds producing eggs for human consumption.
  Indications: For the treatment of infections caused by microorganisms sensitive to doxycycline, especially respiratory infections. |
| Germany | LABORATORIOS CALIER, S.A.
  BARCELONÉS, 26
  08520 Les Franqueses del Valles
  SPAIN | DOXYCYCLINE CALIER 500 mg/g, Pulver zum Eingeben über das Trinkwasser für Huhn und Schwein | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry
  Pigs | Oral
  3-5 days | 20 mg/kg/day | Meat and offal:
  6 days
  Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum |
| Germany | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen
  BELGIUM | HydroDoxx 500 mg/g Pulver zum Eingeben über das Trinkwasser | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chickens (broilers) & Pigs (fattening pigs) | Oral (drinking water) | 20 mg doxycycline (hyclate)/kg x 3-5 days | Meat and offal:
  Chickens: 6 days
  Do not use in laying birds producing eggs for human consumption
  Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum. |
| Greece | Durden Trading Limited
  12, Kennedy Av.
  Nicosia
  CYPRUS | Stardox | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chickens(broiler) Non –egg laying chickens Calves pigs | In drinking water | 20 mg/kg X 4-7 days | Meat and offal:
  14 days
  Indications: CRD caused by Mycoplasma gallisepticum colibacilosis |
| Greece | NEW VET A.E
  Fleming 15
  15123 Marousi Attikis
  GREECE | Nexyclin | Doxycycline hyclate | 400 mg/g | Powder for oral solution | Chickens(broiler) Turkeys pigs | In drinking water | 20 mg/kg | Meat and offal:
  4 days
  Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli Pasteurella multocida, Chlamydia psittaci |
| Greece | VIRBAC S.A.
  1ère avenue - 2065 m - L.I.D.
  06516 CARROS
  FRANCE | Pulmodox | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chickens(broiler) Non –egg laying chickens Calves pigs | In drinking water | 10 mg/kg X 3-5 days | Meat and offal:
  9 days
  Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum |
| Greece | Nutri-Biomed Hellas LTD
  1, V. Hugo & Chlois
  Metamorfosi Attikis
  14452 Athens
  GREECE | Doxyveto | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chickens(broiler) Non –egg laying chickens Calves pigs | In drinking water | 25 mg/kg X 3-5 days | Meat and offal:
  9 days
  Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum |
| Greece | DOPHARMA B.V.
  Zalmweg 24,
  P.O. BOX 205
  4940 AE Raamsdonksveer
  THE NETHERLANDS | Doxycyclin 50 Dopharma | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chickens(broiler) Calves pigs | In drinking water | 25 mg/kg X 3-5 days | Meat and offal:
  9 days
  Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum |
| Greece | Durden Trading Limited
  12, Kennedy Av.
  Nicosia
  CYPRUS | Doxycycline 150/Durden | Doxycycline hydrocloride | 150 mg/g | Powder for oral solution | Chickens(broiler) Non –egg laying chickens Calves pigs | In drinking water | 10 mg/kg X 3-5 days | Meat and offal:
  4 days
  Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli, Haemophilus paragalinarum |
| Greece | AFOI TETOROU ABE
  10 km National road Athens-Lamia
  14451, Metamorfosi
  GREECE | Doxycycline 150/Afoi Tetorou | Doxycycline hydrocloride | 150 mg/g | Powder for oral solution | Chickens(broiler) Non –egg laying chickens Calves pigs | In drinking water | 10 mg/kg X 3-5 days | Meat and offal:4 days
  Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli, Haemophilus paragalinarum |
| Spain | LAB. DR ESTEVE
  Avda Mare de Deu de Montserrat
  221 08041 Barcelona
  SPAIN | DOX ESTEVE | Doxycycline hyclate | 100 mg/g | Water soluble powder | Poultry Pigs Bovine | Oral 3-5 days | 20 mg / Kg/day | Meat and offal:
  9 days
  Indications: Infections caused by Mycoplasma spp (Micoplasmosis, CRD) or Pasteurella multocida (Pasteurellosis).
  Meat and offal:
  Poultry: 5 days
  Turkeys: 7 days
  colibacilosis, C.R.D., micoplasmosis. |
| Spain | S.P. Veterinaria SA Crta. Reus
  Vinyols Km 4.1
  Apartado 60
  Riudoms 43330 (Tarragona) SPAIN | DOXI 100 mg/ml POLVO ORAL | Doxycycline hyclate | 10 g/100 g | Water soluble powder | Poultry
  Turkeys Pigs | Oral
  3-5 days (Poultry and turkeys) 5 days (Pigs) | 50 – 100 mg/l drinking water/day (poultry and turkey) 10 mg/kg/day (pigs) | Meat and offal:
  Broilers: 5 days Turkeys: 7 days Pigs: 4 days |
| Spain | FATRO URIACH VETERINARIA, S.L.
  Constitucion, 1
  08960 Sant Just Desvern
  SPAIN | DOXIDOL | Doxycycline hyclate | 10 g/100 g | Water soluble powder | Poultry
  Pigs | Oral
  3-5 days | 7.5 – 15 mg/kg/day | Meat and offal:
  7 days
  Indications: Colibacilosis
  CRD |
| Spain | DIVASA-FARMAVIC, S.A.
  CTRA. SANT HIPOLIT, KM. 71
  08503 GURB – VIC
  SPAIN | DOXIVET 20 | Doxycycline hyclate | 200 mg/ml | Oral solution | Poultry
  Pigs | Oral
  3-5 days | 10 - 20 mg/Kg/day | Meat and offal:
  7 days
  Indications: Colibacilosis, CRD, Micoplasmosis |
| Spain | MEVET, S. A.
  POLIGONO INDUSTRIAL EL SEGRE, PARCELA409-410
  25191 Lérida
  SPAIN | DOXICIVALL POLVO | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry
  Pigs | Oral
  3-5 days | 20 mg/kg/day | Meat and offal:
  4 days
  Indications: Colibacilosis, CRD, Micoplasmosis |
| Spain | Laboratorios Hipra S.A.
  Avda La Selva 135
  17170 Amer (Girona)
  SPAIN | HIPRADOXI-S | Doxycycline hyclate | 100 mg/ml | Oral solution | Poultry
  Pigs | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  5 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | LAMONS, S.A.
  POL.IND. MECANOVA, NAVES 27-28
  25191 LLEIDA
  SPAIN | DOXICICLINA 10 % LAMONS | Doxycycline hyclate | 100 mg/ml | Oral solution | Poultry
  Pigs | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  5 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | Laboratorios Hipra S.A.
  Avda La Selva 135
  17170 Amer (Girona)
  SPAIN | HIPRADOXI-P | Doxycycline hyclate | 100 mg/g | Water soluble powder | Poultry
  Pigs | Oral
  3-5 days | 20 mg/Kg/day | Meat and offal:
  5 days
  Indications: colibacilosis, C.R.D., and associated infections |
| Spain | POLICHEM, S.A.
  Ctra. Reus-Cambrils, Km. 3
  43206 Reus
  SPAIN | DOXICHEM | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | SUPER'S DIANA, S.L
  Ctra. Barcelona - Ripoll, Km 17
  08150 Parets del Valles
  SPAIN | DOXBRON | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | COTECNICA -COOPERATIVA TECNICA AGROPECUARIA
  Ctra. N II KM 494,5
  25250 Bellpuig (Lerida)
  SPAIN | DOXICICLINA 500 USO VETERINARIO COTECNICA | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | CENAVISA, S.A.
  Camí Pedra Estela S/N
  43205 Reus
  SPAIN | LAFIDOX POLVO ORAL | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | LABORATORIOS SYVA, S.A.
  PARROCO PABLO DIEZ, 49-57
  24010 TROBAJO DEL CAMINO
  SPAIN | SYVADOX 10 % | Doxycycline hyclate | 100 mg/ml | Oral solution | Poultry
  Pigs | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | INVESA INTERNACIONAL, S.A.
  Esmeralda, 19 - 4o

  08950 ESPLUGUES DE LLOBREGAT
  SPAIN | DX-10 | Doxycycline hyclate | 100 mg/ml | Oral solution | Poultry
  Pigs | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | CENAVISA, S.A.
  Camí Pedra Estela S/N
  43205 Reus
  SPAIN | DOXICICLINA 500 GANADEXIL | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry
  Turkeys | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | DIVASA-FARMAVIC, S.A.
  CTRA. SANT HIPOLIT, KM. 71
  08503 GURB – VIC
  SPAIN | DOXIVET 5 | Doxycycline hyclate | 50 mg/g | Water soluble powder | Poultry
  Turkeys | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | INDUSTRIAL VETERINARIA S.A.
  Esmeralda, 19 - 4o

  08950 ESPLUGUES DE LLOBREGAT
  SPAIN | DOXINYL | Doxycycline hyclate | 100 mg/ml | Oral solution | Poultry
  Pigs | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | JAER, S.A.
  Barcelona, 411
  08620 San Vicens del Horts
  SPAIN | MASTERMIX DOXICICLINA | Doxycycline hyclate | 50 mg/g | Water soluble powder | Poultry
  Turkeys | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | Laboratorios Karizoo S.A
  Polígono Industrial La Borda
  Mas Pujades
  11-12
  08140 Caldes de Montbui
  Barcelona
  SPAIN | KARIDOX | Doxycycline hyclate | 100 mg/ml | Oral solution | Poultry
  Pig | Oral
  3-5 days | 10 - 20 mg/Kg/day | Meat and offal:
  7 days
  Indications: C.R.D., micoplasmosis |
| Spain | CHEMO IBERICA, S.A.
  Gran Via Carlos III, 98 7a

  Edificio Trade
  08028 Barcelona
  SPAIN | SOLDOXIN | Doxycycline hyclate | 100 mg/ml | Oral solution | Poultry
  Pig | Oral
  3-5 days | 10 - 20 mg/Kg/day | Meat and offal:
  7 days
  Indications: C.R.D., micoplasmosis |
| Spain | LABORATORIOS CALIER, S.A.
  BARCELONÉS, 26
  08520 Les Franqueses del Valles
  SPAIN | CALIERDOXINA 50 % P O | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry | Oral
  5 days | 20 mg/kg/day | Meat and offal:
  7 days
  Indications: C.R.D., micoplasmosis |
| Spain | LABORATORIOS CALIER, S.A.
  BARCELONÉS, 26
  08520 Les Franqueses del Valles
  SPAIN | GANAMIX DOXICICLINA 50 % P O | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry | Oral
  5 days | 20 mg/kg/day | Meat and offal:
  7 days
  Indications: C.R.D., micoplasmosis |
| Spain | S.P. Veterinaria SA Crta. Reus
  Vinyols Km 4.1
  Apartado 60
  Riudoms 43330 (Tarragona) SPAIN | HIDRODOX 10 % | Doxycycline hyclate | 100 mg/ml | Oral solution | Poultry
  Pigs | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| Spain | VIRBAC ESPAÑA, S.A.
  Angel Guimera, 179-181
  08950 Esplugues de Llobregat
  SPAIN | PULMODOX P.O.S. | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: C.R.D., micoplasmosis |
| Spain | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen
  BELGIUM | DILUDOX | Doxycycline hyclate | 500 mg/g doxycycline hyclate | Powder for oral solution | Chickens (broilers) & Pigs (fattening pigs) | Oral (drinking water) | 20 mg doxycycline (hyclate)/kg x 3-5 days | Meat and offal:
  Chickens: 6 days
  Do not use in laying birds producing eggs for human consumption
  Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum. |
| Spain | LABORATORIOS CALIER, S.A.
  BARCELONÉS, 26
  08520 Les Franqueses del Valles
  SPAIN | DOXICICLINA CALIER 500 mg/g | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry
  Pigs | Oral
  3-5 days | 20 mg/kg/day | Meat and offal:
  6 days
  Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum |
| Spain | LABORATORIOS MAYMO, S.A.
  Via Augusta, 302
  08017 Barcelona
  SPAIN | MAYDOX PS | Doxycycline hydrocloride | 50 mg/g | Water soluble powder | Poultry
  Turkeys | Oral
  3-5 days | 50 – 100 mg/l drinking water/day | Meat and offal:
  7 days
  Indications: colibacilosis, C.R.D., micoplasmosis |
| France | COOPHAVET
  Saint Herblon
  44150 Ancenis
  FRANCE | RONAXAN P.S. 5 % | Doxycycline hyclate | 50 mg/g | Water soluble powder | Turkey
  Porcine
  Broilers
  Calves | Prevention
  1 - 3 days
  Curative treatment:
  3 - 5 days | 10 mg/kg/day | Meat and offal:
  Turkey: 6 days
  Broilers: 4 days
  Indications: Broilers and turkey:
  Preventive and treatment of infections in respiratory system |
| France | FRANVET
  ZI d'Etriche-Route d'Avire
  BP 103
  49500 Segré Cedex
  FRANCE | DOXY 5 FRANVET | Doxycycline hyclate | 50 mg/g | Water soluble powder | Turkey,
  Porcine
  Hens
  Calves | Prevention
  1 - 3 days
  Curative treatment:
  3 - 5 days | 10 mg/kg/day | Meat and offal:
  Turkey: 6 days
  Hens: 4 days
  Indications: Prevention and treatment of infections in respiratory system |
| France | VIRBAC S.A.
  1ère avenue - 2065 m - L.I.D.
  06516 CARROS
  FRANCE | PULMODOX P.O.S. 5 % | Doxycycline hyclate | 50 mg/g | Water soluble powder | Porcine
  Calves
  Poultry | Prevention
  1 - 3 days
  Curative treatment:
  3 - 5 days | 10 mg/kg/day | Meat and offal:
  Turkey: 6 days
  Hens: 4 days
  Indications: Prevention and treatment of infections in respiratory system |
| France | Sogeval Laboratoires
  200 route De Mayenne
  53022 Laval Cedex FRANCE | DOXYVAL 5 % | Doxycycline hyclate | 50 mg/g | Water soluble powder | Turkey
  Porcine
  Broilers
  Calves | Prevention
  1 - 3 days
  Curative treatment:
  3 - 5 days | 10 mg/kg/day | Meat and offal:
  Turkey: 6 days
  Hens: 4 days
  Indications: Prevention and treatment of infections in respiratory system |
| France | Laboratoires Biove
  3 rue de Lorraine
  62510 Arques
  FRANCE | ACTI DOXY 5 | Doxycycline hyclate | 50 mg/g | Water soluble powder | Dindon
  Porcine
  Broilers
  Calves | Prevention
  1 - 3 days
  Curative treatment:
  3 - 5 days | 10 mg/kg/day | Meat and offal:
  Turkey: 6 days
  Hens: 4 days
  Indications: Prevention and treatment of infections in respiratory system |
| France | Ceva Sante Animale France
  La Balastiere
  33501 Libourne Cedex
  FRANCE | DOXYVIT | Doxycycline hyclate | 50 mg/g | Water soluble powder | Turkeys
  Porcine
  Broilers
  Calves | Prevention
  1 - 3 days
  Curative treatment:
  3 - 5 days | 10 mg/kg/day | Meat and offal:
  Turkey: 6 days
  Hens: 4 days
  Indications: Prevention and treatment of infections in respiratory system |
| France | Noe
  10 rue Clement Ader
  ZA Le Patis
  78120 Rambouillet
  FRANCE | COMPOMIX V DOXYCYCLINE | Doxycycline hyclate | 50 mg/g | Water soluble powder | Dindon
  Porcine
  Broilers
  Calves | Prevention
  1 - 3 days
  Curative treatment:
  3 - 5 days | 10 mg/kg/day | Meat and offal:
  Turkey: 6 days
  Hens: 4 days
  Indications: Prevention and treatment of infections in respiratory system |
| France | CHEMO IBERICA, S.A.
  Gran Via Carlos III, 98 7a

  Edificio Trade
  08028 Barcelona
  SPAIN | SOLDOXIN 100 MG/ML SOLUTION BUVABLE POUR POULES POULETS ET PORCINES | Doxycycline hyclate | 100 mg/ml | Oral solution | Porcine
  Hens
  Broilers | CHICKEN (broilers): 10 - 20 mg of doxycycline / kg bw / day | 3 - 5 days | Indications: CHICKENS (BROILERS) Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline. |
| France | Laborartorios Karizoo
  S.A. Pol.Ind. La Borda c/Mas Pujades 11-12
  Caldes de Montbui 08140
  SPAIN | DOXYSOL 10 % | Doxycycline hyclate | 100 mg/ml | Oral solution | Porcine
  Hens
  Broilers | CHICKEN (broilers): 10 - 20 mg of doxycycline / kg bw / day | 3 - 5 days | Indications: CHICKENS (BROILERS). Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline. |
| France | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen
  BELGIUM | HYDRODOXX 500 MG/G poudre pour administration dans l'eau de boisson pour poulets et porcs | Doxycycline hyclate | 500 mg/g doxycycline hyclate | Powder for oral solution | Chickens (broilers) & Pigs (fattening pigs) | Oral (drinking water) | 20 mg doxycycline (hyclate)/kg x 3-5 days | Meat and offal:
  Chickens: 6 days
  Do not use in laying birds producing eggs for human consumption
  Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum. |
| France | LABORATORIOS CALIER, S.A.
  BARCELONÉS, 26
  08520 Les Franqueses del Valles
  SPAIN | DOXYCYCLINE CALIER 500 MG/G poudre pour administration dans l'eau de boisson pour poulets et porcins | Doxycycline hyclate | 500 mg/g | Water soluble powder | Poultry
  Pigs | Oral
  3-5 days | 20 mg/kg/day | Meat and offal:
  6 days
  Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum |
| Hungary | COOPHAVET
  Saint Herblon
  44150 Ancenis
  FRANCE | Ronaxan P.S. 5 % oldható por | Doxycycline hyclate | 5 g/100 g | Powder for oral solution | Chicken | Chicken younger than 2 weeks: 1 g powder/1 litre of drinking water/day. Chicken older than 2 weeks: 2 g powder/1 litre of drinking water. | 10 mg doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  4 days
  Indications: For the treatment of CRD and Mycoplasma diseases, and other infections |
| Hungary | DOPHARMA B.V.
  Zalmweg 24,
  P.O. BOX 205
  4940 AE Raamsdonksveer
  THE NETHERLANDS | Doxycycline 50 % WSP | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chicken | 500 g product dissolved in 1 000 litre of drinking water. | 25 mg doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  4 days
  Indications: For the treatment and control of chicken respiratory diseases |
| Hungary | Kon-Pharma GmbH.
  30625 Hannover
  GERMANY | Doxy 50 % por belsőleges oldathoz | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chicken, turkey | Chicken: 500 mg product dissolved in 1 litre of drinking water. Turkey: 400 mg product/1 litre of drinking water | 30 mg doxycycline/kg bw/day, for 5 days. | Meat and offal:
  Chicken and turkey: 11 days. |
| Hungary | V.M.D. Állatgyógyászati Kft.
  1093 Budapest
  HUNGARY | Doxyveto-50 | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chicken | Continuous treatment: 0,2 g product/1 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 8 hours. | 10 mg doxycycline/kg bw/day, for 5 days. | Meat and offal:
  10 days
  Indications: For the treatment of CRD and pasteurellosis; synovitis in turkey. |
| Hungary | Novartis Animal Health d.o.o.
  Verovskava 57
  1000 Ljubljana
  SLOVENIA | Doxyril 50 % por belsőleges oldathoz | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chicken | 5 g product/100 kg bw/day, dissolved in the drinking water. | 25 mg doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  6 days
  Indications: For the treatment of CRD, pasteurellosis, colibacillosis, Haemophilus and Clostridium infections |
| Hungary | Animal-Med Kft.
  1029 Budapest
  HUNGARY | Anidox 10 % por belsőleges oldathoz | Doxycycline hyclate | 100 mg/g | Powder for oral solution | Chicken | 1 000 g product dissolved in 1 000 litre of drinking water. | 10 mg doxycycline/kg bw/day, for 5 days. | Meat and offal:
  12 days
  Indications: For the treatment of mycoplasmosis, pasteurellosis, colibacillosis. |
| Hungary | Animal-Med Kft.
  1029 Budapest
  HUNGARY | Anidox 100 % por belsőleges oldathoz | Doxycycline hyclate | 1 000 mg/g | Powder for oral solution | Chicken | 100 g product dissolved in 1 000 litre of drinking water. | 10 mg doxycycline/kg bw/day, for 5 days. | Meat and offal:
  12 days
  Indications: For the treatment of infections caused by: Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophilus paragallinarum and Pasteurella multocida |
| Hungary | Lavet Pharmaceuticals Ltd.,
  1161 Budapest Ottó u. 14,
  HUNGARY | Doxyprim 40 % vízoldékony pulvis | Doxycycline hyclate | 400 mg/g | Powder for oral solution | Chicken, turkey | Continuous treatment: 1 g product/3-6 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 4-8 hours. | 10-20 mg/doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  4 days
  Indications: For the treatment of infections caused by: Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophilus paragallinarum and Pasteurella multocida |
| Hungary | CHEMIFARMA S.p.A
  Via Don Eugenio Servadei 16
  47100 Forli
  ITALY | Doxifarm 50 % WSP | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chicken | 40 g product/100 kg bw/100 litre of drinking water. | 20 mg doxycycline/kg bw/day, for 5 days. | Meat and offal:
  5 days
  Indications: For the treatment of CRD, mycoplasmosis, synovitis, colibacillosis, ileitis (necroric and ulcerosus), haemophilus-infection. |
| Hungary | VIRBAC S.A.
  1ère avenue - 2065 m - L.I.D.
  06516 CARROS
  FRANCE | Pulmodox 50 % WSP | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chicken | 500 g product dissolved in 1 000 litre of drinking water. | 25 mg doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  4 days
  Indications: For the treatment of CRD and other respiratory diseases, caused by: Mycoplasma spp., Pasteurella spp., E. coli, and Chlamydia psittaci. |
| Hungary | Phylaxia Pharma Zrt.
  8000 Székesfehérvár
  HUNGARY | Doxyphyl SP | Doxycycline hyclate | 300 mg/g | Powder for oral solution | chicken, turkey | 40 g product/1 200 kg bw/day, calculated amount of the product should be dissolved in the drinking water consumed during 3 hours. | 10 mg doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  chicken: 7 days, turkey: 10 days.
  Indications: For the treatment of respiratory infections caused by Mycoplasma spp., E. coli, Haemophilus paragallinarum, Bordetella avium, and ileitis caused by Clostridium perfringens and Cl. colinum. |
| Hungary | Eurovet Animal Health B.V.
  Handelsveg 25
  PO Box 179
  5530 AD Bladel
  THE NETHERLANDS | Soludox 50 % pulvis | Doxycycline hyclate | 500 mg/g | Powder for oral solution | Chicken | Dissolved in the drinking water. | 10 mg/kg bw and 20 mg/kg bw/day, for 4 days. | Meat and offal:
  chicken treated with 10 mg/kg bw: 5 days, chicken treated with 20 mg/kg bw: 12 days.
  Indications: For the treatment of respiratory and other diseases caused by doxycycline-sensitive bacteria. |
| Hungary | CHEMO IBERICA, S.A.
  Gran Via Carlos III, 98 7a

  Edificio Trade
  08028 Barcelona
  SPAIN | Oridox 100 mg/ml belsőleges oldat | Doxycycline hyclate | 100 mg/ml | Concentrate for oral solution | Chicken | 100 mg/ml oral concentrate dissolving in the drinking water. | 10-20 mg/doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  7 days
  Indications: For the treatment of respiratory and other diseases caused by doxycycline-sensitive bacteria. |
| Hungary | Laboratorios Karizoo S.A
  Polígono Industrial La Borda
  Mas Pujades
  11-12
  08140 Caldes de Montbui
  Barcelona
  SPAIN | Karidox 100 mng/ml belsőleges oldat | Doxycycline hyclate | 100 mg/ml | Concentrate for oral solution | Chicken | 100 mg/ml oral concentrate dissolving in the drinking water. | 10-20 mg/doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  7 days
  Indications: For the treatment and prevention of CRD or other Mycoplasma diseases |
| Hungary | CENAVISA, S.A.
  Camí Pedra Estela S/N
  43205 Reus
  SPAIN | Doxycen belsőleges oldat | Doxycycline hyclate | 200 mg/ml | Concentrate for oral solution | Chicken | 1 ml/20 kg bw/day dissolved in the drinking water. | 10 mg doxycycline/kg bw/day, for 5 days. | Meat and offal:
  5 days
  Indications: For the treatment of CRD, mycoplasmosis and colibacillosis. |
| Hungary | Lavet Pharmaceuticals Ltd.,
  1161 Budapest Ottó u. 14,
  HUNGARY | Doxyvit 100 WSP | Doxycycline hydrocloride | 100 mg/g | Powder for oral solution | Chicken, turkey, goose | Continuous treatment: 1 g product/1 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 6-8 hours. | 10 mg/doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  Chicken, turkey, goose 7 days
  Indications: For the treatment of respiratory and enteric diseases in broiler chickens |
| Hungary | Industria Italiana Integratori TREI S.p.A.
  Viale Corassori 62
  41100 Modena
  ITALY | Doxipan 20 WSP | Doxycycline hydrocloride | 200 mg/g | Powder for oral solution | Chicken | 5-7.5 g product dissolving in 10 litre of drinking water. | 10-15 mg/doxycycline/kg bw/day, for 3-5 days. | Meat and offal:
  5 days
  Indications: For the treatment of CRD, mycoplasmosis, synovitis, colibacillosis, ileitis (necroric and ulcerosus), haemophilus-infection. |
| Hungary | Laboratorios Hipra S.A.
  Avda La Selva 135
  17170 Amer (Girona)
  SPAIN | Hipradoxi-S oral solutio | Doxycycline hydrocloride | 100 mg/ml | Concentrate for oral solution | Chicken | 100 mg/ml oral concentrate dissolving in 1 litre of drinking water. | 10 mg doxycycline/kg bw/day, for 5 days. | Meat and offal:
  5 days
  Indications: For the treatment and prevention of CRD or other Mycoplasma diseases |
| Ireland | S.P. Veterinaria SA Crta. Reus
  Vinyols Km 4.1
  Apartado 60
  Riudoms 43330 (Tarragona) SPAIN | DOXIVEX 10 % Concentrate for oral solution. | Doxycycline hyclate | 100 mg/ml | Concentrate for oral solution | Chickens (broilers) and Pigs | For oral administration via the drinking water. for 3-5 days | Chickens (broilers): 50 - 100 mg Doxycycline / litre of drinking water / day (equivalent to 0.5 - 1.0 ml DOXIVEX 10 % / litre of drinking water / day) for 3-5 days | Meat & offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption
  Indications: Treatment of colibacillosis, chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline |
| Ireland | Huvepharma N.V.
  Uitbreidingstraat 80
  2600 Antwerpen
  BELGIUM | Aquadoxx 500 mg/g water-soluble powder | Doxycycline hyclate | 500 mg/g doxycycline hyclate | Powder for oral solution | Chickens (broilers) & Pigs (fattening pigs) | Oral (drinking water) | 20 mg doxycycline (hyclate)/kg x 3-5 days | Meat and offal:
  Chickens: 6 days
  Do not use in laying birds producing eggs for human consumption
  Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum. |
| Italy | CEVA VETEM S.P.A.
  Via Colleoni n.15
  20041 Agrate Brianza (Milano)
  ITALY | DOXICICLINA 20 % CEVA VETEM | Doxycycline hyclate | Doxycycline 200 g. per 1 kg. of product | Water soluble powder | broiler, turkey | drinking water | Broiler, Turkey: 1 g / 10 kg b.w per 5 days. | Meat and offal:
  broiler: 7 days
  turkey: 8 days
  Indications: Broiler: Treatment of chronic respiratory disease
  Turkey: Treatment of infective synusitis |
| Italy | CHEMIFARMA S.p.A
  Via Don Eugenio Servadei 16
  47100 Forli
  ITALY | DOXICICLINA 50 % CHEMIFARMA | Doxycycline hyclate | Doxycycline 500 g. per 1 kg. of product | Water soluble powder | broiler, swine | drinking water | Broiler: 20 mg of doxycycline / per 1 kg b.w.(per 3 - 5 days) Swine: 20 mg of doxycycline / per 1 kg b.w per 3 - 5 days | Meat and offal:
  broiler: 6 days Do not use in hens producing eggs for human consumption. swine: 5 days
  Indications: Broiler: Chronic respiratory disease caused by: Pasteurella soo, Mycoplasma spp, Haemophilus gallinarum, Bordetella avium, ans Clamidia psittaci. |
| Italy | SINTOFARM S.P.A.
  Via Togliatti n.5
  42016 Guastalla (Reggio Emilia)
  ITALY | DOXIFARM 50 % | Doxycycline hyclate | Doxycycline hyclate 500 mg. (equivalent to 433,3 mg of Doxiclina) per 1 g. of product | Water soluble powder | broiler, swine | drinking water | Broiler: 25 mg of doxycycline hyclate/per 1 kg b.w.(per 3 - 5 days) Swine: 20 mg of doxycycline hyclate/per 1 kg b.w per 5 days | Meat and offal:
  broiler: 6 days Do not use in hens producing eggs for human consumption. swine: 4 days
  Indications: Broiler: Treatment and control of respiratory disease caused by Mycoplasma spp, Haemophilus paragallinarum, Escherichia coli. Enteritis caused by Clostridium perfringens and Clostridium colinum |
| Italy | INDUSTRIA ITAILIANA INTEGRATORI TREI SpA
  Via Affarosa n.4
  42010 Rio Saliceto (Reggio Emilia) ITALY | DOXIPAN 54 | Doxycycline hyclate | Doxycycline 500 g. per 1 kg. of product | Water soluble powder | broiler, turkey, swine | drinking water | Broiler: 10 mg of doxycycline / 1 kg b.w. Turkey: 20 mg of doxycycline / 1 kg b.w. Swine: 10 mg of doxycycline / 1 kg b.w per 5 days | Meat and offal:
  broiler: 3 days Do not use in hens producing eggs for human consumption. turkey: 10 days swine: 4 days
  Indications: Broiler:Chronic respiratory disease. Turkey:Respiratory and joints syndroms caused by Mycoplasms and/or Staphilococcus |
| Italy | INTERVET ITALIA S.R.L.
  Via W. Tobagi n.7
  20068 Peschiera Borromeo (Milano)
  ITALY | NAXOCET | Doxycycline hyclate | Doxycycline hyclate 500 mg. per 1 g. of product | Water soluble powder | broiler | drinking water | Broiler: 20 mg of doxyclyne hyclate/1 kg b.w. per 5 days. | Meat and offal:
  broiler: 8 days Do not use in hens producing eggs for human consumption.
  Indications: Chronic respiratory disease caused by Mycoplasma spp. |
| Lithuania | DOPHARMA B.V.
  Zalmweg 24,
  P.O. BOX 205
  4940 AE Raamsdonksveer
  THE NETHERLANDS | DOXYCYCLINE 50 %, geriamieji milteliai | Doxycycline hyclate | 500 mg/g | Oral powder | Calves, pigs and poultry. | 4–7 days with drinking water | Poultry: 40 mg per 1 kg of body weight, or 200–400 g per 1 000 litres of drinking water, during 4–7 days. | Meat and offal:
  Poultry – 4 days. Do not use in animals producing eggs for human consumption.
  Indications: for the treatment of poultry: ornythosis, caused by Clamydia psittaci, colibacteriosis caused by E. coli, CRD caused by Mycoplasma gallisepticum |
| Lithuania | Lavet Pharmaceuticals Ltd.,
  1161 Budapest Ottó u. 14,
  HUNGARY | DOXYPRIM 40 % geriamieji milteliai | Doxycycline hyclate | 400 mg/g | Oral powder | Chickens, turkeys and pigs. | Should be administered for a period of 5 days in chicken and turkeys together with drinking water. | Chicken and turkeys: 10–20 mg doxycycline hyclate per 1 kg of body weight daily, administrated pulse dosed when the daily requirement is given in limited quantity of water to be consumed by the birds within 4–8 hours or supplied continuously as 67–133 mg ml Doxycycline hyclate per 1 litre of drinking water. | Meat and offal:
  Edible tissues of chickens and turkeys – 4 days.
  Indications: In chickens and turkeys indications include: chronicle respiratoric diseases (Mycoplasma gallisepticum, E. coli), airsacculitis (Mycoplasma meleagridis), infectious synovitis (Mycoplasma synoviae), colibacillosis (E. coli), fowl cholera (Pasteurella multocida), turkey bordetellosis (Bordetella avium), infectious coryza (Haemophilus paragallinarum), necrotic enteritis (Clostridium perfringens), chlamydiosis (Chlamydia psittaci). |
| Lithuania | Eurovet Animal Health B.V.
  Handelsveg 25
  PO Box 179
  5530 AD Bladel
  THE NETHERLANDS | SOLUDOX 50 %, geriamieji milteliai | Doxycycline hyclate | 500 mg/g | Oral powder | Pigs and chickens. | Should be administered orally with drinking water for a period of 4 days. | Chickens: 10* mg doxycycline hyclate per 1 kg of body weight daily for 4 days; 20* mg doxycycline hyclate per 1 kg of body weight daily for 4 days. * The highest dose is recommended in case of infections caused by strains which are moderately susceptible (MIC up to 2 μg/ml), whilst the lowest dosage maybe used for (highly) susceptible strains (MIC up to 0.5–1.0 μg/ml) | Indications: For the treatment of infections caused by micro-organisms susceptible to doxycycline, such as Pasteurella multocida and Ornithobacterium rhinotracheale in chickens. |
| The Netherlands | DOPHARMA B.V.
  Zalmweg 24,
  P.O. BOX 205
  4940 AE Raamsdonksveer
  THE NETHERLANDS | Doxycycline-hyclaat 50 % | Doxycycline hyclate | Per gram powder: 500 mg doxycycline hyclate. | Powder for oral solution | Calves, non-egg laying chickens and turkeys. | Non-egg laying chickens and turkeys: oral via drinking water. bodyweight per day for 4-7 days. | Non-egg laying chickens and turkeys: 20 mg doxycycline hyclate per kg | Turkeys - meat: 28 days.
  Non-egg laying chickens - meat: 14 days.
  Indications: Turkeys:






  — | Ornithosis caused by Chlamydia psittaci |

Member state/EEA

Applicant/Marketing Authorisation Holder

Product name

INN

Strength

Pharmaceutical form

Animal species

Frequency and route of administration

Recommended dose

Withdrawal period(s)/Indications

Austria

Chevita Tierarzneimittel

Gesellschaft

m.b.H. Kaplanstraße 10 AT

4600 Wels

AUSTRIA

Doxymax 500 mg/g - Pulver zur Herstellung einer Lösung zum Einnehmen für Schweine und Hühner

Doxycycline hyclate

500 mg/g

Oral powder

Pigs,

Chicken (broiler)

Chicken:

3-5 days, oral via drinking water

Chicken: 25mg doxycyclin hyclat/kg BW/day = 1g powder/20 kg/day

Meat and offal: Chicken (Broiler) 5 days,

Eggs: not for use in laying hen

Indications: infection of respiratory tract caused by Mycoplasma spp. (M.gallisepticum, Escherichia coli, Septicamia caused by Pasteurella multocida

Belgium

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 % Dopharma

Doxycycline hyclate

500 mg/g

Water soluble powder

Calves, porcine, poultry

Poultry:

50mg/kg/day

3-5 days 500 g/1 000 L drinking water

Meat and offal: 6 days

Indications: infections by micro-organisms in respiratory or gastro-intestinal system

Belgium

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

Pulmodox 50 %

Doxycycline hyclate

500 mg/g

Water soluble powder

Calves, porcine, poultry

Poultry: 50 mg/kg/day

3-5 days 500 g/1 000 L drinking water

Meat and offal: 6 days

Indications: infections by micro-organisms in respiratory or gastro-intestinal system

Belgium

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 %

Doxycycline hyclate

500mg/g

Water soluble powder

Porcine, poultry

Poultry:

10-20mg/kg/day

3-4 days 100-200 g/1 000 L drinkwater

Meat and offal:

3 days/10mg/kg

12 days/20mg/kg

Indications: respiratory diseases

Belgium

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 15 % ad. us. vet..

Doxycycline hyclate

150mg/g

Water soluble powder

Porcine, calves, poultry, fancy birds, pigeons

Poultry:

10-20mg/kg/day

3-5 days 500 g/1 000 L drinkwater

Meat and offal:

7 days

Indications: respiratory diseases caused by germs

Belgium

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

Hydrodoxx 500 mg/g water-soluble powder

Doxycycline hyclate

500mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Bulgaria

Farma Sis OOD

4 San Stefano Str.

Dobrich

BULGARIA

Doxinyl

10 % Oral Suspension

Doxycycline hyclate

100mg/ml

Oral Suspension

Poultry

Via drinking water

50 -100 ml Doxinyl 10 % in 100 l drinking water per day

(50-100 mg Doxycycline in 1 l drinking water) 3-5 days

Meat - 5 days

Bulgaria

Farma Sis OOD

4 San Stefano Str.

Dobrich

BULGARIA

Cyvadox 10 %

Doxycycline hyclate

100mg/ml

Oral Suspension

Poultry

Via drinking water

0,5-1 ml in 1 l drinking water per day \3-5 days\ 50-100 mg Doxycycline

Meat - 7 days

Bulgaria

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 %

w.s.p.

Doxycycline hyclate

500mg/g

Water soluble powder

Poultry

Via drinking water

500g Doxycycline 50 % w.s.p. in 100 l drinking water/3-5 days/

Meat - 4 days

Bulgaria

Farmavet OOD

40 Otec Paisij Str.

Shumen

BULGARIA

Doxycycline 20 %

Pulvis solubilis

Doxycycline hyclate

200mg/g

Water soluble powder

Poultry

Via drinking water

50g Doxycycline 20 % in 100l drinking water/3-5 days/

Meat - 7 days

Bulgaria

Interchemie Werken

De Adelaar BV

Hosterweg 26a

5811 Ccastenray

THE NETHERLANDS

Doxy – WS

Doxycycline hyclate

200mg/g

Water soluble powder

Poultry

Via drinking water

1kg Doxy-WS in 2 000-4 000 l drinking water

Meat - 7 days

Bulgaria

Ceva Sante Animale France

La Balastiere

33501 Libourne Cedex

FRANCE

Doxyvit 50 %

WSP

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Via drinking water

2-3g Doxyvit 50 % WSP in 10 l. Drinking water - 5 days/equivalent to 100-150 mg Doxycycline in 1l water

Meat - 7 days

Bulgaria

Ceva Sante Animale France

La Balastiere

33501 Libourne Cedex

FRANCE

Doxyvit 100

Doxycycline hyclate

100 mg/g

Water soluble powder

Poultry

Via drinking water

10 mg Doxyvit per kg body weight per day

Meat - 7 days

Bulgaria

Vetpartners OOD

Ivan Asen Str.

4270 Parvomaj

BULGARIA

Polidoxichem 500/WSP

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Via drinking water

50-100 mg Doxycycline in 1l drinking water/3-5 days/ equivalent to 0,1-0,2g Polidoxichem 500 WSP in 1l drinking water per day

Meat - 7 days

Bulgaria

Biovet AD

39 Petar Rakov Str.

4550 Peshtera

BULGARIA

Vibravet 10 %

Water soluble premix

Doxycycline hyclate

100 mg/g

Water soluble powder

Poultry

Via drinking water

1g Vibravet 10 % in 1l drinking water /=67-100 mg Doxycycline/per day. 5 days

Meat - 7 days

Cyprus

PREMIER SHUKUROGLOU LTD

HIPRADOXI -S

Doxycycline hyclate

100 mg

Oral solution

Pigs, Chicken (broiler)

By oral route, via drinking water

Broilers: 50-100 mg doxycycline hyclaye/L water for 3-5 days

Broilers: meat: 5 days Pigs: meat:6 days

Czech republic

Industria Italiana Integratori TREI S.p.A.

Viale Corassori 62

41100 Modena

ITALY

DOXIPAN 20

Doxycycline hyclate

20 g/100 g

Powder for oral solution

Chicken-broiler, turkey

Administer orally via drinking water for 5 days.

Broiler:

5-7,5 g of product/10 l drinking water

turkey:

10 – 20 mg doxycycline/kg bodyweight

Chicken broiler: Meat and offal: 5 days.

Turkey: meat and offal: 10 days

Indications:

Chicken broilers: Chronic respiratory diseases and associated infections.

Turkeys: Diseases caused G+ and G- micro-organisms and mycoplasmas, especially respiratory and articular syndrome caused by mycoplasmas and/or staphylococcus.

Czech republic

Pharmagal s.r.o.,

Murgašova 5,

949 01 Nitra,

SLOVAK REPUBLIC

DOXYGAL

Doxycycline hyclate

50 mg/1 g

Powder for oral solution

Poultry

Administer orally via drinking water for 3-5 days.

Therapeutically- preventive: 50 mg doxycycline/1 l drinking water

Therapeutically: 100 mg doxycycline/1 l drinking water

Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications: Used for the treatment of the secondary bacterial infections following to viral origin diseases. Poultry: CRD (mycoplasmosis), colibacillosis

Czech republic

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

DOXYVIT 40 %

Doxycicline hyclate

40g/100g

Powder for oral solution

Chicken-broiler, turkey

Administer orally via drinking water for 3-5 days.

1.Continuous therapy:

1,0g DOXYVIT 40 % per 3-6 L of drinking water

2.Pulse therapy:

10-20 mg doxycycline / kg b.w., intervals 4-8 hours.

Chicken broiler, turkey: Meat and offal: 4 days. Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications:

Treatment and prevention of respiratory, intestinal and systemic infections caused by microorganisms susceptible to doxycycline in broilers and turkeys. Chronic respiratory disease (Mycoplasma gallisepticum, Escherichia coli) Aerosaculitis (Mycoplasma meleagridis) Infectious synovitis (Mycoplasma synoviae) Fowl cholera (Pasterella multocida) Bordetella turkey infections (Bordetella avium) Infectious coryza (Haemophilus paragallinarum) Colibacillosis (Eschrichia coli) Necrotic enteritidis (Clostridium perfringens) Chlamydiosis (Chlamydia psittaci)

Czech republic

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

KARIDOX 100 mg/ml

Doxycycline hyclate

100 mg/1 ml

Oral solution

Chicken-broiler

Administer orally via drinking water for 3-5 days.

10-20 mg doxycycline/kg bodyweight/day (i.e.. 0,5-1,0 ml of product/l of drinking water/day).

Chickens(broilers): Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption

Indications: Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms susceptible to doxycycline.

Czech republic

Tekro, spol. s.r.o.,

Višňová 2/484,

140 00 Praha 4,

CZECH REPUBLIC

MEDITEK DOX 100

Doxycycline hyclate

100g/kg

Powder for oral solution

Broiler

Administer orally via drinking water for 3-5 days.

10 mg Doxycycline hyclate/1kg bodyweight (1,0 kg of product / 1 000 l drinking water)

Chickens (broilers): Meat and offal: 7 days

Indications: Prevention and treatment of infection disease of the respiratory and gastrointestinal tract in pigs and broilers caused by the pathogens susceptible to doxycycline. It is efficient on the several bacteria resistant to first generation tetracyclines.

Czech republic

CHEMO IBERICA, S.A. Gran Via Carlos III, 98 7a Edificio Trade

08028 Barcelona SPAIN

ORIDOX 100 mg/ml, perorální roztok pro podání v pitné vodě pro brojlery a prasata

Doxycycline hyclate

100 mg/1ml

Oral solution

Chicken-broiler

Administer orally via drinking water for 3-5 days.

10-20 mg doxycycline/kg bodyweight/day (i.e.. 0,5-1,0 ml of product/ldrinking water/day

Chickens (broilers): Meat and offal: 7 days.

Eggs: Not permitted for use in laying hens from which eggs are produced for human consumption

Indications: Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms susceptible to doxycycline.

Czech republic

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

Pulmodox O.S.P. 5 %

Doxycycline hyclate

0,05 g/1g

Powder for oral solution

Poultry

Administer orally via drinking water for 3-5 days.

Poultry till 2 weeks: 1 g of the product per L of drinking water and day

Poultry over 2 weeks: 2 g of the product per L of drinking water and day

Duration of the treatment: 3 - 5 days.

Chicken (broilers): Meat and offal: 4 days, Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications:

Treatment of respiratory infections caused by the pathogens susceptible to doxycycline and chickens (broilers).

Czech republic

KELA Laboratoria n.v.

Industrial Zone

De Kluis

St. Lenaartseweg 48

2320 Hoogstraten

BELGIUM

Respidox 5 %

Doxycycline hyclate

50 mg / 1 g

Powder for oral solution

Poultry

Administer orally via drinking water for 3 days.

2 g of product/l drinking water

Poultry: Meat and offal: 7 days

Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications: Treatment of the infections caused by the microrganisms susceptible to doxycycline.

Poultry: CRD, colibacillosis, inflammation of nasal mucosa, synovitis, salmonelosis, fowl cholera, chlamydiosis

Czech republic

COOPHAVET

Saint Herblon

44150 Ancenis

FRANCE

RONAXAN P.S. 5 %

Doxycycline hyclate

50 mg / 1 g

Powder for oral solution

Chickens

Administer orally via drinking water for 5 days.

10 mg doxycycline / kg bodyweight. / day (i.e.. 1 g of product/5 kg bodyweight.)

Chicken (broilers): Meat and offal: 4 days,

Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications: Treatment of respiratory infections caused by the pathogens susceptible to doxycycline in chickens (broilers).

Czech republic

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

Doxycycline Calier 500 mg/g

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

6 days

Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum

Czech republic

Ceva Animal Health Slovakia spol. s.r.o.

Račianska 77

831 02 Bratislava

SLOVENIA

DOXYVIT 100

Doxycycline hydrocloride

100 g/1 000 g

Powder for oral solution

Poultry (chicken, turkey, goose)

Administer orally via drinking water for 5 days.

10 mg doxycycline/kg bodyweight per day, i.e. 0,1 g DOXYVIT 100 / kg bodyweight

Meat and offal: 7 days. Not permitted for use in laying hens from which eggs are produced for human consumption.

Indications: Treatment and prevention of respiratory, intestinal and systemic infections caused by micro-organisms susceptible to doxycycline in hens, turkeys and gouses: chronical respiratory disease (Mycoplasma gallisepticum, Escherichia coli), aerosaculitis (Mycoplasma meleagridis), synovitis (Mycoplasma synoviae), fowl cholera (Pasteurella mul tocida), bordetela turkey infections (Bordetella avium), infectious coryza (Haemophilus paragallinarum), colibacillosis (Esccherichia coli), necrotic enteritis (Clostridium perfringens), chlamydiosis (Chlamydia psittaci), prevention in stress conditions (vaccination, changes in housing, transportation)

Denmark

Laborartorios Karizoo

S.A. Pol.Ind. La Borda c/Mas Pujades 11-12

Caldes de Montbui 08140

SPAIN

Karidox

Doxycycline hyclate

10 %

Oral solution

Chickens, swine

Orally (drinking water) for 3 to 5 days

In chickens: 10-20 mg doxycycline hyclate per kg bodyweight per day for 3 to 5 days (i.e. 0.5-1.0 ml product/litre water/day)

Chickens for slaughter: 7 days Eggs: May not be administered to egg laying poultry if the eggs are intended for human use.

Indications:Prevention and treatment of CRD and mycoplasmosis caused by microorgansisms sensitive to doxycycline.

Denmark

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Oridox

Doxycycline hyclate

10 %

Oral solution

Chickens, swine

Orally (drinking water) for 3 to 5 days

In chickens: 10-20 mg doxycycline hyclate per kg bodyweight per day for 3 to 5 days (i.e. 0.5-1.0 ml product/litre water/day)

Chickens for slaughter: 7 days Eggs: May not be administered to egg laying poultry if the eggs are intended for human use.

Indications: Prevention and treatment of CRD and mycoplasmosis caused by microorgansisms sensitive to doxycycline.

Denmark

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Estonia

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

Hipradoxi-S

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

chicken (broilers)

oral use via drinking water.

50 ... 100 mg doxycycline/litre water

Meat and offal:

5 days. Not authorised for use in laying birds producing eggs for human consumption.

Indications: Colibacillosis, C.R.D. and associated infections.

Estonia

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

Hipradoxi-P

Doxycycline hyclate

100 mg/g

powder for oral solution

chicken (broilers)

oral use via drinking water.

20 mg doxycycline/kg bw/day

Meat and offal:

5 days. Not authorised for use in laying birds producing eggs for human consumption.

Indications: Colibacillosis, C.R.D. and associated infections.

Estonia

Maxx Pharma OÜ

Kaluri tee 5

Haabneeme

74001 Viimsi

Harjumaa

ESTONIA

Doxyprim 40 %

Doxycycline hyclate

400 mg/g

powder for oral solution

chicken, turkeys

oral use via drinking water.

10 ... 20 mg/kg bw/day 5 days

Meat and offal:

4 days. Not authorised for use in laying birds producing eggs for human consumption.

Indications: For the treatment of respiratory, intestinal and systemic infections caused by doxycycline-sensitive organisms.

Estonia

Zoovetvaru

uusaru 5

76505 Saue

Harjumaa

ESTONIA

Doxycin

Doxycycline hyclate

200 mg/g

powder for oral solution

chicken (broilers)

for oral administaration, via drinking water.

10 mg doxycycline/kg bw/day 3-5 days

Meat and offal:

6 days. Do not use in laying birds producing eggs for human consumption.

Indications: For the treatment of infections of the respiratory system and alimentary tract caused by microorganisms sensitive to doxycycline, including mycoplasmas, bordeteliosis, chlamydiosis, pasteurellosis anaerobic infections, salmonellosis, staphylococcosis, colibacillosis.

Estonia

Dutch Farm Veterinary Pharmaceuticals B.V.

Veemweg 1

3771 MT Barnevald

THE NETHERLANDS

Dutch Farm Doxycycline 20 % WSP

Doxycycline hyclate

200 mg/g

powder for oral solution

poultry

for oral administration, via drinking water.

15 mg Doxycycline hyclate/kg bw/day 3-5 days.

Meat and offal:

7 days. Do not use in laying birds producing eggs for human consumption.

Indications: For the treatment of infections caused by microorganisms sensitive to doxycycline, especially respiratory infections.

Germany

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

DOXYCYCLINE CALIER 500 mg/g, Pulver zum Eingeben über das Trinkwasser für Huhn und Schwein

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

Meat and offal:

6 days

Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum

Germany

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx 500 mg/g Pulver zum Eingeben über das Trinkwasser

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Greece

Durden Trading Limited

12, Kennedy Av.

Nicosia

CYPRUS

Stardox

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

20 mg/kg X 4-7 days

Meat and offal:

14 days

Indications: CRD caused by Mycoplasma gallisepticum colibacilosis

Greece

NEW VET A.E

Fleming 15

15123 Marousi Attikis

GREECE

Nexyclin

Doxycycline hyclate

400 mg/g

Powder for oral solution

Chickens(broiler) Turkeys pigs

In drinking water

20 mg/kg

Meat and offal:

4 days

Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli Pasteurella multocida, Chlamydia psittaci

Greece

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

Pulmodox

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

10 mg/kg X 3-5 days

Meat and offal:

9 days

Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum

Greece

Nutri-Biomed Hellas LTD

1, V. Hugo & Chlois

Metamorfosi Attikis

14452 Athens

GREECE

Doxyveto

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

25 mg/kg X 3-5 days

Meat and offal:

9 days

Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum

Greece

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycyclin 50 Dopharma

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chickens(broiler) Calves pigs

In drinking water

25 mg/kg X 3-5 days

Meat and offal:

9 days

Indications: Respiratory infections caused by Mycoplasma spp, E.coli, Haemophilus paragalinarum, Bordetella avium Enteritis caused by Clostridium perfringens and colinum

Greece

Durden Trading Limited

12, Kennedy Av.

Nicosia

CYPRUS

Doxycycline 150/Durden

Doxycycline hydrocloride

150 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

10 mg/kg X 3-5 days

Meat and offal:

4 days

Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli, Haemophilus paragalinarum

Greece

AFOI TETOROU ABE

10 km National road Athens-Lamia

14451, Metamorfosi

GREECE

Doxycycline 150/Afoi Tetorou

Doxycycline hydrocloride

150 mg/g

Powder for oral solution

Chickens(broiler) Non –egg laying chickens Calves pigs

In drinking water

10 mg/kg X 3-5 days

Meat and offal:4 days

Indications: Respiratory infections caused by Mycoplasma gallisepticum, E.coli, Haemophilus paragalinarum

Spain

LAB. DR ESTEVE

Avda Mare de Deu de Montserrat

221 08041 Barcelona

SPAIN

DOX ESTEVE

Doxycycline hyclate

100 mg/g

Water soluble powder

Poultry Pigs Bovine

Oral 3-5 days

20 mg / Kg/day

Meat and offal:

9 days

Indications: Infections caused by Mycoplasma spp (Micoplasmosis, CRD) or Pasteurella multocida (Pasteurellosis).

Meat and offal:

Poultry: 5 days

Turkeys: 7 days

colibacilosis, C.R.D., micoplasmosis.

Spain

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1

Apartado 60

Riudoms 43330 (Tarragona) SPAIN

DOXI 100 mg/ml POLVO ORAL

Doxycycline hyclate

10 g/100 g

Water soluble powder

Poultry

Turkeys Pigs

Oral

3-5 days (Poultry and turkeys) 5 days (Pigs)

50 – 100 mg/l drinking water/day (poultry and turkey) 10 mg/kg/day (pigs)

Meat and offal:

Broilers: 5 days Turkeys: 7 days Pigs: 4 days

Spain

FATRO URIACH VETERINARIA, S.L.

Constitucion, 1

08960 Sant Just Desvern

SPAIN

DOXIDOL

Doxycycline hyclate

10 g/100 g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

7.5 – 15 mg/kg/day

Meat and offal:

7 days

Indications: Colibacilosis

CRD

Spain

DIVASA-FARMAVIC, S.A.

CTRA. SANT HIPOLIT, KM. 71

08503 GURB – VIC

SPAIN

DOXIVET 20

Doxycycline hyclate

200 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

10 - 20 mg/Kg/day

Meat and offal:

7 days

Indications: Colibacilosis, CRD, Micoplasmosis

Spain

MEVET, S. A.

POLIGONO INDUSTRIAL EL SEGRE, PARCELA409-410

25191 Lérida

SPAIN

DOXICIVALL POLVO

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

Meat and offal:

4 days

Indications: Colibacilosis, CRD, Micoplasmosis

Spain

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

HIPRADOXI-S

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

5 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

LAMONS, S.A.

POL.IND. MECANOVA, NAVES 27-28

25191 LLEIDA

SPAIN

DOXICICLINA 10 % LAMONS

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

5 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

HIPRADOXI-P

Doxycycline hyclate

100 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/Kg/day

Meat and offal:

5 days

Indications: colibacilosis, C.R.D., and associated infections

Spain

POLICHEM, S.A.

Ctra. Reus-Cambrils, Km. 3

43206 Reus

SPAIN

DOXICHEM

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

SUPER'S DIANA, S.L

Ctra. Barcelona - Ripoll, Km 17

08150 Parets del Valles

SPAIN

DOXBRON

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

COTECNICA -COOPERATIVA TECNICA AGROPECUARIA

Ctra. N II KM 494,5

25250 Bellpuig (Lerida)

SPAIN

DOXICICLINA 500 USO VETERINARIO COTECNICA

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

CENAVISA, S.A.

Camí Pedra Estela S/N

43205 Reus

SPAIN

LAFIDOX POLVO ORAL

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

LABORATORIOS SYVA, S.A.

PARROCO PABLO DIEZ, 49-57

24010 TROBAJO DEL CAMINO

SPAIN

SYVADOX 10 %

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

INVESA INTERNACIONAL, S.A.

Esmeralda, 19 - 4o

08950 ESPLUGUES DE LLOBREGAT

SPAIN

DX-10

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

CENAVISA, S.A.

Camí Pedra Estela S/N

43205 Reus

SPAIN

DOXICICLINA 500 GANADEXIL

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Turkeys

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

DIVASA-FARMAVIC, S.A.

CTRA. SANT HIPOLIT, KM. 71

08503 GURB – VIC

SPAIN

DOXIVET 5

Doxycycline hyclate

50 mg/g

Water soluble powder

Poultry

Turkeys

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

INDUSTRIAL VETERINARIA S.A.

Esmeralda, 19 - 4o

08950 ESPLUGUES DE LLOBREGAT

SPAIN

DOXINYL

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

JAER, S.A.

Barcelona, 411

08620 San Vicens del Horts

SPAIN

MASTERMIX DOXICICLINA

Doxycycline hyclate

50 mg/g

Water soluble powder

Poultry

Turkeys

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

KARIDOX

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pig

Oral

3-5 days

10 - 20 mg/Kg/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

SOLDOXIN

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pig

Oral

3-5 days

10 - 20 mg/Kg/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

CALIERDOXINA 50 % P O

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

5 days

20 mg/kg/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

GANAMIX DOXICICLINA 50 % P O

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

5 days

20 mg/kg/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1

Apartado 60

Riudoms 43330 (Tarragona) SPAIN

HIDRODOX 10 %

Doxycycline hyclate

100 mg/ml

Oral solution

Poultry

Pigs

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

Spain

VIRBAC ESPAÑA, S.A.

Angel Guimera, 179-181

08950 Esplugues de Llobregat

SPAIN

PULMODOX P.O.S.

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: C.R.D., micoplasmosis

Spain

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

DILUDOX

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Spain

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

DOXICICLINA CALIER 500 mg/g

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

Meat and offal:

6 days

Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum

Spain

LABORATORIOS MAYMO, S.A.

Via Augusta, 302

08017 Barcelona

SPAIN

MAYDOX PS

Doxycycline hydrocloride

50 mg/g

Water soluble powder

Poultry

Turkeys

Oral

3-5 days

50 – 100 mg/l drinking water/day

Meat and offal:

7 days

Indications: colibacilosis, C.R.D., micoplasmosis

France

COOPHAVET

Saint Herblon

44150 Ancenis

FRANCE

RONAXAN P.S. 5 %

Doxycycline hyclate

50 mg/g

Water soluble powder

Turkey

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Broilers: 4 days

Indications: Broilers and turkey:

Preventive and treatment of infections in respiratory system

France

FRANVET

ZI d'Etriche-Route d'Avire

BP 103

49500 Segré Cedex

FRANCE

DOXY 5 FRANVET

Doxycycline hyclate

50 mg/g

Water soluble powder

Turkey,

Porcine

Hens

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

PULMODOX P.O.S. 5 %

Doxycycline hyclate

50 mg/g

Water soluble powder

Porcine

Calves

Poultry

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

Sogeval Laboratoires

200 route De Mayenne

53022 Laval Cedex FRANCE

DOXYVAL 5 %

Doxycycline hyclate

50 mg/g

Water soluble powder

Turkey

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

Laboratoires Biove

3 rue de Lorraine

62510 Arques

FRANCE

ACTI DOXY 5

Doxycycline hyclate

50 mg/g

Water soluble powder

Dindon

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

Ceva Sante Animale France

La Balastiere

33501 Libourne Cedex

FRANCE

DOXYVIT

Doxycycline hyclate

50 mg/g

Water soluble powder

Turkeys

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

Noe

10 rue Clement Ader

ZA Le Patis

78120 Rambouillet

FRANCE

COMPOMIX V DOXYCYCLINE

Doxycycline hyclate

50 mg/g

Water soluble powder

Dindon

Porcine

Broilers

Calves

Prevention

1 - 3 days

Curative treatment:

3 - 5 days

10 mg/kg/day

Meat and offal:

Turkey: 6 days

Hens: 4 days

Indications: Prevention and treatment of infections in respiratory system

France

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

SOLDOXIN 100 MG/ML SOLUTION BUVABLE POUR POULES POULETS ET PORCINES

Doxycycline hyclate

100 mg/ml

Oral solution

Porcine

Hens

Broilers

CHICKEN (broilers): 10 - 20 mg of doxycycline / kg bw / day

3 - 5 days

Indications: CHICKENS (BROILERS) Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.

France

Laborartorios Karizoo

S.A. Pol.Ind. La Borda c/Mas Pujades 11-12

Caldes de Montbui 08140

SPAIN

DOXYSOL 10 %

Doxycycline hyclate

100 mg/ml

Oral solution

Porcine

Hens

Broilers

CHICKEN (broilers): 10 - 20 mg of doxycycline / kg bw / day

3 - 5 days

Indications: CHICKENS (BROILERS). Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.

France

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HYDRODOXX 500 MG/G poudre pour administration dans l'eau de boisson pour poulets et porcs

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

France

LABORATORIOS CALIER, S.A.

BARCELONÉS, 26

08520 Les Franqueses del Valles

SPAIN

DOXYCYCLINE CALIER 500 MG/G poudre pour administration dans l'eau de boisson pour poulets et porcins

Doxycycline hyclate

500 mg/g

Water soluble powder

Poultry

Pigs

Oral

3-5 days

20 mg/kg/day

Meat and offal:

6 days

Indications: Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum

Hungary

COOPHAVET

Saint Herblon

44150 Ancenis

FRANCE

Ronaxan P.S. 5 % oldható por

Doxycycline hyclate

5 g/100 g

Powder for oral solution

Chicken

Chicken younger than 2 weeks: 1 g powder/1 litre of drinking water/day. Chicken older than 2 weeks: 2 g powder/1 litre of drinking water.

10 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

4 days

Indications: For the treatment of CRD and Mycoplasma diseases, and other infections

Hungary

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

500 g product dissolved in 1 000 litre of drinking water.

25 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

4 days

Indications: For the treatment and control of chicken respiratory diseases

Hungary

Kon-Pharma GmbH.

30625 Hannover

GERMANY

Doxy 50 % por belsőleges oldathoz

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken, turkey

Chicken: 500 mg product dissolved in 1 litre of drinking water. Turkey: 400 mg product/1 litre of drinking water

30 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

Chicken and turkey: 11 days.

Hungary

V.M.D. Állatgyógyászati Kft.

1093 Budapest

HUNGARY

Doxyveto-50

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

Continuous treatment: 0,2 g product/1 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 8 hours.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

10 days

Indications: For the treatment of CRD and pasteurellosis; synovitis in turkey.

Hungary

Novartis Animal Health d.o.o.

Verovskava 57

1000 Ljubljana

SLOVENIA

Doxyril 50 % por belsőleges oldathoz

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

5 g product/100 kg bw/day, dissolved in the drinking water.

25 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

6 days

Indications: For the treatment of CRD, pasteurellosis, colibacillosis, Haemophilus and Clostridium infections

Hungary

Animal-Med Kft.

1029 Budapest

HUNGARY

Anidox 10 % por belsőleges oldathoz

Doxycycline hyclate

100 mg/g

Powder for oral solution

Chicken

1 000 g product dissolved in 1 000 litre of drinking water.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

12 days

Indications: For the treatment of mycoplasmosis, pasteurellosis, colibacillosis.

Hungary

Animal-Med Kft.

1029 Budapest

HUNGARY

Anidox 100 % por belsőleges oldathoz

Doxycycline hyclate

1 000 mg/g

Powder for oral solution

Chicken

100 g product dissolved in 1 000 litre of drinking water.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

12 days

Indications: For the treatment of infections caused by: Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophilus paragallinarum and Pasteurella multocida

Hungary

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

Doxyprim 40 % vízoldékony pulvis

Doxycycline hyclate

400 mg/g

Powder for oral solution

Chicken, turkey

Continuous treatment: 1 g product/3-6 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 4-8 hours.

10-20 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

4 days

Indications: For the treatment of infections caused by: Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophilus paragallinarum and Pasteurella multocida

Hungary

CHEMIFARMA S.p.A

Via Don Eugenio Servadei 16

47100 Forli

ITALY

Doxifarm 50 % WSP

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

40 g product/100 kg bw/100 litre of drinking water.

20 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

5 days

Indications: For the treatment of CRD, mycoplasmosis, synovitis, colibacillosis, ileitis (necroric and ulcerosus), haemophilus-infection.

Hungary

VIRBAC S.A.

1ère avenue - 2065 m - L.I.D.

06516 CARROS

FRANCE

Pulmodox 50 % WSP

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

500 g product dissolved in 1 000 litre of drinking water.

25 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

4 days

Indications: For the treatment of CRD and other respiratory diseases, caused by: Mycoplasma spp., Pasteurella spp., E. coli, and Chlamydia psittaci.

Hungary

Phylaxia Pharma Zrt.

8000 Székesfehérvár

HUNGARY

Doxyphyl SP

Doxycycline hyclate

300 mg/g

Powder for oral solution

chicken, turkey

40 g product/1 200 kg bw/day, calculated amount of the product should be dissolved in the drinking water consumed during 3 hours.

10 mg doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

chicken: 7 days, turkey: 10 days.

Indications: For the treatment of respiratory infections caused by Mycoplasma spp., E. coli, Haemophilus paragallinarum, Bordetella avium, and ileitis caused by Clostridium perfringens and Cl. colinum.

Hungary

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 % pulvis

Doxycycline hyclate

500 mg/g

Powder for oral solution

Chicken

Dissolved in the drinking water.

10 mg/kg bw and 20 mg/kg bw/day, for 4 days.

Meat and offal:

chicken treated with 10 mg/kg bw: 5 days, chicken treated with 20 mg/kg bw: 12 days.

Indications: For the treatment of respiratory and other diseases caused by doxycycline-sensitive bacteria.

Hungary

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Oridox 100 mg/ml belsőleges oldat

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

Chicken

100 mg/ml oral concentrate dissolving in the drinking water.

10-20 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

7 days

Indications: For the treatment of respiratory and other diseases caused by doxycycline-sensitive bacteria.

Hungary

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox 100 mng/ml belsőleges oldat

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

Chicken

100 mg/ml oral concentrate dissolving in the drinking water.

10-20 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

7 days

Indications: For the treatment and prevention of CRD or other Mycoplasma diseases

Hungary

CENAVISA, S.A.

Camí Pedra Estela S/N

43205 Reus

SPAIN

Doxycen belsőleges oldat

Doxycycline hyclate

200 mg/ml

Concentrate for oral solution

Chicken

1 ml/20 kg bw/day dissolved in the drinking water.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

5 days

Indications: For the treatment of CRD, mycoplasmosis and colibacillosis.

Hungary

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

Doxyvit 100 WSP

Doxycycline hydrocloride

100 mg/g

Powder for oral solution

Chicken, turkey, goose

Continuous treatment: 1 g product/1 litre of drinking water. Pulse treatment: calculated amount of the product should be dissolved in the drinking water consumed during 6-8 hours.

10 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

Chicken, turkey, goose 7 days

Indications: For the treatment of respiratory and enteric diseases in broiler chickens

Hungary

Industria Italiana Integratori TREI S.p.A.

Viale Corassori 62

41100 Modena

ITALY

Doxipan 20 WSP

Doxycycline hydrocloride

200 mg/g

Powder for oral solution

Chicken

5-7.5 g product dissolving in 10 litre of drinking water.

10-15 mg/doxycycline/kg bw/day, for 3-5 days.

Meat and offal:

5 days

Indications: For the treatment of CRD, mycoplasmosis, synovitis, colibacillosis, ileitis (necroric and ulcerosus), haemophilus-infection.

Hungary

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

Hipradoxi-S oral solutio

Doxycycline hydrocloride

100 mg/ml

Concentrate for oral solution

Chicken

100 mg/ml oral concentrate dissolving in 1 litre of drinking water.

10 mg doxycycline/kg bw/day, for 5 days.

Meat and offal:

5 days

Indications: For the treatment and prevention of CRD or other Mycoplasma diseases

Ireland

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1

Apartado 60

Riudoms 43330 (Tarragona) SPAIN

DOXIVEX 10 % Concentrate for oral solution.

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

Chickens (broilers) and Pigs

For oral administration via the drinking water. for 3-5 days

Chickens (broilers): 50 - 100 mg Doxycycline / litre of drinking water / day (equivalent to 0.5 - 1.0 ml DOXIVEX 10 % / litre of drinking water / day) for 3-5 days

Meat & offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption

Indications: Treatment of colibacillosis, chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline

Ireland

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

Aquadoxx 500 mg/g water-soluble powder

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Italy

CEVA VETEM S.P.A.

Via Colleoni n.15

20041 Agrate Brianza (Milano)

ITALY

DOXICICLINA 20 % CEVA VETEM

Doxycycline hyclate

Doxycycline 200 g. per 1 kg. of product

Water soluble powder

broiler, turkey

drinking water

Broiler, Turkey: 1 g / 10 kg b.w per 5 days.

Meat and offal:

broiler: 7 days

turkey: 8 days

Indications: Broiler: Treatment of chronic respiratory disease

Turkey: Treatment of infective synusitis

Italy

CHEMIFARMA S.p.A

Via Don Eugenio Servadei 16

47100 Forli

ITALY

DOXICICLINA 50 % CHEMIFARMA

Doxycycline hyclate

Doxycycline 500 g. per 1 kg. of product

Water soluble powder

broiler, swine

drinking water

Broiler: 20 mg of doxycycline / per 1 kg b.w.(per 3 - 5 days) Swine: 20 mg of doxycycline / per 1 kg b.w per 3 - 5 days

Meat and offal:

broiler: 6 days Do not use in hens producing eggs for human consumption. swine: 5 days

Indications: Broiler: Chronic respiratory disease caused by: Pasteurella soo, Mycoplasma spp, Haemophilus gallinarum, Bordetella avium, ans Clamidia psittaci.

Italy

SINTOFARM S.P.A.

Via Togliatti n.5

42016 Guastalla (Reggio Emilia)

ITALY

DOXIFARM 50 %

Doxycycline hyclate

Doxycycline hyclate 500 mg. (equivalent to 433,3 mg of Doxiclina) per 1 g. of product

Water soluble powder

broiler, swine

drinking water

Broiler: 25 mg of doxycycline hyclate/per 1 kg b.w.(per 3 - 5 days) Swine: 20 mg of doxycycline hyclate/per 1 kg b.w per 5 days

Meat and offal:

broiler: 6 days Do not use in hens producing eggs for human consumption. swine: 4 days

Indications: Broiler: Treatment and control of respiratory disease caused by Mycoplasma spp, Haemophilus paragallinarum, Escherichia coli. Enteritis caused by Clostridium perfringens and Clostridium colinum

Italy

INDUSTRIA ITAILIANA INTEGRATORI TREI SpA

Via Affarosa n.4

42010 Rio Saliceto (Reggio Emilia) ITALY

DOXIPAN 54

Doxycycline hyclate

Doxycycline 500 g. per 1 kg. of product

Water soluble powder

broiler, turkey, swine

drinking water

Broiler: 10 mg of doxycycline / 1 kg b.w. Turkey: 20 mg of doxycycline / 1 kg b.w. Swine: 10 mg of doxycycline / 1 kg b.w per 5 days

Meat and offal:

broiler: 3 days Do not use in hens producing eggs for human consumption. turkey: 10 days swine: 4 days

Indications: Broiler:Chronic respiratory disease. Turkey:Respiratory and joints syndroms caused by Mycoplasms and/or Staphilococcus

Italy

INTERVET ITALIA S.R.L.

Via W. Tobagi n.7

20068 Peschiera Borromeo (Milano)

ITALY

NAXOCET

Doxycycline hyclate

Doxycycline hyclate 500 mg. per 1 g. of product

Water soluble powder

broiler

drinking water

Broiler: 20 mg of doxyclyne hyclate/1 kg b.w. per 5 days.

Meat and offal:

broiler: 8 days Do not use in hens producing eggs for human consumption.

Indications: Chronic respiratory disease caused by Mycoplasma spp.

Lithuania

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

DOXYCYCLINE 50 %, geriamieji milteliai

Doxycycline hyclate

500 mg/g

Oral powder

Calves, pigs and poultry.

4–7 days with drinking water

Poultry: 40 mg per 1 kg of body weight, or 200–400 g per 1 000 litres of drinking water, during 4–7 days.

Meat and offal:

Poultry – 4 days. Do not use in animals producing eggs for human consumption.

Indications: for the treatment of poultry: ornythosis, caused by Clamydia psittaci, colibacteriosis caused by E. coli, CRD caused by Mycoplasma gallisepticum

Lithuania

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

DOXYPRIM 40 % geriamieji milteliai

Doxycycline hyclate

400 mg/g

Oral powder

Chickens, turkeys and pigs.

Should be administered for a period of 5 days in chicken and turkeys together with drinking water.

Chicken and turkeys: 10–20 mg doxycycline hyclate per 1 kg of body weight daily, administrated pulse dosed when the daily requirement is given in limited quantity of water to be consumed by the birds within 4–8 hours or supplied continuously as 67–133 mg ml Doxycycline hyclate per 1 litre of drinking water.

Meat and offal:

Edible tissues of chickens and turkeys – 4 days.

Indications: In chickens and turkeys indications include: chronicle respiratoric diseases (Mycoplasma gallisepticum, E. coli), airsacculitis (Mycoplasma meleagridis), infectious synovitis (Mycoplasma synoviae), colibacillosis (E. coli), fowl cholera (Pasteurella multocida), turkey bordetellosis (Bordetella avium), infectious coryza (Haemophilus paragallinarum), necrotic enteritis (Clostridium perfringens), chlamydiosis (Chlamydia psittaci).

Lithuania

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

SOLUDOX 50 %, geriamieji milteliai

Doxycycline hyclate

500 mg/g

Oral powder

Pigs and chickens.

Should be administered orally with drinking water for a period of 4 days.

Chickens: 10* mg doxycycline hyclate per 1 kg of body weight daily for 4 days; 20* mg doxycycline hyclate per 1 kg of body weight daily for 4 days. * The highest dose is recommended in case of infections caused by strains which are moderately susceptible (MIC up to 2 μg/ml), whilst the lowest dosage maybe used for (highly) susceptible strains (MIC up to 0.5–1.0 μg/ml)

Indications: For the treatment of infections caused by micro-organisms susceptible to doxycycline, such as Pasteurella multocida and Ornithobacterium rhinotracheale in chickens.

The Netherlands

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline-hyclaat 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Calves, non-egg laying chickens and turkeys.

Non-egg laying chickens and turkeys: oral via drinking water. bodyweight per day for 4-7 days.

Non-egg laying chickens and turkeys: 20 mg doxycycline hyclate per kg

Turkeys - meat: 28 days.

Non-egg laying chickens - meat: 14 days.

Indications: Turkeys:

—

Ornithosis caused by Chlamydia psittaci

| — | Colibacillosis caused by E. coli |
| --- | --- |

—

Colibacillosis caused by E. coli

| — | CRD caused by Mycoplasma gallisepticum |
| --- | --- |

—

CRD caused by Mycoplasma gallisepticum

Non-egg laying chikens Colibacillosis caused by E. coli

The Netherlands

Dutch Farm Veterinary Pharmaceuticals B.V.

Veemweg 1

3771 MT

Barneveld

THE NETHERLANDS

Doxycycline 20 % W.O.

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate

Powder for oral solution

Non-egg laying chickens

Oral via drinking water. for 3 days

10 mg doxycycline hyclate per kg bodyweight per day for 3 days

Meat: 7 days.

Indication non-egg laying chickens:

| — | Polyarthritis caused by Mycoplasma synoviae; |
| --- | --- |

—

Polyarthritis caused by Mycoplasma synoviae;

| — | CRD, amongst others caused by Mycoplasma gallisepticum; |
| --- | --- |

—

CRD, amongst others caused by Mycoplasma gallisepticum;

| — | Colibacillosis caused by Escherichia coli |
| --- | --- |

—

Colibacillosis caused by Escherichia coli

The Netherlands

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline-hyclaat 20 %

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate.

Powder for oral solution

Calves, pigs, chickens and turkeys.

Chickens and turkeys: oral via drinking water for 4-7 days.

Chickens and turkeys: 20 mg doxycycline hyclate per kg bodyweight

Turkeys - meat: 28 days.

Chickens - meat: 14 days, eggs: 10 days.

Indication turkeys:

| — | Ornithosis caused by Chlamydia psittaci |
| --- | --- |

—

Ornithosis caused by Chlamydia psittaci

| — | Colibacillosis caused by E. coli |
| --- | --- |

—

Colibacillosis caused by E. coli

| — | CRD caused by Mycoplasma gallisepticumIndication |
| --- | --- |

—

CRD caused by Mycoplasma gallisepticumIndication

Indication chickens:

| — | Colibacillosis caused by E. coli |
| --- | --- |

—

Colibacillosis caused by E. coli

| — | CRD caused by Mycoplasma gallisepticum |
| --- | --- |

—

CRD caused by Mycoplasma gallisepticum

The netherlands

Dutch Farm International B.V.

Nieuw Walden 112

1394 PE

Nederhorst den Berg

THE NETHERLANDS

Doxycycline 20 % W.O.

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate.

Powder for oral solution

Non-egg laying chickens (broilers).

Oral via drinking water.

10 mg doxycycline hyclate per kg bodyweight per day for 3 days.

Meat: 7 days. Do not administer to chickens producing eggs for human consumption. Indication non-egg laying chickens:

| — | Polyarthritis caused by Mycoplasma synoviae; |
| --- | --- |

—

Polyarthritis caused by Mycoplasma synoviae;

| — | CRD, amongst others caused by Mycoplasma gallisepticum; |
| --- | --- |

—

CRD, amongst others caused by Mycoplasma gallisepticum;

| — | Colibacillosis caused by Escherichia coli. |
| --- | --- |

—

Colibacillosis caused by Escherichia coli.

The Netherlands

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline-hyclaat 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Calves, pigs, non-egg laying chickens.

Non-egg laying chickens: oral via drinking water. for 4-5 days.

Non-egg laying chickens: 20 mg doxycycline hyclate per kg bodyweight per day for 4-5 days.

Non-egg laying chickens - meat: 14 days.

Indication non-egg laying chickens:

| — | Colibacillosis caused by E. coli |
| --- | --- |

—

Colibacillosis caused by E. coli

| — | CRD caused by Mycoplasma gallisepticum |
| --- | --- |

—

CRD caused by Mycoplasma gallisepticum

The Netherlands

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 % WSP

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Non-egg laying chickens.

Non-egg laying chickens: oral via drinking water.

Non-egg laying chickens: 25 mg doxycycline hyclate per kg bodyweight per day for 3-5 days.

Non-egg laying chickens - meat: 6 days.

Indication non-egg laying chickens:

| — | Respiratory infections caused by Mycoplasma spp (M. gallisepticum, M.synoviae en M. meleagridis), E. coli and Haemophilus paragallinarum; |
| --- | --- |

—

Respiratory infections caused by Mycoplasma spp (M. gallisepticum, M.synoviae en M. meleagridis), E. coli and Haemophilus paragallinarum;

| — | Enteritis caused by Clostridium perfringens en Clostridium colinum. |
| --- | --- |

—

Enteritis caused by Clostridium perfringens en Clostridium colinum.

The Netherlands

Interchemie Werken

De Adelaar BV

Hosterweg 26a

5811 Ccastenray

THE NETHERLANDS

Doxy WS

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate.

Powder for oral solution

Non-egg laying chickens (broilers).

Oral via drinking water.

10 mg doxycycline hyclate per kg bodyweight per day for 3 days.

Meat: 7 days.

Indication non-egg laying chickens:

| — | Polyarthritis caused by Mycoplasma synoviae; |
| --- | --- |

—

Polyarthritis caused by Mycoplasma synoviae;

| — | CRD, amongst others caused by Mycoplasma gallisepticum; |
| --- | --- |

—

CRD, amongst others caused by Mycoplasma gallisepticum;

| — | Colibacillosis caused by Escherichia coli. |
| --- | --- |

—

Colibacillosis caused by Escherichia coli.

The Netherlands

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Pigs and non-egg laying chickens.

Non-egg laying chickens: oral via drinking water.

Non-egg laying chickens: - Pasteurellosis caused by Pasteurella multocida: 10 mg doxycycline hyclate per kg bodyweight per day for 3-4 days.infections caused by Ornithobacterium rhinotracheale (ORT): 20 mg doxycycline hyclate per kg bodyweight per day for 3-4 days

Non-egg laying chickens: - Pasteurellosis – meat: 5 days.- ORT – meat: 12 days.

Do not administer to chickens producing eggs for human consumption

The Netherlands

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Doxyfar 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Pigs and non-egg laying chickens.

Non-egg laying chickens: oral via drinking water.

Non-egg laying chickens: Pasteurellosis caused by Pasteurella multocida: 10 mg doxycycline hyclate per kg bodyweight per day for 3-4 - Respiratory infections caused by Ornithobacterium rhinotracheale (ORT): 20 mg doxycycline hyclate per kg bodyweight per day for 3-4 days

Non-egg laying chickens:

| — | Pasteurellosis – meat: 5 days. |
| --- | --- |

—

Pasteurellosis – meat: 5 days.

| — | ORT – meat: 12 days. |
| --- | --- |

—

ORT – meat: 12 days.

Do not administer to chickens producing eggs for human consumption.

The Netherlands

Kepro B.V.

Maagdenburgstraat 38

7421 ZE

Deventer

THE NETHERLANDS

Doxy 200 W.S.P.

Doxycycline hyclate

Per gram powder: 200 mg doxycycline hyclate.

Powder for oral solution

Non-egg laying chickens (broilers).

Oral via drinking water.

10 mg doxycycline hyclate per kg bodyweight per day for 3 days.

Meat: 7 days.

Do not administer to chickens producing eggs for human consumption.

Indication:

| — | Polyarthritis caused by Mycoplasma synoviae; |
| --- | --- |

—

Polyarthritis caused by Mycoplasma synoviae;

| — | CRD, amongst others caused by Mycoplasma gallisepticum; |
| --- | --- |

—

CRD, amongst others caused by Mycoplasma gallisepticum;

| — | Colibacillosis caused by Escherichia coli. |
| --- | --- |

—

Colibacillosis caused by Escherichia coli.

The Netherlands

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 %

Doxycycline hyclate

Per gram powder: 500 mg doxycycline hyclate.

Powder for oral solution

Pigs and non-egg laying chickens.

Non-egg laying chickens: oral via drinking water.

Non-egg laying chickens: 10 mg doxycycline hyclate per kg bodyweight per day for 3-4 days.

Non-egg laying chickens – meat: 5 days.

Indication: Pasteurellosis caused by Pasteurella multocida

The Netherlands

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox 10 % Oral Solution

Doxycycline hyclate

Per ml: 100 mg doxycycline (as hyclate).

Oral solution

Pigs and chickens (broilers).

Chickens (broilers): oral via drinking water.

Chickens (broilers): 10-20 mg doxycycline per kg bodyweight per day for 3-5 days

Chickens (broilers) - meat: 7 days.

Indication: Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.

The Netherlands

Huvepharma, Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx 500 mg/g

Doxycycline hyclate

Per g: 500 mg doxycycline hyclate.

Powder for oral solution

Pigs and chickens (broilers).

Chickens (broilers): oral via drinking water.

Chickens (broilers): 20 mg doxycycline per kg bodyweight per day for 3-5 days

Chickens (broilers) - meat: 6 days.

Do not administer to chickens producing eggs for human consumption.

The Netherlands

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Soldoxin

Doxycycline hyclate

Per ml: 100 mg doxycycline (as hyclate).

Oral solution

Pigs and chickens (broilers).

Chickens (broilers): oral via drinking water.

Chickens (broilers): 10-20 mg doxycycline per kg bodyweight per day for 3-5 days

Chickens (broilers) - meat: 7 days.

Do not administer to chickens producing eggs for human consumption.

Indication: Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.

Poland

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer THE NETHERLANDS

Doxymed 50

Doxycycline hyclate

500 mg/g

powder for oral solution

chickens

250-500 ml product/1 000 liter of drinking water

25 mg doxycyclini hyclate / kg bw/day for 3-5 days

Meat and offal:

4 days. Not for use in laying hens.

Poland

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 50 %

Doxycycline hyclate

500 mg/g

Oral powder

chickens

2 g product/100 kg bw/day in case of Pasteurellosis or 4 g product / 100 kg bw/day in case of Ornithrobacterium rhinotracheale infection.

10 mg doxycycliny hyclate/kg bw/day in case of Pasteurellosis or 20 mg doxycyclini hyclate/kg bw/day in case of Ornithrobacterium rhinotracheale infection for 3-4 days

Meat and offal:

5 days in case of Pasteurellosis.

12 days in case of Ornithrobacterium rhinotracheale infection.

Not for use in laying hens.

Poland

Laboratorios Hipra S.A.

Avda La Selva 135

17170 Amer (Girona)

SPAIN

Hipradoxi-S

Doxycycline hyclate

100 mg/ml

Oral solution

chickens

0,5-1,0 ml product/1 liter of drinking water

50-100 mg doxycyclini hyclate/1 liter of drinking water for 3-5 days

Meat and offal:

5 days. Not for use in laying hens.

Poland

Oropharma n.v.

Dijkstraat 30

9140 Temse

BELGIUM

Ornicure

Doxycycline hyclate

300 mg/4 g

Oral powder

pigeon, parrot

pigeon: 4g prodyct/2 liters of drinking water, parrot: 4 g product/0,5 liter

15 mg/kg bw./ day for 5 days, in case of parrot desease or clinical ornitosis for 3-4 weeks

Not for use in pigeons for human consumption.

Poland

Novartis Animal Health d.o.o.

Verovskava 57

1000 Ljubljana

SLOVENIA

Doxiryl 50 %

Doxycycline hyclate

500 mg/g

powder for oral solution

chicken (broiler)

25 mg doxycyclini hyclate / kg bw/day

25 mg doxycyclini hyclate / kg bw/day for 3-5 days

Meat and offal:

4 days. Not for use in laying hens.

Poland

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1 Apartado 60

Riudoms 43330 (Tarragona) SPAIN

Doxivex 10 %

Doxycycline hyclate

100 mg/ml

Concentrate for oral solution

chicken (broiler)

05-1,0 ml product/1 liter of drinking water

50-100 mg doxycyclini hyclas/1 liter of drinking water/day for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Oridox

Doxycycline hyclate

100 mg/ml

Oral solution

chicken (broiler)

05-1,0 ml product/1 liter of drinking water

10-20 mg doxycyclini hyclas/kg bw/day for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox

Doxycycline hyclate

100 mg/ml

Oral solution

chicken (broiler)

05-1,0 ml product/1 liter of drinking water

10 -20 mg doxycyclini hyclas/kg bw/day for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.

Grójecka 6

05-651 Drwalew

POLAND

Doxymina 20 %

Doxycycline hyclate

200 mg/g

Oral powder

chicken

25-50 g product/1 liter of drinking water

10 mg doxycyclini hyclate/kg bw/day, for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

V.M.D.n.v./ s.a.

Hoge Muew 900

2370 Arendonk

BELGIUM

Doxycycline hyclate 50 %

Doxycycline hyclate

500 mg

powder for oral solution

chicken

25 mg doxycyclini hyclate / kg bw/day

25 mg doxycyclini hyclate / kg bw/day for 3-5 days

Meat and offal:

5 days. Not for use in laying hens.

Poland

INDUSTRIAL VETERINARIA S.A.

Esmeralda, 19 - 4o

08950 ESPLUGUES DE LLOBREGAT SPAIN

Doxinyl

Doxycycline hyclate

100 mg/ml

Oral solution

chicken (broiler)

0,5-1,0 ml product/1 liter of drinking water/day

50-100 mg doxycyclini hyclate/1 liter of drinking water for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

Biofaktor Sp. z o.o.(Skierniewice)

Czysta 4

96-100 Skierniewice

POLAND

Doxycyclinum 20 %

Doxycycline hyclate

200 mg/ml

powder for oral solution

chicken, turkey

25-50 g product/1 liter of drinking water

10 mg doxycyclini hyclate/kg bw/day, for 3-5 days

1 Meat and offal:

4 days. Not for use in laying hens.

Poland

Tarchomińskie Zakłady Farmaceutyczne Polfa S.A.

Fleminga 2

03-176 Warszawa

POLAND

Doxycyclinum wet proszek

Doxycycline hyclate

200 mg/g

powder for oral solution

chicken, turkey,

25-50 g powder/1 liter of drinking water

10 mg doxycyclini hyclate/kg bw/day, for 3-5 days

Meat and offal:

7 days. Not for use in laying hens.

Poland

Sogeval Laboratoires

200 route De Mayenne

53022 Laval Cedex FRANCE

DOXYVAL 20 %

Doxycycline hyclate

20 g/100 g

Oral powder

chicken (broiler)

5 g produkt/100 kg bw/day or 0,5 g/1 liter of drinking water

10 mg doxycyclini hyclate/kg bw/day, for 3-5 days

Meat and offal:

4 days. Not for use in laying hens.

Poland

Eurovet Animal Health B.V.

Handelsveg 25

PO Box 179

5530 AD Bladel

THE NETHERLANDS

Soludox 15 %

Doxycycline hyclate

150 mg/g

Oral powder

chicken, turkey, pigeon, cage bird

10-20 mg doxycyclini hyclas/kg bw/day

10-20 mg/ kg bw/day for 3-5 days. In case of Chlamydia psittaci infection for 30-45 days.

Meat and offal:

7 days. Not for use in laying hens or in pigeons for human consumption.

Portugal

CEVA Saúde Animal –Produtos farmacêuticos e Imunológicos

Lda. Ceva Saúde Animal Lda.

Rua Doutor António

Loureiro Borges 9/9a 9o A Miraflores

1495-131 Algés

PORTUGAL

DOXYPRIM 400 mg / g Pó para Solução Oral para Suínos, Frangos e Perus.

Doxycycline hyclate

Doxycycline hyclate 400 mg / g

Powder for oral solution

Swine, Chicken, Turkey

For oral administration in drinking water

Broilers and Turkeys: 20 mg Doxycycline hyclate/kg bw, for 5 days.

Chicken (Broilers) meat and offal: 5 days; Tukeys meat and offal:6 days;

Not permitted for use in laying birds producing eggs for human consumption

Portugal

DIVASA FARMAVIC DE PORTUGAL

Produtos e Equipamentos Veterinários

Lda. Parque Empresarial de Vialonga

Armazém no 21

Casal do Bagulho

Granja de Alpriate

2625-607 Vialonga

PORTUGAL

DOXYVET-10

Doxycycline hyclate

Doxycycline hyclate 10g; Bromexin Cloridrate 1g

Oral solution

Bovine (Calves), Swine, Broilers, Turkeys, Ovine, Goat (Kid)

For oral administration in drinking water

Broilers and Turkeys: 50-100 mg/liter of water/day, for 3-5 days (Equivalent to 0,5-1 ml of DOXIVET-10 / liter of water/day

Meat and offal:

5 days

Portugal

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

VETADOXI 50

Doxycycline hyclate

Doxycycline hyclate 500 mg/g

Oral powder

Bovine (Calves), Swine and Birds

For oral administration in drinking water, milk or feed

25 mg/Kg bw in birds; 200 g/1 000 L water/day 3-5 days; 500 g/1 000 L drinking water birds

Meat and offal:

5 days; Not permitted for use in laying birds producing eggs for human consumption

Portugal

S.P. Veterinaria SA Crta. Reus

Vinyols Km 4.1

Apartado 60

Riudoms 43330 (Tarragona) SPAIN

Hidrodox 10 % Concentrado para solução oral para aves (frangos de carne) e suínos

Doxycycline hyclate

Doxycycline (as hyclate) 100 mg

Concentrate for Oral Solution

Chickens (broilers) and swine

For oral administration in drinking water

Broilers: 50 – 100 mg Doxycycline hyclate/L drinking water/day (0,5-1,0 ml of VMP/drinking water/day) 3-5 days.

Birds (Broilers) meat and offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption

Portugal

Univete SA

Rua D. Jerónimo Osório, 5

B 1400-119 Lisboa

PORTUGAL

UNIDOXINA 200 mg/ml solução oral para suínos e aves

Doxycycline hyclate

Doxycycline (as hyclate) 200 mg

Oral solution

Chickens (broilers) and swine

For oral administration in drinking water

Broilers and Turkeys: 20 mg Doxycycline hyclate/kg bw, for 5 days.

Chicken (Broilers) meat and offal: 7 days. Not permitted for use in laying birds producing eggs for human consumption

Romania

DELOS IMPEX' 96 SRL

17, Pictor Ştefan Luchian

sector 2

Bucharest

ROMANIA

Doxidem 20

Doxycycline hyclate

200 mg/ml doxycycline hyclate

Oral solution

Poultry

(not for use in animals from which eggs are produced for human consumption)

Oral

| — | 75 ml of product/100 litres drinking water/day for 3-5 consecutive days in young poultry up to 4 weeks |
| --- | --- |

—

75 ml of product/100 litres drinking water/day for 3-5 consecutive days in young poultry up to 4 weeks

| — | 150 ml of product/100 litres drinking water/day for 3-5 consecutive days in adult poultry |
| --- | --- |

—

150 ml of product/100 litres drinking water/day for 3-5 consecutive days in adult poultry

Meat and offal: 28 days

Indications:

Poultry For the treatment of mycoplasmosis, pasteurellosis, colibacillosis, staphylococcosis.

Chronic respiratory disease, infections caused by Pasteurella spp., Mycoplasma spp., Salmonella spp., E. coli., Haemophillus paragallinarium, Staphylococcus, hepatitis caused by Campylobacter and dermatitis.

Romania

DELOS IMPEX' 96 SRL

17, Pictor Ştefan Luchian

sector 2

Bucharest

ROMANIA

Doxidem 50

Doxycycline hyclate

500 mg/g

doxycycline hyclate

Water soluble powder

Poultry

(not for use in animals from which eggs are produced for human consumption)

Pigs

Oral

(drinking water)

| — | 20-40 mg of product/kg body weight/day for 5 consecutive days, per os; |
| --- | --- |

—

20-40 mg of product/kg body weight/day for 5 consecutive days, per os;

| — | 200-300 g of product/1 000 litres of drinking water for 5 consecutive days |
| --- | --- |

—

200-300 g of product/1 000 litres of drinking water for 5 consecutive days

Meat and offal: 28 days

Indications: Chronic respiratory disease, infections caused by Pasteurella spp., Mycoplasma spp., Salmonella spp., E. coli., Haemophillus paragallinarium, Staphylococcus, hepatitis caused by Campylobacter, dermatitis and other diseases caused by microorganisms sensitives to doxycycline.

Romania

DOPHARMA B.V.

Zalmweg 24,

P.O. BOX 205

4940 AE Raamsdonksveer

THE NETHERLANDS

Doxycycline 50 % WSP

Doxycycline hyclate

500 mg/g

doxycycline hyclate

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption)

Calves

Pig

Oral

(drinking water)

40 mg/kg of body weight or 200-400 g/1 000 litres of drinking water for 4-7 days

Meat and offal: Poultry 4 days

Indications:

| — | Ornithosis caused by Chlamydia psittaci in turkeys; |
| --- | --- |

—

Ornithosis caused by Chlamydia psittaci in turkeys;

| — | Colibacillosis caused by E. coli in chickens and turkeys; |
| --- | --- |

—

Colibacillosis caused by E. coli in chickens and turkeys;

| — | CRD caused by Mycoplasma gallisepticum in chickens and turkeys; |
| --- | --- |

—

CRD caused by Mycoplasma gallisepticum in chickens and turkeys;

Romania

FRANVET

ZI d'Etriche-Route d'Avire

BP 103

49500 Segré Cedex

FRANCE

Doxy 5 Franvet

Doxycycline hyclate

50 mg/g doxycycline (as hyclate)

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption) Calves Pig

Oral (drinking water or liquid feed)

| — | 1 g of product/1 litre drinking water/day for 3-5 days in poultry up to 2 weeks |
| --- | --- |

—

1 g of product/1 litre drinking water/day for 3-5 days in poultry up to 2 weeks

| — | 2 g of product/1 litre drinking water/day for 3-5 days in poultry over 2 weeks |
| --- | --- |

—

2 g of product/1 litre drinking water/day for 3-5 days in poultry over 2 weeks

Meat and offal: Poultry 4 days

Indications: For the prevention and treatment of respiratory infections caused by doxycycline sensitive microorganisms.

Romania

INDUSTRIA ITAILIANA INTEGRATORI TREI SpA

Via Affarosa n.4

42010 Rio Saliceto (Reggio Emilia)

ITALY

Doxipan 20

Doxycycline hyclate

200 mg/g doxycycline hyclate

Water soluble powder

Poultry

pig

Oral (drinking water)

5-7,5 g of product for every 10 litres of drinking water

Meat and offal: Poultry 5 days

Indications: Chronic respiratory disease and associated complications.

Romania

PHYLAXIA PHARMA LTD

1103 Budapest

Gergely u.79

HUNGARY

Doxyphyl SP A.U.V.

Doxycycline hyclate

300 mg/g doxycycline hyclate

Water soluble powder

Poultry (chicken, hens, turkeys) v

Oral (drinking water)

10 mg/kg b.w. for 3-5 days or 100 mg of product/1 litre of drinking water

Chickens, hens: 7 days Turkey: 7 days (not for use in animals from which eggs are produced for human consumption)

Indications: For the prevention and treatment of several bacterial infections.

Romania

LABORATORIOS SYVA S.A.

Avda. Parroco Pablo Diez, 49-57

24010 Leon

SPAIN

Syvadox 10 %

Doxycycline hyclate

100 mg/1 ml doxycycline (as hyclate)

Oral solution

Chickens (not for use in animals from which eggs are produced for human consumption)

Oral (drinking water)

50-100 mg doxycycline/1 litre of drinking water/day (equivalent to 0,5-1,0 ml of product/1litre of drinking water/day for 3-5 days

Chickens 7 days (not for use in animals from which eggs are produced for human consumption)

Indications: Colibacillosis, CRD, mycoplasmosis – caused by previously mentioned germs sensitive to doxycycline.

Romania

VMD

Berendonk 74

2370 Arendonk

BELGIUM

Doxyveto 50S

Doxycycline hyclate

500 mg/g doxycycline (as hyclate)

Water soluble powder

Poultry Swine calves lambs

Oral (drinking water or feed)

20 mg doxycycline/kg b.w. /day in drinking water or 300 g of product/1 000 litres of drinking water or 600 g/1 000 kg of feed for 3-5 days

Poultry 8 days

Indications: CRD (Mycoplasma gallisepticum), Ornithosis (Chlamidia psittaci), Infectious synovitis (Mycoplasma synoviae), Fowl cholera (Pasteurella multocida).

Romania

CHEMIFARMA S.p.A

Via Don Eugenio Servadei 16

47100 Forli

ITALY

Doxiciclina 50 %

Doxycycline hyclate

500 mg/g doxycycline

Water soluble powder

Broiler chickens swine

Oral (per os, drinking water or liquid feed)

40 g of product/100 kg b.w. (20 mg of doxycycline/kg b.w) corresponding to about 15-30 g of product/100 litres of water for 3-5 days.

Broiler chickens 5 days

Indications: Chronic respiratory disease and other respiratory illnesses, specially produced by Pasteurella spp., Mycoplasma spp., Haemophilus gallinarium, Bordetella avium and Chlamidia psittaci.

Romania

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

Doxiprim 40 % Soluble Powder

Doxycycline hyclate

400 mg/g doxycycline hyclate

Water soluble powder

Chickens turkeys (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

20 mg doxycycline hyclate/kg b.w.

Chickens and turkeys 4 days (not for use in animals from which eggs are produced for human consumption)

Indications: treatment of respiratory, intestinal and systemic infections caused by doxycycline sensitive organisms: CRD (Mycoplasma gallisepticum, E. Coli), airsaculitis (Mycoplasma maleagridis), infectious synovitis (Mycoplasma synoviae), fowl cholera (Pasteurella multocida), infectious coryza (Haemophylus paragallinarum), colibacillosis (E. Coli), turkeys bordetellosis (Bordetella avium), necrotic enteritidis (Clostridium perfringens), chlamydiosis (Chlamidia psittaci). Prevention of secundary becterial infections due to stress conditions, vaccination, change of housing, transport.

Romania

Novartis Animal Health d.o.o.

Verovskava 57

1000 Ljubljana

SLOVENIA

Doxyril 50 %

Doxycycline hyclate

500 mg/g doxycycline hyclate

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

25 mg doxycycline hyclate/kg b.w. during 3 to 5 consecutive days

Poultry 4 days (not for use in animals from which eggs are produced for human consumption)

Indication: Respiratory tract Infections caused by Mycoplasma spp. (M. gallisepticum, M. synoviae and M. melagridis), E. coli, Haemophylus paragallinarium and Ornithobacterium rhinotracheale. Enteritidis caused by Clostridium perfringens and Clostridium colinum. Septicemia caused by Pasteurella multocida.

Romania

CEVA SANTE ANIMALE ROMANIA SRL

5 Chindiei, sector 4,

Bucharest

ROMANIA

Doxyvit 50 % WSP

Doxycycline hyclate

500 mg/g doxycycline hyclate

Water soluble powder

Poultry (chickens and turkeys) (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

15 mg doxycycline/kg b.w. for 5 consecutive days or 2 g of product/10 litres drinking water and equivalent to 100 mg of doxycycline/litre of drinking water

Poultry (chickens and turkeys) 7 days (not for use in animals from which eggs are produced for human consumption)

Indications: Colibacillosis, CRD and mycoplasmosis, Clostridium perfringens, chlamydiosis, infectious coryza caused by Bordetella avium.

Romania

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox 100 mg/ml oral solution for use in drinking water for chickens and pigs

Doxycycline hyclate

100 mg/ml doxycycline (as hyclate)

Oral solution

Poultry (chickens) (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

10-20 mg doxycycline/kg b.w. for 3 - 5 days.

Poultry (chickens) t days (not for use in animals from which eggs are produced for human consumption)

Indications:

Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.

Romania

S.C. VIM SPECTRUM SRL

409 Sighisoarei

Targu Mures

ROMANIA

Vidoxim 10 % powder for oral solution for pigs and poultry

Doxycycline hyclate

100 mg/g doxycycline hyclate

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

1 000 g of product/1 000 litres drinking water for 5 days

Poultry 10 days (not for use in animals from which eggs are produced for human consumption)

Indications:

Infections caused by Mycoplasma gallisepticum, E. coli, Bordetella avium, Haemophylus paragallinarium and Pasteurela multocida.

Romania

S.C. VIM SPECTRUM SRL

409 Sighisoarei

Targu Mures

ROMANIA

Vidoxim 100 % powder for oral solution for pigs and poultry

Doxycycline hyclate

1 000 mg/g doxycycline hyclate

Water soluble powder

Poultry (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

100 g of product/1 000 litres drinking water for 5 days

Poultry 10 days (not for use in animals from which eggs are produced for human consumption)

Indications: Infections caused by M. gallisepticum, E. coli, Bordetella avium, Haemophylus paragallinarium and P. multocida.

Romania

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Oridox (Soldoxin) 100 mg/ml oral solution for use in drinking water for chickens and pigs

Doxycycline hyclate

100 mg/ml doxycycline (as hyclate)

Oral solution

Chickens (broilers) (not for use in animals from which eggs are produced for human consumption) pigs

Oral (drinking water)

10-20 mg doxycycline/kg b.w. for 3 - 5 days.

Poultry (chickens) 7 days (not for use in animals from which eggs are produced for human consumption) Prevention and treatment of CRD and mycoplasmosis caused by microorganisms sensitive to doxycycline.

Romania

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx 500 mg/g Water Soluble Powder

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Do not use in laying birds producing eggs for human consumption

Indications:

Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

Romania

CEVA PHYLAXIA VETERINARY BIOLOGICALS CO. LTD.

1107 Budapesta

Szallas u.5

HUNGARY

Doxivit 100

Doxycycline hydrocloride

100 mg/g doxycycline hydrochloride

Water soluble powder

Poultry (chickens, turkeys and goose) pigs

Oral (drinking water)

10 mg doxycycline hydrochloride/kg b.w. daily for 5 days

Poultry) 7 days (not for use in animals from which eggs are produced for human consumption)

Indications:

CRD (Mycoplasma gallisepticum, E. Coli), infectious coryza (Haemophylus paragallinarum), fowl cholera (Pasteurella multocida), colibacillosis (E. Coli), airsaculitis (Mycoplasma maleagridis), chlamydiosis (Chlamidia psittaci), necrotic enteritis (Clostridium perfringens).

Romania

PHARMATEKA BT

1046 Budapest

Szigyarto u. 10 / 20 Kossuth Str.

Pusztaberki, 2658

HUNGARY

DOXY H 10 %

Doxycycline hydrocloride

100 mg/g doxycycline hydrochloride

Water soluble powder

Poultry

Oral (drinking water)

1 g of product/1 litre of drinking water for 3-5 days

Poultry 10 days (not for use in animals from which eggs are produced for human consumption)

Romania

s.c. romvac company s.a.Şos.

Centurii, nr. 7

Voluntari

ROMANIA

Doxiciclina 10 %

Doxycycline hydrocloride

100 mg/g doxycycline hydrochloride

Water soluble powder

Poultry, including pigeons pigs bovine (calves)

Oral (drinking water)

2 g of product/10 kg b.w./day for 5-8 days

Poultry (chickens) 5 days (not for use in animals from which eggs are produced for human consumption)

Romania

S.C. Crida pharm s.r.l

2 Intrarea Vagonetului

Bl. 101, Ap. 47, sector 6

Bucharest

ROMANIA

Doxicol 60 %

Doxycycline hydrocloride

600 mg/g doxycycline hydrochloride

Water soluble powder

Poultry

pigs

Oral (drinking water or feed)

broiler 0-14 days:

50g/1 000 litres of water; broiler 15 -28 days: 100g/1 000 litres of water;broiler 29 -35 days: 120g/1 000 litres of water;

Poultry 5 days (not for use in animals from which eggs are produced for human consumption)

Indications:

prevention and treatment of colibacillosis, respiratory diseases, mycoplasmosis.

Slovenia

Novartis Veterina d.o.o.

Verovškova 57

1000 Ljubljana

SLOVENIA

DOXYRIL 50 %

Doxycycline hyclate

50 %

(500 mg/g)

powder for oral solution

pigs, poultry

Pigs and poultry: once a day, three to five days consecutively in drinking water

Pigs: 20 mg of doxycycline hycate per 1 kg of BW; Poultry 25 mg of doxycycline hycate per 1 kg of BW

Meat and offal:

poultry: 4 days;

Indications: respiratory infections (M gallisepticum, M, synoviae in M, melagridis), Escherichia coli, Haemophilus paragallinarum, Ornithobacterium rhinotracheale; Enteritis (Clostridium perfringens and Clostridium colinum; Septicemia (Pasteurella multocida)

Slovak republic

Trei Bio pharmaceutical division, Industria Italiana Integratori Trei

Via Affarosa n.4

42010 Rio Saliceto (Reggio Emilia)

ITALY

DOXIPAN 20 plv.sol. ad us.vet.

Doxycycline hyclate

20 g/100 g

Water soluble powder

Calves, pigs, poultry-broilers, turkey

for 5 days in drinking water

Poultry-broilers: 5-7,5 g product/10 litre of drinking water Turkey:10-20 mg active substance/b. w. corresponding to 50-100 g product/100 liter d.w. Calves, pigs: 10 mg active substance/b.w./day corresponding to 0,5 g product/10 kg b.w.

Meat: Broilers 5 days, turkeys 10 days,

Indications: Broilers: chronic respiratory disease and assotiated complications

Turkeys: infections caused by G-positive and G-negative germs, mycoplasmas sensitive to doxycycline especially respiratory and articular syndrom caused by mycoplasma and/or staphylococcus

Slovak republic

DIVASA-FARMAVIC, S.A.

CTRA. SANT HIPOLIT, KM. 71

08503 GURB – VIC

SPAIN

DOXIVET 10 % plv.sol. a.u.v.

Doxycycline hyclate

100 mg/ml

Water soluble powder

Poultry: (chickens and turkeys), bovine and swine

for 4 - 5 days in drinking water

0,5 ml of product/litre of drinking water

Meat: 5 days

Indications: Treatment of CRD, mycoplasmosis, porcine enzootic pneumonia, bronchopneumonias, chlamidiasis, unspecific diarheas.

Slovak republic

Novartis Animal Health d.o.o.

Verovskava 57

1000 Ljubljana

SLOVENIA

DOXYRIL 500 mg/g prášok na perorálny roztok ad us.vet.

Doxycycline hyclate

500 mg/g

Water soluble powder

Pigs, broilers

during 3 to 5 consecutive days in drinking water

Pigs: 20 mg doxycycline hyclate/kg b.w. Broilers: 25 mg doxycycline hyclate/kg b.w.

Eddible tissues: broilers 4 days.

Indications: Treatment of infections caused by microorganisms susceptible to doxycycline, particularly: Broilers: respiratory tract infections caused by Mycoplasma spp. (M.gallisepticum, M.synoviae and M.meleagridis), Escherichia coli, Haemophilus paragallinarum and Ornithobacterium rhinotracheale, enteritis caused by Clostridium perfringens and Clostridium colinum, septicemia caused by Pasteurella multocida

Slovak republic

Lavet Pharmaceuticals Ltd.,

1161 Budapest Ottó u. 14,

HUNGARY

DOXYVIT 40 % plv.sol.

Doxycycline hyclate

40 g/100 g

Water soluble powder

Poultry: (chickens and turkeys) and swine

3-5 days in drinking water, poutry in drinking water, pigs: in drinking water, in feed

Chickens and turkeys:10-20 mg active doxycyclini hyclate/kg b.w.)/day, continual treatment: 1 g product/3-6 litre of drinking water, repeated treatment: 25-50 mg product/kg b.w.(10-20 mg doxycycline hyclate/kg b.w.) in drinking water

Meat of chickens and turkey: 4 days,

Indications: Treatment and prophylaxis of respiratory, intestinal and systematic infections caused by doxycycline sensitive organism: Chickens, turkeys: chronic respiratory disease (Mycoplasma gallisepticum, E.coli), airsacculitis (M.meleagridis), infectious synovitis (M.synoviae), fowl cholera (P. multocida), turkey bordetellosis (Bordetella avium), infectious coryza (Haemophilus paragallinarum), collibacilosis (E.coli), necrotic enteritis (Clostridium prefringens), chlamydiiosis (CH. psittaci),

Slovak republic

Tekro, spol. s.r.o.,

Višňová 2/484,

140 00 Praha 4,

CZECH REPUBLIC

Meditek DOX 100 plv.sol. ad us.vet.

Doxycycline hyclate

100 g/1 000 g

Water soluble powder

Broilers, pigs

3-5 days in drinking water

Broilers: 10 mg doxycyclini hyclate/kg b.w (corresponding to 1 kg product/1 000 litre of drinking water)

Meat of broilers and pigs: 7 days.

Indications: Treatment and prevention of respiratory and gastrointestinal diseases caused by organism sensitive to doxycycline: broilers: CRD, mycoplasmosis, aerosaculitis, synovitis, pasteurellosis, infectious cholera, colibacillosis, chlamidiosis, necrotic enteritis

Slovak republic

Pharmagal s.r.o.,

Murgašova 5,

949 01 Nitra,

SLOVAK REPUBLIC

DOXYGAL plv.sol. ad us.vet.

Doxycycline hyclate

5 g/100 g

Water soluble powder

Pigs, poultry, calves, rabbits

Poultry: prevention 5 days, treatment 3 days, in drinking water Pigs, calves, rabbits: 5 days, in drinking water, in feed

Poultry: prevention: 50 mg active substance/1 litre of drinking water (1 g product/1 litre water), treatment: 100 mg active substance/1 litre water (2 g product/1 litre water)

Meat of poultry and rabbits: 7 days

Indications: Poultry: CRD (mycoplasmosis), colibacillosis.

Slovak republic

COOPHAVET

Saint Herblon

44150 Ancenis

FRANCE

RONAXAN 5 % plv.sol. ad us.vet.

Doxycycline hyclate

5 g/100 g

Water soluble powder

Pigs, poultry, calves

Prevention: 1-3 days, treatment: 3-5 days, in drinking, in feed

10 mg active substance/kg b.w./day (1 g product/5 kg b.w./day) Polutry:

| — | less than 2 weeks old: 1 g product/litre of drinking water/day, |
| --- | --- |

—

less than 2 weeks old: 1 g product/litre of drinking water/day,

| — | more than 2 weeks old: 2 g/litre water/day |
| --- | --- |

—

more than 2 weeks old: 2 g/litre water/day

Meat of poultry 4 days

Indications: Poultry: preventive and curative treatment of respiratory infections,

Slovak republic

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

KARIDOX 100 mg/ml roztok pre podávanie hydine a ošípaným perorálne v pitnej vode

Doxycycline hyclate

100 mg/ml

Water soluble powder

Chicken (broilers), pigs

Broilers: 3-5 days, Pigs: 5 days, in drinking water

Broilers: 10 -20 mg of doxycycline/kg b.w./day, (0,5-1,0 ml of product/litre of drinking water),

Meat and offals: chicken (broilers) 7 days

Indications: Chicken (broilers): prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganism sensitive to doxycycline.

Slovak republic

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

ORIDOX 100 mg/ml roztok pre podávanie hydine a ošípaným perorálne v pitnej vode

Doxycycline hyclate

100 mg/ml

Water soluble powder

Chicken (broilers), pigs

Broilers: 3-5 days, Pigs. 5 days, in drinking water

Broilers: 10 -20 mg of doxycycline/kg b.w./day, (0,5-1,0 ml of product/litre of drinking water),

Meat and offals: chicken (broilers) 7 days,

Indications: Chicken (broilers): prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganism sensitive to doxycycline.

United kingdom

Laboratorios Karizoo S.A

Polígono Industrial La Borda

Mas Pujades

11-12

08140 Caldes de Montbui

Barcelona

SPAIN

Karidox 100 mg/ml Oral Solution for use in drinking water for Chickens and Pigs

Doxycycline hyclate

100 mg/ml doxycycline (as doxycycline hyclate)

Oral solution

Chickens (broilers) & Pigs

Oral (drinking water)

10-20 mg doxycycline/kg x 3-5 days

Meat & offal:

Chickens (broilers): 7 days

Indications: CHICKENS (BROILERS):

Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.

United kingdom

CHEMO IBERICA, S.A.

Gran Via Carlos III, 98 7a

Edificio Trade

08028 Barcelona

SPAIN

Soldoxin 100 mg/ml Oral Solution for use in drinking water for chickens and pigs

Doxycycline hyclate

100 mg/ml doxycycline (as doxycycline hyclate)

Oral solution

Chickens (broilers) & Pigs

Oral (drinking water)

10-20 mg doxycycline/kg x 3-5 days

Meat & offal:

Chickens (broilers): 7 days

Indications: CHICKENS (BROILERS):

Prevention and treatment of chronic respiratory disease (CRD) and mycoplasmosis caused by microorganisms sensitive to doxycycline.

United kingdom

Huvepharma N.V.

Uitbreidingstraat 80

2600 Antwerpen

BELGIUM

HydroDoxx 500 mg/g Water Soluble Powder

Doxycycline hyclate

500 mg/g doxycycline hyclate

Powder for oral solution

Chickens (broilers) & Pigs (fattening pigs)

Oral (drinking water)

20 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:

Chickens: 6 days

Indications: Chickens (broilers): Prevention and treatment of Chronic Respiratory Disease (CRD) caused by Mycoplasma gallisepticum.

UNITED KINGDOM

VMD NV, HOGE MAUW

900-2370 Arendonk

BELGIUM

Doxyveto 50 s plus

Doxycycline hyclate

50 % w/w doxycycline hyclate

Powder for oral administration

Non-egg laying chickens

Oral (drinking water)

25 mg doxycycline (hyclate)/kg x 3-5 days

Meat and offal:6 days

Indications: Respiratory infections caused by Mycoplasma spp., E. coli and Haemophilus paragallinarum.

Enteritis caused by Clostridium perfringens and Clostridium colinum

---

ANNEX XV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION Holder IN THE MEMBER STATES

| Member State / EEA | Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Frequency and route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Belgium | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Denmark | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Germany | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Greece | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Spain | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Finland | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Ireland | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Luxemburg | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| The Netherlands | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Norway | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |
| Portugal | Intervet International B.V.
  P.O. Box 31
  5830 AA Boxmeer
  The Netherlands | Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs | Tablet | 0,625; 1,25 or 2,5 mg of ramipril | Dogs | Daily, oral | 0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment |

Member State / EEA

Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Frequency and route of administration

Recommended dose

Austria

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Belgium

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Denmark

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Germany

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Greece

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Spain

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Finland

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Ireland

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Luxemburg

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

The Netherlands

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Norway

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

Portugal

Intervet International B.V.

P.O. Box 31

5830 AA Boxmeer

The Netherlands

Vasotop P 0,625 mg; Vasotop P 1,25 mg; Vasotop P 2,5 mg, tablet for dogs

Tablet

0,625; 1,25 or 2,5 mg of ramipril

Dogs

Daily, oral

0,125 mg/kg; 0,25 mg/kg if the animal does not respond after 2 weeks of treatment

---

ANNEX XVI

LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)

| Member State EU/EEA | Marketing Authorisation Holder | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Abbott GmbH
  Perfektastraße 84A
  A–1230 Wien
  Austria | Reductil 10 mg - Hartkapseln | 10 mg | Capsule, hard | oral use |
| Austria | Abott GmbH
  Perfektastraße 84A
  A–1230 Wien
  Austria | Reductil 15 mg - Hartkapseln | 15 mg | Capsule, hard | oral use |
| Austria | Teva Pharma B.V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Sibutramin Teva 10 mg Kapseln | 10 mg | Capsule, hard | oral use |
| Austria | Teva Pharma B.V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Sibutramin Teva 15 mg Kapseln | 15 mg | Capsule, hard | oral use |
| Belgium | Abbott SA
  rue du Bosquet 2
  1348 Ottignies/LLN
  Belgium | Reductil 10 mg | 10 mg | Capsule, hard | oral use |
| Belgium | Abbott SA
  rue du Bosquet 2
  1348 Ottignies/LLN
  Belgium | Reductil 15 mg | 15 mg | Capsule, hard | oral use |
| Belgium | SandozNV
  TelecomGardens
  Medialaan 40
  1800 Vilvoorde
  Belgium | Sibutramin Sandoz 10 mg | 10 mg | Capsule, hard | oral use |
| Belgium | SandozNV
  TelecomGardens
  Medialaan 40
  1800 Vilvoorde
  Belgium | Sibutramin Sandoz 15 mg | 15 mg | Capsule, hard | oral use |
| Belgium | Teva pharma belgium
  Laarstraat 16
  2610 Wilrijk
  Belgium | Sibutramin Teva 10 mg | 10 mg | Capsule, hard | oral use |
| Belgium | Teva pharma belgium
  Laarstraat 16
  2610 Wilrijk
  Belgium | Sibutramin Teva 15 mg | 15 mg | Capsule, hard | oral use |
| Bulgaria | Abbott GmbH & Co KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reductil | 10 mg | Capsule, hard | oral use |
| Bulgaria | Abbott GmbH & Co KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reductil | 15 mg | Capsule, hard | oral use |
| Bulgaria | Sandoz d.d., Verovskova 57
  SI - 1000 Ljubljana
  Slovenia | Sibutramin Sandoz | 10 mg | Capsule, hard | oral use |
| Bulgaria | Sandoz d.d.
  Verovskova 57
  SI-1000 Ljubljana
  Slovenia | Sibutramin Sandoz | 15 mg | Capsule, hard | oral use |
| Bulgaria | Zentiva k.s.
  U kabelovny 130
  102 37 Prague 10
  Czech Republic | Lindaxa | 10 mg | Capsule, hard | oral use |
| Bulgaria | Zentiva k.s.
  U kabelovny 130
  102 37 Prague 10
  Czech Republic | Lindaxa | 15 mg | Capsule, hard | oral use |
| Bulgaria | Teva Pharmaceuticals Bulgaria EOOD
  15 N.V. Gogol str.
  Sredetz district
  1124 Sofia
  Bulgaria | Meissa | 10 mg | Capsule, hard | oral use |
| Bulgaria | Teva Pharmaceuticals Bulgaria EOOD
  15 N.V. Gogol str.
  Sredetz district
  1124 Sofia
  Bulgaria | Meissa | 15 mg | Capsule, hard | oral use |
| Czech Republic | Abbott GmbH & Co.KG
  Max-Planck-Ring-2
  65202 Wiesbaden
  Germany | MERIDIA 10 MG | 10 mg | Capsule, hard | oral use |
| Czech Republic | Abbott GmbH & Co.KG
  Max-Planck-Ring-2
  65202 Wiesbaden
  Germany | MERIDIA 15 MG | 15 mg | Capsule, hard | oral use |
| Czech Republic | Zentiva, k.s.
  U kabelovny 130, 102 37
  Prague 10
  Czech Republic | LINDAXA 10 | 10 mg | Capsule, hard | oral use |
| Czech Republic | Zentiva, k.s.
  U kabelovny 130, 102 37
  Prague 10
  Czech Republic | LINDAXA 15 | 15 mg | Capsule, hard | oral use |
| Czech Republic | TEVA Pharmaceuticals ČR, s.r.o.
  Radlická 3185/Ic
  150 00 Prague 5
  Czech Republic | SIBUTRAMIN-TEVA 10 MG TOBOLKY | 10 mg | Capsule, hard | oral use |
| Czech Republic | TEVA Pharmaceuticals ČR, s.r.o.
  Radlická 3185/Ic
  150 00 Prague 5
  Czech Republic | SIBUTRAMIN-TEVA 15 MG TOBOLKY | 15 mg | Capsule, hard | oral use |
| Denmark | Abbott Scandinavia AB
  Postboks 509
  SE-169 29, Solna
  Sweden | Reductil | 10 mg | Capsule, hard | oral use |
| Denmark | Abbott Scandinavia AB
  Postboks 509
  SE-169 29, Solna
  Sweden | Reductil | 15 mg | Capsule, hard | oral use |
| Denmark | 1A Farma A/S
  Herstedøstervej 27-29
  DK–2620 Albertslund
  Denmark | Sibutramin ‘1A Farma’ | 10 mg | Capsule, hard | oral use |
| Denmark | 1A Farma A/S
  Herstedøstervej 27-29
  DK–2620 Albertslund
  Denmark | Sibutramin ‘1A Farma’ | 15 mg | Capsule, hard | oral use |
| Denmark | Sandoz A/S
  C. F. Tietgens Boulevard 40
  DK–5220 Odense SØ
  Denmark | Sibutramin ‘Sandoz’ | 10 mg | Capsule, hard | oral use |
| Denmark | Sandoz A/S
  C. F. Tietgens Boulevard 40
  DK–5220 Odense SØ
  Denmark | Sibutramin ‘Sandoz’ | 15 mg | Capsule, hard | oral use |
| Denmark | Teva Danmark A/S
  Østergade 38
  DK–1100 København K
  Denmark | Sibutramin ‘Teva’ | 10 mg | Capsule, hard | oral use |
| Denmark | Teva Danmark A/S
  Østergade 38
  DK–1100 København K
  Denmark | Sibutramin ‘Teva’ | 15 mg | Capsule, hard | oral use |
| Estonia | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | REDUCTIL | 10mg | Capsule, hard | oral use |
| Estonia | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | REDUCTIL | 15mg | Capsule, hard | oral use |
| Estonia | Sandoz d.d.
  Verovskova 57
  1000 Ljubljana
  Slovenia | SIBUTRIL | 10mg | Capsule, hard | oral use |
| Estonia | Sandoz d.d.
  Verovskova 57
  1000 Ljubljana
  Slovenia | SIBUTRIL | 15mg | Capsule, hard | oral use |
| Estonia | Zentiva, k.s.
  U Kabelovny 130
  Dolni Mecholupy
  102 37 Prague 10
  Czech Republic | LINDAXA 10 | 10mg | Capsule, hard | oral use |
| Estonia | Zentiva, k.s.
  U Kabelovny 130
  Dolni Mecholupy
  102 37 Prague 10
  Czech Republic | LINDAXA 15 | 15mg | Capsule, hard | oral use |
| Estonia | Teva Pharma B.V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | SIBUTRAMINE TEVA | 10mg | Capsule, hard | oral use |
| Estonia | Teva Pharma B.V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | SIBUTRAMINE TEVA | 15mg | Capsule, hard | oral use |
| Finland | Abbott ScandinaviaAB
  P.O. Box 509
  16929 Solna
  Sweden | Reductil | 10 mg, 15 mg | Capsule, hard | oral use |
| Finland | Sandoz A/S C.F.
  Tietgens Boulevard 40
  5220 Odense SØ
  Denmark | Sibutramin Sandoz | 10 mg, 15 mg | Capsule, hard | oral use |
| Finland | Teva Sweden AB
  Järnvägsgatan 11
  Box 1070
  25110 Helsingborg
  Sweden | Sibutramine Teva | 10 mg, 15 mg | Capsule, hard | oral use |
| France | ABBOT France
  10, RUE D'ARCUEIL
  SILIC 233
  94528 RUNGIS CEDEX
  FRANCE | SIBUTRAL 10 mg, gélule | 10 mg | capsule | oral use |
| France | ABBOT France
  10, RUE D'ARCUEIL
  SILIC 233
  94528 RUNGIS CEDEX
  FRANCE | SIBUTRAL 15 mg, gélule | 15 mg | capsule | oral use |
| Germany | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reductil 10 mg Hartkapseln | 10 mg | Capsule, hard | oral use |
| Germany | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reductil 15 mg Hartkapseln | 15 mg | Capsule, hard | oral use |
| Germany | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Zelium 10 mg Hartkapseln | 10 mg | Capsule, hard | oral use |
| Germany | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Zelium 15 mg Hartkapseln | 15 mg | Capsule, hard | oral use |
| Germany | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reduxade 10 mg Hartkapseln | 10 mg | Capsule, hard | oral use |
| Germany | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reduxade 15 mg Hartkapseln | 15 mg | Capsule, hard | oral use |
| Germany | 1 A Pharma GmbH
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Sibutramin - 1A Pharma 10 mg Hartkapseln | 10 mg | Capsule, hard | oral use |
| Germany | 1 A Pharma GmbH
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Sibutramin - 1A Pharma 15 mg Hartkapseln | 15 mg | Capsule, hard | oral use |
| Germany | HEXAL AG
  Postfach 1263
  83602 Holzkirchen
  Germany | Sibutramin-HEXAL 10 mg Hartkapseln | 10 mg | Capsule, hard | oral use |
| Germany | HEXAL AG
  Postfach 1263
  83602 Holzkirchen
  Germany | Sibutramin-HEXAL 15 mg Hartkapseln | 15 mg | Capsule, hard | oral use |
| Greece | Abbott Laboratories (Hellas) S.A.
  512, Vouliagmenis Avenue
  GR 17456, Alimos
  Athens
  Greece | Reductil | 10 mg | Capsule, hard | oral use |
| Greece | Abbott Laboratories (Hellas) S.A.
  512, Vouliagmenis Avenue
  GR 17456, Alimos
  Athens
  Greece | Reductil | 15 mg | Capsule, hard | oral use |
| Greece | Teva Pharmaceuticals Europe B.V.
  European Headquarters
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Sibutramine/Teva | 10mg | Capsule, hard | oral use |
| Greece | Teva Pharmaceuticals Europe B.V.
  European Headquarters
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Sibutramine/Teva | 15 mg | Capsule, hard | oral use |
| Hungary | Zentiva k. s.
  U Kabelovny 130
  102 37 Praha 10
  Czech Republic | LINDAXA | 10mg | Capsule, hard | oral use |
| Hungary | Zentiva k. s.
  U Kabelovny 130
  102 37 Praha 10
  Czech Republic | LINDAXA | 15mg | Capsule, hard | oral use |
| Hungary | Teva Magyarország zrt.
  Rákóczi út 70-72.
  1074 Budapest
  Hungary | MINIMECTIL | 10mg | Capsule, hard | oral use |
| Hungary | Teva Magyarország zrt.
  Rákóczi út 70-72.
  1074 Budapest
  Hungary | MINIMECTIL | 15mg | Capsule, hard | oral use |
| Hungary | Abbott Laboratories Kft.
  Teve u. 1/a-c
  1139 Budapest
  Hungary | REDUCTIL | 10mg | Capsule, hard | oral use |
| Hungary | Abbott Laboratories Kft.
  Teve u. 1/a-c
  1139 Budapest
  Hungary | REDUCTIL | 15mg | Capsule, hard | oral use |
| Iceland | Abbott Scandinavia
  Gårdsvägen 8
  Box 5091
  SE-169 29 Solna
  Sweden | Reductil | 10 mg | Capsule, hard | oral use |
| Iceland | Abbott Scandinavia
  Gårdsvägen 8
  Box 5091
  SE-169 29 Solna
  Sweden | Reductil | 15 mg | Capsule, hard | oral use |
| Ireland | Teva Pharma B.V.
  Computerweg 10
  3542 Dr Utrecht
  Netherlands | Sibutramine Teva 10 mg Capsules | 10 mg | Capsule, hard | oral use |
| Ireland | Teva Pharma B.V.
  Computerweg 10
  3542 Dr Utrecht
  Netherlands | Sibutramine Teva 15 mg Capsules | 15 mg | Capsule, hard | oral use |
| Ireland | Abbot Laboratories Ireland Ltd
  4051 Kingswood Drive
  Citywest Business Campus
  Dublin 24
  Ireland | Reductil 10 mg capsules, hard | 10 mg | Capsule, hard | oral use |
| Ireland | Abbot Laboratories Ireland Ltd
  4051 Kingswood Drive
  Citywest Business Campus
  Dublin 24
  Ireland | Reductil 15 mg capsules, hard | 15 mg | Capsule, hard | oral use |
| Ireland | Rowex Ltd
  Bantry
  Co.Cork
  Ireland | Sitrane 10 mg hard capsules | 10 mg | Capsule, hard | oral use |
| Ireland | Rowex Ltd
  Bantry
  Co.Cork
  Ireland | Sitrane 15 mg hard capsules | 15 mg | Capsule, hard | oral use |
| Italy | ABBOTT srl
  Via Pontina Km 52
  04010 Campoverde di Aprilia
  Italy | REDUXATE | 10 mg | capsule | oral use |
| Italy | ABBOTT srl
  Via Pontina Km 52
  04010 Campoverde di Aprilia
  Italy | REDUXATE | 15 mg | capsule | oral use |
| Italy | ABBOTT srl
  Via Pontina Km 52
  04010 Campoverde di Aprilia
  Italy | ECTIVA | 10 mg | capsule | oral use |
| Italy | ABBOTT srl
  Via Pontina Km 52
  04010 Campoverde di Aprilia
  Italy | ECTIVA | 15 mg | capsule | oral use |
| Italy | ABBOTT srl
  Via Pontina Km 52
  04010 Campoverde di Aprilia
  Italy | REDUCTIL | 10 mg | capsule | oral use |
| Italy | ABBOTT srl
  Via Pontina Km 52
  04010 Campoverde di Aprilia
  Italy | REDUCTIL | 15 mg | capsule | oral use |
| Latvia | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reductil 15 mg hard capsules | 15 mg | Capsule, hard | oral use |
| Latvia | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reductil 10 mg hard capsules | 10 mg | Capsule, hard | oral use |
| Latvia | Sandoz d.d.
  Verovškova 57
  1000 Ljubljana
  Slovenia | Sibutril 15 mg capsules, hard | 15 mg | Capsule, hard | oral |
| Latvia | Sandoz d.d.
  Verovškova 57
  1000 Ljubljana
  Slovenia | Sibutril 10 mg capsules, hard | 10 mg | Capsule, hard | oral |
| Lithuania | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reductil | 10 mg | Capsule, hard | oral use |
| Lithuania | Abbott GmbH & Co. KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | Reductil | 15 mg | Capsule, hard | oral use |
| Lithuania | Zentiva k. s.
  U kabelovny 130
  10237 Prague 10 Dolni Mecholupy Czech Republic | Lindaxa | 10 mg | Capsule, hard | oral use |
| Lithuania | Zentiva k. s.
  U kabelovny 130
  10237 Prague 10 Dolni Mecholupy Czech Republic | Lindaxa | 15 mg | Capsule, hard | oral use |
| Lithuania | Sandoz d.d.
  Verovskova 57
  1000 Ljubljana
  Slovenia | Sibutril | 10 mg | Capsule, hard | oral use |
| Lithuania | Sandoz d.d.
  Verovskova 57
  1000 Ljubljana
  Slovenia | Sibutril | 15 mg | Capsule, hard | oral use |
| Lithuania | Teva Pharma B.V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Sibutramine Teva | 10 mg | Capsule, hard | oral use |
| Lithuania | Teva Pharma B.V.
  Computerweg 10
  3542 DR Utrecht
  The Netherlands | Sibutramine Teva | 15 mg | Capsule, hard | oral use |
| Luxembourg | Abbott Laboratoires 2, rue du Bosquet B- 1348 Ottignies L.L.N.
  Belgium | Reductil | 10mg | capsule | oral use |
| Luxembourg | Abbott Laboratoires 2, rue du Bosquet B- 1348 Ottignies L.L.N.
  Belgium | Reductil | 15mg | capsules | oral use |
| Malta | Abbott Laboratories Limited Queenborough
  Kent
  ME11 5EL
  United Kingdom | Reductil | 10mg | Capsule, hard | oral use |
| Malta | Abbott Laboratories Limited Queenborough
  Kent
  ME11 5EL
  United Kingdom | Reductil | 15mg | Capsule, hard | oral use |
| Netherlands | Abbott B.V.
  Siriusdreef 51
  2132 WT, Hoofddorp
  Netherlands | Reductil 10 mg, capsules, hard | 10 mg | Capsule, hard | oral use |
| Netherlands | Abbott B.V.
  Siriusdreef 51
  2132 WT, Hoofddorp
  Netherlands | Reductil 15 mg, capsules, hard | 15 mg | Capsule, hard | oral use |
| Netherlands | Sandoz B.V.
  Veluwezoom 22
  1327 AH, Almere
  Netherlands | Sibutramine HCL monohydraat Sandoz 10 mg, harde capsules | 10 mg | Capsule, hard | oral use |
| Netherlands | Sandoz B.V.
  Veluwezoom 22
  1327 AH, Almere
  Netherlands | Sibutramine HCL monohydraat Sandoz 15 mg, harde capsules | 15 mg | Capsule, hard | oral use |
| Netherlands | Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144
  8226 JX, Lelystad
  Netherlands | Reductil 15 mg, capsules | 15 mg | Capsule, hard | oral use |
| Netherlands | Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144
  8226 JX, Lelystad
  Netherlands | Reductil 10 mg, capsules | 10 mg | Capsule, hard | oral use |
| Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA, Haarlem
  Netherlands | Sibutramine HCL- monohydraat 10 mg PCH, capsules | 10 mg | Capsule, hard | oral use |
| Netherlands | Pharmachemie B.V.
  Swensweg 5
  2031 GA, Haarlem
  Netherlands | Sibutramine HCL- monohydraat 15 mg PCH, capsules | 15 mg | Capsule, hard | oral use |
| Norway | Abbot Scandinavia
  AB Box 509
  169 29 Solna
  Sweden | REDUCTIL | 10 mg | Capsule, hard | oral use |
| Norway | Abbot Scandinavia
  AB Box 509
  169 29 Solna
  Sweden | REDUCTIL | 15 mg | Capsule, hard | oral use |
| Norway | Euromedica NorgeAS
  Jerikoveien 28 C
  1067 Oslo
  Norway | REDUCTIL | 10 mg | Capsule, hard | oral use |
| Norway | Euromedica NorgeAS
  Jerikoveien 28 C
  1067 Oslo
  Norway | REDUCTIL | 15 mg | Capsule, hard | oral use |
| Norway | Sandoz A/
  Edvard Thomsens Vej 14
  2300 København S
  Danmark | SIBUTRAMIN SANDOZ | 10 mg | Capsule, hard | oral use |
| Norway | Sandoz A/
  Edvard Thomsens Vej 14
  2300 København S
  Danmark | SIBUTRAMIN SANDOZ | 15 mg | Capsule, hard | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  53 Emilii Plater St.
  00-113 Warsaw
  Poland | Afibron | 10 mg | Capsule, hard | oral use |
| Poland | Teva Pharmaceuticals Polska Sp. z o.o.
  53 Emilii Plater St.
  00-113 Warsaw
  Poland | Afibron | 15 mg | Capsule, hard | oral use |
| Poland | Zentiva a.s.
  U Kabelovny 130
  Dolni Mecholupy
  102 37 Praha 10
  Czech Republic | Lindaxa 10 | 10 mg | Capsule, hard | oral use |
| Poland | Zentiva a.s.
  U Kabelovny 130
  Dolni Mecholupy
  102 37 Praha 10
  Czech Republic | Lindaxa 15 | 15 mg | Capsule, hard | oral use |
| Poland | Abbott Laboratories Poland Sp. z o. o.
  ul. Postępu 18A
  02-676 Warsaw
  Poland | Meridia 10 | 10 mg | Capsule, hard | oral use |
| Poland | Abbott Laboratories Poland Sp. z o. o.
  ul. Postępu 18A
  02-676 Warsaw
  Poland | Meridia 15 | 15 mg | Capsule, hard | oral use |
| Poland | Sandoz GmbH
  Biochemiestrasse 10
  A–6250 Kundl
  Austria | Obesan | 10 mg | Capsule, hard | oral use |
| Poland | Sandoz GmbH
  Biochemiestrasse 10
  A–6250 Kundl
  Austria | Obesan | 15 mg | Capsule, hard | oral use |
| Poland | 1A Pharma GmbH
  Keltenring 1 + 3
  82041 Oberhaching | Sibutramine-1A Pharma | 10 mg | Capsule, hard | oral use |
| Poland | 1A Pharma GmbH
  Keltenring 1 + 3
  82041 Oberhaching
  Germany | Sibutramine-1A Pharma | 15 mg | Capsule, hard | oral use |
| Poland | Biofarm Sp. z o.o.
  Wałbrzyska 13, 60-198
  Poznan
  Poland | Zelixa | 10 mg | Film-coated tablet | oral use |
| Poland | Biofarm Sp. z o.o.
  Wałbrzyska 13, 60-198
  Poznan
  Poland | Zelixa | 15 mg | Film-coated tablet | oral use |
| Portugal | ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,
  2610-008 AMADORA
  Portugal | Zelium | 10 mg | Capsule, hard | oral use |
| Portugal | ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,
  2610-008 AMADORA
  Portugal | Zelium | 15 mg | Capsule, hard | oral use |
| Portugal | ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,
  2610-008 AMADORA
  Portugal | Reductil | 10 mg | Capsule, hard | oral use |
| Portugal | ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,
  2610-008 AMADORA
  Portugal | Reductil | 15 mg | Capsule, hard | oral use |
| Portugal | Teva Pharma –
  Produtos Farmacêuticos, Lda.
  EmpreendimentoLagoasPark
  Edifício 1 - 3
  2740-264 Porto Salvo
  Portugal | Sibutramina Teva | 10 mg | Capsule, hard | oral use |
| Portugal | Teva Pharma –
  Produtos Farmacêuticos, Lda.
  EmpreendimentoLagoasPark
  Edifício 1 - 3
  2740-264 Porto Salvo
  Portugal | Sibutramina Teva | 15 mg | Capsule, hard | oral use |
| Portugal | Solufarma - Produtos Farmacêuticos Unipessoal, Lda.
  Rua do Tejo, 56 - 9o A Esq
  2775-325 Parede
  Portugal | Sibutramina Sibulaite | 10 mg | Capsule, hard | oral use |
| Portugal | Solufarma - Produtos Farmacêuticos Unipessoal, Lda
  Rua do Tejo, 56 - 9o A Esq
  2775-325 Parede
  Portugal | Sibutramina Sibulaite | 15 mg | Capsule, hard | oral use |
| Portugal | Solufarma - Produtos Farmacêuticos Unipessoal, Lda
  Rua do Tejo, 56 - 9o A Esq
  2775-325 Parede
  Portugal | Sibutramina Solufarma | 10 mg | Capsule, hard | oral use |
| Portugal | Solufarma - Produtos Farmacêuticos Unipessoal, Lda
  Rua do Tejo, 56 - 9o A Esq
  2775-325 Parede
  Portugal | Sibutramina Solufarma | 15 mg | Capsule, hard | oral use |
| Portugal | Farmoz - Sociedade Técnico Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Farmoz | 10 mg | Capsule, hard | oral use |
| Portugal | Farmoz - Sociedade Técnico Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Farmoz | 15 mg | Capsule, hard | oral use |
| Portugal | Pentafarma - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, no 2 -Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Egostar | 10 mg | Capsule, hard | oral use |
| Portugal | Pentafarma - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, no 2 Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Egostar | 15 mg | Capsule, hard | oral use |
| Portugal | Pentafarma - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, no 2 Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Blixie | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Blixie | 15 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Atrolex | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Atrolex | 15 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Argam | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Argam | 15 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Orexinib | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Orexinib | 15 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Snomas | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Snomas | 15 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Arpedex | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Arpedex | 15 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Marcoliz | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Marcoliz | 15 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Ocram | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Ocram | 15 mg | Capsule, hard | oral use |
| Portugal | Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda
  Av. Sidónio Pais, n.o 24,
  rés-do-chão esq
  São Sebastião da Pedreira
  1000 Lisboa
  Portugal | Sibutramina Strami | 10 mg | Capsule, hard | oral use |
| Portugal | Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda
  Av. Sidónio Pais, n.o 24,
  rés-do-chão esq,
  São Sebastião da Pedreira
  1000 Lisboa
  Portugal | Sibutramina Strami | 15 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Fililex | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina Fililex | 15 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina West Pharma | 10 mg | Capsule, hard | oral use |
| Portugal | Tecnimede - Sociedade Técnico-Medicinal, S.A.
  Rua da Tapada Grande, 2
  Abrunheira
  2710-089 Sintra
  Portugal | Sibutramina West Pharma | 15 mg | Capsule, hard | oral use |
| Portugal | Generis Farmacêutica, S.A.
  Office Park da Beloura,
  Edifício 4,
  Quinta da Beloura
  2710-444 Sintra
  Portugal | Sibutramina Generis | 8,37 mg | Capsule, hard | oral use |
| Portugal | Generis Farmacêutica, S.A.
  Office Park da Beloura,
  Edifício 4,
  Quinta da Beloura
  2710-444 Sintra
  Portugal | Sibutramina Generis | 12 556 mg | Capsule, hard | oral use |
| Portugal | Sandoz Farmacêutica, Lda.
  Alameda da Beloura,
  Edifício 1, 2o - Escritório 15
  2710-693 Sintra
  Portugal | Sibutramina Sandoz | 10 mg | Capsule, hard | oral use |
| Portugal | Sandoz Farmacêutica, Lda.
  Alameda da Beloura, Edifício 1, 2o - Escritório 15
  2710-693 Sintra
  Portugal | Sibutramina Sandoz | 15 mg | Capsule, hard | oral use |
| Romania | Abbott GmbH & Co.KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | REDUCTIL 10 mg, capsule | 10 mg | Capsule, hard | oral use |
| Romania | Abbott GmbH & Co.KG
  Max-Planck-Ring 2
  65205 Wiesbaden
  Germany | REDUCTIL 15 mg, capsule | 15 mg | Capsule, hard | oral use |
| Romania | SANDOZ S.R.L. ROMÂNIA
  Str. Livezeni nr. 7A,
  Târgu Mureş,
  Romania | MINIMACIN 10 mg, capsule | 10 mg | Capsule, hard | oral use |
| Romania | SANDOZ S.R.L. ROMÂNIA
  Str. Livezeni nr. 7A,
  Târgu Mureş,
  Romania | MINIMACIN 15 mg, capsule | 15 mg | Capsule, hard | oral use |
| Romania | S.C. TERAPIA S.A.
  Str. Fabricii, nr. 124,
  Cluj-Napoca,
  Romania | SILUTON 10 mg, capsule | 10 mg | Capsule, hard | oral use |
| Romania | S.C. TERAPIA S.A.
  Str. Fabricii, nr. 124,
  Cluj-Napoca,
  Romania | SILUTON 15 mg, capsule | 15 mg | Capsule, hard | oral use |
| Romania | TEVA PHARMACEUTICALS S.R.L.
  Str. Domniţa Ruxandra nr 12, parter,
  Sector 2, Bucureşti
  Romania | SIBUTRAMINĂ TEVA 10 mg, capsule | 10 mg | Capsule, hard | oral use |
| Romania | TEVA PHARMACEUTICALS S.R.L.
  Str. Domniţa Ruxandra nr 12, parter,
  Sector 2, Bucureşti
  Romania | SIBUTRAMINĂ TEVA 15 mg, capsule | 15 mg | Capsule, hard | oral use |
| Romania | ZENTIVA a.s.,
  U kabelovny 130,
  102 37 Praga-10 Dolní Měcholupy, Czech Republic | LINDAXA 10 mg, capsule | 10 mg | Capsule, hard | oral use |
| Romania | ZENTIVA a.s.,
  U kabelovny 130,
  102 37 Praga-10 Dolní Měcholupy
  Czech Republic | LINDAXA 15 mg, capsule | 15 mg | Capsule, hard | oral use |
| Slovakia | Zentiva, k.s.
  Evropská 846/176a
  160 00 Praha 6
  Czech Republic | LINDAXA 10 | 10 mg | Capsule, hard | oral use |
| Slovakia | Zentiva, k.s. Evropská 846/176a
  160 00 Praha 6
  Czech Republic | LINDAXA 15 | 15 mg | Capsule, hard | oral use |
| Slovakia | TEVA Pharmaceuticals Slovakia s.r.o. Teslova 26, 821 02, Bratislava
  Slovak Republic | Sibutramin - Teva 10 mg kapsuly | 10 mg | Capsule, hard | oral use |
| Slovakia | TEVA Pharmaceuticals Slovakia s.r.o. Teslova 26, 821 02
  Bratislava
  Slovak Republic | Sibutramin - Teva 15 mg kapsuly | 15 mg | Capsule, hard | oral use |
| Slovakia | Abbott Laboratories Slovakia s.r.o.
  Karadžicova 10
  821 08 Bratislava
  Slovak Republic | Reductil 10 mg | 10 mg | capsule | oral use |
| Slovakia | Abbott Laboratories Slovakia s.r.o.
  Karadžicova 10
  821 08 Bratislava
  Slovak Republic | Reductil 15 mg | 15 mg | capsule | oral use |
| Slovenia | Abbott Laboratories d.o.o.
  Dolenjska c. 242c
  SI–1000 Ljubljana
  Slovenia | Reductil 10 mg trde kapsule | 10 mg | Capsule, hard | oral use |
| Slovenia | Abbott Laboratories d.o.o.
  Dolenjska c. 242c
  SI–1000 Ljubljana
  Slovenia | Reductil 15 mg trde kapsule | 15 mg | Capsule, hard | oral use |
| Slovenia | Lek farmacevtska družba d.d., Verovškova c. 57
  SI–1000 Ljubljana
  Slovenia | Sibutramin Lek 10 mg trde kapsule | 10 mg | Capsule, hard | oral use |
| Slovenia | Lek farmacevtska družba d.d., Verovškova c. 57
  SI–1000 Ljubljana
  Slovenia | Sibutramin Lek 15 mg trde kapsule | 15 mg | Capsule, hard | oral use |
| Spain | ABBOTT LABORATORIES, S.A.
  Avda. de Burgos
  28050 Madrid
  Spain | REDUCTIL | 10mg | Capsule, hard | oral use |
| Spain | ABBOTT LABORATORIES, S.A.
  Avda. de Burgos
  28050 Madrid
  Spain | REDUCTIL | 15 mg | Capsule, hard | oral use |
| Spain | TEVA GENERICOS ESPAÑOLA, S.L.
  Guzmán el Bueno 133
  Edificio Britania 4oIzq.
  28003 MADRID
  Spain | SIBUTRAMINA TEVA | 10mg | Capsule, hard | oral use |
| Spain | TEVA GENERICOS ESPAÑOLA, S.L.
  Guzmán el Bueno 133
  Edificio Britania 4oIzq.
  28003 MADRID
  Spain | SIBUTRAMINA TEVA | 15 mg | Capsule, hard | oral use |
| Spain | IDIFARMA, DESARROLLO FARMACEUTICO
  Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)
  Spain | SIBUTRAMINA IDIFARMA | 10 mg | Capsule, hard | oral use |
| Spain | IDIFARMA, DESARROLLO FARMACEUTICO.
  Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)
  Spain | SIBUTRAMINA IDIFARMA | 15 mg | Capsule, hard | oral use |
| Sweden | Abbott ScandinaviaAB
  Box 509169 29 Solna
  Sweden | Reductil | 10 mg | Capsule, hard | oral use |
| Sweden | Abbott ScandinaviaAB
  Box 509169 29 Solna
  Sweden | Reductil | 15 mg | Capsule, hard | oral use |
| Sweden | Sandoz A/S, C.F.
  Tietgens Boulevard 40
  DK–5220 Odense SØ
  Danmark | Sibutramin Sandoz | 10 mg | Capsule, hard | oral use |
| Sweden | Sandoz A/S, C.F.
  Tietgens Boulevard 40
  DK–5220 Odense SØ
  Danmark | Sibutramin Sandoz | 15 mg | Capsule, hard | oral use |
| Sweden | Teva Sweden AB
  Box 1070
  251 10 Helsingborg
  Sweden | Sibutramine Teva | 10 mg | Capsule, hard | Oral use |
| Sweden | Teva Sweden AB
  Box 1070
  251 10 Helsingborg
  Sweden | Sibutramine Teva | 15 mg | Capsule, hard | Oral use |
| United Kingdom | Abbott Laboratories Limited
  Queenborough
  Kent ME11 5EL
  United Kingdom | Reductil 10mg | 10mg | Capsule, hard | oral use |
| United Kingdom | Abbott Laboratories Limited
  Queenborough
  Kent ME11 5EL
  United Kingdom | Reductil 15mg | 15mg | Capsule, hard | oral use |
| United Kingdom | Teva UK Limited
  Brampton Road
  HampdenPark
  Eastbourne, East Sussex BN22 9AG
  United Kingdom | Sibutramine Hydrochloride 15mg Capsules | 10mg | Capsule, hard | oral use |
| United Kingdom | Teva UK Limited
  Brampton Road
  HampdenPark
  Eastbourne, East Sussex BN22 9AG
  United Kingdom | Sibutramine Hydrochloride 15mg Capsules | 15mg | Capsule, hard | oral use |

Member State EU/EEA

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Austria

Abbott GmbH

Perfektastraße 84A

A–1230 Wien

Austria

Reductil 10 mg - Hartkapseln

10 mg

Capsule, hard

oral use

Austria

Abott GmbH

Perfektastraße 84A

A–1230 Wien

Austria

Reductil 15 mg - Hartkapseln

15 mg

Capsule, hard

oral use

Austria

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramin Teva 10 mg Kapseln

10 mg

Capsule, hard

oral use

Austria

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramin Teva 15 mg Kapseln

15 mg

Capsule, hard

oral use

Belgium

Abbott SA

rue du Bosquet 2

1348 Ottignies/LLN

Belgium

Reductil 10 mg

10 mg

Capsule, hard

oral use

Belgium

Abbott SA

rue du Bosquet 2

1348 Ottignies/LLN

Belgium

Reductil 15 mg

15 mg

Capsule, hard

oral use

Belgium

SandozNV

TelecomGardens

Medialaan 40

1800 Vilvoorde

Belgium

Sibutramin Sandoz 10 mg

10 mg

Capsule, hard

oral use

Belgium

SandozNV

TelecomGardens

Medialaan 40

1800 Vilvoorde

Belgium

Sibutramin Sandoz 15 mg

15 mg

Capsule, hard

oral use

Belgium

Teva pharma belgium

Laarstraat 16

2610 Wilrijk

Belgium

Sibutramin Teva 10 mg

10 mg

Capsule, hard

oral use

Belgium

Teva pharma belgium

Laarstraat 16

2610 Wilrijk

Belgium

Sibutramin Teva 15 mg

15 mg

Capsule, hard

oral use

Bulgaria

Abbott GmbH & Co KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil

10 mg

Capsule, hard

oral use

Bulgaria

Abbott GmbH & Co KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil

15 mg

Capsule, hard

oral use

Bulgaria

Sandoz d.d., Verovskova 57

SI - 1000 Ljubljana

Slovenia

Sibutramin Sandoz

10 mg

Capsule, hard

oral use

Bulgaria

Sandoz d.d.

Verovskova 57

SI-1000 Ljubljana

Slovenia

Sibutramin Sandoz

15 mg

Capsule, hard

oral use

Bulgaria

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Lindaxa

10 mg

Capsule, hard

oral use

Bulgaria

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Czech Republic

Lindaxa

15 mg

Capsule, hard

oral use

Bulgaria

Teva Pharmaceuticals Bulgaria EOOD

15 N.V. Gogol str.

Sredetz district

1124 Sofia

Bulgaria

Meissa

10 mg

Capsule, hard

oral use

Bulgaria

Teva Pharmaceuticals Bulgaria EOOD

15 N.V. Gogol str.

Sredetz district

1124 Sofia

Bulgaria

Meissa

15 mg

Capsule, hard

oral use

Czech Republic

Abbott GmbH & Co.KG

Max-Planck-Ring-2

65202 Wiesbaden

Germany

MERIDIA 10 MG

10 mg

Capsule, hard

oral use

Czech Republic

Abbott GmbH & Co.KG

Max-Planck-Ring-2

65202 Wiesbaden

Germany

MERIDIA 15 MG

15 mg

Capsule, hard

oral use

Czech Republic

Zentiva, k.s.

U kabelovny 130, 102 37

Prague 10

Czech Republic

LINDAXA 10

10 mg

Capsule, hard

oral use

Czech Republic

Zentiva, k.s.

U kabelovny 130, 102 37

Prague 10

Czech Republic

LINDAXA 15

15 mg

Capsule, hard

oral use

Czech Republic

TEVA Pharmaceuticals ČR, s.r.o.

Radlická 3185/Ic

150 00 Prague 5

Czech Republic

SIBUTRAMIN-TEVA 10 MG TOBOLKY

10 mg

Capsule, hard

oral use

Czech Republic

TEVA Pharmaceuticals ČR, s.r.o.

Radlická 3185/Ic

150 00 Prague 5

Czech Republic

SIBUTRAMIN-TEVA 15 MG TOBOLKY

15 mg

Capsule, hard

oral use

Denmark

Abbott Scandinavia AB

Postboks 509

SE-169 29, Solna

Sweden

Reductil

10 mg

Capsule, hard

oral use

Denmark

Abbott Scandinavia AB

Postboks 509

SE-169 29, Solna

Sweden

Reductil

15 mg

Capsule, hard

oral use

Denmark

1A Farma A/S

Herstedøstervej 27-29

DK–2620 Albertslund

Denmark

Sibutramin ‘1A Farma’

10 mg

Capsule, hard

oral use

Denmark

1A Farma A/S

Herstedøstervej 27-29

DK–2620 Albertslund

Denmark

Sibutramin ‘1A Farma’

15 mg

Capsule, hard

oral use

Denmark

Sandoz A/S

C. F. Tietgens Boulevard 40

DK–5220 Odense SØ

Denmark

Sibutramin ‘Sandoz’

10 mg

Capsule, hard

oral use

Denmark

Sandoz A/S

C. F. Tietgens Boulevard 40

DK–5220 Odense SØ

Denmark

Sibutramin ‘Sandoz’

15 mg

Capsule, hard

oral use

Denmark

Teva Danmark A/S

Østergade 38

DK–1100 København K

Denmark

Sibutramin ‘Teva’

10 mg

Capsule, hard

oral use

Denmark

Teva Danmark A/S

Østergade 38

DK–1100 København K

Denmark

Sibutramin ‘Teva’

15 mg

Capsule, hard

oral use

Estonia

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

REDUCTIL

10mg

Capsule, hard

oral use

Estonia

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

REDUCTIL

15mg

Capsule, hard

oral use

Estonia

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

SIBUTRIL

10mg

Capsule, hard

oral use

Estonia

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

SIBUTRIL

15mg

Capsule, hard

oral use

Estonia

Zentiva, k.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Prague 10

Czech Republic

LINDAXA 10

10mg

Capsule, hard

oral use

Estonia

Zentiva, k.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Prague 10

Czech Republic

LINDAXA 15

15mg

Capsule, hard

oral use

Estonia

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

SIBUTRAMINE TEVA

10mg

Capsule, hard

oral use

Estonia

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

SIBUTRAMINE TEVA

15mg

Capsule, hard

oral use

Finland

Abbott ScandinaviaAB

P.O. Box 509

16929 Solna

Sweden

Reductil

10 mg, 15 mg

Capsule, hard

oral use

Finland

Sandoz A/S C.F.

Tietgens Boulevard 40

5220 Odense SØ

Denmark

Sibutramin Sandoz

10 mg, 15 mg

Capsule, hard

oral use

Finland

Teva Sweden AB

Järnvägsgatan 11

Box 1070

25110 Helsingborg

Sweden

Sibutramine Teva

10 mg, 15 mg

Capsule, hard

oral use

France

ABBOT France

10, RUE D'ARCUEIL

SILIC 233

94528 RUNGIS CEDEX

FRANCE

SIBUTRAL 10 mg, gélule

10 mg

capsule

oral use

France

ABBOT France

10, RUE D'ARCUEIL

SILIC 233

94528 RUNGIS CEDEX

FRANCE

SIBUTRAL 15 mg, gélule

15 mg

capsule

oral use

Germany

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Germany

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Zelium 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Zelium 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Germany

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reduxade 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reduxade 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Germany

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Germany

Sibutramin - 1A Pharma 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Germany

Sibutramin - 1A Pharma 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Germany

HEXAL AG

Postfach 1263

83602 Holzkirchen

Germany

Sibutramin-HEXAL 10 mg Hartkapseln

10 mg

Capsule, hard

oral use

Germany

HEXAL AG

Postfach 1263

83602 Holzkirchen

Germany

Sibutramin-HEXAL 15 mg Hartkapseln

15 mg

Capsule, hard

oral use

Greece

Abbott Laboratories (Hellas) S.A.

512, Vouliagmenis Avenue

GR 17456, Alimos

Athens

Greece

Reductil

10 mg

Capsule, hard

oral use

Greece

Abbott Laboratories (Hellas) S.A.

512, Vouliagmenis Avenue

GR 17456, Alimos

Athens

Greece

Reductil

15 mg

Capsule, hard

oral use

Greece

Teva Pharmaceuticals Europe B.V.

European Headquarters

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramine/Teva

10mg

Capsule, hard

oral use

Greece

Teva Pharmaceuticals Europe B.V.

European Headquarters

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramine/Teva

15 mg

Capsule, hard

oral use

Hungary

Zentiva k. s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

LINDAXA

10mg

Capsule, hard

oral use

Hungary

Zentiva k. s.

U Kabelovny 130

102 37 Praha 10

Czech Republic

LINDAXA

15mg

Capsule, hard

oral use

Hungary

Teva Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Hungary

MINIMECTIL

10mg

Capsule, hard

oral use

Hungary

Teva Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Hungary

MINIMECTIL

15mg

Capsule, hard

oral use

Hungary

Abbott Laboratories Kft.

Teve u. 1/a-c

1139 Budapest

Hungary

REDUCTIL

10mg

Capsule, hard

oral use

Hungary

Abbott Laboratories Kft.

Teve u. 1/a-c

1139 Budapest

Hungary

REDUCTIL

15mg

Capsule, hard

oral use

Iceland

Abbott Scandinavia

Gårdsvägen 8

Box 5091

SE-169 29 Solna

Sweden

Reductil

10 mg

Capsule, hard

oral use

Iceland

Abbott Scandinavia

Gårdsvägen 8

Box 5091

SE-169 29 Solna

Sweden

Reductil

15 mg

Capsule, hard

oral use

Ireland

Teva Pharma B.V.

Computerweg 10

3542 Dr Utrecht

Netherlands

Sibutramine Teva 10 mg Capsules

10 mg

Capsule, hard

oral use

Ireland

Teva Pharma B.V.

Computerweg 10

3542 Dr Utrecht

Netherlands

Sibutramine Teva 15 mg Capsules

15 mg

Capsule, hard

oral use

Ireland

Abbot Laboratories Ireland Ltd

4051 Kingswood Drive

Citywest Business Campus

Dublin 24

Ireland

Reductil 10 mg capsules, hard

10 mg

Capsule, hard

oral use

Ireland

Abbot Laboratories Ireland Ltd

4051 Kingswood Drive

Citywest Business Campus

Dublin 24

Ireland

Reductil 15 mg capsules, hard

15 mg

Capsule, hard

oral use

Ireland

Rowex Ltd

Bantry

Co.Cork

Ireland

Sitrane 10 mg hard capsules

10 mg

Capsule, hard

oral use

Ireland

Rowex Ltd

Bantry

Co.Cork

Ireland

Sitrane 15 mg hard capsules

15 mg

Capsule, hard

oral use

Italy

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

REDUXATE

10 mg

capsule

oral use

Italy

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

REDUXATE

15 mg

capsule

oral use

Italy

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

ECTIVA

10 mg

capsule

oral use

Italy

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

ECTIVA

15 mg

capsule

oral use

Italy

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

REDUCTIL

10 mg

capsule

oral use

Italy

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italy

REDUCTIL

15 mg

capsule

oral use

Latvia

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil 15 mg hard capsules

15 mg

Capsule, hard

oral use

Latvia

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil 10 mg hard capsules

10 mg

Capsule, hard

oral use

Latvia

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenia

Sibutril 15 mg capsules, hard

15 mg

Capsule, hard

oral

Latvia

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenia

Sibutril 10 mg capsules, hard

10 mg

Capsule, hard

oral

Lithuania

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil

10 mg

Capsule, hard

oral use

Lithuania

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

Reductil

15 mg

Capsule, hard

oral use

Lithuania

Zentiva k. s.

U kabelovny 130

10237 Prague 10 Dolni Mecholupy Czech Republic

Lindaxa

10 mg

Capsule, hard

oral use

Lithuania

Zentiva k. s.

U kabelovny 130

10237 Prague 10 Dolni Mecholupy Czech Republic

Lindaxa

15 mg

Capsule, hard

oral use

Lithuania

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Sibutril

10 mg

Capsule, hard

oral use

Lithuania

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Sibutril

15 mg

Capsule, hard

oral use

Lithuania

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramine Teva

10 mg

Capsule, hard

oral use

Lithuania

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

The Netherlands

Sibutramine Teva

15 mg

Capsule, hard

oral use

Luxembourg

Abbott Laboratoires 2, rue du Bosquet B- 1348 Ottignies L.L.N.

Belgium

Reductil

10mg

capsule

oral use

Luxembourg

Abbott Laboratoires 2, rue du Bosquet B- 1348 Ottignies L.L.N.

Belgium

Reductil

15mg

capsules

oral use

Malta

Abbott Laboratories Limited Queenborough

Kent

ME11 5EL

United Kingdom

Reductil

10mg

Capsule, hard

oral use

Malta

Abbott Laboratories Limited Queenborough

Kent

ME11 5EL

United Kingdom

Reductil

15mg

Capsule, hard

oral use

Netherlands

Abbott B.V.

Siriusdreef 51

2132 WT, Hoofddorp

Netherlands

Reductil 10 mg, capsules, hard

10 mg

Capsule, hard

oral use

Netherlands

Abbott B.V.

Siriusdreef 51

2132 WT, Hoofddorp

Netherlands

Reductil 15 mg, capsules, hard

15 mg

Capsule, hard

oral use

Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH, Almere

Netherlands

Sibutramine HCL monohydraat Sandoz 10 mg, harde capsules

10 mg

Capsule, hard

oral use

Netherlands

Sandoz B.V.

Veluwezoom 22

1327 AH, Almere

Netherlands

Sibutramine HCL monohydraat Sandoz 15 mg, harde capsules

15 mg

Capsule, hard

oral use

Netherlands

Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144

8226 JX, Lelystad

Netherlands

Reductil 15 mg, capsules

15 mg

Capsule, hard

oral use

Netherlands

Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144

8226 JX, Lelystad

Netherlands

Reductil 10 mg, capsules

10 mg

Capsule, hard

oral use

Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA, Haarlem

Netherlands

Sibutramine HCL- monohydraat 10 mg PCH, capsules

10 mg

Capsule, hard

oral use

Netherlands

Pharmachemie B.V.

Swensweg 5

2031 GA, Haarlem

Netherlands

Sibutramine HCL- monohydraat 15 mg PCH, capsules

15 mg

Capsule, hard

oral use

Norway

Abbot Scandinavia

AB Box 509

169 29 Solna

Sweden

REDUCTIL

10 mg

Capsule, hard

oral use

Norway

Abbot Scandinavia

AB Box 509

169 29 Solna

Sweden

REDUCTIL

15 mg

Capsule, hard

oral use

Norway

Euromedica NorgeAS

Jerikoveien 28 C

1067 Oslo

Norway

REDUCTIL

10 mg

Capsule, hard

oral use

Norway

Euromedica NorgeAS

Jerikoveien 28 C

1067 Oslo

Norway

REDUCTIL

15 mg

Capsule, hard

oral use

Norway

Sandoz A/

Edvard Thomsens Vej 14

2300 København S

Danmark

SIBUTRAMIN SANDOZ

10 mg

Capsule, hard

oral use

Norway

Sandoz A/

Edvard Thomsens Vej 14

2300 København S

Danmark

SIBUTRAMIN SANDOZ

15 mg

Capsule, hard

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.

00-113 Warsaw

Poland

Afibron

10 mg

Capsule, hard

oral use

Poland

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.

00-113 Warsaw

Poland

Afibron

15 mg

Capsule, hard

oral use

Poland

Zentiva a.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Praha 10

Czech Republic

Lindaxa 10

10 mg

Capsule, hard

oral use

Poland

Zentiva a.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Praha 10

Czech Republic

Lindaxa 15

15 mg

Capsule, hard

oral use

Poland

Abbott Laboratories Poland Sp. z o. o.

ul. Postępu 18A

02-676 Warsaw

Poland

Meridia 10

10 mg

Capsule, hard

oral use

Poland

Abbott Laboratories Poland Sp. z o. o.

ul. Postępu 18A

02-676 Warsaw

Poland

Meridia 15

15 mg

Capsule, hard

oral use

Poland

Sandoz GmbH

Biochemiestrasse 10

A–6250 Kundl

Austria

Obesan

10 mg

Capsule, hard

oral use

Poland

Sandoz GmbH

Biochemiestrasse 10

A–6250 Kundl

Austria

Obesan

15 mg

Capsule, hard

oral use

Poland

1A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Sibutramine-1A Pharma

10 mg

Capsule, hard

oral use

Poland

1A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Germany

Sibutramine-1A Pharma

15 mg

Capsule, hard

oral use

Poland

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198

Poznan

Poland

Zelixa

10 mg

Film-coated tablet

oral use

Poland

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198

Poznan

Poland

Zelixa

15 mg

Film-coated tablet

oral use

Portugal

ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Zelium

10 mg

Capsule, hard

oral use

Portugal

ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Zelium

15 mg

Capsule, hard

oral use

Portugal

ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Reductil

10 mg

Capsule, hard

oral use

Portugal

ABBOTT LABORATORIOS, LDA Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Reductil

15 mg

Capsule, hard

oral use

Portugal

Teva Pharma –

Produtos Farmacêuticos, Lda.

EmpreendimentoLagoasPark

Edifício 1 - 3

2740-264 Porto Salvo

Portugal

Sibutramina Teva

10 mg

Capsule, hard

oral use

Portugal

Teva Pharma –

Produtos Farmacêuticos, Lda.

EmpreendimentoLagoasPark

Edifício 1 - 3

2740-264 Porto Salvo

Portugal

Sibutramina Teva

15 mg

Capsule, hard

oral use

Portugal

Solufarma - Produtos Farmacêuticos Unipessoal, Lda.

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Sibulaite

10 mg

Capsule, hard

oral use

Portugal

Solufarma - Produtos Farmacêuticos Unipessoal, Lda

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Sibulaite

15 mg

Capsule, hard

oral use

Portugal

Solufarma - Produtos Farmacêuticos Unipessoal, Lda

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Solufarma

10 mg

Capsule, hard

oral use

Portugal

Solufarma - Produtos Farmacêuticos Unipessoal, Lda

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Solufarma

15 mg

Capsule, hard

oral use

Portugal

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Farmoz

10 mg

Capsule, hard

oral use

Portugal

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Farmoz

15 mg

Capsule, hard

oral use

Portugal

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no 2 -Abrunheira

2710-089 Sintra

Portugal

Sibutramina Egostar

10 mg

Capsule, hard

oral use

Portugal

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no 2 Abrunheira

2710-089 Sintra

Portugal

Sibutramina Egostar

15 mg

Capsule, hard

oral use

Portugal

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no 2 Abrunheira

2710-089 Sintra

Portugal

Sibutramina Blixie

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Blixie

15 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Atrolex

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Atrolex

15 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Argam

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Argam

15 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Orexinib

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Orexinib

15 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Snomas

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Snomas

15 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Arpedex

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Arpedex

15 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Marcoliz

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Marcoliz

15 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Ocram

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Ocram

15 mg

Capsule, hard

oral use

Portugal

Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda

Av. Sidónio Pais, n.o 24,

rés-do-chão esq

São Sebastião da Pedreira

1000 Lisboa

Portugal

Sibutramina Strami

10 mg

Capsule, hard

oral use

Portugal

Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda

Av. Sidónio Pais, n.o 24,

rés-do-chão esq,

São Sebastião da Pedreira

1000 Lisboa

Portugal

Sibutramina Strami

15 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Fililex

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Fililex

15 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina West Pharma

10 mg

Capsule, hard

oral use

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina West Pharma

15 mg

Capsule, hard

oral use

Portugal

Generis Farmacêutica, S.A.

Office Park da Beloura,

Edifício 4,

Quinta da Beloura

2710-444 Sintra

Portugal

Sibutramina Generis

8,37 mg

Capsule, hard

oral use

Portugal

Generis Farmacêutica, S.A.

Office Park da Beloura,

Edifício 4,

Quinta da Beloura

2710-444 Sintra

Portugal

Sibutramina Generis

12 556 mg

Capsule, hard

oral use

Portugal

Sandoz Farmacêutica, Lda.

Alameda da Beloura,

Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Sibutramina Sandoz

10 mg

Capsule, hard

oral use

Portugal

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Sibutramina Sandoz

15 mg

Capsule, hard

oral use

Romania

Abbott GmbH & Co.KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

REDUCTIL 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

Abbott GmbH & Co.KG

Max-Planck-Ring 2

65205 Wiesbaden

Germany

REDUCTIL 15 mg, capsule

15 mg

Capsule, hard

oral use

Romania

SANDOZ S.R.L. ROMÂNIA

Str. Livezeni nr. 7A,

Târgu Mureş,

Romania

MINIMACIN 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

SANDOZ S.R.L. ROMÂNIA

Str. Livezeni nr. 7A,

Târgu Mureş,

Romania

MINIMACIN 15 mg, capsule

15 mg

Capsule, hard

oral use

Romania

S.C. TERAPIA S.A.

Str. Fabricii, nr. 124,

Cluj-Napoca,

Romania

SILUTON 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

S.C. TERAPIA S.A.

Str. Fabricii, nr. 124,

Cluj-Napoca,

Romania

SILUTON 15 mg, capsule

15 mg

Capsule, hard

oral use

Romania

TEVA PHARMACEUTICALS S.R.L.

Str. Domniţa Ruxandra nr 12, parter,

Sector 2, Bucureşti

Romania

SIBUTRAMINĂ TEVA 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

TEVA PHARMACEUTICALS S.R.L.

Str. Domniţa Ruxandra nr 12, parter,

Sector 2, Bucureşti

Romania

SIBUTRAMINĂ TEVA 15 mg, capsule

15 mg

Capsule, hard

oral use

Romania

ZENTIVA a.s.,

U kabelovny 130,

102 37 Praga-10 Dolní Měcholupy, Czech Republic

LINDAXA 10 mg, capsule

10 mg

Capsule, hard

oral use

Romania

ZENTIVA a.s.,

U kabelovny 130,

102 37 Praga-10 Dolní Měcholupy

Czech Republic

LINDAXA 15 mg, capsule

15 mg

Capsule, hard

oral use

Slovakia

Zentiva, k.s.

Evropská 846/176a

160 00 Praha 6

Czech Republic

LINDAXA 10

10 mg

Capsule, hard

oral use

Slovakia

Zentiva, k.s. Evropská 846/176a

160 00 Praha 6

Czech Republic

LINDAXA 15

15 mg

Capsule, hard

oral use

Slovakia

TEVA Pharmaceuticals Slovakia s.r.o. Teslova 26, 821 02, Bratislava

Slovak Republic

Sibutramin - Teva 10 mg kapsuly

10 mg

Capsule, hard

oral use

Slovakia

TEVA Pharmaceuticals Slovakia s.r.o. Teslova 26, 821 02

Bratislava

Slovak Republic

Sibutramin - Teva 15 mg kapsuly

15 mg

Capsule, hard

oral use

Slovakia

Abbott Laboratories Slovakia s.r.o.

Karadžicova 10

821 08 Bratislava

Slovak Republic

Reductil 10 mg

10 mg

capsule

oral use

Slovakia

Abbott Laboratories Slovakia s.r.o.

Karadžicova 10

821 08 Bratislava

Slovak Republic

Reductil 15 mg

15 mg

capsule

oral use

Slovenia

Abbott Laboratories d.o.o.

Dolenjska c. 242c

SI–1000 Ljubljana

Slovenia

Reductil 10 mg trde kapsule

10 mg

Capsule, hard

oral use

Slovenia

Abbott Laboratories d.o.o.

Dolenjska c. 242c

SI–1000 Ljubljana

Slovenia

Reductil 15 mg trde kapsule

15 mg

Capsule, hard

oral use

Slovenia

Lek farmacevtska družba d.d., Verovškova c. 57

SI–1000 Ljubljana

Slovenia

Sibutramin Lek 10 mg trde kapsule

10 mg

Capsule, hard

oral use

Slovenia

Lek farmacevtska družba d.d., Verovškova c. 57

SI–1000 Ljubljana

Slovenia

Sibutramin Lek 15 mg trde kapsule

15 mg

Capsule, hard

oral use

Spain

ABBOTT LABORATORIES, S.A.

Avda. de Burgos

28050 Madrid

Spain

REDUCTIL

10mg

Capsule, hard

oral use

Spain

ABBOTT LABORATORIES, S.A.

Avda. de Burgos

28050 Madrid

Spain

REDUCTIL

15 mg

Capsule, hard

oral use

Spain

TEVA GENERICOS ESPAÑOLA, S.L.

Guzmán el Bueno 133

Edificio Britania 4oIzq.

28003 MADRID

Spain

SIBUTRAMINA TEVA

10mg

Capsule, hard

oral use

Spain

TEVA GENERICOS ESPAÑOLA, S.L.

Guzmán el Bueno 133

Edificio Britania 4oIzq.

28003 MADRID

Spain

SIBUTRAMINA TEVA

15 mg

Capsule, hard

oral use

Spain

IDIFARMA, DESARROLLO FARMACEUTICO

Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)

Spain

SIBUTRAMINA IDIFARMA

10 mg

Capsule, hard

oral use

Spain

IDIFARMA, DESARROLLO FARMACEUTICO.

Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)

Spain

SIBUTRAMINA IDIFARMA

15 mg

Capsule, hard

oral use

Sweden

Abbott ScandinaviaAB

Box 509169 29 Solna

Sweden

Reductil

10 mg

Capsule, hard

oral use

Sweden

Abbott ScandinaviaAB

Box 509169 29 Solna

Sweden

Reductil

15 mg

Capsule, hard

oral use

Sweden

Sandoz A/S, C.F.

Tietgens Boulevard 40

DK–5220 Odense SØ

Danmark

Sibutramin Sandoz

10 mg

Capsule, hard

oral use

Sweden

Sandoz A/S, C.F.

Tietgens Boulevard 40

DK–5220 Odense SØ

Danmark

Sibutramin Sandoz

15 mg

Capsule, hard

oral use

Sweden

Teva Sweden AB

Box 1070

251 10 Helsingborg

Sweden

Sibutramine Teva

10 mg

Capsule, hard

Oral use

Sweden

Teva Sweden AB

Box 1070

251 10 Helsingborg

Sweden

Sibutramine Teva

15 mg

Capsule, hard

Oral use

United Kingdom

Abbott Laboratories Limited

Queenborough

Kent ME11 5EL

United Kingdom

Reductil 10mg

10mg

Capsule, hard

oral use

United Kingdom

Abbott Laboratories Limited

Queenborough

Kent ME11 5EL

United Kingdom

Reductil 15mg

15mg

Capsule, hard

oral use

United Kingdom

Teva UK Limited

Brampton Road

HampdenPark

Eastbourne, East Sussex BN22 9AG

United Kingdom

Sibutramine Hydrochloride 15mg Capsules

10mg

Capsule, hard

oral use

United Kingdom

Teva UK Limited

Brampton Road

HampdenPark

Eastbourne, East Sussex BN22 9AG

United Kingdom

Sibutramine Hydrochloride 15mg Capsules

15mg

Capsule, hard

oral use

---

ANNEX XVII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Product Name | Strength/dextropropoxyphene/paracetamol/caffeine | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- |
| Greece | Stargen Ltd
  Favierou 48
  Athens 10438
  Greece | Romidon | 75mg/2ml | Solution for injection | Intramuscular, intravenous use |
| Greece | Norma Hellas S.A.
  Menandrou 54
  Athens 10431
  Greece | Zideron | 75mg/2ml | Solution for injection | Intramuscular, intravenous use |

Member State

Marketing Authorisation Holder

Product Name

Strength/dextropropoxyphene/paracetamol/caffeine

Pharmaceutical Form

Route of Administration

Greece

Stargen Ltd

Favierou 48

Athens 10438

Greece

Romidon

75mg/2ml

Solution for injection

Intramuscular, intravenous use

Greece

Norma Hellas S.A.

Menandrou 54

Athens 10431

Greece

Zideron

75mg/2ml

Solution for injection

Intramuscular, intravenous use

---

ANNEX XVIII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATIONS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Invented Name | Strength/dextropropoxyphene/paracetamol/caffeine | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Laboratories SMB s.a.
  26-28 Rue de la Pastorale
  B–1080 Bruxelles
  Belgium | Algophene smb | 30 mg/400 mg | Capsule, hard | Oral use |
| Cyprus | Remedica LTD
  PO Box 51706
  3508 Lemesos
  Cyprus | Destirol | 32,5 mg/325 mg | Tablet | Oral use |
| Cyprus | Interpak LTD
  PO Box 51166
  3502 Lemesos
  Cyprus | Dologesic | 32,5 mg/325 mg | Tablet | Oral use |
| Cyprus | Medochemie LTD
  MedochemieBuilding
  1-10 Constantinoupoleos Str.,
  3011 Limassol,
  Cyprus | Medonol | 32,5 mg/325 mg | Tablet | Oral use |
| Cyprus | Phadisco LTD
  PO Box 22173
  1518 Lefkosia
  Cyprus | Distalgesic | 32,5 mg/325 mg | Tablet | Oral use |
| France | Arrow Generiques
  26, avenue Tony Garnier
  69007 Lyon
  France | Dextropropoxyphene Paracetamol almus | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Arrow Generiques
  26, avenue Tony Garnier
  69007 Lyon
  France | Dextropropoxyphene Paracetamol arrow | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Sanofi-aventis France
  1-13 Bd Romain Rolland
  75014 Paris
  France | Dextropropoxyphene Paracetamol Biogalenique | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Sanofi- aventis France
  1-13, boulevard Romain Rolland
  75014 Paris
  France | Di-antalvic | 30 mg/400 mg | Suppository | Rectal use |
| France | Biogaran
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | Dextropropoxyphene Paracetamol biogaran | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Bouchara Recordati
  68, rue Marjolin,
  BP 67 92302 Levallois-Perret Cedex
  France | Dioalgo | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Chemical Farma
  3 quai Louis Blériot
  75016 PARIS
  France | Dextroref | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Dci Pharma
  180, rue Eugène Avinée
  59120 Loos
  France | Dextropropoxyphene Paracetamol dci Pharma | 30 mg/400 mg | Capsule, hard | Oral use |
| France | EG Labo - Laboratoires EuroGenerics
  ‘Le Quintet’ bâtiment A
  12, rue Danjou
  92517 Boulogne Billancourt Cedex
  France | Dextropropoxyphene Paracetamol eg | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Expanpharm International
  6, rue de la Rochefoucauld
  16000 Angoulême
  France | Dextropropoxyphene Paracetamol Expanpharm | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Substipharm
  8 Rue Bellini
  75116 Paris
  France | Dextropropoxyphene Paracetamol hexal | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Teva Santé
  Le Palatin 1
  1, cours du Triangle
  92936 Paris La Défense Cedex
  France | Dextropropoxyphene Paracetamol ivax | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Labo Concept Pharm
  26, boulevard Paul Vaillant Couturier
  94200 Ivry Sur Seine
  France | Dextropropoxyphene Paracetamol isomed | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Qualimed
  117 Allée des Parcs
  69800 Saint Priest
  France | Dextropropoxyphene Paracetamol qualimed | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Ranbaxy Pharmacie Generiques
  11-15 Quai de Dion Bouton
  92800 Puteaux
  France | Dextropropoxyphene Paracetamol rpg | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Laboratoires Alter
  3, avenue de la Baltique
  ZI de Courtaboeuf
  91140 Villebon Sur Yvette
  France | Dextropropoxyphene Paracetamol alter | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Sanofi-aventis France
  1-13, boulevard Romain Rolland
  75014 Paris
  France | Di-antalvic | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Laboratoires Therabel Lucien Pharma
  19 Rue Alphone de Neuville
  75017 Paris
  France | Di dolko | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Leurquin Mediolanum
  68-88, rue Louis Ampère
  93330 Neuilly-sur-Marne
  France | Talvidol | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Mylan SAS
  117 Allée des Parcs
  69800 Saint Priest
  France | Dextropropoxyphene Paracetamol Mylan | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Ratiopharm GmbH
  Graf Arco Strasse 3 89079 Ulm
  Germany | Dextropropoxyphene Paracetamol Ratiopharm | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Sandoz
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | Dextropropoxyphene Paracetamol G Gam | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Sandoz
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | Dextropropoxyphene Paracetamol Sandoz | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Teva Santé
  Le Palatin 1
  1, cours du Triangle
  92936 Paris la Défense Cedex
  France | Dextropropoxyphene Paracetamol Teva | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Sodephar
  176, rue de l'Arbrisseau
  59000 Lille
  France | Dextropropoxyphene Paracetamol Sodephar | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Actavis France
  Centre d'Affaires la Boursidière
  92357 le Plessis-Robinson
  France | Dextropropoxyphene Paracetamol Actavis | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Actavis France
  Centre d'Affaires la Boursidière
  92357 le Plessis-Robinson
  France | Dexap | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Sanofi-aventis France
  1-13 Bd Romain Rolland
  75014 Paris
  France | Dialgirex | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Sanofi-aventis France
  1-13 Bd Romain Rolland
  75014 Paris
  France | Dextropropoxyphene/Paracetamol Theraplix | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Zydus France
  25, rue des Peupliers
  ZAC Les Hautes Pâtures
  Parc d'Activités des Peupliers
  92000 Nanterre
  France | Dextropropoxyphene Paracetamol Zydus | 30 mg/400 mg | Capsule, hard | Oral use |
| France | Alter
  3, avenue de la Baltique
  91140 Villebon Sur Yvette
  France | Dextropropoxyphene/Paracetamol/Cafeine Alter | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Arrow Generiques
  26, avenue Tony Garnier
  69007 Lyon
  France | Dextropropoxyphene/Paracetamol/Cafeine Almus | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Arrow Generiques
  26, avenue Tony Garnier
  69007 Lyon
  France | Dextropropoxyphene/Paracetamol/Cafeine Arrow | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Arrow Generiques
  26, avenue Tony Garnier
  69007 Lyon
  France | Dextropropoxyphene/Paracetamol/Cafeine Offilink | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Plus Pharmacie
  26, boulevard Paul Vaillant-Couturier
  94200 Ivry-sur-Seine
  France | Dextropropoxyphene / Paracetamol / Cafeine Isomed | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Biogaran
  15, boulevard Charles de Gaulle
  92700 Colombes
  France | Dextropropoxyphene/Paracetamol/Cafeine Biogaran | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Eg Labo - Laboratoires EUROGENERICS
  ‘Le Quintet’ - bâtiment A
  92517 Boulogne Billancourt Cedex
  France | Dextropropoxyphene/Paracetamol/Cafeine Eg | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Ranbaxy Pharmacie Generiques
  1115 Quai de Dion Bouton
  Immeuble Avant Seine
  92816 Puteaux Cédex
  France | Dextropropoxyphene/Paracetamol/Cafeine Rpg | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Mylan SAS
  117 Allée des Parcs
  69800 Saint Priest
  France | Dextropropoxyphene/Paracetamol/Cafeine Mylan | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Mylan SAS
  117 Allée des Parcs
  69800 Saint Priest
  France | Dextropropoxyphene/Paracetamol/Cafeine Mylan Pharma | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Qualimed (Lyon)
  117 Allée des Parcs
  69800 Saint Priest
  France | Dextropropoxyphene/Paracetamol/Cafeine Qualimed | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Laboratoire Ratiopharm
  19, boulevard Paul Vaillant Couturier
  94200 Ivry sur Seine
  France | Dextropropoxyphene/Paracetamol/Cafeine Ratiopharm | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Sandoz
  49, avenue Georges Pompidou
  92593 Levallois-Perret
  France | Dextropropoxyphene/Paracetamol/Cafeine G Gam | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Sandoz
  49, avenue Georges Pompidou
  92300 Levallois-Perret
  France | Dextropropoxyphene/Paracetamol/Cafeine Sandoz | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | TEVA Santé
  Le Palatin 1
  1, cours du Triangle
  92936 Paris la Défense Cedex
  France | Dextropropoxyphene/Paracetamol/Cafeine Teva | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Zydus France
  25, rue des Peupliers
  ZAC Les Hautes Pâtures
  Parc d'Activités des Peupliers
  92000 Nanterre
  France | Dextropropoxyphene/Paracetamol/Cafeine Zydus | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Sanofi-aventis France
  1-13 Bd Romain Rolland
  75014 Paris
  France | Propofan | 27 mg/400 mg/30 mg | Tablet | Oral use |
| France | Sanofi-aventis France
  1-13 Bd Romain Rolland
  75014 Paris
  France | Dextropropoxyphene/Paracetamol/Cafeine Winthrop | 27 mg/400 mg/30 mg | Tablet | Oral use |
| Luxembourg | S.M.B
  26-28 rue de la Pastorale
  B–1080 Bruxelles
  Belgium | Algophene | 30 mg/400 mg | Capsule | Oral use |
| Malta | Medochemie LTD
  MedochemieBuilding
  1-10 Constantinoupoleos Str.,
  3011 Limassol,
  Cyprus | Medonol | 32,5 mg/325 mg | Tablet | Oral use |
| Malta | Phadisco Ltd
  185 Giannou Kranidioti Avenue
  CY–2235
  Latsia
  Cyprus | Distalgesic | 32,5 mg/325 mg | Tablet | Oral use |
| Norway | Actavis group hf
  Dalshraun 1
  220 Hafnafjordur
  Iceland | Aporex | 70 mg/400 mg | Tablet | Oral use |
| Portugal | Ferraz Lynce S.A
  Rua Consiglieri Pedroso
  123 Queluz de Baixo Apartado 1001
  2731901 Barcarena
  Portugal | Algifene | 25 mg/300 mg | Coated tablet | Oral use |

Member State

Marketing Authorisation Holder

Invented Name

Strength/dextropropoxyphene/paracetamol/caffeine

Pharmaceutical Form

Route of Administration

Belgium

Laboratories SMB s.a.

26-28 Rue de la Pastorale

B–1080 Bruxelles

Belgium

Algophene smb

30 mg/400 mg

Capsule, hard

Oral use

Cyprus

Remedica LTD

PO Box 51706

3508 Lemesos

Cyprus

Destirol

32,5 mg/325 mg

Tablet

Oral use

Cyprus

Interpak LTD

PO Box 51166

3502 Lemesos

Cyprus

Dologesic

32,5 mg/325 mg

Tablet

Oral use

Cyprus

Medochemie LTD

MedochemieBuilding

1-10 Constantinoupoleos Str.,

3011 Limassol,

Cyprus

Medonol

32,5 mg/325 mg

Tablet

Oral use

Cyprus

Phadisco LTD

PO Box 22173

1518 Lefkosia

Cyprus

Distalgesic

32,5 mg/325 mg

Tablet

Oral use

France

Arrow Generiques

26, avenue Tony Garnier

69007 Lyon

France

Dextropropoxyphene Paracetamol almus

30 mg/400 mg

Capsule, hard

Oral use

France

Arrow Generiques

26, avenue Tony Garnier

69007 Lyon

France

Dextropropoxyphene Paracetamol arrow

30 mg/400 mg

Capsule, hard

Oral use

France

Sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris

France

Dextropropoxyphene Paracetamol Biogalenique

30 mg/400 mg

Capsule, hard

Oral use

France

Sanofi- aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

Di-antalvic

30 mg/400 mg

Suppository

Rectal use

France

Biogaran

15, boulevard Charles de Gaulle

92700 Colombes

France

Dextropropoxyphene Paracetamol biogaran

30 mg/400 mg

Capsule, hard

Oral use

France

Bouchara Recordati

68, rue Marjolin,

BP 67 92302 Levallois-Perret Cedex

France

Dioalgo

30 mg/400 mg

Capsule, hard

Oral use

France

Chemical Farma

3 quai Louis Blériot

75016 PARIS

France

Dextroref

30 mg/400 mg

Capsule, hard

Oral use

France

Dci Pharma

180, rue Eugène Avinée

59120 Loos

France

Dextropropoxyphene Paracetamol dci Pharma

30 mg/400 mg

Capsule, hard

Oral use

France

EG Labo - Laboratoires EuroGenerics

‘Le Quintet’ bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

Dextropropoxyphene Paracetamol eg

30 mg/400 mg

Capsule, hard

Oral use

France

Expanpharm International

6, rue de la Rochefoucauld

16000 Angoulême

France

Dextropropoxyphene Paracetamol Expanpharm

30 mg/400 mg

Capsule, hard

Oral use

France

Substipharm

8 Rue Bellini

75116 Paris

France

Dextropropoxyphene Paracetamol hexal

30 mg/400 mg

Capsule, hard

Oral use

France

Teva Santé

Le Palatin 1

1, cours du Triangle

92936 Paris La Défense Cedex

France

Dextropropoxyphene Paracetamol ivax

30 mg/400 mg

Capsule, hard

Oral use

France

Labo Concept Pharm

26, boulevard Paul Vaillant Couturier

94200 Ivry Sur Seine

France

Dextropropoxyphene Paracetamol isomed

30 mg/400 mg

Capsule, hard

Oral use

France

Qualimed

117 Allée des Parcs

69800 Saint Priest

France

Dextropropoxyphene Paracetamol qualimed

30 mg/400 mg

Capsule, hard

Oral use

France

Ranbaxy Pharmacie Generiques

11-15 Quai de Dion Bouton

92800 Puteaux

France

Dextropropoxyphene Paracetamol rpg

30 mg/400 mg

Capsule, hard

Oral use

France

Laboratoires Alter

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette

France

Dextropropoxyphene Paracetamol alter

30 mg/400 mg

Capsule, hard

Oral use

France

Sanofi-aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

Di-antalvic

30 mg/400 mg

Capsule, hard

Oral use

France

Laboratoires Therabel Lucien Pharma

19 Rue Alphone de Neuville

75017 Paris

France

Di dolko

30 mg/400 mg

Capsule, hard

Oral use

France

Leurquin Mediolanum

68-88, rue Louis Ampère

93330 Neuilly-sur-Marne

France

Talvidol

30 mg/400 mg

Capsule, hard

Oral use

France

Mylan SAS

117 Allée des Parcs

69800 Saint Priest

France

Dextropropoxyphene Paracetamol Mylan

30 mg/400 mg

Capsule, hard

Oral use

France

Ratiopharm GmbH

Graf Arco Strasse 3 89079 Ulm

Germany

Dextropropoxyphene Paracetamol Ratiopharm

30 mg/400 mg

Capsule, hard

Oral use

France

Sandoz

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Dextropropoxyphene Paracetamol G Gam

30 mg/400 mg

Capsule, hard

Oral use

France

Sandoz

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Dextropropoxyphene Paracetamol Sandoz

30 mg/400 mg

Capsule, hard

Oral use

France

Teva Santé

Le Palatin 1

1, cours du Triangle

92936 Paris la Défense Cedex

France

Dextropropoxyphene Paracetamol Teva

30 mg/400 mg

Capsule, hard

Oral use

France

Sodephar

176, rue de l'Arbrisseau

59000 Lille

France

Dextropropoxyphene Paracetamol Sodephar

30 mg/400 mg

Capsule, hard

Oral use

France

Actavis France

Centre d'Affaires la Boursidière

92357 le Plessis-Robinson

France

Dextropropoxyphene Paracetamol Actavis

30 mg/400 mg

Capsule, hard

Oral use

France

Actavis France

Centre d'Affaires la Boursidière

92357 le Plessis-Robinson

France

Dexap

30 mg/400 mg

Capsule, hard

Oral use

France

Sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris

France

Dialgirex

30 mg/400 mg

Capsule, hard

Oral use

France

Sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris

France

Dextropropoxyphene/Paracetamol Theraplix

30 mg/400 mg

Capsule, hard

Oral use

France

Zydus France

25, rue des Peupliers

ZAC Les Hautes Pâtures

Parc d'Activités des Peupliers

92000 Nanterre

France

Dextropropoxyphene Paracetamol Zydus

30 mg/400 mg

Capsule, hard

Oral use

France

Alter

3, avenue de la Baltique

91140 Villebon Sur Yvette

France

Dextropropoxyphene/Paracetamol/Cafeine Alter

27 mg/400 mg/30 mg

Tablet

Oral use

France

Arrow Generiques

26, avenue Tony Garnier

69007 Lyon

France

Dextropropoxyphene/Paracetamol/Cafeine Almus

27 mg/400 mg/30 mg

Tablet

Oral use

France

Arrow Generiques

26, avenue Tony Garnier

69007 Lyon

France

Dextropropoxyphene/Paracetamol/Cafeine Arrow

27 mg/400 mg/30 mg

Tablet

Oral use

France

Arrow Generiques

26, avenue Tony Garnier

69007 Lyon

France

Dextropropoxyphene/Paracetamol/Cafeine Offilink

27 mg/400 mg/30 mg

Tablet

Oral use

France

Plus Pharmacie

26, boulevard Paul Vaillant-Couturier

94200 Ivry-sur-Seine

France

Dextropropoxyphene / Paracetamol / Cafeine Isomed

27 mg/400 mg/30 mg

Tablet

Oral use

France

Biogaran

15, boulevard Charles de Gaulle

92700 Colombes

France

Dextropropoxyphene/Paracetamol/Cafeine Biogaran

27 mg/400 mg/30 mg

Tablet

Oral use

France

Eg Labo - Laboratoires EUROGENERICS

‘Le Quintet’ - bâtiment A

92517 Boulogne Billancourt Cedex

France

Dextropropoxyphene/Paracetamol/Cafeine Eg

27 mg/400 mg/30 mg

Tablet

Oral use

France

Ranbaxy Pharmacie Generiques

1115 Quai de Dion Bouton

Immeuble Avant Seine

92816 Puteaux Cédex

France

Dextropropoxyphene/Paracetamol/Cafeine Rpg

27 mg/400 mg/30 mg

Tablet

Oral use

France

Mylan SAS

117 Allée des Parcs

69800 Saint Priest

France

Dextropropoxyphene/Paracetamol/Cafeine Mylan

27 mg/400 mg/30 mg

Tablet

Oral use

France

Mylan SAS

117 Allée des Parcs

69800 Saint Priest

France

Dextropropoxyphene/Paracetamol/Cafeine Mylan Pharma

27 mg/400 mg/30 mg

Tablet

Oral use

France

Qualimed (Lyon)

117 Allée des Parcs

69800 Saint Priest

France

Dextropropoxyphene/Paracetamol/Cafeine Qualimed

27 mg/400 mg/30 mg

Tablet

Oral use

France

Laboratoire Ratiopharm

19, boulevard Paul Vaillant Couturier

94200 Ivry sur Seine

France

Dextropropoxyphene/Paracetamol/Cafeine Ratiopharm

27 mg/400 mg/30 mg

Tablet

Oral use

France

Sandoz

49, avenue Georges Pompidou

92593 Levallois-Perret

France

Dextropropoxyphene/Paracetamol/Cafeine G Gam

27 mg/400 mg/30 mg

Tablet

Oral use

France

Sandoz

49, avenue Georges Pompidou

92300 Levallois-Perret

France

Dextropropoxyphene/Paracetamol/Cafeine Sandoz

27 mg/400 mg/30 mg

Tablet

Oral use

France

TEVA Santé

Le Palatin 1

1, cours du Triangle

92936 Paris la Défense Cedex

France

Dextropropoxyphene/Paracetamol/Cafeine Teva

27 mg/400 mg/30 mg

Tablet

Oral use

France

Zydus France

25, rue des Peupliers

ZAC Les Hautes Pâtures

Parc d'Activités des Peupliers

92000 Nanterre

France

Dextropropoxyphene/Paracetamol/Cafeine Zydus

27 mg/400 mg/30 mg

Tablet

Oral use

France

Sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris

France

Propofan

27 mg/400 mg/30 mg

Tablet

Oral use

France

Sanofi-aventis France

1-13 Bd Romain Rolland

75014 Paris

France

Dextropropoxyphene/Paracetamol/Cafeine Winthrop

27 mg/400 mg/30 mg

Tablet

Oral use

Luxembourg

S.M.B

26-28 rue de la Pastorale

B–1080 Bruxelles

Belgium

Algophene

30 mg/400 mg

Capsule

Oral use

Malta

Medochemie LTD

MedochemieBuilding

1-10 Constantinoupoleos Str.,

3011 Limassol,

Cyprus

Medonol

32,5 mg/325 mg

Tablet

Oral use

Malta

Phadisco Ltd

185 Giannou Kranidioti Avenue

CY–2235

Latsia

Cyprus

Distalgesic

32,5 mg/325 mg

Tablet

Oral use

Norway

Actavis group hf

Dalshraun 1

220 Hafnafjordur

Iceland

Aporex

70 mg/400 mg

Tablet

Oral use

Portugal

Ferraz Lynce S.A

Rua Consiglieri Pedroso

123 Queluz de Baixo Apartado 1001

2731901 Barcarena

Portugal

Algifene

25 mg/300 mg

Coated tablet

Oral use

| Member State | Marketing Authorisation Holder | Product Name | Strength/dextropropoxyphene/paracetamol/caffeine | Pharmaceutical Form | Route of Administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Pfizer s-a.
  Boulevard de la Plaine 111050 Bruxelles
  Belgium | Depronal | 150 mg | Prolonged-release capsule, hard | Oral use |
| Denmark | Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør
  Denmark | Abalgin | 65 mg | Capsule, hard | Oral use |
| Denmark | Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør
  Denmark | Abalgin | 65 mg | Film-coated tablet | Oral use |
| Denmark | Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør
  Denmark | Abalgin retard | 150 mg | Prolonged-release capsule | Oral use |
| Denmark | NordMedica A/S, Bredgade 41, DK–1260 Copenhagen K
  Denmark | Doloxene | 100 mg | Capsule, hard | Oral use |
| Finland | Alternova A/S, Lodshusvej 11
  4230 Skaelskoer
  Denmark | Abalgin | 65 mg | Capsule, hard | Oral use |
| Finland | Alternova A/S, Lodshusvej 11
  4230 Skaelskoer
  Denmark | Abalgin retard | 150 mg | Prolonged-release capsule, hard | Oral use |
| France | Sanofi Aventis France
  1-13 boulevard Romain Rolland
  75014 Paris
  France | Antalvic adultes | 65mg | Tablet | Oral use |
| Greece | Stargen Ltd
  Favierou 48
  Athens 10439
  Greece | Romidon | 65 mg | Capsule, hard | Oral use |
| Luxembourg | PFIZER s-a.
  Boulevard de la Plaine 11
  1050 Bruxelles
  Belgium | Depronal | 150 mg | Prolonged-release capsule | Oral use |
| Netherlands | Pfizer B.V.
  Rivium Westlaan 142
  2909 LD Capelle a/d Ijssel
  Nederlands | Depronal | 150 mg | Modified release capsule | Oral use |
| Spain | Parke Davis, S.L. Avda. de Europa, 20 B. Parque Empresarial La Moraleja; Alcobendas;
  28108 Madrid
  España | Deprancol a.s. | 150 mg | Prolonged-release capsule, hard | Oral use |
| Sweden | Meda AB, Box 906
  170 09 Solna
  Sweden | Doloxene | 50 mg | Capsule, hard | Oral use |
| Sweden | Meda AB, Box 906
  170 09 Solna
  Sweden | Doloxene | 100 mg | Capsule, hard | Oral use |
| Sweden | BioPhausiaAB, Blasieholmsgatan 2111 48 Stockholm
  Sweden | Dexofen | 50 mg | Tablet | Oral use |
| Sweden | BioPhausiaAB, Blasieholmsgatan 2111 48 Stockholm
  Sweden | Dexofen | 100 mg | Tablet | Oral use |

Member State

Marketing Authorisation Holder

Product Name

Strength/dextropropoxyphene/paracetamol/caffeine

Pharmaceutical Form

Route of Administration

Belgium

Pfizer s-a.

Boulevard de la Plaine 111050 Bruxelles

Belgium

Depronal

150 mg

Prolonged-release capsule, hard

Oral use

Denmark

Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør

Denmark

Abalgin

65 mg

Capsule, hard

Oral use

Denmark

Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør

Denmark

Abalgin

65 mg

Film-coated tablet

Oral use

Denmark

Dansk Lægemiddelforsyning DLF ApS, Lodshusvej 11, DK–4230 Skælskør

Denmark

Abalgin retard

150 mg

Prolonged-release capsule

Oral use

Denmark

NordMedica A/S, Bredgade 41, DK–1260 Copenhagen K

Denmark

Doloxene

100 mg

Capsule, hard

Oral use

Finland

Alternova A/S, Lodshusvej 11

4230 Skaelskoer

Denmark

Abalgin

65 mg

Capsule, hard

Oral use

Finland

Alternova A/S, Lodshusvej 11

4230 Skaelskoer

Denmark

Abalgin retard

150 mg

Prolonged-release capsule, hard

Oral use

France

Sanofi Aventis France

1-13 boulevard Romain Rolland

75014 Paris

France

Antalvic adultes

65mg

Tablet

Oral use

Greece

Stargen Ltd

Favierou 48

Athens 10439

Greece

Romidon

65 mg

Capsule, hard

Oral use

Luxembourg

PFIZER s-a.

Boulevard de la Plaine 11

1050 Bruxelles

Belgium

Depronal

150 mg

Prolonged-release capsule

Oral use

Netherlands

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

Nederlands

Depronal

150 mg

Modified release capsule

Oral use

Spain

Parke Davis, S.L. Avda. de Europa, 20 B. Parque Empresarial La Moraleja; Alcobendas;

28108 Madrid

España

Deprancol a.s.

150 mg

Prolonged-release capsule, hard

Oral use

Sweden

Meda AB, Box 906

170 09 Solna

Sweden

Doloxene

50 mg

Capsule, hard

Oral use

Sweden

Meda AB, Box 906

170 09 Solna

Sweden

Doloxene

100 mg

Capsule, hard

Oral use

Sweden

BioPhausiaAB, Blasieholmsgatan 2111 48 Stockholm

Sweden

Dexofen

50 mg

Tablet

Oral use

Sweden

BioPhausiaAB, Blasieholmsgatan 2111 48 Stockholm

Sweden

Dexofen

100 mg

Tablet

Oral use

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ANNEX XIX

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EEA)

| Member State (EEA) | Marketing Authorisation Holder | Invented Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| CY - Cyprus | Les Laboratoires Servier
  22, rue Garnier
  F- 92200 Neuilly-sur-Seine
  France | Lipophoral Tablets 150mg | 150 mg | tablet | oral |
| FR - France | Les laboratoires Servier
  22 rue Garnier
  F-92200 Neuilly-sur-Seine
  France | Mediator | 150 mg | tablet | oral |
| FR - France | Mylan SAS
  117 allée des Parcs
  69800 Saint-Priest
  France | Benfluorex Mylan | 150 mg | tablet | oral |
| FR - France | Qualimed
  117 allée des Parcs
  69800 Saint-Priest
  France | Benfluorex Qualimed | 150 mg | tablet | oral |
| LU - Luxembourg | Les Laboratoires Servier
  22, rue Garnier
  F- 92200 Neuilly-sur-Seine
  France | Mediator | 150 mg | tablet | oral |
| PT - Portugal | Servier Portugal - Especialidades Farmacêuticas, Lda.
  Av. António Augusto de Aguiar 128, 1069-133 Lisboa
  Portugal | Mediator | 150 mg | coated tablet | oral |

Member State (EEA)

Marketing Authorisation Holder

Invented Name

Strength

Pharmaceutical Form

Route of administration

CY - Cyprus

Les Laboratoires Servier

22, rue Garnier

F- 92200 Neuilly-sur-Seine

France

Lipophoral Tablets 150mg

150 mg

tablet

oral

FR - France

Les laboratoires Servier

22 rue Garnier

F-92200 Neuilly-sur-Seine

France

Mediator

150 mg

tablet

oral

FR - France

Mylan SAS

117 allée des Parcs

69800 Saint-Priest

France

Benfluorex Mylan

150 mg

tablet

oral

FR - France

Qualimed

117 allée des Parcs

69800 Saint-Priest

France

Benfluorex Qualimed

150 mg

tablet

oral

LU - Luxembourg

Les Laboratoires Servier

22, rue Garnier

F- 92200 Neuilly-sur-Seine

France

Mediator

150 mg

tablet

oral

PT - Portugal

Servier Portugal - Especialidades Farmacêuticas, Lda.

Av. António Augusto de Aguiar 128, 1069-133 Lisboa

Portugal

Mediator

150 mg

coated tablet

oral

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