# Official Journal C 288/2009

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2009.288.eng |
| --- | --- |
| Official Journal
  of the European Union | C 288 |
| | |
| English edition | Information and Notices | Volume 5227 November 2009 |

ISSN 1725-2423

doi:10.3000/17252423.C_2009.288.eng

Official Journal

of the European Union

C 288

English edition

Information and Notices

Volume 5227 November 2009

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES |
| | Commission |
| 2009/C 288/01 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 1 |
| 2009/C 288/02 | Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  ) | 11 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

2009/C 288/01

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 2009(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  )

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

)

1

2009/C 288/02

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 2009(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council

or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council

)

11

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS AND BODIES

Commission

| 27.11.2009 | EN | Official Journal of the European Union | C 288/1 |
| --- | --- | --- | --- |

27.11.2009

EN

Official Journal of the European Union

C 288/1

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 2009

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

2009/C 288/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.10.2009 | Onglyza | Saxagliptin | Bristol Myers Squibb/AstraZeneca EEIG, Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/09/545/001-010 | Film-coated tablet | A10BH03 | 5.10.2009 |
| 1.10.2009 | Cimzia | certolizumab pegol | UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | EU/1/09/544/001-002 | Solution for injection | L04AB05 | 6.10.2009 |
| 1.10.2009 | Simponi | golimumab | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546/001-004 | Solution for injection in pre-filled pen | L04AB06 | 6.10.2009 |
| 5.10.2009 | ChondroCelect | Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins | TiGenix NV, Romeinse straat 12/2, B-3001 Leuven, België | EU/1/09/563/001 | Implantation suspension | Non applicable | 7.10.2009 |
| 14.10.2009 | Enyglid | Repaglinide | KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/580/001-018 | Tablet | A10B X02 | 16.10.2009 |
| 15.10.2009 | Resolor | prucalopride | Movetis NV, Veedijk 58, B-2300 Turnhout, België | EU/1/09/581/001-002 | Film-coated tablets | A03AE04 | 19.10.2009 |
| 15.10.2009 | Imprida HCT | amlodipine besylate / valsartan / hydrochlorothiazide | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/570/001-060 | Film-coated tablet | C09DX01 | 19.10.2009 |
| 16.10.2009 | Clopidogrel MYLAN Pharma | Clopidogrel | Mylan S.A.S, 117 allee des Parcs, 69800 Saint Priest, France | EU/1/09/568/001-018 | Film-coated tablet | B01AC-04 | 20.10.2009 |
| 16.10.2009 | PANDEMIC INFLUENZA VACCINE H5N1 BAXTER | Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated) | Baxter AG, Industriestraße 67, A - 1221 Wien, Österreich | EU/1/09/571/001 | Suspension for injection | J07BB01 | 20.10.2009 |
| 16.10.2009 | Exforge HCT | amlodipine besylate / valsartan / hydrochlorothiazide | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/569/001-060 | Film-coated tablet | C09DX01 | 20.10.2009 |
| 16.10.2009 | ALENDRONATE SODIUM AND COLECALCIFEROL, MSD | alendronic acid / colecalciferol | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572/001-009 | Tablet | M05BB03 | 20.10.2009 |
| 19.10.2009 | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14 | GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/578/001 | Suspension and Emulsion for emulsion for injection | J07BB02 | 21.10.2009 |
| 19.10.2009 | Foclivia | A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen | Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina, 1 - Siena, Italia | EU/1/09/577/001-004 | Suspension for injection | J07BB02 | 21.10.2009 |
| 23.10.2009 | Lamivudine Teva | Lamivudine | Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/566/001-005 | Film-coated tablet | J05AF05 | 27.10.2009 |
| 23.10.2009 | Biopoin | epoetin theta | CT Arzneimittel GmbH, Lengeder Straße 42a, D-13407 Berlin, Deutschland | EU/1/09/565/001-028 | Solution for injection | B03XA01 | 27.10.2009 |
| 23.10.2009 | ARCALYST | Rilonacept | Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom | EU/1/09/582/001 | Powder and solvent for solution for injection | L04AC04 | 27.10.2009 |
| 23.10.2009 | ILARIS | Canakinumab | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/564/001-002 | Powder for solution for injection | L04AC08 | 27.10.2009 |
| 29.10.2009 | Eporatio | epoetin theta | ratiopharm GmbH, Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573/001-028 | Solution for injection | B03XA01 | 2.11.2009 |
| 30.10.2009 | Irbesartan Teva | Irbesartan | Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/576/001-039 | Film-coated tablet | C09C A04 | 4.11.2009 |

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

1.10.2009

Onglyza

Saxagliptin

Bristol Myers Squibb/AstraZeneca EEIG, Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/09/545/001-010

Film-coated tablet

A10BH03

5.10.2009

1.10.2009

Cimzia

certolizumab pegol

UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

EU/1/09/544/001-002

Solution for injection

L04AB05

6.10.2009

1.10.2009

Simponi

golimumab

Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546/001-004

Solution for injection in pre-filled pen

L04AB06

6.10.2009

5.10.2009

ChondroCelect

Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins

TiGenix NV, Romeinse straat 12/2, B-3001 Leuven, België

EU/1/09/563/001

Implantation suspension

Non applicable

7.10.2009

14.10.2009

Enyglid

Repaglinide

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/580/001-018

Tablet

A10B X02

16.10.2009

15.10.2009

Resolor

prucalopride

Movetis NV, Veedijk 58, B-2300 Turnhout, België

EU/1/09/581/001-002

Film-coated tablets

A03AE04

19.10.2009

15.10.2009

Imprida HCT

amlodipine besylate / valsartan / hydrochlorothiazide

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/570/001-060

Film-coated tablet

C09DX01

19.10.2009

16.10.2009

Clopidogrel MYLAN Pharma

Clopidogrel

Mylan S.A.S, 117 allee des Parcs, 69800 Saint Priest, France

EU/1/09/568/001-018

Film-coated tablet

B01AC-04

20.10.2009

16.10.2009

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated)

Baxter AG, Industriestraße 67, A - 1221 Wien, Österreich

EU/1/09/571/001

Suspension for injection

J07BB01

20.10.2009

16.10.2009

Exforge HCT

amlodipine besylate / valsartan / hydrochlorothiazide

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/569/001-060

Film-coated tablet

C09DX01

20.10.2009

16.10.2009

ALENDRONATE SODIUM AND COLECALCIFEROL, MSD

alendronic acid / colecalciferol

Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/09/572/001-009

Tablet

M05BB03

20.10.2009

19.10.2009

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14

GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/578/001

Suspension and Emulsion for emulsion for injection

J07BB02

21.10.2009

19.10.2009

Foclivia

A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen

Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina, 1 - Siena, Italia

EU/1/09/577/001-004

Suspension for injection

J07BB02

21.10.2009

23.10.2009

Lamivudine Teva

Lamivudine

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/566/001-005

Film-coated tablet

J05AF05

27.10.2009

23.10.2009

Biopoin

epoetin theta

CT Arzneimittel GmbH, Lengeder Straße 42a, D-13407 Berlin, Deutschland

EU/1/09/565/001-028

Solution for injection

B03XA01

27.10.2009

23.10.2009

ARCALYST

Rilonacept

Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom

EU/1/09/582/001

Powder and solvent for solution for injection

L04AC04

27.10.2009

23.10.2009

ILARIS

Canakinumab

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/564/001-002

Powder for solution for injection

L04AC08

27.10.2009

29.10.2009

Eporatio

epoetin theta

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

EU/1/09/573/001-028

Solution for injection

B03XA01

2.11.2009

30.10.2009

Irbesartan Teva

Irbesartan

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/576/001-039

Film-coated tablet

C09C A04

4.11.2009

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- |
| 1.10.2009 | Epoetin alfa Hexal | Hexal AG., Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411/021-026 | 5.10.2009 |
| 1.10.2009 | Mixtard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/231/001-037 | 5.10.2009 |
| 1.10.2009 | Protaphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/234/001-017 | 5.10.2009 |
| 1.10.2009 | Insulatard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/233/001-017 | 5.10.2009 |
| 1.10.2009 | Actrapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/230/001-017 | 5.10.2009 |
| 1.10.2009 | Actraphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/229/001-037 | 6.10.2009 |
| 1.10.2009 | Binocrit | Sandoz GmbH, Biochemiestrasse 10, Kundl 6250, Österreich | EU/1/07/410/021-026 | 5.10.2009 |
| 2.10.2009 | Tasmar | Meda AB, Pipers väg 2A, Solna 170 09, Sverige | EU/1/97/044/001-008 | 6.10.2009 |
| 6.10.2009 | CELVAPAN | Baxter AG, Industriestraße 67, 1221 Wien, Österreich | EU/1/08/506/001 | 8.10.2009 |
| 7.10.2009 | Agenerase | Glaxo Group Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/00/148/001-004 | 9.10.2009 |
| 7.10.2009 | IntronA | Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/99/127/031-039 | 9.10.2009 |
| 8.10.2009 | Mirapexin | Boehringer Ingelheim International GmbH, Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/97/051/013-027 | 12.10.2009 |
| 8.10.2009 | Sifrol | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050/013-027 | 12.10.2009 |
| 8.10.2009 | Nplate | Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland | EU/1/08/497/001-004 | 12.10.2009 |
| 8.10.2009 | Circadin | RAD Neurim Pharmaceuticals EEC Limited, One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | EU/1/07/392/001-002 | 12.10.2009 |
| 13.10.2009 | NovoMix | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/142/004-005
  EU/1/00/142/009-022 | 15.10.2009 |
| 13.10.2009 | Olanzapine Neopharma | Neopharma Limited, 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom | EU/1/07/426/001-011 | 15.10.2009 |
| 13.10.2009 | CellCept | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005/001-006 | 15.10.2009 |
| 13.10.2009 | Kinzalkomb | Bayer Schering Pharma AG, D-13342 Berlin, Deutschland | EU/1/02/214/001-015 | 15.10.2009 |
| 14.10.2009 | alli | Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/401/001-006 | 16.10.2009 |
| 14.10.2009 | Onsenal | Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/03/259/001-006 | 16.10.2009 |
| 14.10.2009 | PritorPlus | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/02/215/001-021 | 16.10.2009 |
| 14.10.2009 | Ammonaps | Swedish Orphan International AB, Drottninggatan 98, 111 60 Stockholm, Sverige | EU/1/99/120/001-004 | 19.10.2009 |
| 15.10.2009 | Nexavar | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/06/342/001 | 19.10.2009 |
| 16.10.2009 | Helixate NexGen | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/00/144/001-004 | 20.10.2009 |
| 16.10.2009 | Aptivus | Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland | EU/1/05/315/001-002 | 20.10.2009 |
| 16.10.2009 | KOGENATE Bayer | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/00/143/001-011 | 20.10.2009 |
| 19.10.2009 | Thalidomide Celgene | Celgene Europe Limited, Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | EU/1/08/443/001 | 21.10.2009 |
| 19.10.2009 | Ribavirin Teva Pharma BV | Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/527/001-016 | 21.10.2009 |
| 19.10.2009 | Revlimid | Celgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom | EU/1/07/391/001-004 | 21.10.2009 |
| 19.10.2009 | Prepandrix | GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, Rixensart, 1330 Belgique | EU/1/08/453/002 | 21.10.2009 |
| 19.10.2009 | Wilzin | Orphan Europe S.a.r.l., Immeuble Le Wilson, 70 Avenue du Général de Gaulle, 92800 Puteaux, France | EU/1/04/286/001-002 | 21.10.2009 |
| 19.10.2009 | Olanzapine Teva | Teva Pharma B.V., Computerweg 10, DR Utrecht 3542,Nederland | EU/1/07/427/001-057 | 21.10.2009 |
| 20.10.2009 | Vidaza | Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom | EU/1/08/488/001 | 22.10.2009 |
| 21.10.2009 | Xarelto | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/08/472/001-008 | 23.10.2009 |
| 21.10.2009 | Metalyse | Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland | EU/1/00/169/004-006 | 23.10.2009 |
| 21.10.2009 | Filgrastim Hexal | HEXAL AG, Industriestrasse 25, 83607 Holzkirchen, Deutschland | EU/1/08/496/001-008 | 26.10.2009 |
| 21.10.2009 | Zarzio | Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/08/495/001-008 | 23.10.2009 |
| 23.10.2009 | Rebif | Merck Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063/001-010 | 27.10.2009 |
| 23.10.2009 | Prezista | Janssen-Cilag International NV, Turnhoutseweg, 30 - 2340 Beerse – België | EU/1/06/380/001-005 | 27.10.2009 |
| 23.10.2009 | Olanzapine Mylan | Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/08/475/001-034 | 27.10.2009 |
| 23.10.2009 | Norvir | Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/96/016/001
  EU/1/96/016/003-004 | 27.10.2009 |
| 23.10.2009 | PEGASYS | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/221/001-010 | 27.10.2009 |
| 23.10.2009 | Invanz | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216/001-002 | 27.10.2009 |
| 23.10.2009 | Procoralan | Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/05/316/001-014 | 27.10.2009 |
| 23.10.2009 | Teslascan | GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 Oslo, Norway | EU/1/97/040/001-002 | 27.10.2009 |
| 23.10.2009 | Vistide | Gilead Sciences International Limited, Cambridge, CB21 6GT, United Kingdom | EU/1/97/037/001 | 27.10.2009 |
| 23.10.2009 | RotaTeq | Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, Lyon 69007, France | EU/1/06/348/001-002 | 27.10.2009 |
| 23.10.2009 | Tamiflu | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222/001-004 | 27.10.2009 |
| 23.10.2009 | Corlentor | Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/05/317/001-014 | 27.10.2009 |
| 23.10.2009 | Neulasta | Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland | EU/1/02/227/001-004 | 27.10.2009 |
| 23.10.2009 | Ellaone | Laboratoire HRA Pharma, 15, rue Béranger, 75003 Paris, France | EU/1/09/522/001 | 27.10.2009 |
| 28.10.2009 | Xelevia | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382/001-018 | 30.10.2009 |
| 28.10.2009 | TESAVEL | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435/001-018 | 30.10.2009 |
| 28.10.2009 | Pradaxa | Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/08/442/001-008 | 2.11.2009 |
| 28.10.2009 | Aranesp | Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland | EU/1/01/185/001-022
  EU/1/01/185/031-099 | 30.10.2009 |
| 28.10.2009 | Zerit | Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/96/009/001-009 | 30.10.2009 |
| 28.10.2009 | Arava | Sanofi-Aventis Deutschland GmbH, 65926 Frankfurt am Main, Deutschland | EU/1/99/118/001-010 | 30.10.2009 |
| 28.10.2009 | Yondelis | Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), España | EU/1/07/417/001-002 | 30.10.2009 |
| 28.10.2009 | Myozyme | Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/06/333/001-003 | 2.11.2009 |
| 28.10.2009 | SUTENT | Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/06/347/001-008 | 30.10.2009 |
| 28.10.2009 | Integrilin | Glaxo Group Ltd, Greenford, Middlesex, UB6 ONN, United Kingdom | EU/1/99/109/001-002 | 30.10.2009 |
| 28.10.2009 | BeneFIX | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-007 | 30.10.2009 |
| 28.10.2009 | RoActemra | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492/001-006 | 30.10.2009 |
| 28.10.2009 | Beromun | Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland | EU/1/99/097/001 | 2.11.2009 |
| 28.10.2009 | Epivir | Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/96/015/001-005 | 30.10.2009 |
| 28.10.2009 | IXIARO | Intercell AG, Campus Vienna Biocenter 3 A-1030 Wien, Österreich | EU/1/08/501/001-002 | 30.10.2009 |
| 28.10.2009 | Efficib | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457/001-016 | 30.10.2009 |
| 28.10.2009 | Janumet | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455/001-016 | 30.10.2009 |
| 28.10.2009 | Noxafil | SP Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/05/320/001 | 30.10.2009 |
| 28.10.2009 | Velcade | Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274/001-002 | 30.10.2009 |
| 28.10.2009 | Zostavax | Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, 69007 Lyon, France | EU/1/06/341/001-013 | 30.10.2009 |
| 28.10.2009 | Velmetia | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456/001-016 | 30.10.2009 |
| 29.10.2009 | Sebivo | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/388/001-003 | 2.11.2009 |
| 29.10.2009 | ADROVANCE | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/364/001-009 | 2.11.2009 |
| 29.10.2009 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-005 | 2.11.2009 |
| 29.10.2009 | INOmax | INO Therapeutics AB, SE-181 81 Lidingö, Sverige | EU/1/01/194/001-002 | 3.11.2009 |
| 30.10.2009 | Xagrid | Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295/001 | 4.11.2009 |
| 30.10.2009 | Zalasta | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/07/415/001-056 | 4.11.2009 |
| 30.10.2009 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Deutschland | EU/1/06/368/001-168 | 4.11.2009 |

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

1.10.2009

Epoetin alfa Hexal

Hexal AG., Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411/021-026

5.10.2009

1.10.2009

Mixtard

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/231/001-037

5.10.2009

1.10.2009

Protaphane

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234/001-017

5.10.2009

1.10.2009

Insulatard

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233/001-017

5.10.2009

1.10.2009

Actrapid

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/230/001-017

5.10.2009

1.10.2009

Actraphane

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/229/001-037

6.10.2009

1.10.2009

Binocrit

Sandoz GmbH, Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/07/410/021-026

5.10.2009

2.10.2009

Tasmar

Meda AB, Pipers väg 2A, Solna 170 09, Sverige

EU/1/97/044/001-008

6.10.2009

6.10.2009

CELVAPAN

Baxter AG, Industriestraße 67, 1221 Wien, Österreich

EU/1/08/506/001

8.10.2009

7.10.2009

Agenerase

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

EU/1/00/148/001-004

9.10.2009

7.10.2009

IntronA

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

EU/1/99/127/031-039

9.10.2009

8.10.2009

Mirapexin

Boehringer Ingelheim International GmbH, Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051/013-027

12.10.2009

8.10.2009

Sifrol

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/050/013-027

12.10.2009

8.10.2009

Nplate

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497/001-004

12.10.2009

8.10.2009

Circadin

RAD Neurim Pharmaceuticals EEC Limited, One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom

EU/1/07/392/001-002

12.10.2009

13.10.2009

NovoMix

Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/142/004-005

EU/1/00/142/009-022

15.10.2009

13.10.2009

Olanzapine Neopharma

Neopharma Limited, 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom

EU/1/07/426/001-011

15.10.2009

13.10.2009

CellCept

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/005/001-006

15.10.2009

13.10.2009

Kinzalkomb

Bayer Schering Pharma AG, D-13342 Berlin, Deutschland

EU/1/02/214/001-015

15.10.2009

14.10.2009

alli

Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/401/001-006

16.10.2009

14.10.2009

Onsenal

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

EU/1/03/259/001-006

16.10.2009

14.10.2009

PritorPlus

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/02/215/001-021

16.10.2009

14.10.2009

Ammonaps

Swedish Orphan International AB, Drottninggatan 98, 111 60 Stockholm, Sverige

EU/1/99/120/001-004

19.10.2009

15.10.2009

Nexavar

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/06/342/001

19.10.2009

16.10.2009

Helixate NexGen

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/00/144/001-004

20.10.2009

16.10.2009

Aptivus

Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland

EU/1/05/315/001-002

20.10.2009

16.10.2009

KOGENATE Bayer

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/00/143/001-011

20.10.2009

19.10.2009

Thalidomide Celgene

Celgene Europe Limited, Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom

EU/1/08/443/001

21.10.2009

19.10.2009

Ribavirin Teva Pharma BV

Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/527/001-016

21.10.2009

19.10.2009

Revlimid

Celgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom

EU/1/07/391/001-004

21.10.2009

19.10.2009

Prepandrix

GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, Rixensart, 1330 Belgique

EU/1/08/453/002

21.10.2009

19.10.2009

Wilzin

Orphan Europe S.a.r.l., Immeuble Le Wilson, 70 Avenue du Général de Gaulle, 92800 Puteaux, France

EU/1/04/286/001-002

21.10.2009

19.10.2009

Olanzapine Teva

Teva Pharma B.V., Computerweg 10, DR Utrecht 3542,Nederland

EU/1/07/427/001-057

21.10.2009

20.10.2009

Vidaza

Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom

EU/1/08/488/001

22.10.2009

21.10.2009

Xarelto

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/08/472/001-008

23.10.2009

21.10.2009

Metalyse

Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland

EU/1/00/169/004-006

23.10.2009

21.10.2009

Filgrastim Hexal

HEXAL AG, Industriestrasse 25, 83607 Holzkirchen, Deutschland

EU/1/08/496/001-008

26.10.2009

21.10.2009

Zarzio

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/08/495/001-008

23.10.2009

23.10.2009

Rebif

Merck Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/98/063/001-010

27.10.2009

23.10.2009

Prezista

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

EU/1/06/380/001-005

27.10.2009

23.10.2009

Olanzapine Mylan

Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/08/475/001-034

27.10.2009

23.10.2009

Norvir

Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

27.10.2009

23.10.2009

PEGASYS

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/221/001-010

27.10.2009

23.10.2009

Invanz

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/02/216/001-002

27.10.2009

23.10.2009

Procoralan

Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/316/001-014

27.10.2009

23.10.2009

Teslascan

GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 Oslo, Norway

EU/1/97/040/001-002

27.10.2009

23.10.2009

Vistide

Gilead Sciences International Limited, Cambridge, CB21 6GT, United Kingdom

EU/1/97/037/001

27.10.2009

23.10.2009

RotaTeq

Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

27.10.2009

23.10.2009

Tamiflu

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/222/001-004

27.10.2009

23.10.2009

Corlentor

Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/317/001-014

27.10.2009

23.10.2009

Neulasta

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227/001-004

27.10.2009

23.10.2009

Ellaone

Laboratoire HRA Pharma, 15, rue Béranger, 75003 Paris, France

EU/1/09/522/001

27.10.2009

28.10.2009

Xelevia

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/382/001-018

30.10.2009

28.10.2009

TESAVEL

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/435/001-018

30.10.2009

28.10.2009

Pradaxa

Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/08/442/001-008

2.11.2009

28.10.2009

Aranesp

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland

EU/1/01/185/001-022

EU/1/01/185/031-099

30.10.2009

28.10.2009

Zerit

Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/96/009/001-009

30.10.2009

28.10.2009

Arava

Sanofi-Aventis Deutschland GmbH, 65926 Frankfurt am Main, Deutschland

EU/1/99/118/001-010

30.10.2009

28.10.2009

Yondelis

Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), España

EU/1/07/417/001-002

30.10.2009

28.10.2009

Myozyme

Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/06/333/001-003

2.11.2009

28.10.2009

SUTENT

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

EU/1/06/347/001-008

30.10.2009

28.10.2009

Integrilin

Glaxo Group Ltd, Greenford, Middlesex, UB6 ONN, United Kingdom

EU/1/99/109/001-002

30.10.2009

28.10.2009

BeneFIX

Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-007

30.10.2009

28.10.2009

RoActemra

Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/08/492/001-006

30.10.2009

28.10.2009

Beromun

Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland

EU/1/99/097/001

2.11.2009

28.10.2009

Epivir

Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/96/015/001-005

30.10.2009

28.10.2009

IXIARO

Intercell AG, Campus Vienna Biocenter 3 A-1030 Wien, Österreich

EU/1/08/501/001-002

30.10.2009

28.10.2009

Efficib

Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457/001-016

30.10.2009

28.10.2009

Janumet

Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455/001-016

30.10.2009

28.10.2009

Noxafil

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

EU/1/05/320/001

30.10.2009

28.10.2009

Velcade

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

EU/1/04/274/001-002

30.10.2009

28.10.2009

Zostavax

Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/341/001-013

30.10.2009

28.10.2009

Velmetia

Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456/001-016

30.10.2009

29.10.2009

Sebivo

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/388/001-003

2.11.2009

29.10.2009

ADROVANCE

Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/364/001-009

2.11.2009

29.10.2009

Remicade

Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

2.11.2009

29.10.2009

INOmax

INO Therapeutics AB, SE-181 81 Lidingö, Sverige

EU/1/01/194/001-002

3.11.2009

30.10.2009

Xagrid

Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295/001

4.11.2009

30.10.2009

Zalasta

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/07/415/001-056

4.11.2009

30.10.2009

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Deutschland

EU/1/06/368/001-168

4.11.2009

—   Lift of suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004)

| 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 |
| --- | --- | --- | --- | --- |
| 8.10.2009 | Optison | GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 Oslo, Norway | EU/1/98/065/001-002 | 12.10.2009 |

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

8.10.2009

Optison

GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 Oslo, Norway

EU/1/98/065/001-002

12.10.2009

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
| --- | --- | --- | --- | --- |
| 1.10.2009 | Oxyglobin | Biopure Netherlands B.V., Parnassustoren, Locatellikade 1, 1076 AZ Amsterdam, Nederland | EU/2/99/015/001-002 | 5.10.2009 |
| 1.10.2009 | Stronghold | Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/99/014/001-012 | 5.10.2009 |
| 6.10.2009 | Nobilis Influenza H5N2 | Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/06/061/001-004 | 8.10.2009 |
| 8.10.2009 | Naxcel | Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/05/053/003 | 12.10.2009 |
| 8.10.2009 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited, Loughrea, Co. Galway, IRELAND | EU/2/07/078/005-008 | 12.10.2009 |
| 8.10.2009 | Meloxidyl | CEVA SANTE ANIMALE, Z.I. la Ballastière, 33500 Libourne, France | EU/2/06/070/004 | 12.10.2009 |
| 21.10.2009 | Suprelorin | VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France | EU/2/07/072/001-002 | 23.10.2009 |
| 30.10.2009 | Easotic | VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France | EU/2/08/085/001 | 4.11.2009 |

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

1.10.2009

Oxyglobin

Biopure Netherlands B.V., Parnassustoren, Locatellikade 1, 1076 AZ Amsterdam, Nederland

EU/2/99/015/001-002

5.10.2009

1.10.2009

Stronghold

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

EU/2/99/014/001-012

5.10.2009

6.10.2009

Nobilis Influenza H5N2

Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/06/061/001-004

8.10.2009

8.10.2009

Naxcel

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

EU/2/05/053/003

12.10.2009

8.10.2009

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited, Loughrea, Co. Galway, IRELAND

EU/2/07/078/005-008

12.10.2009

8.10.2009

Meloxidyl

CEVA SANTE ANIMALE, Z.I. la Ballastière, 33500 Libourne, France

EU/2/06/070/004

12.10.2009

21.10.2009

Suprelorin

VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France

EU/2/07/072/001-002

23.10.2009

30.10.2009

Easotic

VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France

EU/2/08/085/001

4.11.2009

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 |
| London E14 4HB |
| UNITED KINGDOM |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

London E14 4HB

UNITED KINGDOM

---

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

---

| 27.11.2009 | EN | Official Journal of the European Union | C 288/11 |
| --- | --- | --- | --- |

27.11.2009

EN

Official Journal of the European Union

C 288/11

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 2009

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC of the European Parliament and of the Council
   (1)
  or Article 38 of Directive 2001/82/EC of the European Parliament and of the Council
   (2)
  )

2009/C 288/02

-   Issuing, maintenance or modification of a national marketing authorisation

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 1.10.2009 | Simponi | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | This Decision is addressed to the Member States | 5.10.2009 |
| 1.10.2009 | Ivermectin | See Annex I | See Annex I | 5.10.2009 |
| 1.10.2009 | Topamax | See Annex II | See Annex II | 5.10.2009 |
| 1.10.2009 | Cimzia | UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | This Decision is addressed to the Member States | 5.10.2009 |
| 2.10.2009 | Avalox | See Annex III | See Annex III | 6.10.2009 |
| 2.10.2009 | Octegra | See Annex IV | See Annex IV | 6.10.2009 |
| 5.10.2009 | ChondroCelect | TiGenix NV, Romeinse straat 12/2, B-3001 Leuven, België | This Decision is addressed to the Member States | 6.10.2009 |
| 6.10.2009 | Fentrix | See Annex V | See Annex V | 7.10.2009 |
| 15.10.2009 | Meronem | See Annex VI | See Annex VI | 19.10.2009 |
| 15.10.2009 | Pulmotil AC | See Annex VII | See Annex VII | 19.10.2009 |
| 15.10.2009 | Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix | See Annex VIII | See Annex VIII | 19.10.2009 |
| 16.10.2009 | Nimesulide | See Annex IX | See Annex IX | 19.10.2009 |
| 19.10.2009 | Augmentin | See Annex X | See Annex X | 21.10.2009 |
| 23.10.2009 | ILARIS | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | This Decision is addressed to the Member States | 26.10.2009 |
| 23.10.2009 | ARCALYST | Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom | This Decision is addressed to the Member States | 26.10.2009 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

1.10.2009

Simponi

Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland

This Decision is addressed to the Member States

5.10.2009

1.10.2009

Ivermectin

See Annex I

See Annex I

5.10.2009

1.10.2009

Topamax

See Annex II

See Annex II

5.10.2009

1.10.2009

Cimzia

UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

This Decision is addressed to the Member States

5.10.2009

2.10.2009

Avalox

See Annex III

See Annex III

6.10.2009

2.10.2009

Octegra

See Annex IV

See Annex IV

6.10.2009

5.10.2009

ChondroCelect

TiGenix NV, Romeinse straat 12/2, B-3001 Leuven, België

This Decision is addressed to the Member States

6.10.2009

6.10.2009

Fentrix

See Annex V

See Annex V

7.10.2009

15.10.2009

Meronem

See Annex VI

See Annex VI

19.10.2009

15.10.2009

Pulmotil AC

See Annex VII

See Annex VII

19.10.2009

15.10.2009

Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix

See Annex VIII

See Annex VIII

19.10.2009

16.10.2009

Nimesulide

See Annex IX

See Annex IX

19.10.2009

19.10.2009

Augmentin

See Annex X

See Annex X

21.10.2009

23.10.2009

ILARIS

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

This Decision is addressed to the Member States

26.10.2009

23.10.2009

ARCALYST

Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom

This Decision is addressed to the Member States

26.10.2009

-   Revocation of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 30.10.2009 | Fentrans | See Annex XI | See Annex XI | 4.11.2009 |
| 30.10.2009 | Matripain | See Annex XII | See Annex XII | 4.11.2009 |
| 30.10.2009 | Matrigesic | See Annex XIII | See Annex XIII | 4.11.2009 |
| 30.10.2009 | Fentador | See Annex XIV | See Annex XIV | 4.11.2009 |
| 30.10.2009 | Fentastad | See Annex XV | See Annex XV | 4.11.2009 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

30.10.2009

Fentrans

See Annex XI

See Annex XI

4.11.2009

30.10.2009

Matripain

See Annex XII

See Annex XII

4.11.2009

30.10.2009

Matrigesic

See Annex XIII

See Annex XIII

4.11.2009

30.10.2009

Fentador

See Annex XIV

See Annex XIV

4.11.2009

30.10.2009

Fentastad

See Annex XV

See Annex XV

4.11.2009

---

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

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

---

ANNEX I

LIST OF THE NAMES, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder and address | Invented name | Strengths | Animal species | Route of administration | Recommended dose |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Chanelle Animal Health Ltd |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Member State

Marketing Authorisation Holder and address

Invented name

Strengths

Animal species

Route of administration

Recommended dose

Austria

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec injection Injektionslöng für Rinder und Schweine

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Austria

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Austria

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Austria

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

Ivertin

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Austria

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 10 mg/ml Injektionssuspension für Rinder, Schafe und Schweine

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Austria

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin – Injektionslösung für Tiere

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Austria

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Austria

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC Injektionslösung Für Tiere: Rinder, Schafe, Schweine

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Austria

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin

Injektionlösung für Rinder

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Belgium

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

BOVIMEC B

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Belgium

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

ECOMECTIN 10 MG/ML

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Belgium

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

IVERTIN CATTLE

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Belgium

| MERIAL Belgium S.A. |
| --- |
| Bld Sylvain Dupuis 243 |
| 1070 Bruxelles |
| Belgium |

MERIAL Belgium S.A.

Bld Sylvain Dupuis 243

1070 Bruxelles

Belgium

IVOMEC F

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Belgium

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Belgium

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC 1 % Solution injectable

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Belgium

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC F solution injectable

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Belgium

| MERIAL Belgium S.A. |
| --- |
| Bld Sylvain Dupuis 243 |
| 1070 Bruxelles |
| Belgium |

MERIAL Belgium S.A.

Bld Sylvain Dupuis 243

1070 Bruxelles

Belgium

Ivomec

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Belgium

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

QUALIMEC 10 MG/ML

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Belgium

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Oplossing voor

Injectie voor rundvee

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Bulgaria

| Intervet International B.V. |
| --- |
| Wim de Korvrstraat 35, |
| 5831 AA, Boxmeer, |
| The Netherlands |

Intervet International B.V.

Wim de Korvrstraat 35,

5831 AA, Boxmeer,

The Netherlands

Ivotan LA

Ivermectin 10 mg/ml

Cattle, Sheep, Goats, Pigs

Subcutaneous

| Cattle, Sheep, Goats: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep, Goats:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Bulgaria

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 % injectable solution

Ivermectin 10 mg/ml

Cattle, Sheep, Goats, Pigs

Subcutaneous

| Cattle, Sheep, Goats: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep, Goats:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Bulgaria

| Alfasan International B.V., |
| --- |
| P.O. Box 78, |
| 3440 AB Woerden, |
| The Netherlands |

Alfasan International B.V.,

P.O. Box 78,

3440 AB Woerden,

The Netherlands

Alfamec 1 %

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Bulgaria

| BIOVET JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Pesthera |
| Bulgaria |

BIOVET JSC

39 Petar Rakov Str.

4550 Pesthera

Bulgaria

Pandex 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Goats, Pigs

Subcutaneous

| Cattle, Sheep, Goats: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep, Goats:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Bulgaria

| Centrovet Ltd. |
| --- |
| Av.Los Cerrilos 602 |
| Santiago, |
| Chile |

Centrovet Ltd.

Av.Los Cerrilos 602

Santiago,

Chile

Microdes Plus

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Bulgaria

| Interchemie werken „de Adelaar” BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| The Netherlands |

Interchemie werken „de Adelaar” BV

Horsterweg 26A

5811 AC Castenray

The Netherlands

Intermectin

Ivermectin 10 mg/ml

Cattle, Sheep, Goats, Pigs

Subcutaneous

| Cattle, Sheep, Goats: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep, Goats:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Bulgaria

| Invesa International S.A. |
| --- |
| Esmeralda 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

Invesa International S.A.

Esmeralda 19

08950 Esplugues de Llobregat

Barcelona

Spain

Promectine

Ivermectin 10 mg/ml

Cattle, pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Bulgaria

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Divamectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Cyprus

| Panchris Feeds Ltd. |
| --- |
| P.O.Box 40261, |
| 6302 Larnaca |
| Cyprus |

Panchris Feeds Ltd.

P.O.Box 40261,

6302 Larnaca

Cyprus

Bimectin Injection

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Cyprus

| Vetagrica Ltd |
| --- |
| 3 Othellou Street, |
| 2540 Dhali Industrial Estate |
| Nicosia |
| Cyprus |

Vetagrica Ltd

3 Othellou Street,

2540 Dhali Industrial Estate

Nicosia

Cyprus

Ivomec Super Injection for Cattle

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Cyprus

| Spyros Stavrinides Chemicals Ltd |
| --- |
| 28 Stasinou Avenue, |
| 1060 Nicosia, |
| Cyprus |

Spyros Stavrinides Chemicals Ltd

28 Stasinou Avenue,

1060 Nicosia,

Cyprus

Noromectin injection

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Czech Republic

| Vétoquinol s.r.o., |
| --- |
| Zámečnícka 411, |
| 288 02 Nymburk, |
| Czech Republic |

Vétoquinol s.r.o.,

Zámečnícka 411,

288 02 Nymburk,

Czech Republic

Biomectin 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Czech Republic

| Bremer Pharma GmbH |
| --- |
| Cherbourger Str. 25 |
| 27540 Bremerhaven |
| Germany |

Bremer Pharma GmbH

Cherbourger Str. 25

27540 Bremerhaven

Germany

Bremamectin

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Czech Republic

| CEVA Animal Health Slovakia, spol. s r.o. |
| --- |
| Račianska 77 |
| 83 102 BRATISLAVA |
| Slovak Republic |

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

Račianska 77

83 102 BRATISLAVA

Slovak Republic

Cevamec 1 % inj. ad us. vet.

Ivermectin 10 mg/ml

Cattle, Sheep, Goats, Pigs

Subcutaneous

| Cattle, Sheep, Goats: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep, Goats:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Czech Republic

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Czech Republic

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 % inj. ad. us. vet.

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Czech Republic

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec Super inj. a.u.v.

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle, sheep

Subcutaneous

200 μg ivermectin/kg bw

Czech Republic

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Inj ad us vet

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Czech Republic

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec inj. ad us. vet.

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Czech Republic

| Bioveta a.s., |
| --- |
| Komenského 212 |
| 683 23 Ivanovice na Hané |
| Czech Republic |

Bioveta a.s.,

Komenského 212

683 23 Ivanovice na Hané

Czech Republic

Biomec 10 mg/ml

Injekční roztok

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Czech Republic

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin injekční roztok pro skot

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Denmark

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Vet

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Denmark

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec Vet

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Denmark

| Bimeda (a division of Cross Vetpharm Group Limited) |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda (a division of Cross Vetpharm Group Limited)

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimec Vet

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Denmark

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomec vet.

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Denmark

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Ivermectin »Virbac« Vet., injektionsvæske, opløsning

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Denmark

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Coopermec Vet

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Denmark

| Merial Norden A/S |
| --- |
| Mileparken 20 E |
| 2740 Skovlunde |
| Denmark |

Merial Norden A/S

Mileparken 20 E

2740 Skovlunde

Denmark

Ivomec vet., injektionsvæske 10 mg/ml

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Estonia

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Estonia

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 %

injection, süstelahus

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Estonia

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Estonia

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Multi Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Estonia

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 % injectable solution

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Estonia

| Bremer Pharma GmbH |
| --- |
| Cherbourger Str. 25 |
| 27540 Bremerhaven |
| Germany |

Bremer Pharma GmbH

Cherbourger Str. 25

27540 Bremerhaven

Germany

Bremamectin

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Estonia

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Finland

| Scanvet Eläinlääkkeet Oy |
| --- |
| PL 27 |
| 13721 PAROLA |
| Finland |

Scanvet Eläinlääkkeet Oy

PL 27

13721 PAROLA

Finland

Animec vet

Ivermectin 10 mg/ml

Cattle, Reindeer, Pigs

Subcutaneous

| Cattle, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Finland

| Bimeda (a division of Cross Vetpharm Group Limited) |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda (a division of Cross Vetpharm Group Limited)

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin vet

Ivermectin 10 mg/ml

Cattle, Reindeer, Pigs

Subcutaneous

| Cattle, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Finland

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec

10 mg/ml vet injektioneste, liuos

Ivermectin 10 mg/ml

Cattle, Reindeer, Pigs

Subcutaneous

| Cattle, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Finland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec injection10 mg/ml solution for injection

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Finland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Vet 10mg/ml

Solution for Injection

Ivermectin 10 mg/ml

Cattle, Reindeer, Pigs

Subcutaneous

| Cattle, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Finland

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC VET 10 mg/ml injektioneste, liuos

Ivermectin 10 mg/ml

Cattle, Reindeer, Pigs

Subcutaneous

| Cattle, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

France

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

France

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC D

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

France

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC SOLUTION INJECTABLE POUR BOVINS

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

France

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC D SOLUTION INJECTABLE

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

France

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC Solution Injectable pour Bovins Porçins Ovins

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

France

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

IVERMECTINE ECO 10 MG/ML SOLUTION I NJECTABLE

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

France

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

QUALIMEC 10 MG/ML SOLUTION

INJECTABLE

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

France

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

IVERTIN BOVIN

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

France

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

CEVAMEC BOVINS OVINS SOLUTION INJECTABLE

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

France

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Magamectine iInjectable, solution injectable

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

France

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Medimec Injectable, Solution Injectable

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

France

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 % Solution Injectable Bovine, Porcins

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

France

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectine Solution Injectable pour bovins

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

France

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Divamectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Germany

| MERIAL GmbH |
| --- |
| Am Söldnermoos 6 |
| D-85399 Hallbergmoos |
| Germany |

MERIAL GmbH

Am Söldnermoos 6

D-85399 Hallbergmoos

Germany

Ivomec

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Germany

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chanectin Injektion

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Germany

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

Diapec R

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Germany

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

Wedemec R

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Germany

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Sumex Injektion für Rinder

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Germany

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 % Injektion

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Germany

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec

Inektionslösung

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Greece

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 %

1 % Evέσiμo Δiάλuμa

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Greece

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin 1 %

1 % Evέσiμo Δiάλuμa

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Greece

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Greece

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

ECOMECTIN

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Greece

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Greece

| Chanelle Pharmaceuticals Manufacturing Ltd., |
| --- |
| Loughrea, Co. Galway, |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Animec Inj. Sol.

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Greece

| VETERIN ABEE |
| --- |
| Aspropyrgos Attikis |
| 19300 |
| Greece |

VETERIN ABEE

Aspropyrgos Attikis

19300

Greece

VETERMEC

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Greece

| PNG Gerolymatos S.A. |
| --- |
| 13, Asklipiou |
| 145 68 KRYONERI, ATTICA |
| Greece |

PNG Gerolymatos S.A.

13, Asklipiou

145 68 KRYONERI, ATTICA

Greece

VALANEQ

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Greece

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

MAXIMEC

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Greece

| SCHERING PLOUGH SA |
| --- |
| 65,Ag Dimitriou |
| 17455, Athens |
| Greece |

SCHERING PLOUGH SA

65,Ag Dimitriou

17455, Athens

Greece

TIZOVAL

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Hungary

| Chanelle Pharmaceuticals Manufacturing Ltd., |
| --- |
| Loughrea, Co. Galway, |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Animec Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| Bayer Hungária Ltd. |
| --- |
| H-1123 Budapest |
| Alkotás u. 50. |
| Hungary |

Bayer Hungária Ltd.

H-1123 Budapest

Alkotás u. 50.

Hungary

Baymec Trio 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| Ceva-Phylaxia Oltóanyagtermelő Zrt. |
| --- |
| Szállás u. 5 |
| 1107 Budapest |
| Hungary |

Ceva-Phylaxia Oltóanyagtermelő Zrt.

Szállás u. 5

1107 Budapest

Hungary

Cevamec 1 % injekció A.U.V

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| Divasa Farmavic Hungaria Ltd. |
| --- |
| H-6070 Izsák, Kossuth L. u. 60. |
| Hungary |

Divasa Farmavic Hungaria Ltd.

H-6070 Izsák, Kossuth L. u. 60.

Hungary

ECOMECTIN

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| Bremer Pharma GmbH. |
| --- |
| Werkstrasse 42 |
| 34414 Warburg-Scherfede |
| Germany |

Bremer Pharma GmbH.

Werkstrasse 42

34414 Warburg-Scherfede

Germany

FROMMECTIN

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| Invesa International S.A. |
| --- |
| Esmeralda 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

Invesa International S.A.

Esmeralda 19

08950 Esplugues de Llobregat

Barcelona

Spain

IVERGEN PREMIUM LA

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| Veterina Polska Sp. Zo.o. |
| --- |
| Ul. Mogilska 80, |
| 31546 Krakow |
| Poland |

Veterina Polska Sp. Zo.o.

Ul. Mogilska 80,

31546 Krakow

Poland

Iverktin Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

IVERTIN

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| VMD Animal Health Ltd. |
| --- |
| Közraktár u. 22/b. II. 3., |
| 1093 Budapest |
| Hungary |

VMD Animal Health Ltd.

Közraktár u. 22/b. II. 3.,

1093 Budapest

Hungary

IVERVETo 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec injekció A.U.V.

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec super injekció A.U.V.

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Hungary

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Hungary

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Vetimec 10 mg/ml solution for injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| C-Corp, |
| --- |
| 78 Coombe Road, |
| New Malden, |
| Surrey KT3 4QS, |
| United Kingdom |

C-Corp,

78 Coombe Road,

New Malden,

Surrey KT3 4QS,

United Kingdom

Kilo-mec 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| C-Corp, |
| --- |
| 78 Coombe Road, |
| New Malden, |
| Surrey KT3 4QS, |
| United Kingdom |

C-Corp,

78 Coombe Road,

New Malden,

Surrey KT3 4QS,

United Kingdom

Mastermectin 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| C-Corp, |
| --- |
| 78 Coombe Road, |
| New Malden, |
| Surrey KT3 4QS, |
| United Kingdom |

C-Corp,

78 Coombe Road,

New Malden,

Surrey KT3 4QS,

United Kingdom

Coopermec 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Injectable Solution

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec for Cattle Swine and Sheep 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Super Solution for Injection

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Ireland

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Panomec 1 % Solution for Injection for Cattle, Sheep and Pigs

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Ivomec Classic Injection for Cattle and Sheep

1 % w/v

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Ivomec Super Injection for Cattle

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Ireland

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec 10 mg/ml Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Fatromectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Divamectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chanimec Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec 1 % solution Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chanectin Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Sumex Injection for Cattle, 1 %, Solution for injection for cattle

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Anisec Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Aniject Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chaniject Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Sumiject Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Medimec Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Topimec Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin 1,0 % w/v Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Mectaject 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bovimectin 1 % solution for injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec Injection for Cattle & Sheep

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Trimectin Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bovimec 1 % w/v Solution for Injection for Cattle

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Multi Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Primectin 1 % w/v Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Solution for Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Ireland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Enovex Injection 1 % w/v

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Ireland

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closiver Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Iceland

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec vet.

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Italy

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Baymec 1 % Soluzione

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Italy

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injection

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Italy

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

Ivertin cattle

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Italy

| INTERVET PRODUCTIONS SRL |
| --- |
| Via Nettunense km 20, 300 |
| 04011 Aprilia |
| Italy |

INTERVET PRODUCTIONS SRL

Via Nettunense km 20, 300

04011 Aprilia

Italy

Ivogell

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Italy

| Merial Italia S.p.A. a Socio Unico, |
| --- |
| Via Vittor Pisani, 16 |
| Milano |
| Italy |

Merial Italia S.p.A. a Socio Unico,

Via Vittor Pisani, 16

Milano

Italy

Ivomec

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Italy

| Merial Italia S.p.A. a Socio Unico, |
| --- |
| Via Vittor Pisani, 16 |
| Milano |
| Italy |

Merial Italia S.p.A. a Socio Unico,

Via Vittor Pisani, 16

Milano

Italy

Ivomec Plus

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Italy

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec iniettable

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Italy

| Fatro |
| --- |
| Via Emilia, 285 |
| 40064 Ozzano Emilia (Bologna) |
| Italy |

Fatro

Via Emilia, 285

40064 Ozzano Emilia (Bologna)

Italy

Tolomec

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Italy

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC Soluzione iniettabile

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Italy

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC F soluzione iniettabile

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Italy

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Soluzione iniettabile per bovini

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Italy

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Divamectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Latvia

| Chanelle Pharmaceuticals Manufacturing Ltd., |
| --- |
| Loughrea, Co. Galway, |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Animec Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Latvia

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin

Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Latvia

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Latvia

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Latvia

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 10 mg/ml

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Latvia

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC 1 % Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Latvia

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec Plus

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Latvia

| Pharmaceutical Company |
| --- |
| PFO „VETOS-FARMA” sp. z.o.o., |
| Dzierzoniwska street 21 |
| 58-260 Bielawa |
| Poland |

Pharmaceutical Company

PFO „VETOS-FARMA” sp. z.o.o.,

Dzierzoniwska street 21

58-260 Bielawa

Poland

Iwermektyna 1 % Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Latvia

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Lithuania

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC PLUS, injekcinis tirpalas

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Lithuania

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC 1 %, injekcinis tirpalas

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Lithuania

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %, injekcinis tirpalas

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Lithuania

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 %, injekcinis tirpalas

Ivermectin 10 mg/ml

Cattle, Sheep, Goats, Pigs

Subcutaneous

| Cattle, Sheep, Goats: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep, Goats:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Lithuania

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injekcinis tirpalas

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Lithuania

| Invesa International S.A. |
| --- |
| Esmeralda 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

Invesa International S.A.

Esmeralda 19

08950 Esplugues de Llobregat

Barcelona

Spain

PROMECTINE

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Lithuania

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

BIMECTIN

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Lithuania

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

ECOMECTIN 10 mg/ml

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Luxembourg

| MERIAL Belgium S.A. |
| --- |
| Bld Sylvain Dupuis 243 |
| 1070 Bruxelles |
| Belgium |

MERIAL Belgium S.A.

Bld Sylvain Dupuis 243

1070 Bruxelles

Belgium

Ivomec solution pour injection

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Luxembourg

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 %

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Luxembourg

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 % inj.sol. bovine and porcine

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Luxembourg

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin 1 % solution for injection

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Luxembourg

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec 1 % solution for injection

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Luxembourg

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec solution pour injection bovine

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Malta

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Malta

| Laboratorios HIPRA S.A. |
| --- |
| Avda. La Selva, 135 |
| 17170 Amer, Girona |
| Spain |

Laboratorios HIPRA S.A.

Avda. La Selva, 135

17170 Amer, Girona

Spain

Iveripra-I

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Malta

| Interchemie werken „de Adelaar” BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| The Netherlands |

Interchemie werken „de Adelaar” BV

Horsterweg 26A

5811 AC Castenray

The Netherlands

Intermectin

Ivermectin 10 mg/ml

Cattle, Sheep, Goats, Pigs

Subcutaneous

| Cattle, Sheep, Goats: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep, Goats:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Malta

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Multi Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Malta

| INDUSTRIAL VETERINARIA, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

INDUSTRIAL VETERINARIA, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona

Spain

Promectine

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

The Netherlands

| Merial B.V. |
| --- |
| Kleermakerstraat 10 |
| 1991 JL Velserbroek |
| The Netherlands |

Merial B.V.

Kleermakerstraat 10

1991 JL Velserbroek

The Netherlands

Ivomec

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| Merial B.V. |
| --- |
| Kleermakerstraat 10 |
| 1991 JL Velserbroek |
| The Netherlands |

Merial B.V.

Kleermakerstraat 10

1991 JL Velserbroek

The Netherlands

Ivomec Plus

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

The Netherlands

| Merial B.V. |
| --- |
| Kleermakerstraat 10 |
| 1991 JL Velserbroek |
| The Netherlands |

Merial B.V.

Kleermakerstraat 10

1991 JL Velserbroek

The Netherlands

Panomec Injectievloeistof

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec Injection

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Euromec Injectie

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Injectie

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injectie

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec Injectie

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

Ivertin Cattle

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

The Netherlands

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin Injectie

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec F

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

The Netherlands

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ges-o-mec 10 mg/ml oplossing voor injectie

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec 10 mg/g solution for injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

The Netherlands

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| The Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Iverveto 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Norway

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec vet, injeksjonsvæske, oppløsning 10 mg/ml

Ivermectin 10 mg/ml

Cattle, Sheep, Reindeer, Pigs

Subcutaneous

| Cattle, Sheep, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Norway

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Vet Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Norway

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC VET

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Poland

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Poland

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Poland

| Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A. |
| --- |
| ul. Grójecka 6 |
| 05-651 Drwalew |
| Poland |

Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.

ul. Grójecka 6

05-651 Drwalew

Poland

Ivermina 1 % Inj

Ivermectin 10 mg/ml

Cattle, pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Poland

| Pharmaceutical Company |
| --- |
| PFO „VETOS-FARMA” sp. z.o.o., |
| Dzierzoniwska street 21 |
| 58-260 Bielawa |
| Poland |

Pharmaceutical Company

PFO „VETOS-FARMA” sp. z.o.o.,

Dzierzoniwska street 21

58-260 Bielawa

Poland

Iwermektyna 1 % Iniekcja

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Poland

| Agri- Biovet Sp. z o.o. |
| --- |
| ul. Smocza 27 |
| 01-048 Warsaw |
| Poland |

Agri- Biovet Sp. z o.o.

ul. Smocza 27

01-048 Warsaw

Poland

Pandex 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Poland

| Scan Vet Poland Sp. z o.o. |
| --- |
| Skiereszewo, ul. Kiszkowska 9 |
| 62-200 Gniezno |
| Poland |

Scan Vet Poland Sp. z o.o.

Skiereszewo, ul. Kiszkowska 9

62-200 Gniezno

Poland

Paramectin 1 %

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Poland

| Przedsiębiorstwo Wielobranżowe Vet Agro Sp. z o.o. |
| --- |
| ul. Gliniana 32 |
| 20-616 Lublin |
| Poland |

Przedsiębiorstwo Wielobranżowe Vet Agro Sp. z o.o.

ul. Gliniana 32

20-616 Lublin

Poland

Vetamectin

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Portugal

| Bimeda (a division of Cross Vetpharm Group Limited) |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda (a division of Cross Vetpharm Group Limited)

Broomhill Road

Tallaght

Dublin 24

Ireland

Tizoval Bovinos 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Portugal

| Calier Portugal S.A |
| --- |
| Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro |
| Estrada de Albarraque |
| 2710 - 335 Sintra |
| Portugal |

Calier Portugal S.A

Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro

Estrada de Albarraque

2710 - 335 Sintra

Portugal

Ivertin

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Portugal

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chanectin Injectável

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Portugal

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec Injectável para bovinos e ovinos 1 %

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Portugal

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 % Sol Injectável

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Portugal

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Vectimax 10 mg/Ml Sol. Inj.

Este é

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Portugal

| Merial Portuguesa - Saúde Animal, Lda |
| --- |
| AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas |
| 2635-432 Rio de Mouro |
| Portugal |

Merial Portuguesa - Saúde Animal, Lda

AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas

2635-432 Rio de Mouro

Portugal

Ivomec F

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Portugal

| Merial Portuguesa - Saúde Animal, Lda |
| --- |
| AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas |
| 2635-432 Rio de Mouro |
| Portugal |

Merial Portuguesa - Saúde Animal, Lda

AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas

2635-432 Rio de Mouro

Portugal

Ivomec 1 % Bovinos, Solução Injectável

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Portugal

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Injectável 1 %

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Portugal

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injectável 1 %

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Portugal

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec F, Solução Injectável

1mg/ml

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Portugal

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC, Solução injectavel

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Portugal

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin FF, solução injectável para bovinos

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Romania

| ANTIBIOTICE IASI S.A. |
| --- |
| Str. Valea Lupului, nr. 1, Iași, jud. Iași |
| Romania |

ANTIBIOTICE IASI S.A.

Str. Valea Lupului, nr. 1, Iași, jud. Iași

Romania

Ivermectina 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| BIOWET GORZOW PHARMACEUTICALS |
| --- |
| COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK |
| Poland |

BIOWET GORZOW PHARMACEUTICALS

COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| BIOVET JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Pesthera |
| Bulgaria |

BIOVET JSC

39 Petar Rakov Str.

4550 Pesthera

Bulgaria

Pandex 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| Bioveta a.s., |
| --- |
| Komenského 212 |
| 683 23 Ivanovice na Hané |
| Czech Republic |

Bioveta a.s.,

Komenského 212

683 23 Ivanovice na Hané

Czech Republic

Biomec inj.

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| Bremer Pharma GmbH |
| --- |
| Cherbourger Str. 25 |
| 27540 Bremerhaven |
| Germany |

Bremer Pharma GmbH

Cherbourger Str. 25

27540 Bremerhaven

Germany

Bremamectin

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| CEVA SANTE ANIMALE |
| --- |
| Str. Chindiei, nr. 5 |
| Sector 4 |
| 040185 București |
| Romania |

CEVA SANTE ANIMALE

Str. Chindiei, nr. 5

Sector 4

040185 București

Romania

Cevamec 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD. |
| --- |
| Jordan NA UR 11710 PO BOX 285 |
| Jordania |

DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD.

Jordan NA UR 11710 PO BOX 285

Jordania

Ivodad 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| DUTCH FARM VETERINARY PHARMACEUTICALS |
| --- |
| B.V. |
| Veemweg 1-3771 MT BARNEVELEND |
| The Netherlands |

DUTCH FARM VETERINARY PHARMACEUTICALS

B.V.

Veemweg 1-3771 MT BARNEVELEND

The Netherlands

Dufamec 1 % inj.

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 % injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| FARMAVET S.A. |
| --- |
| Str. Petricani 198, |
| Chișinău |
| Republica Moldova |

FARMAVET S.A.

Str. Petricani 198,

Chișinău

Republica Moldova

Ivermectina 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| HEMOFARM – HEMOVET |
| --- |
| Beogradski Put BB |
| Vrsac |
| Serbia |

HEMOFARM – HEMOVET

Beogradski Put BB

Vrsac

Serbia

Ivermektin S

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| Laboratorios HIPRA S.A. |
| --- |
| Avda. La Selva, 135 |
| 17170 Amer, Girona |
| Spain |

Laboratorios HIPRA S.A.

Avda. La Selva, 135

17170 Amer, Girona

Spain

Iveripra I

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| Interchemie werken „de Adelaar” BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| The Netherlands |

Interchemie werken „de Adelaar” BV

Horsterweg 26A

5811 AC Castenray

The Netherlands

Intermectin

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| INTERVET PRODUCTIONS SRL |
| --- |
| Via Nettunense km 20, 300 |
| 04011 Aprilia |
| Italy |

INTERVET PRODUCTIONS SRL

Via Nettunense km 20, 300

04011 Aprilia

Italy

Ivogell

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| INTERVET ROMANIA S.R.L. |
| --- |
| Șoseaua de Centură, nr. 27-28, |
| 077040 Chiajna, Ilfov |
| Romania |

INTERVET ROMANIA S.R.L.

Șoseaua de Centură, nr. 27-28,

077040 Chiajna, Ilfov

Romania

Ivotan LA

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| PANTEX |
| --- |
| Ganzestaartsedijk 8 – 5525 KC Duizel |
| The Netherlands |

PANTEX

Ganzestaartsedijk 8 – 5525 KC Duizel

The Netherlands

Panmectin 10

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| PASTEUR – Filiala Filipești |
| --- |
| Str. Principală, nr. 944, Filipeștii de Pădure, |
| Jud. Prahova |
| Romania |

PASTEUR – Filiala Filipești

Str. Principală, nr. 944, Filipeștii de Pădure,

Jud. Prahova

Romania

Evomec

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| S.C. ROMVAC COMPANY S.A. |
| --- |
| Șos. Centurii, nr. 7, Voluntari |
| Romania |

S.C. ROMVAC COMPANY S.A.

Șos. Centurii, nr. 7, Voluntari

Romania

Romivermectin B1 1 %

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| SYVA |
| --- |
| Av. Párroco Pablo Diez, 49 – 57 |
| 24010 – Leon |
| Spain |

SYVA

Av. Párroco Pablo Diez, 49 – 57

24010 – Leon

Spain

Zoomectin

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Romania

| VMD Animal Health Ltd. |
| --- |
| Közraktár u. 22/b. II. 3., |
| 1093 Budapest |
| Hungary |

VMD Animal Health Ltd.

Közraktár u. 22/b. II. 3.,

1093 Budapest

Hungary

Iverveto 1 % Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Slovak Republic

| Vétoquinol s.r.o., |
| --- |
| Zámečnícka 411, |
| 288 02 Nymburk, |
| Czech Republic |

Vétoquinol s.r.o.,

Zámečnícka 411,

288 02 Nymburk,

Czech Republic

Biomectin

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Slovak Republic

| CEVA Animal Health Slovakia, spol. s r.o. |
| --- |
| Račianska 77 |
| 83 102 BRATISLAVA |
| Slovak Republic |

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

Račianska 77

83 102 BRATISLAVA

Slovak Republic

Cevamec 1 % inj. ad us. vet.

Ivermectin 10 mg/ml

Cattle, Sheep, Goats, Pigs

Subcutaneous

| Cattle, Sheep, Goats: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep, Goats:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Slovak Republic

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injection ad us vet

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Slovak Republic

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 % inj. ad us.vet.

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Slovak Republic

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec Super inj. ad us.vet.

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Slovak Republic

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Slovak Republic

| Pharmagal spol.s.r.o. |
| --- |
| Murgašova 5 |
| 949 01 Nitra |
| Slovak Republic |

Pharmagal spol.s.r.o.

Murgašova 5

949 01 Nitra

Slovak Republic

Galmectin

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Slovak Republic

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin injekčny roztok pre hovädzi dobytok

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Slovenia

| VET4VET d.o.o. |
| --- |
| Gerbičeva 50, |
| 1000 Ljubljana |
| Slovenia |

VET4VET d.o.o.

Gerbičeva 50,

1000 Ljubljana

Slovenia

Animec Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Slovenia

| VETERINA Plus d.o.o.,Dunajska 51, |
| --- |
| 1000 Ljubljana, |
| Slovenia |

VETERINA Plus d.o.o.,Dunajska 51,

1000 Ljubljana,

Slovenia

IVERKTIN 1 % solution for injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Slovenia

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC solution for injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Spain

| DIVASA FARMAVIC, S.A. |
| --- |
| Ctra. Sant Hipolit, km 71 |
| 08503 – Gurb-Vic |
| Barcelona |
| Spain |

DIVASA FARMAVIC, S.A.

Ctra. Sant Hipolit, km 71

08503 – Gurb-Vic

Barcelona

Spain

DIVAMECTIN 1 % SOLUCION

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

Spain

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 % Solution Inyectable para Bovino y Porcino

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Spain

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC SOLUCIÓN INYECTABLE PARA BOVINOS

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Spain

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

TIZOVAL

VACUNO INYECTABLE

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Spain

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

CHANECTIN INYECTABLE

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Spain

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Inyectable

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Spain

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

IVERTIN BOVINO

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Spain

| INDUSTRIAL VETERINARIA, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

INDUSTRIAL VETERINARIA, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona

Spain

PROMECTINE

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Spain

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

SUMEX INYECTABLE BOVINO

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Spain

| Laboratorios HIPRA S.A. |
| --- |
| Avda. La Selva, 135 |
| 17170 Amer, Girona |
| Spain |

Laboratorios HIPRA S.A.

Avda. La Selva, 135

17170 Amer, Girona

Spain

IVERIPRA-I

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Spain

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

ECOMECTIN 10 MG/ML SOLUCION INYECTABLE

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Spain

| Chemo Iberica |
| --- |
| Gran Vía Carlos III, 98 – 7oth floor. |
| 08028 Barcelona, |
| Spain |

Chemo Iberica

Gran Vía Carlos III, 98 – 7oth floor.

08028 Barcelona,

Spain

BOVECTIN

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Spain

| MERIAL LABORATORIOS S.A |
| --- |
| Tarragona, 161-Locales D/E |
| 08014 Barcelona |
| Spain |

MERIAL LABORATORIOS S.A

Tarragona, 161-Locales D/E

08014 Barcelona

Spain

Ivomec Inyectable Para Vacuno

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

Spain

| MERIAL LABORATORIOS S.A |
| --- |
| Tarragona, 161-Locales D/E |
| 08014 Barcelona |
| Spain |

MERIAL LABORATORIOS S.A

Tarragona, 161-Locales D/E

08014 Barcelona

Spain

Ivomec F Inyectable Para Vacuno

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Spain

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Solucion inyectable para bovino

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Sweden

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec® vet.

Ivermectin 10 mg/ml

Cattle, Reindeer, Pigs

Subcutaneous

| Cattle, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Sweden

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2 |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2

2080-104 Almeirim

Portugal

Virbamec vet. 10 mg/ml injektionsvätska, lösning

Ivermectin 10 mg/ml

Cattle, Reindeer, Pigs

Subcutaneous

| Cattle, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Sweden

| Bimeda (a division of Cross Vetpharm Group Limited) |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda (a division of Cross Vetpharm Group Limited)

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin® vet.

Ivermectin 10 mg/ml

Cattle, Reindeer, Pigs

Subcutaneous

| Cattle, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Sweden

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin vet Solution for Injection 10 mg/ml

Ivermectin 10 mg/ml

Cattle, Reindeer, Pigs

Subcutaneous

| Cattle, Reindeer: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Reindeer:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Sweden

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin, 10 mg/ml, Injektionsvätska, lösning

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

Sweden

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec, 10 mg/ml, Injektionsvätska, lösning

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

Ivertin Cattle

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

United Kingdom

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Ivomec Classic Injection for Cattle and Sheep

Ivermectin 10 mg/ml

Cattle, Sheep

Subcutaneous

200 μg ivermectin/kg bw

United Kingdom

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Ivomec Super Injection for Cattle

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

United Kingdom

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Panomec Injection for Cattle, Sheep and Pigs

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec Injection

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Injectable Solution For Cattle and Swine

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Injectable Solution for Cattle, Swine and Sheep

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Super

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Enovex Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Multi Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Injection

Ivermectin 10 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Multi Injection 1 % w/v Solution for Injection for Cattle, Sheep and Pigs

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin 1 % w/v Solution for Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Ecomec 1 % Injection

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Qualimintic 1 % Injection

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| Alstoe Ltd |
| --- |
| Sheriff Hutton Industrial Park |
| Sheriff Hutton |
| York |
| YO60 6RZ |
| United Kingdom |

Alstoe Ltd

Sheriff Hutton Industrial Park

Sheriff Hutton

York

YO60 6RZ

United Kingdom

Alstomec

Ivermectin 10 mg/ml

Cattle, Pigs

Subcutaneous

| Cattle: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 10 mg/ml Solution for Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec 10 mg/ml Solution for Injection

Ivermectin 10 mg/ml

Cattle, Sheep, Pigs

Subcutaneous

| Cattle, Sheep: | 200 μg ivermectin/kg bw |
| --- | --- |
| Pigs: | 300 μg ivermectin/kg bw |

Cattle, Sheep:

200 μg ivermectin/kg bw

Pigs:

300 μg ivermectin/kg bw

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closiver Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

United Kingdom

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Norofas Solution for Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Cattle

Subcutaneous

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

---

ANNEX II

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 |
| --- | --- | --- | --- | --- | --- |
| Austria | Janssen-Cilag Pharma GmbH |
| Pfarrgasse 75 1232 Wien, Austria |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of administration

Austria

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 1232 Wien, Austria

Topamax 100 mg – Filmtabletten

100 milligram(s)

Film-coated tablet

Oral use

Austria

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 1232 Wien, Austria |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 1232 Wien, Austria

Topamax 200 mg - Filmtabletten

200 milligram(s)

Film-coated tablet

Oral use

Austria

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 1232 Wien, Austria |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 1232 Wien, Austria

Topamax 25 mg - Filmtabletten

25 milligram(s)

Film-coated tablet

Oral use

Austria

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 1232 Wien, Austria |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 1232 Wien, Austria

Topamax 50 mg - Filmtabletten

50 milligram(s)

Film-coated tablet

Oral use

Austria

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 1232 Wien, Austria |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 1232 Wien, Austria

Topamax 15 mg - Granulat in Kapseln

15 milligram(s)

granuals in capsule

Oral use

Austria

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 1232 Wien, Austria |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 1232 Wien, Austria

Topamax 25 mg - Granulat in Kapseln

25 milligram(s)

granuals in capsule

Oral use

Austria

| Janssen-Cilag Pharma GmbH - |
| --- |
| Pfarrgasse 75 A-1232 Wien, Austria |

Janssen-Cilag Pharma GmbH -

Pfarrgasse 75 A-1232 Wien, Austria

Topamax 50 mg - Granulat in Kapseln

50 milligram(s)

granuals in capsule

Oral use

Belgium

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax 15 mg harde capsules

15 milligram(s)

Capsule, hard

Oral use

Belgium

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax 25 mg harde capsules

25 milligram(s)

Capsule, hard

Oral use

Belgium

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax 50 mg harde capsules

50 milligram(s)

Capsule, hard

Oral use

Belgium

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax 100 mg tabletten

100 milligram(s)

Tablet

Oral use

Belgium

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax 200 mg tabletten

200 milligram(s)

Tablet

Oral use

Belgium

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax 25 mg tabletten

25 milligram(s)

Tablet

Oral use

Belgium

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax 50 mg tabletten

50 milligram(s)

Tablet

Oral use

Bulgaria

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Slovenia

TOPAMAX

15 milligram(s)

Capsule

Oral use

Bulgaria

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Slovenia

TOPAMAX

25 milligram(s)

Capsule

Oral use

Bulgaria

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Slovenia

TOPAMAX

100 milligram(s)

Tablet

Oral use

Bulgaria

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Slovenia

TOPAMAX

25 milligram(s)

Tablet

Oral use

Bulgaria

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Slovenia

TOPAMAX

50 milligram(s)

Tablet

Oral use

Cyprus

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, 2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, 2340 Beerse, Belgium

TOPAMAX 100 mg tabs

100 milligram(s)

Tablet

Oral use

Cyprus

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, 2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, 2340 Beerse, Belgium

TOPAMAX 200 mg tabs

200 milligram(s)

Tablet

Oral use

Cyprus

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, 2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, 2340 Beerse, Belgium

TOPAMAX 25 mg tabs

25 milligram(s)

Film-coated tablet

Oral use

Cyprus

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, 2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, 2340 Beerse, Belgium

TOPAMAX 50 mg tabs

50 milligram(s)

Film-coated tablet

Oral use

Cyprus

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, 2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, 2340 Beerse, Belgium

TOPAMAX 15 mg Sprinkles

15 milligram(s)

Sprinkle capsule

Oral use

Cyprus

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, 2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, 2340 Beerse, Belgium

TOPAMAX 25 mg Sprinkles

25 milligram(s)

Sprinkle capsule

Oral use

Cyprus

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, 2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, 2340 Beerse, Belgium

TOPAMAX 50 mg Sprinkles

50 milligram(s)

Sprinkle capsule

Oral use

Czech Republic

| Janssen-Cilag s.r.o |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o

Karla Engliše 3201/6

150 00 Praha 5

Topamax 100 mg

100 milligram(s)

Film-coated tablet

Oral use

Czech Republic

| Janssen-Cilag s.r.o |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o

Karla Engliše 3201/6

150 00 Praha 5

Topamax 25 mg

25 milligram(s)

Film-coated tablet

Oral use

Czech Republic

| Janssen-Cilag s.r.o |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o

Karla Engliše 3201/6

150 00 Praha 5

Topamax 50 mg

50 milligram(s)

Film-coated tablet

Oral use

Czech Republic

| Janssen-Cilag s.r.o |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o

Karla Engliše 3201/6

150 00 Praha 5

Topamax 15 mg

15 milligram(s)

Capsule

Oral use

Czech Republic

| Janssen-Cilag s.r.o |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o

Karla Engliše 3201/6

150 00 Praha 5

Topamax 25 mg

25 milligram(s)

Capsule

Oral use

Denmark

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19, 3460 Birkerød, Denmark |

Janssen-Cilag A/S

Hammerbakken 19, 3460 Birkerød, Denmark

Topimax

15 milligram(s)

Capsule, hard

Oral use

Denmark

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19, 3460 Birkerød, Denmark |

Janssen-Cilag A/S

Hammerbakken 19, 3460 Birkerød, Denmark

Topimax

25 milligram(s)

Capsule, hard

Oral use

Denmark

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19, 3460 Birkerød, Denmark |

Janssen-Cilag A/S

Hammerbakken 19, 3460 Birkerød, Denmark

Topimax

50 milligram(s)

Capsule, hard

Oral use

Denmark

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19, 3460 Birkerød, Denmark |

Janssen-Cilag A/S

Hammerbakken 19, 3460 Birkerød, Denmark

Topimax

100 milligram(s)

Film-coated tablet

Oral use

Denmark

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19, 3460 Birkerød, Denmark |

Janssen-Cilag A/S

Hammerbakken 19, 3460 Birkerød, Denmark

Topimax

200 milligram(s)

Film-coated tablet

Oral use

Denmark

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19, 3460 Birkerød, Denmark |

Janssen-Cilag A/S

Hammerbakken 19, 3460 Birkerød, Denmark

Topimax

25 milligram(s)

Film-coated tablet

Oral use

Denmark

| Janssen-Cilag A/S |
| --- |
| Hammerbakken 19, 3460 Birkerød, Denmark |

Janssen-Cilag A/S

Hammerbakken 19, 3460 Birkerød, Denmark

Topimax

50 milligram(s)

Film-coated tablet

Oral use

Estonia

| UAB Johnson & Johnson - LT |
| --- |
| Geležinio Vilko g. 18A |
| LT-08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Lithuania

TOPAMAX 100 mg

100 milligram(s)

Film-coated tablet

Oral use

Estonia

| UAB Johnson & Johnson - LT |
| --- |
| Geležinio Vilko g. 18A |
| LT-08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Lithuania

TOPAMAX 200 mg

200 milligram(s)

Film-coated tablet

Oral use

Estonia

| UAB Johnson & Johnson - LT |
| --- |
| Geležinio Vilko g. 18A |
| LT-08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Lithuania

TOPAMAX 25 mg

25 milligram(s)

Film-coated tablet

Oral use

Estonia

| UAB Johnson & Johnson - LT |
| --- |
| Geležinio Vilko g. 18A |
| LT-08104 Vilnius |
| Lithuania |

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Lithuania

TOPAMAX 50 mg

50 milligram(s)

Film-coated tablet

Oral use

Finland

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finland |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finland

Topimax 15 mg kapseli, kova

15 milligram(s)

Capsule, hard

Oral use

Finland

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finland |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finland

Topimax 100 mg tabletti, kalvopäällysteinen

100 milligram(s)

Film-coated tablet

Oral use

Finland

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finland |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finland

Topimax 200 mg tabletti, kalvopäällysteinen

200 milligram(s)

Film-coated tablet

Oral use

Finland

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finland |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finland

Topimax 25 mg tabletti, kalvopäällysteinen

25 milligram(s)

Film-coated tablet

Oral use

Finland

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finland |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finland

Topimax 50 mg tabletti, kalvopäällysteinen

50 milligram(s)

Film-coated tablet

Oral use

Finland

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finland |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finland

Topimax 25 mg kapseli, kova

25 milligram(s)

Capsule, hard

Oral use

Finland

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finland |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finland

Topimax 50 mg kapseli, kova

50 milligram(s)

Capsule, hard

Oral use

France

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France

EPITOMAX 100 mg, COMPRIME PELLICULE

100 milligram(s)

Film-coated tablet

Oral use

France

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France

EPITOMAX 200 mg, COMPRIME PELLICULE

200 milligram(s)

Film-coated tablet

Oral use

France

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France

EPITOMAX 50 mg, COMPRIME PELLICULE

50 milligram(s)

Film-coated tablet

Oral use

France

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France

EPITOMAX 15 mg, GELULE

15 milligram(s)

Sprinkle capsule

Oral use

France

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France

EPITOMAX 25 mg, GELULE

25 milligram(s)

Sprinkle capsule

Oral use

France

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 France

EPITOMAX 50 mg, GELULE

50 milligram(s)

Sprinkle capsule

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Cilag 25 mg Hartkapseln

25 milligram(s)

Capsule, hard

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Janssen 25 mg Hartkapseln

25 milligram(s)

Capsule, hard

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Cilag 50 mg Hartkapseln

50 milligram(s)

Capsule, hard

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Janssen 50 mg Hartkapseln

50 milligram(s)

Capsule, hard

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topamax 100 mg Filmtabletten

100 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Janssen 100 mg Filmtabletten

100 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

TOPAMAX MIGRÄNE 100 mg Filmtabletten

100 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat - Cilag 100 mg Filmtabletten

100 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Cilag 100 mg Filmtabletten

100 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topamax 200 mg Filmtabletten

200 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

TOPAMAX MIGRÄNE 200 mg Filmtabletten

200 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat - Cilag 200 mg Filmtabletten

200 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Cilag 200 mg Filmtabletten

200 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Janssen 200 mg Filmtabletten

200 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topamax 25 mg Filmtabletten

25 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

TOPAMAX MIGRÄNE 25 mg Filmtabletten

25 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Cilag 25 mg Filmtabletten

25 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Janssen 25 mg Filmtabletten

25 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topamax 50 mg Filmtabletten

50 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

TOPAMAX MIGRÄNE 50 mg Filmtabletten

50 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Cilag 50 mg Filmtabletten

50 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topiramat-Janssen 50 mg Filmtabletten

50 milligram(s)

Film-coated tablet

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topamax 25 mg Kapseln

25 milligram(s)

Capsule hard

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

TOPAMAX MIGRÄNE 25 mg Hartkapseln

25 milligram(s)

Capsule

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

Topamax 50 mg Kapseln

50 milligram(s)

Capsule hard

Oral use

Germany

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Germany |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Germany

TOPAMAX MIGRÄNE 50 mg Hartkapseln

50 milligram(s)

Capsule

Oral use

Greece

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Greece |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Greece

TOPAMAC

100 milligram(s)

Film-coated tablet

Oral use

Greece

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Greece |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Greece

TOPAMAC

200 milligram(s)

Film-coated tablet

Oral use

Greece

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Greece |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Greece

TOPAMAC

25 milligram(s)

Film-coated tablet

Oral use

Greece

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Greece |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Greece

TOPAMAC

50 milligram(s)

Film-coated tablet

Oral use

Greece

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Greece |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Greece

TOPAMAC

15 milligram(s)

Capsule, hard

Oral use

Greece

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Greece |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Greece

TOPAMAC

25 milligram(s)

Capsule, hard

Oral use

Greece

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Greece |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Greece

TOPAMAC

50 milligram(s)

Capsule, hard

Oral use

Hungary

| Janssen-Cilag Kft. - HU |
| --- |
| 2045 Törökbálint Tó park, Hungary |

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, Hungary

Topamax 100 mg film-coated tablet

100 milligram(s)

Film-coated tablet

Oral use

Hungary

| Janssen-Cilag Kft. - HU |
| --- |
| 2045 Törökbálint Tó park, Hungary |

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, Hungary

Topamax 200 mg film-coated tablets

200 milligram(s)

Film-coated tablet

Oral use

Hungary

| Janssen-Cilag Kft. - HU |
| --- |
| 2045 Törökbálint Tó park, Hungary |

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, Hungary

Topamax 25 mg film-coated tablet

25 milligram(s)

Film-coated tablet

Oral use

Hungary

| Janssen-Cilag Kft. - HU |
| --- |
| 2045 Törökbálint Tó park, Hungary |

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, Hungary

Topamax 50 mg film-coated tablet

50 milligram(s)

Film-coated tablet

Oral use

Iceland

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 15 mg hylki, hörð

15 milligram(s)

Capsule, hard

Oral use

Iceland

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 25 mg hylki, hörð

25 milligram(s)

Capsule, hard

Oral use

Iceland

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 50 mg hylki, hörð

50 milligram(s)

Capsule, hard

Oral use

Iceland

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 100 mg filmuhúðaðar töflur

100 milligram(s)

Film-coated tablet

Oral use

Iceland

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 200 mg filmuhúðaðar töflur

200 milligram(s)

Film-coated tablet

Oral use

Iceland

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 25 mg filmuhúðaðar töflur

25 milligram(s)

Film-coated tablet

Oral use

Iceland

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 50 mg filmuhúðaðar töflur

50 milligram(s)

Film-coated tablet

Oral use

Ireland

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX 100 mg Tablets

100 milligram(s)

Film-coated tablet

Oral use

Ireland

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX 200 mg Tablets

200 milligram(s)

Film-coated tablet

Oral use

Ireland

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX 25 mg Tablets

25 milligram(s)

Film-coated tablet

Oral use

Ireland

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX 50 mg Tablets

50 milligram(s)

Film-coated tablet

Oral use

Ireland

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX Sprinkle Capsules 15 mg.

15 milligram(s)

Sprinkle capsule

Oral use

Ireland

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX Sprinkle Capsules 25 mg.

25 milligram(s)

Sprinkle capsule

Oral use

Ireland

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX Sprinkle Capsules 50 mg

50 milligram(s)

Sprinkle capsule

Oral use

Italy

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, Italy |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italy

TOPAMAX 15 mg capsule rigide, 60 capsule

15 milligram(s)

Capsule, hard

Oral use

Italy

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, Italy |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italy

TOPAMAX 100 mg compresse rivestite con film, 60 compresse

100 milligram(s)

Film-coated tablet

Oral use

Italy

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| Italy |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italy

EPITOMAX 100 mg compresse rivestite con film, 60 compresse

100 milligram(s)

Film-coated tablet

Oral use

Italy

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, Italy |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italy

TOPAMAX 200 mg compresse rivestite con film, 60 compresse

200 milligram(s)

Film-coated tablet

Oral use

Italy

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| Italy |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italy

EPITOMAX 200 mg compresse rivestite con film, 60 compresse

200 milligram(s)

Film-coated tablet

Oral use

Italy

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, Italy |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italy

TOPAMAX 25 mg compresse rivestite con film, 60 compresse

25 milligram(s)

Film-coated tablet

Oral use

Italy

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| Italy |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italy

EPITOMAX 25 mg compresse rivestite con film, 60 compresse

25 milligram(s)

Film-coated tablet

Oral use

Italy

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| Italy |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italy

TOPAMAX 300 mg compresse rivestite con film, 60 compresse

300 milligram(s)

Film-coated tablet

Oral use

Italy

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| Italy |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italy

EPITOMAX 300 mg compresse rivestite con film, 60 compresse

300 milligram(s)

Film-coated tablet

Oral use

Italy

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, Italy |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italy

TOPAMAX 400 mg compresse rivestite con film, 60 compresse

400 milligram(s)

Film-coated tablet

Oral use

Italy

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| Italy |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italy

EPITOMAX 400 mg compresse rivestite con film, 60 compresse

400 milligram(s)

Film-coated tablet

Oral use

Italy

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, Italy |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italy

TOPAMAX 50 mg compresse rivestite con film, 60 compresse

50 milligram(s)

Film-coated tablet

Oral use

Italy

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| Italy |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italy

EPITOMAX 50 mg compresse rivestite con film, 60 compresse

50 milligram(s)

Film-coated tablet

Oral use

Italy

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, Italy |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italy

TOPAMAX 25 mg capsule rigide, 60 capsule

25 milligram(s)

Capsule, hard

Oral use

Italy

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, Italy |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italy

TOPAMAX 50 mg capsule rigide, 60 capsule

50 milligram(s)

Capsule, hard

Oral use

Latvia

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania

Topamax 100 mg coated tablets

100 milligram(s)

Coated tablet

Oral use

Latvia

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania

Topamax 25 mg coated tablets

25 milligram(s)

Coated tablet

Oral use

Latvia

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania

Topamax 50 mg coated tablets

50 milligram(s)

Coated tablet

Oral use

Latvia

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania

Topamax 15 mg sprinkle capsules

15 milligram(s)

Sprinkle capsule

Oral use

Latvia

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Lithuania

Topamax 25 mg sprinkle capsules

25 milligram(s)

Sprinkle capsule

Oral use

Lithuania

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania |

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania

Topamax

100 milligram(s)

Tablet

Oral use

Lithuania

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania |

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania

Topamax

200 milligram(s)

Tablet

Oral use

Lithuania

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania |

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania

Topamax

25 milligram(s)

Tablet

Oral use

Lithuania

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania |

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Lithuania

Topamax

50 milligram(s)

Tablet

Oral use

Luxembourg

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax gélules 15 mg

15 milligram(s)

Capsule, hard

Oral use

Luxembourg

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax comprimés 100 mg

100 milligram(s)

Tablet

Oral use

Luxembourg

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax comprimés 200 mg

200 milligram(s)

Tablet

Oral use

Luxembourg

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax comprimés 25 mg

25 milligram(s)

Tablet

Oral use

Luxembourg

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax comprimés 50 mg

50 milligram(s)

Tablet

Oral use

Luxembourg

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax gélules 25 mg

25 milligram(s)

Capsule, hard

Oral use

Luxembourg

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Belgium |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgium

Topamax gélules 50 mg

50 milligram(s)

Capsule, hard

Oral use

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgium

Topamax

100 milligram(s)

Tablet

Oral use

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgium

Topamax

200 milligram(s)

Tablet

Oral use

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgium

Topamax

25 milligram(s)

Tablet

Oral use

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgium

Topamax

50 milligram(s)

Tablet

Oral use

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgium

Topamax

15 milligram(s)

Hard capsule

Oral use

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgium

Topamax

25 milligram(s)

Hard capsule

Oral use

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgium

Topamax

50 milligram(s)

Hard capsule

Oral use

Netherlands

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| The Netherlands |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

The Netherlands

Topamax omhulde tabletten 100 mg, omhulde tabletten

100 milligram(s)

Coated tablet

Oral use

Netherlands

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| The Netherlands |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

The Netherlands

Topamax omhulde tabletten 200 mg, omhulde tabletten

200 milligram(s)

Coated tablet

Oral use

Netherlands

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| The Netherlands |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

The Netherlands

Topamax omhulde tabletten 25 mg, omhulde tabletten

25 milligram(s)

Coated tablet

Oral use

Netherlands

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| The Netherlands |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

The Netherlands

Topamax omhulde tabletten 50 mg, omhulde tabletten

50 milligram(s)

Coated tablet

Oral use

Netherlands

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| The Netherlands |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

The Netherlands

Topamax Sprinkle capsules 15 mg, capsules

15 milligram(s)

Capsule

Oral use

Netherlands

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| The Netherlands |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

The Netherlands

Topamax Sprinkle capsules 25 mg, capsules

25 milligram(s)

Capsule

Oral use

Netherlands

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| The Netherlands |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

The Netherlands

Topamax Sprinkle capsules 50 mg, capsules

50 milligram(s)

Capsule

Oral use

Norway

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norway |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norway

Topimax 15 mg Kapsel, hard

15 milligram(s)

Capsule, hard

Oral use

Norway

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norway |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norway

Topimax 25 mg Kapsel, hard

25 milligram(s)

Capsule, hard

Oral use

Norway

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norway |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norway

Topimax 50 mg Kapsel, hard

50 milligram(s)

Capsule, hard

Oral use

Norway

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norway |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norway

Topimax 100 mg Tabletter filmdrasjert

100 milligram(s)

Film-coated tablet

Oral use

Norway

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norway |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norway

Topimax 200 mg Tabletter filmdrasjert

200 milligram(s)

Film-coated tablet

Oral use

Norway

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norway |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norway

Topimax 25 mg Tabletter filmdrasjert

25 milligram(s)

Film-coated tablet

Oral use

Norway

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norway |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norway

Topimax 50 mg Tabletter filmdrasjert

50 milligram(s)

Film-coated tablet

Oral use

Poland

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgium

Topamax 100 mg tabletki powlekane

100 milligram(s)

Film-coated tablet

Oral use

Poland

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgium

Topamax 200 mg tabletki powlekane

200 milligram(s)

Film-coated tablet

Oral use

Poland

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgium

Topamax 25 mg tabletki powlekane

25 milligram(s)

Film-coated tablet

Oral use

Poland

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgium

Topamax 50 mg tabletki powlekane

50 milligram(s)

Film-coated tablet

Oral use

Poland

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgium

Topamax 15 mg kapsulki

15 milligram(s)

Capsule

Oral use

Poland

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgium |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgium

Topamax 25 mg kapsulki

25 milligram(s)

Capsule

Oral use

Portugal

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal

Topamax

100 milligram(s)

Film-coated tablet

Oral use

Portugal

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal

Topamax

200 milligram(s)

Film-coated tablet

Oral use

Portugal

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal

Topamax

25 milligram(s)

Film-coated tablet

Oral use

Portugal

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal

Topamax

50 milligram(s)

Film-coated tablet

Oral use

Portugal

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal

Topamax

15 milligram(s)

capsule, hard

Oral use

Portugal

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal

Topamax

25 milligram(s)

capsule, hard

Oral use

Portugal

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal

Topamax

50 milligram(s)

capsule, hard

Oral use

Romania

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenia |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenia

TOPAMAX 100 tablets

100 milligram(s)

Tablet

Oral use

Romania

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenia |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenia

TOPAMAX 200 tablets

200 milligram(s)

Tablet

Oral use

Romania

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenia |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenia

TOPAMAX 25 tablets

25 milligram(s)

Tablet

Oral use

Romania

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenia |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenia

TOPAMAX 50 tablets

50 milligram(s)

Tablet

Oral use

Romania

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenia |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenia

TOPAMAX sprinkle caps

50 milligram(s)

Sprinkle capsule

Oral use

Slovak Republic

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovak Republic |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovak Republic

Topamax 15 mg cps

15 milligram(s)

Prolonged-release capsule, hard

Oral use

Slovak Republic

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovak Republic |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovak Republic

Topamax 25 mg cps

25 milligram(s)

Prolonged-release capsule, hard

Oral use

Slovak Republic

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovak Republic |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovak Republic

Topamax 100

100 milligram(s)

Film-coated tablet

Oral use

Slovak Republic

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovak Republic |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovak Republic

Topamax 200

200 milligram(s)

Film-coated tablet

Oral use

Slovak Republic

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovak Republic |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovak Republic

Topamax 25

25 milligram(s)

Film-coated tablet

Oral use

Slovak Republic

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovak Republic |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovak Republic

Topamax 50

50 milligram(s)

Film-coated tablet

Oral use

Slovenia

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Slovenia

TOPAMAX 100 mg filmsko oblozene tablete

100 milligram(s)

Film-coated tablet

Oral use

Slovenia

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Slovenia

TOPAMAX 200 mg filmsko oblozene tablete

200 milligram(s)

Film-coated tablet

Oral use

Slovenia

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Slovenia

TOPAMAX 25 mg filmsko oblozene tablete

25 milligram(s)

Film-coated tablet

Oral use

Slovenia

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Slovenia

TOPAMAX 50 mg filmsko oblozene tablete

50 milligram(s)

Film-coated tablet

Oral use

Slovenia

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenia |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Slovenia

TOPAMAX 15 mg kapsule

15 milligram(s)

hard capsule

Oral use

Spain

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain

TOPAMAX 100 mg Comprimidos recubiertos

100 milligram(s)

Coated tablet

Oral use

Spain

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain

TOPAMAX 200 mg Comprimidos recubiertos

200 milligram(s)

Coated tablet

Oral use

Spain

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain

TOPAMAX 25 mg Comprimidos recubiertos

25 milligram(s)

Coated tablet

Oral use

Spain

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain

TOPAMAX 50 mg Comprimidos recubiertos

50 milligram(s)

Coated tablet

Oral use

Spain

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain

TOPAMAX DISPERSABLE 15 mg, cápsulas

15 milligram(s)

Sprinkle capsule

Oral use

Spain

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain

TOPAMAX DISPERSABLE 25 mg, cápsulas

25 milligram(s)

Sprinkle capsule

Oral use

Spain

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain

TOPAMAX DISPERSABLE 50 mg, cápsulas

50 milligram(s)

Sprinkle capsule

Oral use

Sweden

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 15 mg kapslar, hårda

15 milligram(s)

Capsule, hard

Oral use

Sweden

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 25 mg kapslar, hårda

25 milligram(s)

Capsule, hard

Oral use

Sweden

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 50 mg kapslar, hårda

50 milligram(s)

Capsule, hard

Oral use

Sweden

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 100 mg tabletter, filmdragerade

100 milligram(s)

Film-coated tablet

Oral use

Sweden

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 200 mg tabletter, filmdragerade

200 milligram(s)

Film-coated tablet

Oral use

Sweden

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 25 mg tabletter, filmdragerade

25 milligram(s)

Film-coated tablet

Oral use

Sweden

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Sverige |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Sverige

Topimax 50 mg tabletter, filmdragerade

50 milligram(s)

Film-coated tablet

Oral use

United Kingdom

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX 100 mg Tablets

100 milligram(s)

Tablet

Oral use

United Kingdom

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX 200 mg Tablets

200 milligram(s)

Tablet

Oral use

United Kingdom

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX 25 mg Tablets

25 milligram(s)

Tablet

Oral use

United Kingdom

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX 50 mg Tablets

50 milligram(s)

Tablet

Oral use

United Kingdom

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX Sprinkle Capsules 15 mg

15 milligram(s)

Sprinkle capsule

Oral use

United Kingdom

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX Sprinkle Capsules 25 mg

25 milligram(s)

Sprinkle capsule

Oral use

United Kingdom

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP14 4HJ |
| United Kingdom |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP14 4HJ

United Kingdom

TOPAMAX Sprinkle Capsules 50 mg

50 milligram(s)

Sprinkle capsule

Oral use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Bayer Austria GmbH |
| Herbststraße 6-10 |
| 1160 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

Bayer Austria GmbH

Herbststraße 6-10

1160 Wien

Austria

Avelox 400 mg - Infusionslösung

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Belgium

| Bayer SA-NV |
| --- |
| Avenue Louise 143 Louizalaan |
| B-1050 Brussel |
| Belgium |

Bayer SA-NV

Avenue Louise 143 Louizalaan

B-1050 Brussel

Belgium

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Cyprus

| Bayer Hellas S.A. |
| --- |
| Sorou 18-20 |
| 151 25 Marousi - Athens |
| Greece |

Bayer Hellas S.A.

Sorou 18-20

151 25 Marousi - Athens

Greece

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Czech Republic

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avelox 400 mg/ 250 ml infuzní roztok

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Denmark

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Estonia

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Finland

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

France

| Bayer Santé |
| --- |
| 13, rue Jean Jaurès |
| 92807 Puteaux Cedex |
| France |

Bayer Santé

13, rue Jean Jaurès

92807 Puteaux Cedex

France

Izilox 400 mg / 250 ml, solution pour perfusion

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Germany

| Bayer Vital GmbH |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer Vital GmbH

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avalox 400 mg / 250 ml Infusionslösung

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Greece

| Bayer Hellas S.A. |
| --- |
| Sorou 18-20 |
| 151 25 Marousi - Athens |
| Greece |

Bayer Hellas S.A.

Sorou 18-20

151 25 Marousi - Athens

Greece

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Hungary

| Bayer Hungária Kft |
| --- |
| Alkotás ut.50 |
| 1123 Budapest |
| Hungary |

Bayer Hungária Kft

Alkotás ut.50

1123 Budapest

Hungary

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Ireland

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Italy

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avalox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Látvia

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Lithuania

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Luxembourg

| Bayer SA-NV |
| --- |
| Avenue Louise 143 Louizalaan |
| B-1050 Brussel |
| Belgium |

Bayer SA-NV

Avenue Louise 143 Louizalaan

B-1050 Brussel

Belgium

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Malta

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avalox 400 mg/250 ml Solution for Infusion

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Netherlands

| Bayer BV |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| Netherlands |

Bayer BV

Energieweg 1

3641 RT Mijdrecht

Netherlands

Avelox 400 mg/250 ml oplossing voor infusie

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Poland

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Portugal

| BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda. |
| --- |
| Rua Quinta do Pinheiro, 5 |
| 2794-003 Carnaxide |
| Portugal |

BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Portugal

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Slovak Republic

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

AVELOX 400 mg/250 ml infúzny roztok

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Slovenia

| BAYER d.o.o. |
| --- |
| Bravničarjeva 13 |
| 1000 Ljubljana |
| Slovenia |

BAYER d.o.o.

Bravničarjeva 13

1000 Ljubljana

Slovenia

Avelox 400 mg/250 ml raztopina za infundiranje

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Spain

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Muzolil

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Sweden

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Germany

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

United Kingdom

| Bayer plc |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| United Kingdom |

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

United Kingdom

Avelox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration | Content
  (concentration) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Bayer HealthCare AG |
| 51368 Leverkusen |
| Germany |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

Bayer HealthCare AG

51368 Leverkusen

Germany

Octegra 400 mg - Infusionslösung

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Belgium

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

51368 Leverkusen

Germany

Proflox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

France

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

51368 Leverkusen

Germany

Octegra 400 mg / 250 ml, solution pour perfusion

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Germany

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

51368 Leverkusen

Germany

Octegra 400 mg / 250 ml Infusionslösung

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Greece

| Elpen Pharmaceutical Co, Inc |
| --- |
| 95, Marathonos Avenue |
| 190-09 Pikermi |
| Greece |

Elpen Pharmaceutical Co, Inc

95, Marathonos Avenue

190-09 Pikermi

Greece

Octegra

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Luxembourg

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

51368 Leverkusen

Germany

Proflox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Netherlands

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Germany |

Bayer HealthCare AG

51368 Leverkusen

Germany

Octegra 400 mg/250 ml oplossing voor infusie

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

Portugal

| Bialfar - Produtos Farmacêuticos S.A. |
| --- |
| À Av. da Siderurgia Nacional |
| 4745-457 S. Mamede do Coronado |
| Portugal |

Bialfar - Produtos Farmacêuticos S.A.

À Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugal

Proflox

400 mg

Solution for infusion

Intravenous use

400 mg / 250 ml

---

ANNEX V

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

| Member State EU/EEA | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | Helm Pharmaceuticals GmbH |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Member State EU/EEA

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm 25 Mikrogramm/h Transdermales Pflaster

25 μg/h

transdermal patch

transdermal route

Austria

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm 50 Mikrogramm/h Transdermales Pflaster

50 μg/h

transdermal patch

transdermal route

Austria

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm 75 Mikrogramm/h Transdermales Pflaster

75 μg/h

transdermal patch

transdermal route

Austria

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm 100 Mikrogramm/h Transdermales Pflaster

100 μg/h

transdermal patch

transdermal route

Belgium

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm Pharmaceuticals 25 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

25 μg/h

transdermal patch

transdermal route

Belgium

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm Pharmaceuticals 50 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

50 μg/h

transdermal patch

transdermal route

Belgium

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm Pharmaceuticals 75 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

75 μg/h

transdermal patch

transdermal route

Belgium

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm Pharmaceuticals 100 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

100 μg/h

transdermal patch

transdermal use

Germany

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentrix 25 μ/h Transdermales Pflaster

25 μg/h

transdermal patch

transdermal use

Germany

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentrix 50 μ/h Transdermales Pflaster

50 μg/h

transdermal patch

transdermal use

Germany

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentrix 75 μ/h Transdermales Pflaster

75 μg/h

transdermal patch

transdermal use

Germany

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentrix 100 μ/h Transdermales Pflaster

100 μg/h

transdermal patch

transdermal use

Italy

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm 25 μg/h cerotto transdermico

25 μg/h

transdermal patch

transdermal use

Italy

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm 50 μg/h cerotto transdermico

50 μg/h

transdermal patch

transdermal use

Italy

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm 75 μg/h cerotto transdermico

75 μg/h

transdermal patch

transdermal use

Italy

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanyl Helm 100 μg/h cerotto transdermico

100 μg/h

transdermal patch

transdermal use

Netherlands

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentrix 25 μg/h Pleister voor transderaal gebruik

25 μg/h

transdermal patch

transdermal use

Netherlands

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentrix 50 μg/h Pleister voor transderaal gebruik

50 μg/h

transdermal patch

transdermal use

Netherlands

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentrix 75 μg/h Pleister voor transderaal gebruik

75 μg/h

transdermal patch

transdermal use

Netherlands

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentrix 100 μg/h Pleister voor transderaal gebruik

100 μg/h

transdermal patch

transdermal use

Portugal

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanilo Helm

25 μg/h

transdermal patch

transdermal use

Portugal

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanilo Helm

50 μg/h

transdermal patch

transdermal use

Portugal

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanilo Helm

75 μg/h

transdermal patch

transdermal use

Portugal

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanilo Helm

100 μg/h

transdermal patch

transdermal use

Slovenia

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanil HELM 25 mikrogramov/h transdermalni obliži

25 μg/h

transdermal patch

transdermal use

Slovenia

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanil HELM 50 mikrogramov/h transdermalni obliži

50 μg/h

transdermal patch

transdermal use

Slovenia

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanil HELM 75 mikrogramov/h transdermalni obliži

75 μg/h

transdermal patch

transdermal use

Slovenia

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanil HELM 100 mikrogramov/h transdermalni obliži

100 μg/h

transdermal patch

transdermal use

Spain

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanilo Matrix Helm 25 microgramos/hora parches transdérmicos EFG

25 μg/h

transdermal patch

transdermal use

Spain

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanilo Matrix Helm 50 microgramos/hora parches transdérmicos EFG

50 μg/h

transdermal patch

transdermal use

Spain

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanilo Matrix Helm 75 microgramos/hora parches transdérmicos EFG

75 μg/h

transdermal patch

transdermal use

Spain

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Germany |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Germany

Fentanilo Matrix Helm 100 microgramos/hora parches transdérmicos EFG

100 μg/h

transdermal patch

transdermal 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 |

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

Optinem i.v. 500 mg - Trockenstechampullen

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20ml

Austria

| AstraZeneca Österreich GmbH, |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7

A-1037 Wien

Austria

Optinem i.v. 1 g - Trockenstechampullen

1 g

Powder for solution for injection or infusion

Intravenous use

1 g /30 ml

Belgium

| NV AstraZeneca SA |
| --- |
| Rue Egide Van Ophemstraat 110 |
| 1180 Brussel |
| Belgium |

NV AstraZeneca SA

Rue Egide Van Ophemstraat 110

1180 Brussel

Belgium

Meronem IV 500 mg

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Belgium

| NV AstraZeneca SA |
| --- |
| Rue Egide Van Ophemstraat 110 |
| 1180 Brussel |
| Belgium |

NV AstraZeneca SA

Rue Egide Van Ophemstraat 110

1180 Brussel

Belgium

Meronem IV 1 g

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Bulgaria

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Meronem

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Bulgaria

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton LU1 3LU

United Kingdom

Meronem

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Cyprus

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Cyprus

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Czech Republic

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem

500 mg

Powder for solution for injection

Intravenous use

500 mg/20 ml

Czech Republic

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem

1 g

Powder for solution for injection

Intravenous use

1 g/30 ml

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Meronem

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Denmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Meronem

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Estonia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Meronem

500mg

Powder for solution for injection or infusion

Intravenous use

500 mg/10 ml

Estonia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Meronem

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/20 ml

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Meronem 500 mg

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Meronem 1 g

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 RUEIL-MALMAISON Cédex |
| France |

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cédex

France

Meronem

500 mg poudre pour solution injectable IV

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

France

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 RUEIL-MALMAISON Cédex |
| France |

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cédex

France

Meronem

1 g poudre pour solution injectable IV

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Germany

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Germany |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

Meronem 500 mg

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/10 ml

5 mg / ml

Germany

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Germany |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Germany

Meronem 1 000 mg

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/20 ml

5 mg / ml

Greece

| ”CANA” SA Pharmaceutical laboratories |
| --- |
| 446 Irakliou Ave. |
| 14122 Iraklio Attikis |
| Greece |

”CANA” SA Pharmaceutical laboratories

446 Irakliou Ave.

14122 Iraklio Attikis

Greece

Meronem

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Greece

| ”CANA” SA Pharmaceutical laboratories |
| --- |
| 446 Irakliou Ave |
| 14122 Iraklio Attikis |
| Greece |

”CANA” SA Pharmaceutical laboratories

446 Irakliou Ave

14122 Iraklio Attikis

Greece

Meronem

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Hungary

| AstraZeneca Kft. |
| --- |
| H-2045 Törökbálint |
| Park u. 3. |
| Hungary |

AstraZeneca Kft.

H-2045 Törökbálint

Park u. 3.

Hungary

Meronem 500 mg intravenas injekcio

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Hungary

| AstraZeneca Kft. |
| --- |
| H-2045 Törökbálint |
| Park u. 3. |
| Hungary |

AstraZeneca Kft.

H-2045 Törökbálint

Park u. 3.

Hungary

Meronem 1 g intravenas injekcio

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Iceland

| AstraZeneca UK Ltd. |
| --- |
| Alderley Park |
| Macclesfield |
| Cheshire SK10 4TG |
| United Kingdom |

AstraZeneca UK Ltd.

Alderley Park

Macclesfield

Cheshire SK10 4TG

United Kingdom

Meronem 500 mg stungulyfs-/innrennslisstofn, lausn.

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Iceland

| AstraZeneca UK Ltd. |
| --- |
| Alderley Park |
| Macclesfield |
| Cheshire SK10 4TG |
| United Kingdom |

AstraZeneca UK Ltd.

Alderley Park

Macclesfield

Cheshire SK10 4TG

United Kingdom

Meronem 1 g stungulyfs-/innrennslisstofn, lausn.

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Ireland

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Meronem IV 0.5 g powder for solution for injection or infusion.

0,5 g

Powder for solution for injection or infusion.

Intravenous use

500 mg/20 ml

Ireland

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Meronem IV 1 g powder for solution for injection or infusion.

1 g

Powder for solution for injection or infusion.

Intravenous use

1 g/30 ml

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

MERREM

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

MERREM

1 g

Powder for solution for injection or infusion

Intravenous use

1 g

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

MERREM

500 mg

Powder and solvent for solution for injection

Intramuscular use

500 mg/2 ml

(not marketed)

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

MERREM

250 mg

Powder and solvent for solution for injection or infusion

Intravenous use

250 mg/5 ml

(not marketed)

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

MERREM

500 mg

Powder and solvent for solution for injection or infusion

Intravenous use

500 mg/10 ml

(not marketed)

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

MERREM

1 g

Powder and solvent for solution for injection or infusion

Intravenous use

1 g/20 ml

(not marketed)

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

MERREM

250 mg

Powder and solvent for solution for infusion

Intravenous use

250 mg/100 ml

(not marketed)

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

MERREM

500 mg

Powder and solvent for solution for infusion

Intravenous use

500 mg/100 ml

(not marketed)

Italy

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via F. Sforza |
| 20080 Basiglio (MI) |
| Italy |

AstraZeneca S.p.A.

Palazzo Volta

Via F. Sforza

20080 Basiglio (MI)

Italy

MERREM

1 g

Powder and solvent for solution for infusion

Intravenous use

1 g/100 ml

(not marketed)

Latvia

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem 500 mg

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Latvia

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem 1 g

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Lithuania

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem IV

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/10 ml

Lithuania

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem IV

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/20 ml

Luxembourg

| NV AstraZeneca SA |
| --- |
| Rue Egide Van Ophemstraat 110 |
| 1180 Brussel |
| Belgium |

NV AstraZeneca SA

Rue Egide Van Ophemstraat 110

1180 Brussel

Belgium

Meronem IV 500 mg

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Luxembourg

| NV AstraZeneca SA |
| --- |
| Rue Egide Van Ophemstraat 110 |
| 1180 Brussel |
| Belgium |

NV AstraZeneca SA

Rue Egide Van Ophemstraat 110

1180 Brussel

Belgium

Meronem IV 1 g

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Malta

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem IV 0,5 g powder for solution for injection or infusion.

0,5 g

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Malta

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem IV 1 g powder for solution for injection or infusion.

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Netherlands

| AstraZeneca BV |
| --- |
| at the Louis Pasteurlaan 5 |
| 2719 EE, Zoetermeer, Netherlands |

AstraZeneca BV

at the Louis Pasteurlaan 5

2719 EE, Zoetermeer, Netherlands

Meronem i.v.

250 mg

Powder for solution for injection or infusion

Intravenous use

In the process of being cancelled

Netherlands

| AstraZeneca BV |
| --- |
| at the Louis Pasteurlaan 5 |
| 2719 EE, Zoetermeer, Netherlands |

AstraZeneca BV

at the Louis Pasteurlaan 5

2719 EE, Zoetermeer, Netherlands

Meronem i.v.

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Netherlands

| AstraZeneca BV |
| --- |
| at the Louis Pasteurlaan 5 |
| 2719 EE, Zoetermeer, Netherlands |

AstraZeneca BV

at the Louis Pasteurlaan 5

2719 EE, Zoetermeer, Netherlands

Meronem i.v.

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Norway

| AstraZeneca AS |
| --- |
| Hoffsveien 70 |
| B/Postboks 200 |
| Vinderen |
| 0319 OSLO |
| Norway |

AstraZeneca AS

Hoffsveien 70

B/Postboks 200

Vinderen

0319 OSLO

Norway

Meronem

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Norway

| AstraZeneca AS |
| --- |
| Hoffsveien 70 |
| B/Postboks 200 |
| Vinderen |
| 0319 OSLO |
| Norway |

AstraZeneca AS

Hoffsveien 70

B/Postboks 200

Vinderen

0319 OSLO

Norway

Meronem

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Poland

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem

500 mg

Powder for solution for injection

Intravenous use

500 mg/20 ml

Poland

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem

1 g

Powder for solution for injection

Intravenous use

1 g/30 ml

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, n.o 7, Valejas |
| 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Valejas

2745-663 Barcarena, Portugal

Meronem

500 mg

Powder for solution for injection

Intramuscular use

500 mg/2 ml

(not marketed)

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, n.o 7, Valejas |
| 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Valejas

2745-663 Barcarena, Portugal

Meronem

500 mg

Powder for solution infusion

Intravenous use

500 mg/20 ml

Portugal

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, n.o 7, Valejas |
| 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Valejas

2745-663 Barcarena, Portugal

Meronem

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Romania

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Meronem i.v. 500 mg

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Romania

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Meronem i.v. 1 g

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Slovak Republic

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

United Kingdom

Meronem 500 mg i.v.

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Slovenia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Meronem 500 mg prasek za raztopino za injiciranje ali infundiranje

500 mg

Powder for solution for injection or infusion

Intravenous use

50 mg/ml

Slovenia

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Meronem 1 g prasek za raztopino za injiciranje ali infundiranje

1 g

Powder for solution for injection or infusion

Intravenous use

50 mg/ml

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache |
| 56 Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache

56 Edificio Roble

28033 Madrid

Spain

Meronem I.V., 500

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

Spain

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache |
| 56 Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache

56 Edificio Roble

28033 Madrid

Spain

Meronem I.V., 1 000

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje |
| Sweden |

AstraZeneca AB

151 85 Södertälje

Sweden

Meronem

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/10 ml

for injection or variable concentration for infusion

Sweden

| AstraZeneca AB |
| --- |
| 151 85 Södertälje |
| Sweden |

AstraZeneca AB

151 85 Södertälje

Sweden

Meronem

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/20 ml

for injection or variable concentration for infusion

United Kingdom

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Meronem IV 500 mg

500 mg

Powder for solution for injection or infusion

Intravenous use

500 mg/20 ml

United Kingdom

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Meronem IV 1 g

1 g

Powder for solution for injection or infusion

Intravenous use

1 g/30 ml

---

ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Member State

Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Pulmotil AC

Oral solution

Tilmicosin 250 mg/ml

Chickens

Turkeys

Pigs

Calves

Oral

Belgium

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgium

Pulmotil AC

Oral solution

Tilmicosin 250 mg/ml

Chickens

Turkeys

Pigs

Calves

Oral

Cyprus

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Oral solution

Tilmicosin

250 mg/ml

Chickens

Pigs

Oral

Czech Republic

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC sol. ad us. vet.

Oral solution

Tilmicosin

250 mg/ml

Chickens (broilers)

Pigs

Calves

Oral

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil AC

Oral solution

Tilmicosin 250 mg/ml

Cattle (calves)

Pigs for fattening

Chickens

Oral

Greece

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Oral solution

Tilmicosin 250 mg/ml

Chickens

Turkeys

Pigs

Calves

Oral

Spain

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Spain |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Spain

PULMOTIL AC

Oral solution

Tilmicosin 250 mg/ml

Pigs

Poultry (except laying hens)

Turkeys

Cattle

Oral

France

| Lilly France SA |
| --- |
| Départament Elanco Santé Animale |
| 13 Rue Pagès |
| 92158 Suresnes Cedex |
| France |

Lilly France SA

Départament Elanco Santé Animale

13 Rue Pagès

92158 Suresnes Cedex

France

PULMOTIL AC

Oral solution

Tilmicosin 250 mg/ml

Pigs

Calves

Chickens

Turkeys

Oral

Hungary

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC oral solution

Oral solution

Tilmicosin 250 mg/ml

Cattle (calf)

Pigs

Chickens

Turkeys

Oral

Ireland

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil AC

Oral Solution

Tilmicosin 250 mg/ml

Chicken

Turkeys

Pigs

Oral

United Kingdom

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil AC

Oral solution

Tilmicosin 250 mg/ml

Chickens

Turkeys

Oral

Italy

| Eli Lilly Italia |
| --- |
| Elanco Animal Health |
| Via A. Gramsci, 731-733 |
| 50019 Sesto Fiorentino |
| Florence |
| Italia |

Eli Lilly Italia

Elanco Animal Health

Via A. Gramsci, 731-733

50019 Sesto Fiorentino

Florence

Italia

Pulmotil AC

Oral Solution

Tilmicosin 250 mg/ml

Chickens

Turkeys

Pigs

Calves

Oral

Luxembourg

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgium

Pulmotil AC

Oral Solution

Tilmicosin 250 mg/ml

Chickens

Turkeys

Pigs

Calves

Oral

The Netherlands

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| The Netherlands |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

Pulmotil AC

Oral solution

Tilmicosin 250 mg/ml

Chicken

Turkey

Pig

Calves

Oral

Portugal

| Lilly Portugal - Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugal |

Lilly Portugal - Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugal

Pulmotil AC

Oral Solution

Tilmicosin 250 mg/ml

Chickens

Turkeys

Pigs

Calves

Oral

Poland

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Oral solution

Tilmicosin 250 mg/ml

Chickens

Pigs

Calves

Oral

Slovak Republic

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Oral solution

Tilmicosin 250 mg/ml

Chickens

Pigs

Calves

Oral

Romania

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Oral solution

Tilmicosin 250 mg/ml

Pigs

Broilers

Calves

Oral

---

ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATE

40 g tilmicosin per 1 000 g

| Member State | Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Belgium | Eli Lilly Benelux N.V. |
| Elanco Animal Health |
| Rue de l’Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Member State

Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Route of administration

Belgium

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52

Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 40 VET Premix

Premix for medicated feeding stuff

40 g tilmicosin per 1 000 g

Pigs

Oral

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 40 AMV

Premix for medicated feeding stuff

40 g tilmicosin per 1 000 g

Pigs

Oral

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 40 Granulat

Premix for medicated feeding stuff

40 g tilmicosin per 1 000 g

Pigs

Oral

Denmark

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Denmark |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Denmark

Pulmotil Vet

Premix for medicated feeding stuff

40 g tilmicosin per 1 000 g

Pigs

Oral

Spain

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Spain |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Spain

PULMOTIL 40

Premix for medicated feeding stuff

40 g tilmicosin per 1 000 g

Pigs

Oral

France

| Lilly France SA |
| --- |
| Départament Elanco Santé Animale |
| 13 Rue Pagès |
| 92158 Suresnes Cedex |
| France |

Lilly France SA

Départament Elanco Santé Animale

13 Rue Pagès

92158 Suresnes Cedex

France

Pulmotil Tilmicosine 40 Porcins

Premix for medicated feeding stuff

40 g tilmicosin per 1 000 g

Pigs

Oral

Ireland

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G40 Premix

Premix for medicated feeding stuff

40 g tilmicosin per 1 000 g

Pigs

Oral

The Netherlands

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| The Netherlands |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

Pulmotil G40 premix

Premix for medicated feeding stuff

40 g tilmicosin per 1 000 g

Pigs

Oral

Portugal

| Lilly Portugal — Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugal |

Lilly Portugal — Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugal

PULMOTIL G40 Pré Mistura para alimento medicamentoso

Premix for medicated feeding stuff

40 g tilmicosin per 1 000 g

Pigs

Oral

100 g tilmicosin per 1 000 g

| Member State | Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Member State

Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

PULMOTIL Prämix 10 % — Granulat für Schweine

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Belgium

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l’Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52

Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 100 VET Premix

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Belgium

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l’Etuve 52-Bte |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52-Bte

Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 100 Granules

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 100 AMV

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 100

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Denmark

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Denmark |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Denmark

Pulmotil Vet

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Denmark

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Denmark |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Denmark

Pulmotil Vet Oralt pulver

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Spain

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Spain |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Spain

PULMOTIL 100

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Ireland

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G100 Premix

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Italy

| Eli Lilly Italia |
| --- |
| Elanco Animal Health |
| Via A. Gramsci, 731-733 |
| 50019 Sesto Fiorentino |
| Florence |
| Italia |

Eli Lilly Italia

Elanco Animal Health

Via A. Gramsci, 731-733

50019 Sesto Fiorentino

Florence

Italia

PULMOTIL G100 PREMIX

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Luxembourg

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 100 Vet Premix

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

The Netherlands

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| The Netherlands |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

Pulmotil G100 premix

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

Portugal

| Lilly Portugal — Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugal |

Lilly Portugal — Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugal

PULMOTIL G100 Pré Mistura para alimento medicamentoso

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

United Kingdom

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G100 Premix

Premix for medicated feeding stuff

100 g tilmicosin per 1 000 g

Pigs

Oral

200 g tilmicosin per 1 000 g

| Member State | Marketing Authorisation Holder | Invented name | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Member State

Marketing Authorisation Holder

Invented name

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Pulmotil Prämix 20 %

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs, Rabbit

Oral

Belgium

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l’Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52

Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 200 VET Premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs, Rabbits

Oral

Czech Republic

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

PULMOTIL 200 prm. ad us. vet.

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Cyprus

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil G200

Premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 20 % AMV

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Germany

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 20 %

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Denmark

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Denmark |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Denmark

Pulmotil Vet

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Greece

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil 200 medicated premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Spain

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Spain |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Spain

PULMOTIL 200

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Hungary

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil G 200 premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Ireland

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G200 Premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Italy

| Eli Lilly Italia |
| --- |
| Elanco Animal Health |
| Via A. Gramsci, 731-733 |
| 50019 Sesto Fiorentino |
| Florence |
| Italia |

Eli Lilly Italia

Elanco Animal Health

Via A. Gramsci, 731-733

50019 Sesto Fiorentino

Florence

Italia

PULMOTIL G200 PREMIX

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs, Rabbits

Oral

Latvia

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil 200 premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Luxembourg

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 200 Vet Premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs, Rabbits

Oral

The Netherlands

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| The Netherlands |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

Pulmotil G200 premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Poland

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmontil 200

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Portugal

| Lilly Portugal — Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugal |

Lilly Portugal — Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugal

PULMOTIL G200 Pré Mistura para alimento medicamentoso

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Romania

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil 200 Vet Premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

Slovak Republic

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

PULMOTIL G 200

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Fattening pigs

Oral

United Kingdom

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G200 Premix

Premix for medicated feeding stuff

200 g tilmicosin per 1 000 g

Pigs

Oral

---

ANNEX IX

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

| Member State | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 100 mg - Tabletten | 100 mg | Tablet | oral use |
| Austria | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 100 mg - Granulat | 100 mg | Granules for oral suspension | oral use |
| Austria | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 100 mg - Suppositorien | 100 mg | Suppository | rectal use |
| Austria | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 200 mg - Suppositorien | 200 mg | Suppository | rectal use |
| Austria | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 100 mg - Tabletten | 100 mg | Tablet | oral use |
| Austria | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 100 mg - Granulat | 100 mg | Granules for oral suspension | oral use |
| Austria | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 100 mg - Suppositirien | 100 mg | Suppository | rectal use |
| Austria | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 200 mg - Suppositorien | 200 mg | Suppository | rectal use |
| Belgium | THERABEL PHARMA S.A., |
| Rue E.Van Ophem, 108 B-1180 Uccle |

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 100 mg - Tabletten

100 mg

Tablet

oral use

Austria

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 100 mg - Granulat

100 mg

Granules for oral suspension

oral use

Austria

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 100 mg - Suppositorien

100 mg

Suppository

rectal use

Austria

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 200 mg - Suppositorien

200 mg

Suppository

rectal use

Austria

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 100 mg - Tabletten

100 mg

Tablet

oral use

Austria

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 100 mg - Granulat

100 mg

Granules for oral suspension

oral use

Austria

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 100 mg - Suppositirien

100 mg

Suppository

rectal use

Austria

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 200 mg - Suppositorien

200 mg

Suppository

rectal use

Belgium

THERABEL PHARMA S.A.,

Rue E.Van Ophem, 108 B-1180 Uccle

AULIN 100 MG

100 mg

Tablet

oral use

Belgium

| THERABEL PHARMA S.A., |
| --- |
| Rue E.Van Ophem, 108 B-1180 Uccle |

THERABEL PHARMA S.A.,

Rue E.Van Ophem, 108 B-1180 Uccle

AULIN 100 MG

100 mg

Granules for oral suspension

oral use

Belgium

| THERABEL PHARMA S.A., |
| --- |
| Rue E.Van Ophem, 108 B-1180 Uccle |

THERABEL PHARMA S.A.,

Rue E.Van Ophem, 108 B-1180 Uccle

MESULID

100 mg

Granules for oral suspension

oral use

Belgium

| THERABEL PHARMA S.A., |
| --- |
| Rue E.Van Ophem, 108 B-1180 Uccle |

THERABEL PHARMA S.A.,

Rue E.Van Ophem, 108 B-1180 Uccle

MESULID 100 MG

100 mg

Tablet

oral use

Bulgaria

Tchaika Pharma Sofia 1172 1, G. M. Dimitrov Blvd

AllGone

100 mg

Effervescent tablet

oral use

Bulgaria

Sopharma Sofia 122016, Iliensko shosse

Ameolin

100 mg

Tablet

oral use

Bulgaria

CSC Pharmaceuticals Sofia 159210, Assen Jordanov street

100 mg

Tablet

oral use

Bulgaria

CSC Pharmaceuticals Sofia 159210, Assen Jordanov street

Aulin 100

100 mg

Granules

oral use

Bulgaria

Inbioteh Sofia 1000 5, Triaditza street ‘Sofia palace’

Biolin

100 mg

Tablet

oral use

Bulgaria

ZentivaSofia 140725, N.Vaptzarov Blvd

Coxtral

100 mg

Tablet

oral use

Bulgaria

Actavis Sofia 1000 2, Kniaginia Maria Luisa Blvd

Enetra

100 mg

Tablet

oral use

Bulgaria

Medochemie Sofia 111320, Fr. Jolio Currie street

Aponil

100 mg

Tablet

oral use

Bulgaria

CSC Pharmaceuticals Sofia 159210, Assen Jordanov street

Nimed

100 mg

Tablet

oral use

Bulgaria

Laboratori Guidotti S.p.A.(Menarini Group) Sofia 111317, Kosta Lultchev street

Nimesil

100 mg

Granules

oral use

CZ - Czech Republic

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Czech Republic |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Czech Republic

AULIN

100 mg

Granules for oral solution

Oral use

CZ - Czech Republic

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Czech Republic |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Czech Republic

AULIN

100 mg

Tablet

Oral use

CZ - Czech Republic

| ZENTIVA, a.s. |
| --- |
| Empiria Palace |
| Na strži 63 |
| 140 62 Praha 4, Czech Republic |

ZENTIVA, a.s.

Empiria Palace

Na strži 63

140 62 Praha 4, Czech Republic

COXTRAL 100 MG TABLETY

100 mg

Tablet

Oral use

CZ - Czech Republic

CSC Pharmaceuticals Handels GmbH Gewerbestrasse 18-20 A-2102 Bisamberg, Austria

MESULID

100 mg

Granules for oral solution

Oral use

CZ - Czech Republic

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Czech Republic |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Czech Republic

NIMED

100 mg

Tablet

Oral use

CZ - Czech Republic

| LABORATORI GUIDOTTI S.p.A., Via Livornese 897, |
| --- |
| I - 56010 La Vettola, PISA, Italy |

LABORATORI GUIDOTTI S.p.A., Via Livornese 897,

I - 56010 La Vettola, PISA, Italy

NIMESIL

100 mg

Granules for oral suspension

Oral use

Cyprus

MEDOCHEMIE LTD, POBOX 51409, 3505 LEMESOS, CYPRUS

APONIL

100 mg

Tablet

ORAL

Cyprus

CDL PHARMACEUTICAL LTD, POBOX 40981, 6308 LARNACA, CYPRUS

ELINAP

100 mg

Tablet

ORAL

Cyprus

CHR. K. UNIMED LTD, 21 DAVLOU, PLATI, 2114 AGLANTZIA, LEFKOSIA, CYPRUS

FLOGOSTOP

100 mg

Tablet

ORAL

Cyprus

PT HADJIGEORGIOU CO LTD, POBOX 53158, 3301 LEMESOS, CYPRUS

NIMELIDE

100 mg

Tablet

ORAL

Cyprus

CODAL SYNTO LTD, POBOX 51785, 3508 LEMESOS, CYPRUS

NIMM

100 mg

Tablet

ORAL

Cyprus

THE STAR MEDICINES IMPORTERS & CO LTD, POBOX 50151, 3601 LEMESOS, CYPRUS

RITAMINE

100 mg

Tablet

ORAL

Cyprus

COSMED HOLDINGS LTD, P.O.BOX 42145, 6531 LARNACA, CYPRUS

SPECILID

100 mg

Tablet

ORAL

Estonia

| Zentiva a.s. U Kabelovny 130 |
| --- |
| Dolni Mecholupy |
| 102 37 Praque 10 |

Zentiva a.s. U Kabelovny 130

Dolni Mecholupy

102 37 Praque 10

COXTRAL

100 mg

Tablet

oral use

France

| THERABEL LUCIEN PHARMA |
| --- |
| 123 rue Jules Guesde |
| 92309 LEVALLOIS-PERRET Cedex |
| France |

THERABEL LUCIEN PHARMA

123 rue Jules Guesde

92309 LEVALLOIS-PERRET Cedex

France

NEXEN

100 mg

Tablet

Oral

France

| THERABEL LUCIEN PHARMA |
| --- |
| 123 rue Jules Guesde |
| 92309 LEVALLOIS-PERRET Cedex |
| France |

THERABEL LUCIEN PHARMA

123 rue Jules Guesde

92309 LEVALLOIS-PERRET Cedex

France

NEXEN

100 mg

Granules for oral solution

Oral

France

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| DUBLIN 15 |
| IRELAND |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

DUBLIN 15

IRELAND

OXETIAN

100 mg

Tablet

Oral

France

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| DUBLIN 15 |
| IRELAND |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

DUBLIN 15

IRELAND

OXETIAN

100 mg

Granules for oral solution

Oral

Greece

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| 5TH Km PAEANIAS-MARKOPOULO AVENUE |
| KOROPI, ATTIKIS, 19400 |

BOEHRINGER INGELHEIM HELLAS S.A.

5TH Km PAEANIAS-MARKOPOULO AVENUE

KOROPI, ATTIKIS, 19400

MESULID

100 mg

Tablet

ORAL

Greece

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| 5TH Km PAEANIAS-MARKOPOULO AVENUE |
| KOROPI, ATTIKIS, 19400 |

BOEHRINGER INGELHEIM HELLAS S.A.

5TH Km PAEANIAS-MARKOPOULO AVENUE

KOROPI, ATTIKIS, 19400

MESULID

200 mg

Suppository

RECTAL

Greece

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| 5TH Km PAEANIAS-MARKOPOULO AVENUE |
| KOROPI, ATTIKIS, 19400 |

BOEHRINGER INGELHEIM HELLAS S.A.

5TH Km PAEANIAS-MARKOPOULO AVENUE

KOROPI, ATTIKIS, 19400

MESULID

100 mg

Granules for oral solution

ORAL

Greece

| FARMEDIA A.E. |
| --- |
| ATHINAS 22 & APOLLONOS |
| GERAKAS, ATTIKIS, 15344 |

FARMEDIA A.E.

ATHINAS 22 & APOLLONOS

GERAKAS, ATTIKIS, 15344

MULTIFORMIL

100 mg

Tablet

ORAL

Greece

| PHARMATHEN INTERNATIONAL S.A. GREECE, |
| --- |
| DERVENAKIWN 4, PALLINI, ATTIKIS 15351 |

PHARMATHEN INTERNATIONAL S.A. GREECE,

DERVENAKIWN 4, PALLINI, ATTIKIS 15351

BIOXIDOL

100 mg

Tablet

ORAL

Greece

| ALET PHARMACEUTICALS |
| --- |
| M. ALEXANDER 121, AGIA VARVARA, 12351 |

ALET PHARMACEUTICALS

M. ALEXANDER 121, AGIA VARVARA, 12351

SPECILID

100 mg

Tablet

ORAL

Greece

| BIOSPRAY ABEE |
| --- |
| 18TH Km MARATHONOS AVENUE, PALLINI, 15344 |

BIOSPRAY ABEE

18TH Km MARATHONOS AVENUE, PALLINI, 15344

FLOGOSTOP

100 mg

Tablet

ORAL

Greece

| BIOMEDICA-CHEMICA A.E. |
| --- |
| G. LYRA 25, KATW KIFISSIA |

BIOMEDICA-CHEMICA A.E.

G. LYRA 25, KATW KIFISSIA

NIMESULIDE/BIOMEDICA CHEMICA

100 mg

Tablet

ORAL

Greece

| LEOVAN, M. LEWN & SIA EE |
| --- |
| ARGONAFTWN 22, ARGYROUPOLI, 16452 |

LEOVAN, M. LEWN & SIA EE

ARGONAFTWN 22, ARGYROUPOLI, 16452

RISTOLZIT

100 mg

Tablet

ORAL

Greece

| NORMA HELLAS A.E. |
| --- |
| MENANDROU 54, ATHENS, 10431 |

NORMA HELLAS A.E.

MENANDROU 54, ATHENS, 10431

MYXINA

100 mg

Tablet

ORAL

Greece

| GENEPHARM A.E. |
| --- |
| 18TH Km MARATHONOS AVENUE, PALLINI, ATTIKIS, 15351 |

GENEPHARM A.E.

18TH Km MARATHONOS AVENUE, PALLINI, ATTIKIS, 15351

NIMELIDE

100 mg

Tablet

ORAL

Greece

| BROS EPE |
| --- |
| AVGIS & GALLINIS 15, N. KIFISSIA |

BROS EPE

AVGIS & GALLINIS 15, N. KIFISSIA

DISCORID

100 mg

Tablet

ORAL

Greece

| RAFARM AEBE |
| --- |
| KORINTHOU 12, N. PSYCHIKO, 15451 |

RAFARM AEBE

KORINTHOU 12, N. PSYCHIKO, 15451

VENTOR

100 mg

Tablet

ORAL

Greece

| RAFARM AEBE |
| --- |
| KORINTHOU 12, N. PSYCHIKO, 15451 |

RAFARM AEBE

KORINTHOU 12, N. PSYCHIKO, 15451

VENTOR

100 mg

Granules for oral solution

ORAL

Greece

| ARMEDICA A.E. |
| --- |
| AGIAS MARKELLIS 17, ATHENS, 11855 |

ARMEDICA A.E.

AGIAS MARKELLIS 17, ATHENS, 11855

ALENCAST

100 mg

Tablet

ORAL

Greece

| GAP A.E. |
| --- |
| AGISILAOU 46, AGIOS DIMITRIOS, 17341 |

GAP A.E.

AGISILAOU 46, AGIOS DIMITRIOS, 17341

G-REVM

100 mg

Tablet

ORAL

Greece

| VIOFAR EPE |
| --- |
| ETHNIKIS ANTISTASEOS & TRIFYLLIAS, AHARNAI, 13671 |

VIOFAR EPE

ETHNIKIS ANTISTASEOS & TRIFYLLIAS, AHARNAI, 13671

VOLONTEN

100 mg

Tablet

ORAL

Greece

| KLEVA EPE |
| --- |
| PARNITHOS AVENUE 189, |
| AHARNAI, ATTIKIS, 13671 |

KLEVA EPE

PARNITHOS AVENUE 189,

AHARNAI, ATTIKIS, 13671

ELINAP

100 mg

Powder for oral solution

ORAL

Greece

| KLEVA EPE |
| --- |
| PARNITHOS AVENUE 189, |
| AHARNAI, ATTIKIS, 13671 |

KLEVA EPE

PARNITHOS AVENUE 189,

AHARNAI, ATTIKIS, 13671

ELINAP

100 mg

Tablet

ORAL

Greece

| MINERVA PHARMAKEFTIKI A.E. |
| --- |
| KIFISSOU AVENUE 132, PERISTERI, 12131 |

MINERVA PHARMAKEFTIKI A.E.

KIFISSOU AVENUE 132, PERISTERI, 12131

MIN-A-PON

100 mg

Tablet

ORAL

Greece

| ANFARM HELLAS A.E. |
| --- |
| K. PALEOLOGOU & PERIKLEOUS 27, HALANDRI, 15232 |

ANFARM HELLAS A.E.

K. PALEOLOGOU & PERIKLEOUS 27, HALANDRI, 15232

LEMESIL

100 mg

Tablet

ORAL

Greece

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| MARATHONOS AVENUE 95, PIKERMI, 19009 |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

MARATHONOS AVENUE 95, PIKERMI, 19009

ROLAKET

100 mg

Tablet

ORAL

Greece

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| MARATHONOS AVENUE 95, PIKERMI, 19009 |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

MARATHONOS AVENUE 95, PIKERMI, 19009

ROLAKET

200 mg

Suppository

RECTAL

Greece

| ANTOR EPE |
| --- |
| P. MAVROMIHALI 1, VRILISSIA, 15235 |

ANTOR EPE

P. MAVROMIHALI 1, VRILISSIA, 15235

MELIMONT

100 mg

Tablet

ORAL

Greece

| HELP ABEE |
| --- |
| VALAORITOU 10, METAMORFOSI, ATTIKIS, 14452 |

HELP ABEE

VALAORITOU 10, METAMORFOSI, ATTIKIS, 14452

MOSUOLIT

100 mg

Tablet

ORAL

Greece

| FINIXFARM EPE |
| --- |
| DERVENAKION 38 & SAHINI, GERAKAS, 15344 |

FINIXFARM EPE

DERVENAKION 38 & SAHINI, GERAKAS, 15344

KARTAL

100 mg

Tablet

ORAL

Greece

| PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS |
| --- |
| DILOU 9, PERISTERI, ATTIKIS, 12134 |

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

DILOU 9, PERISTERI, ATTIKIS, 12134

FLADALGIN

100 mg

Tablet

ORAL

Greece

| REMEK PHARMACEUTICALS ABEE |
| --- |
| PENTELIS 34, PALAIO FALIRO, ATTIKIS, 17564 |

REMEK PHARMACEUTICALS ABEE

PENTELIS 34, PALAIO FALIRO, ATTIKIS, 17564

MESUPON

100 mg

Tablet

ORAL

Greece

| FARMANIC CHEMIPHARMA S.A. |
| --- |
| FYLIS 137, KAMATERO, ATTIKIS, 13451 |

FARMANIC CHEMIPHARMA S.A.

FYLIS 137, KAMATERO, ATTIKIS, 13451

CHEMISULIDE

100 mg

Tablet

ORAL

Greece

| REMEDINA ABEE |
| --- |
| GOUNARI 25 & AREOS, KAMATERO, ATTIKIS, 13451 |

REMEDINA ABEE

GOUNARI 25 & AREOS, KAMATERO, ATTIKIS, 13451

AMOCETIN

100 mg

Tablet

ORAL

Greece

| COSMOPHARM EPE |
| --- |
| P.O. BOX 42, KORINTHOS, 20100 |

COSMOPHARM EPE

P.O. BOX 42, KORINTHOS, 20100

LIZEPAT

100 mg

Tablet

ORAL

Greece

| DEMO ABEE |
| --- |
| 21ST Km NATIONAL HIGHWAY ATHENS-LAMIA, 14565 |

DEMO ABEE

21ST Km NATIONAL HIGHWAY ATHENS-LAMIA, 14565

RITAMINE

100 mg

Tablet

ORAL

Greece

| BALU EPE |
| --- |
| 30 Km ATHENS-LAVRION, MARKOPOULO |

BALU EPE

30 Km ATHENS-LAVRION, MARKOPOULO

NIBERAN

100 mg

Tablet

ORAL

Greece

| SANDOZ GMBH, KUNDL, AUSTRIA |
| --- |
| BIOCHEMIESTRASSE 10, A-6250, KUNDL AUSTRIA |

SANDOZ GMBH, KUNDL, AUSTRIA

BIOCHEMIESTRASSE 10, A-6250, KUNDL AUSTRIA

NIMESULIDE / HEXAL

100 mg

Tablet

ORAL

Greece

| SANDOZ GMBH, KUNDL, AUSTRIA |
| --- |
| BIOCHEMIESTRASSE 10, A-6250, KUNDL AUSTRIA |

SANDOZ GMBH, KUNDL, AUSTRIA

BIOCHEMIESTRASSE 10, A-6250, KUNDL AUSTRIA

NIMESULIDE / HEXAL

100 mg

Powder for oral solution

ORAL

Greece

| VELKA HELLAS AEBE |
| --- |
| KAPODISTRIOU & KORINTHOU 12, NEO PSYCHIKO, 15451 |

VELKA HELLAS AEBE

KAPODISTRIOU & KORINTHOU 12, NEO PSYCHIKO, 15451

NAOFID

100 mg

Tablet

ORAL

Greece

| DOCTUM A.E. K.T. GIOKARIS & SIA |
| --- |
| 1 Km PAEANIAS-MARKOPOULOU AVENUE, PAEANIA, ATTIKIS, 19002 |

DOCTUM A.E. K.T. GIOKARIS & SIA

1 Km PAEANIAS-MARKOPOULOU AVENUE, PAEANIA, ATTIKIS, 19002

ERLECIT

100 mg

Tablet

ORAL

Greece

| VOCATE PHARMAKEFTIKI A.E. |
| --- |
| GOUNARI 150, GLYFADA, 16674 |

VOCATE PHARMAKEFTIKI A.E.

GOUNARI 150, GLYFADA, 16674

TRANZICALM

100 mg

Tablet

ORAL

Greece

| MEDICHROM A.E. |
| --- |
| 6 Km MARKOPOULOU-KOROPI AVENUE, MARKOPOULO, MESOGEION, 19003 |

MEDICHROM A.E.

6 Km MARKOPOULOU-KOROPI AVENUE, MARKOPOULO, MESOGEION, 19003

NIMESUL

100 mg

Tablet

ORAL

Greece

| FARAN ABEE |
| --- |
| PRODUCTION AND TRADING MEDICINES |
| AVEROF 19A, ATHENS, 10433 |

FARAN ABEE

PRODUCTION AND TRADING MEDICINES

AVEROF 19A, ATHENS, 10433

AFLOGEN

100 mg

Tablet

ORAL

Greece

| GEROLYMATOS P.N. AEBE |
| --- |
| ASKLEPIOU, KRYONERI, ATTIKIS |

GEROLYMATOS P.N. AEBE

ASKLEPIOU, KRYONERI, ATTIKIS

EDRIGYL

100 mg

Tablet

ORAL

Greece

| GEROLYMATOS P.N. AEBE |
| --- |
| ASKLEPIOU, KRYONERI, ATTIKIS |

GEROLYMATOS P.N. AEBE

ASKLEPIOU, KRYONERI, ATTIKIS

EDRIGYL

100 mg

Granules for oral solution

ORAL

Greece

| GEROLYMATOS P.N. AEBE |
| --- |
| ASKLEPIOU, KRYONERI, ATTIKIS |

GEROLYMATOS P.N. AEBE

ASKLEPIOU, KRYONERI, ATTIKIS

EDRIGYL

200 mg

Suppository

RECTAL

Greece

| S.J.A. PHARM O.E. |
| --- |
| ARKOLEON 11, KATO PATISSIA, 10445 |

S.J.A. PHARM O.E.

ARKOLEON 11, KATO PATISSIA, 10445

CLIOVYL

100 mg

Tablet

ORAL

Greece

| COUP ABEE |
| --- |
| AGIAS VARVARAS 53-55, DAFNI, ATHENS, 17235 |

COUP ABEE

AGIAS VARVARAS 53-55, DAFNI, ATHENS, 17235

MELICAT

100 mg

Tablet

ORAL

Greece

| PHARMACYPRIA HELLAS A.E. |
| --- |
| PASTER 6, AMPELOKIPOI, 11521 |

PHARMACYPRIA HELLAS A.E.

PASTER 6, AMPELOKIPOI, 11521

LALIDE

100 mg

Tablet

ORAL

Greece

| PHARMACYPRIA HELLAS A.E. |
| --- |
| PASTER 6, AMPELOKIPOI, 11521 |

PHARMACYPRIA HELLAS A.E.

PASTER 6, AMPELOKIPOI, 11521

LALIDE

50 mg /5 ml

Oral suspension

ORAL

Greece

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

100 mg

Tablet

ORAL

Greece

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

100 mg

Effervescent tablets

ORAL

Greece

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

100 mg

Granules for oral solution

ORAL

Greece

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

200 mg

Suppository

RECTAL

Greece

| EVAGGELOS KALOFOLIAS & SIA O.E. |
| --- |
| MENANDROU 54, ATHENS, 10431 |

EVAGGELOS KALOFOLIAS & SIA O.E.

MENANDROU 54, ATHENS, 10431

ALGOVER

100 mg

Tablet

ORAL

Greece

| FARMILIA E.E. |
| --- |
| FAVIEROU 48, ATHENS |

FARMILIA E.E.

FAVIEROU 48, ATHENS

AUROMELID

100 mg

Tablet

ORAL

Greece

| AURORA PHARMACEUTICALS EPE |
| --- |
| EVROU & MESSINIAS, GERAKAS, 15344 |

AURORA PHARMACEUTICALS EPE

EVROU & MESSINIAS, GERAKAS, 15344

SUDINET

100 mg

Tablet

ORAL

Greece

| LEOVAN M. LEON & SIA E.E. |
| --- |
| ARGONAFTON 22, ARGYROUPOLI, 16452 |

LEOVAN M. LEON & SIA E.E.

ARGONAFTON 22, ARGYROUPOLI, 16452

LASAZIN

100 mg

Tablet

ORAL

Greece

| PHARMACHEM EPE |
| --- |
| YMITOU 73, VRILISSIA, ATTIKIS, 15235 |

PHARMACHEM EPE

YMITOU 73, VRILISSIA, ATTIKIS, 15235

NIMESULIDE / PHARMACHEM

100 mg

Tablet

ORAL

Greece

| ANTONIOS POLYCHRONIS OF MARINOU |
| --- |
| IONIAS 29, NEO PSYCHIKO, 15451 |

ANTONIOS POLYCHRONIS OF MARINOU

IONIAS 29, NEO PSYCHIKO, 15451

OMNIBUS

100 mg

Tablet

ORAL

Greece

| ZWITTER PHARMACEUTICALS EPE, GREECE |
| --- |
| PENTELIS AVENUE 34-36, ATHENS, 15234 |

ZWITTER PHARMACEUTICALS EPE, GREECE

PENTELIS AVENUE 34-36, ATHENS, 15234

RHEMID

100 mg

Tablet

ORAL

Greece

| MED-ONE S.A., HELLAS |
| --- |
| PARNITHOS AVENUE 211, AHARNAI, 13671 |

MED-ONE S.A., HELLAS

PARNITHOS AVENUE 211, AHARNAI, 13671

ALGOSULID

100 mg

Tablet

ORAL

Greece

| MED-ONE S.A., HELLAS |
| --- |
| PARNITHOS AVENUE 211, AHARNAI, 13671 |

MED-ONE S.A., HELLAS

PARNITHOS AVENUE 211, AHARNAI, 13671

ALGOSULID

100 mg

Powder for oral solution

ORAL

Greece

| LAMDA PHARMAKEFTIKI A.E. |
| --- |
| EVRIPIDOU 18, ATHENS, 10559 |

LAMDA PHARMAKEFTIKI A.E.

EVRIPIDOU 18, ATHENS, 10559

NIMESORAL

100 mg

Tablet

ORAL

Greece

| MEDARTE FARMAKEFTIKI ABEE |
| --- |
| SPYROU VRETTOU 10, METAMORFOSI, 14452 |

MEDARTE FARMAKEFTIKI ABEE

SPYROU VRETTOU 10, METAMORFOSI, 14452

NIMESULIDE / MEDICON

100 mg

Tablet

ORAL

Greece

| FARMAMUST EPE |
| --- |
| PANTAZOPOULOU SQUARE 7, KOLONOS, ATTIKIS, 10443 |

FARMAMUST EPE

PANTAZOPOULOU SQUARE 7, KOLONOS, ATTIKIS, 10443

LOVIREM

100 mg

Tablet

ORAL

Greece

| B.I. FARMA A.E. |
| --- |
| ARISTOTELOUS 79-81, ATHENS, 10434 |

B.I. FARMA A.E.

ARISTOTELOUS 79-81, ATHENS, 10434

NIMESULIDE / B.I. FARMA

100 mg

Tablet

ORAL

Greece

| LAVIPHARM HELLAS A.E. |
| --- |
| AGIAS MARINAS, PAEANIA, ATTIKIS, 19002 |

LAVIPHARM HELLAS A.E.

AGIAS MARINAS, PAEANIA, ATTIKIS, 19002

AULIN

100 mg

Tablet

ORAL

Greece

| LAVIPHARM HELLAS A.E. |
| --- |
| AGIAS MARINAS, PAEANIA, ATTIKIS, 19002 |

LAVIPHARM HELLAS A.E.

AGIAS MARINAS, PAEANIA, ATTIKIS, 19002

AULIN

200 mg

Suppository

RECTAL

Greece

| LAVIPHARM HELLAS A.E. |
| --- |
| AGIAS MARINAS, PAEANIA, ATTIKIS, 19002 |

LAVIPHARM HELLAS A.E.

AGIAS MARINAS, PAEANIA, ATTIKIS, 19002

AULIN

100 mg

Granules for oral solution

ORAL

Hungary

Chinoin Zrt.1045 Budapest, Tó u.1-5

Winsulid

100 mg

Granules

oral

Hungary

Chinoin Zrt.1045 Budapest, Tó u.1-5

Winsulid

100 mg

Tablet

oral

Hungary

Sanofi-Aventis 1045 Budapest, Tó u.1-5

Mesulid

100 mg

Granules

oral

Hungary

Sanofi-Aventis 1045 Budapest, Tó u.1-5

Mesulid

100 mg

Tablet

oral

Hungary

PannonPharma Gyógyszergyártó Kft. 1016 Budapest Derék u.2

Nimelid

100 mg

Tablet

oral

Hungary

Eurodrug Lab.BV 4032 Debrecen,Bartha Boldizsár u. 7

Nidol

100 mg

Tablet

oral

Hungary

Lab.Guidotti S.p.A. 2040 Budaörs,Terrapark, Neumann János u.1/B tömb, D ép

Xilox

100 mg

Granules

oral

Ireland

Helsinn Birex Pharm. Ltd. Damastown Mulhuddart Dublin 15 Ireland

Aulin

100 mg

Tablet

Oral

Ireland

Helsinn Birex Pharm. Ltd. Damastown Mulhuddart Dublin 15 Ireland

Aulin

100 mg

Granules

Oral

Ireland

Helsinn Birex Therapeutics Ltd. Damastown Mulhuddart Dublin 15 Ireland

Mesulid

100 mg

Tablet

Oral

Ireland

Helsinn Birex Therapeutics Ltd. Damastown Mulhuddart Dublin 15 Ireland

Mesulid

100 mg

Granules

Oral

Ireland

Pinewood Laboratories Ltd Ballymacarbry Clonmel Co. Tipperary Ireland

Mesine

100 mg

Tablet

Oral

Ireland

PCO Manufacturing Ltd. Unit 222 Western Industrial Estate, Naas Road, Dublin 12 Ireland

Aulin

100 mg

Tablet

Oral

Ireland

B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, United Kingdom

Aulin

100 mg

Granules

Oral

Ireland

B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, United Kingdom

Aulin

100 mg

Tablet

Oral

Italy

FRANCIA FARMAC.IND.FAR.BIO.SRL VIA DEI PESTAGALLI, 7 20138 MILANO

ALGIMESIL

100 mg

Granules

oral use

Italy

FRANCIA FARMAC.IND.FAR.BIO.SRL VIA DEI PESTAGALLI, 7 20138 MILANO

ALGIMESIL

100 mg

Tablet

oral use

Italy

SIAR PHARMA Srl, VIA VERDI 33, 20060 BUSSERO

ALGOLIDER

100 mg

Granules

oral use

Italy

SIAR PHARMA Srl, VIA VERDI 33, 20060 BUSSERO

ALGOLIDER

100 mg

Tablet

oral use

Italy

SELVI LABORAT.BIOTERAPICO SpA, VIA PROCOIO, 28, 00065 FIANO ROMANO

ANTALGO

100 mg

Granules

oral use

Italy

ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA

AREUMA

200 mg

Suppository

rectal use

Italy

ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA

AREUMA

100 mg

Granules

oral use

Italy

ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA

AREUMA

100 mg

Tablet

oral use

Italy

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN

200 mg

Suppository

rectal use

Italy

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN

100 mg

Granules

oral use

Italy

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN

100 mg

Tablet

oral use

Italy

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN BETA

400 mg

Granules

oral use

Italy

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN BETA

400 mg

Tablet

oral use

Italy

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN MITE

50 mg

Granules

oral use

Italy

AGIPS FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO

DELFOS

100 mg

Granules

oral use

Italy

AGIPS FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO

DELFOS

100 mg

Tablet

oral use

Italy

SARDA PHARMACEUTICA Srl, VIA CASTIGLIONE 92/B 09100 CAGLIARI

DIMESUL

100 mg

Granules

oral use

Italy

SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA

DOMES

100 mg

Granules

oral use

Italy

SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA

DOMES

100 mg

Tablet

oral use

Italy

SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA

DOMES

100 mg

Orodispersible tablet

oral use

Italy

SIFI SpA, VIA ERCOLE PATTI 36, 95020 LAVINAIO - ACI S.ANTONIO

EDEMAX

100 mg

Granules

oral use

Italy

SIFI SpA, VIA ERCOLE PATTI 36, 95020 LAVINAIO - ACI S.ANTONIO

EDEMAX

100 mg

Tablet

oral use

Italy

AESCULAPIUS FARMACEUTICI Srl,VIA COZZAGLIO, 24, 25125 BRESCIA

EFRIDOL

100 mg

Granules

oral use

Italy

AESCULAPIUS FARMACEUTICI Srl,VIA COZZAGLIO, 24, 25125 BRESCIA

EFRIDOL

100 mg

Tablet

oral use

Italy

I.B.N. SAVIO Srl, VIA E.BAZZANO, 14, 16019 RONCO SCRIVIA

EUDOLENE

100 mg

Granules

oral use

Italy

NCSN FARMACEUTICI Srl, VIA SVETONIO, 6, 00136 ROMA

FANSIDOL

100 mg

Granules

oral use

Italy

NCSN FARMACEUTICI Srl, VIA SVETONIO, 6, 00136 ROMA

FANSIDOL

100 mg

Capsule

oral use

Italy

SOFAR SpA, VIA ISONZO, 8, 20100 MILANO

FANSULIDE

100 mg

Granules

oral use

Italy

SOFAR SpA, VIA ISONZO, 8, 20100 MILANO

FANSULIDE

100 mg

Tablet

oral use

Italy

PRODOTTI FORMENTI Srl, VIA CORREGGIO, 43, 20149 MILANO

FLAMINIDE

100 mg

Granules

oral use

Italy

PRODOTTI FORMENTI Srl, VIA CORREGGIO, 43, 20149 MILANO

FLAMINIDE

100 mg

Tablet

oral use

Italy

C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO

FLOLID

100 mg

Suppository

rectal use

Italy

C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO

FLOLID

100 mg

Granules

oral use

Italy

C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO

FLOLID

100 mg

Tablet

oral use

Italy

ALMUS Srl, VIA CESAREA, 11/10, 16121 GENOVA

IDEALID

100 mg

Tablet

oral use

Italy

MAGIS FARMACEUTICI SpA, VIA CACCIAMALI, 34-36-38/B, 25125 BRESCIA

ISODOL

100 mg

Granules

oral use

Italy

MAGIS FARMACEUTICI SpA, VIA CACCIAMALI, 34-36-38/B, 25125 BRESCIA

ISODOL

100 mg

Tablet

oral use

Italy

BONISCONTRO & GAZZONE Srl, VIA PAVIA,6, 20136 MILANO

LEDOREN

100 mg

Granules

oral use

Italy

BONISCONTRO & GAZZONE Srl, VIA PAVIA,6, 20136 MILANO

LEDOREN

100 mg

Tablet

oral use

Italy

ALTA CARE LAB.ITALIA Srl, VIALE DELLE MILIZIE, 134, 00192 ROMA

LIDERSOLV

100 mg

Granules

oral use

Italy

ALTA CARE LAB.ITALIA Srl, VIALE DELLE MILIZIE, 134, 00192 ROMA

LIDERSOLV

100 mg

Tablet

oral use

Italy

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID

200 mg

Suppository

rectal use

Italy

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID

100 mg

Granules

oral use

Italy

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID

100 mg

Tablet

oral use

Italy

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID FAST

400 mg

Granules

oral use

Italy

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID MITE

50 mg

Granules

oral use

Italy

NEW RESEARCH Srl, V.DELLA TENUTA DI TORRENOVA142, 00133 ROMA

NERELID

100 mg

Granules

oral use

Italy

NEW RESEARCH Srl, V.DELLA TENUTA DI TORRENOVA142, 00133 ROMA

NERELID

100 mg

Capsule

oral use

Italy

I.BIR.N Srl Ist.Biot.Nazionale, VIA VITTORIO GRASSI, 9/15, 00155 ROMA

NIDE

100 mg

Granules

oral use

Italy

I.BIR.N Srl Ist.Biot.Nazionale, VIA VITTORIO GRASSI, 9/15, 00155 ROMA

NIDE

100 mg

Capsule

oral use

Italy

MOLTENI & C. F.LLI ALITTI SpA, STR.STATALE 67, LOC.GRANATIERI, 50018 SCANDICCI

NIDEMOL

200 mg

Suppository

rectal use

Italy

MOLTENI & C. F.LLI ALITTI SpA, STR.STATALE 67, LOC.GRANATIERI, 50018 SCANDICCI

NIDEMOL

100 mg

Granules

oral use

Italy

ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO

NIMEDEX

400 mg

Granules

oral use

Italy

ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO

NIMEDEX

400 mg

Tablet

oral use

Italy

ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO

NIMEDEX

400 mg

Granules

oral use

Italy

KRUGHER PHARMA Srl, VIA VOLTURNO, 10/12, 50019 SESTO FIORENTINO

NIMENOL

100 mg

Granules

oral use

Italy

KRUGHER PHARMA Srl, VIA VOLTURNO, 10/12, 50019 SESTO FIORENTINO

NIMENOL

100 mg

Granules

oral use

Italy

LAB.GUIDOTTI SpA, VIA LIVORNESE, 89, 56010 LA VETTOLA - PISA

NIMESULENE

200 mg

Suppository

rectal use

Italy

LAB.GUIDOTTI SpA, VIA LIVORNESE, 89, 56010 LA VETTOLA - PISA

NIMESULENE

100 mg

Granules

oral use

Italy

LAB.GUIDOTTI SpA, VIA LIVORNESE, 89, 56010 LA VETTOLA - PISA

NIMESULENE

100 mg

Tablet

oral use

Italy

ANGENERICO SpA, VIA NOCERA UMBRA, 75, 00181 ROMA

NIMESULIDE

200 mg

Suppository

rectal use

Italy

DOROM Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

200 mg

Suppository

rectal use

Italy

TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

200 mg

Suppository

rectal use

Italy

MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, CINISELLO BALSAMO

NIMESULIDE

200 mg

Suppository

rectal use

Italy

DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO

NIMESULIDE

200 mg

Suppository

rectal use

Italy

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Chewable tablet

oral use

Italy

BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA

NIMESULIDE

100 mg

Granules

oral use

Italy

BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA

NIMESULIDE

100 mg

Granules

oral use

Italy

MIPHARM SpA, VIA QUARANTA, 12, 20141 MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

FARMAC.FORMENTI SpA, VIA CORREGGIO, 43, 20149 MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

SANDOZ SpA, L.GO U.BOCCIONI, 1, 21040 ORIGGIO

NIMESULIDE

100 mg

Granules

oral use

Italy

LABORATORI ALTER Srl, VIA EGADI, 7, 20144 MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

ANGENERICO SpA, VIA NOCERA UMBRA, 75, 00181 ROMA

NIMESULIDE

100 mg

Granules

oral use

Italy

DOROM Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

POLIFARMA SpA, VIALE DELL'ARTE, 69, 00144 ROMA

NIMESULIDE

100 mg

Granules

oral use

Italy

TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Granules

oral use

Italy

GET Srl, 'VIA DANTE ALIGHIERI, 73, 18038 SANREMO

NIMESULIDE

100 mg

Granules

oral use

Italy

JET GENERICI Srl, VIA MARIO LALLI, 8, 56127 PISA

NIMESULIDE

100 mg

Granules

oral use

Italy

ROBIN Srl, P.LE DURANTE FRANCESCO, 11, MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121 MILANO

NIMESULIDE

100 mg

Granules

oral use

Italy

PLIVA PHARMA SpA, VIA TRANQUILLO CREMONA, 10, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Granules

oral use

Italy

ALMUS Srl, VIA CESAREA, 11/10, 16121 GENOVA

NIMESULIDE

100 mg

Granules

oral use

Italy

HEXAL SpA, VIA PARACELSO, 16, 20041 AGRATE BRIANZA

NIMESULIDE

100 mg

Granules

oral use

Italy

UNION HEALTH Srl, VIA ROCCAMANDOLFI, 1, 00156 ROMA

NIMESULIDE

100 mg

Granules

oral use

Italy

BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA

NIMESULIDE

100 mg

Tablet

oral use

Italy

MIPHARM SpA, VIA QUARANTA, 12, 20141 MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

FARMAC.FORMENTI SpA, VIA CORREGGIO, 43, 20149 MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

LABORATORI ALTER Srl, VIA EGADI, 7, 20144 MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Tablet

oral use

Italy

GET Srl, 'VIA DANTE ALIGHIERI, 73, 18038 SANREMO

NIMESULIDE

100 mg

Tablet

oral use

Italy

ROBIN Srl, P.LE DURANTE FRANCESCO, 11, MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO

NIMESULIDE

100 mg

Tablet

Italy

RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121 MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

PLIVA PHARMA SpA, VIA TRANQUILLO CREMONA, 10, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Tablet

oral use

Italy

HEXAL SpA, VIA PARACELSO, 16, 20041 AGRATE BRIANZA

NIMESULIDE

100 mg

Tablet

oral use

Italy

UNION HEALTH Srl, VIA ROCCAMANDOLFI, 1, 00156 ROMA

NIMESULIDE

100 mg

Tablet

oral use

Italy

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO

NIMESULIDE

100 mg

Tablet

oral use

Italy

SANDOZ SpA, L.GO U.BOCCIONI, 1, 21040 ORIGGIO

NIMESULIDE

100 mg

Capsule

oral use

Italy

FARMAC.CABER SpA, VIALE CITTA' D'EUROPA, 681, ROMA

NIMS

100 mg

Granules

oral use

Italy

LEVOFARMA Srl, VIA CONFORTI, 42, 84083 CASTEL SAN GIORGIO

NOALGOS

100 mg

Granules

oral use

Italy

LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122 MILANO

NOXALIDE

100 mg

Granules

oral use

Italy

LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122 MILANO

NOXALIDE

60 ml 5 %

Drops

oral use

Italy

TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO

ORONIME

100 mg

Orodispersible tablet

oral use

Italy

PANTAFARM Srl, VIA PALESTRO, 14, 00185 ROMA

PANTAMES

100 mg

Orodispersible tablet

oral use

Italy

VECCHI & PIAM Sapa, VIA PADRE G.SEMERIA, 5, 16131 GENOVA

REMOV

100 mg

Granules

oral use

Italy

VECCHI & PIAM Sapa, VIA PADRE G.SEMERIA, 5, 16131 GENOVA

REMOV

100 mg

Tablet

oral use

Italy

IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA

RESULIN

200 mg

Suppository

rectal use

Italy

IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA

RESULIN

100 mg

Granules

oral use

Italy

IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA

RESULIN

100 mg

Tablet

oral use

Italy

NOVARTIS CONSUMER HEALTH SpA, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

REUMALIDE

200 mg

Suppository

rectal use

Italy

NOVARTIS CONSUMER HEALTH SpA, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

REUMALIDE

100 mg

Granules

oral use

Italy

MDM SpA, VIALE PAPINIANO, 22/B, 20100 MILANO

SOLVING

100 mg

Granules

oral use

Italy

MDM SpA, VIALE PAPINIANO, 22/B, 20100 MILANO

SOLVING

100 mg

Tablet

oral use

Italy

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Granules

oral use

Italy

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Tablet

oral use

Italy

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Granules

oral use

Italy

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Tablet

oral use

Italy

TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO

SULIDE

100 mg

Granules

oral use

Italy

TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO

SULIDE

100 mg

Tablet

oral use

Italy

ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO

SULMEDIL

200 mg

Suppository

rectal use

Italy

ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO

SULMEDIL

100 mg

Granules

oral use

Italy

ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO

SULMEDIL

100 mg

Tablet

oral use

Latvia

Helsinn Birex Pharmaceutical Ltd., Damastown, Mulhurddart, Dublin 15, Ireland

Mesulid

100 mg

Tablet

Oral

Latvia

Laboratori Guidotti S. P. A., Via Trieste 40, I-56126 Pisza, Italy

Nimesil

100 mg

granules for oral suspension

Oral

Latvia

Medochemie Ltd., P. O. Box 51409, CY-3505 Limassol, Cyprus

Aponil

100 mg

Tablet

Oral

Latvia

Zentiva a. S., Nitrianska 100, 92027 Hlohovec, Slovakia

Coxtral

100 mg

Tablet

Oral

Lithuania

Medochemie Ltd., P. O. Box 51409 CY-3505 Limassol, Cyprus

Aponil

100 mg

Tablet

oral use

Lithuania

Zentiva a. s., U kabelovny 130102 37 Praha 10 Dolni Mecholupy, Czech Republic

Coxtral

100 mg

Tablet

oral use

Lithuania

Helsinn Birex Pharmaceuticals Ltd., Damastown Mulhuddart Dublin 15, Ireland

Mesulid

100 mg

Tablet

oral use

Lithuania

Laboratori Guidotti S.p.A., Via Livornese, 897-56010 Pisa-La Viettola, Italy

Nimesil

100 mg

granules for oral suspension

oral use

Malta

Vecchi & C Piam S A, Via Padre G Semeria, 5, Genoa 16131, Italy

Remov

100 mg

Tablet

Oral

Poland

| Zentiva a.s. U Kabelovny 130 |
| --- |
| Dolni Mecholupy |
| 102 37 Praque 10 |

Zentiva a.s. U Kabelovny 130

Dolni Mecholupy

102 37 Praque 10

COXTRAL

100 mg

tablet

oral use

Poland

Medicom International s.r.o., Paterni 7, Brno, 63500 Czech Republik

AULIN

100 mg

Granules for oral use

oral use

Poland

LABORATORI GUIDOTTI S.p.A. Via Livornese 897 I - 56010 San Piero a Grado PISA, Italy

NIMESIL

100 mg

Tablet

oral use

Poland

Medicom International s.r.o., Paterni 7, Brno, 63500 Czech Republik

AULIN

100 mg

Granules for oral use

oral use

Portugal

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada - Dafundo |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada - Dafundo

Aulin

100 mg

Tablet

Oral

Portugal

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada - Dafundo |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada - Dafundo

Aulin

100 mg

Powder for oral suspension

Oral

Portugal

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada - Dafundo |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada - Dafundo

Aulin

200 mg

Suppository

Rectal

Portugal

| Rega Farma - Promoção de |
| --- |
| Produtos Farmacêuticos, S.A. |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada |

Rega Farma - Promoção de

Produtos Farmacêuticos, S.A.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada

Donulide

100 mg

Tablet

Oral

Portugal

| Rega Farma - Promoção de |
| --- |
| Produtos Farmacêuticos, S.A. |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada |

Rega Farma - Promoção de

Produtos Farmacêuticos, S.A.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada

Donulide

100 mg

Powder for oral suspension

Oral

Portugal

| Labesfal - Laboratórios Almiro, |
| --- |
| S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios Almiro,

S.A. 3465-051 Campo de Besteiros

Nimalge

200 mg

Suppository

Rectal

Portugal

| Vida - Produtos Farmacêuticos, |
| --- |
| S.A. Vala do Carregado 2600-726 Castanheira do Ribatejo |

Vida - Produtos Farmacêuticos,

S.A. Vala do Carregado 2600-726 Castanheira do Ribatejo

Nimartin

100 mg

Coated tablet

Oral

Portugal

| Sanofi-Aventis - Produtos |
| --- |
| Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo |

Sanofi-Aventis - Produtos

Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo

Nimed

100 mg

Coated tablet

Oral

Portugal

| Sanofi-Aventis - Produtos |
| --- |
| Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo |

Sanofi-Aventis - Produtos

Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo

Nimed

100 mg

Powder for oral solution

Oral

Portugal

| Sanofi-Aventis - Produtos |
| --- |
| Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo |

Sanofi-Aventis - Produtos

Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo

Nimed

200 mg

Suppository

Rectal

Portugal

Laboratori Guidotti, S.p.A. Via Trieste, 40 I-56126 Pisa

Nimesulene

100 mg

Powder for oral suspension

Oral

Portugal

| Alter, S.A. Estrada Marco do |
| --- |
| Grilo - Zemouto 2830 Coina |

Alter, S.A. Estrada Marco do

Grilo - Zemouto 2830 Coina

Nimesulida Alter 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Arrowblue Produtos Farmacêuticos |
| --- |
| S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa |

Arrowblue Produtos Farmacêuticos

S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa

Nimesulida Arrowblue

100 mg

Tablet

Oral

Portugal

| Farmoquímica Baldacci, S.A. |
| --- |
| Rua Duarte Galvão, 44 1549-005 Lisboa |

Farmoquímica Baldacci, S.A.

Rua Duarte Galvão, 44 1549-005 Lisboa

Nimesulida Baldacci 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Bluepharma - Indústria Farmacêutica, |
| --- |
| S.A. São Martinho do Bispo 3045-016 Coimbra |

Bluepharma - Indústria Farmacêutica,

S.A. São Martinho do Bispo 3045-016 Coimbra

Nimesulida Bluepharma 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Rua Alfredo da Silva, 16 2610-016 Amadora |

Ciclum Farma Unipessoal, Lda.

Rua Alfredo da Silva, 16 2610-016 Amadora

Nimesulida Ciclum 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

Edol Themaxis - Produtos Farmacêuticos S.A. Avenida 25 de Abril, no 6 - 6A 2795-195 Linda-a-Velha

Nimesulida Edol

100 mg

Tablet

Oral

Portugal

| Farmoz - Sociedade Técnico-Medicinal |
| --- |
| S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho |

Farmoz - Sociedade Técnico-Medicinal

S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho

Nimesulida Farmoz 100 mg Comprimidos

100 mg

Coated tablet

Oral

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra |

Generis Farmacêutica, S.A.

Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra

Nimesulida Generis 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra |

Generis Farmacêutica, S.A.

Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra

Nimesulida Generis 100 mg Granulado para Solução Oral

100 mg

Powder for oral solution

Oral

Portugal

Companhia Portuguesa Higiene Pharma - Produtos Farmacêuticos, S.A. Rua dos Bem Lembrados, 141 - Manique 2645-471 Alcabideche

Nimesulida Gerilide 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

Companhia Portuguesa Higiene Pharma - Produtos Farmacêuticos, S.A. Rua dos Bem Lembrados, 141 - Manique 2645-471 Alcabideche

Nimesulida Gerilide 100 mg Granulado para Solução Oral

100 mg

Powder for oral solution

Oral

Portugal

| Germed Farmacêutica, Lda. |
| --- |
| Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide |

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide

Nimesulida Germed 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Germed Farmacêutica, Lda. |
| --- |
| Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide |

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide

Nimesulida Germed 100 mg Granulado para suspensão oral

100 mg

Powder for oral suspension

Oral

Portugal

| gp - genéricos portugueses, Lda. |
| --- |
| Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora |

gp - genéricos portugueses, Lda.

Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora

Nimesulida gp 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Laboratórios Inibsa, S.A. |
| --- |
| Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra |

Laboratórios Inibsa, S.A.

Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra

Nimesulida Inibsa 100 mg comprimidos

100 mg

Tablet

Oral

Portugal

| Laboratórios Inibsa, S.A. |
| --- |
| Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra |

Laboratórios Inibsa, S.A.

Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra

Nimesulida Inibsa 100 mg granulado para suspensão oral

100 mg

Powder for oral suspension

Oral

Portugal

| Tecnimede - Sociedade Técnico-Medicinal |
| --- |
| S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho |

Tecnimede - Sociedade Técnico-Medicinal

S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho

Nimesulida Isartrox 100 mg Comprimidos

100 mg

Coated tablet

Oral

Portugal

| Jaba Farmacêutica, S.A. |
| --- |
| Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra |

Jaba Farmacêutica, S.A.

Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra

Nimesulida Jabasulide 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Jaba Farmacêutica, S.A. |
| --- |
| Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra |

Jaba Farmacêutica, S.A.

Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra

Nimesulida Jabasulide 100 mg Granulado Para Solução Oral

100 mg

Powder for oral solution

Oral

Portugal

| Labesfal - Laboratórios |
| --- |
| Almiro, S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios

Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Labesfal

200 mg

Suppository

Rectal

Portugal

| Labesfal - Laboratórios |
| --- |
| Almiro, S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios

Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Labesfal 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Labesfal - Laboratórios |
| --- |
| Almiro, S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios

Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Labesfal 100 mg Granulado para Suspensão Oral

100 mg

Powder for oral suspension

Oral

Portugal

| Vetiquima - |
| --- |
| Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela |

Vetiquima -

Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela

21994 83 00

100 mg

Tablet

Oral

Portugal

| Vetiquima - |
| --- |
| Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela |

Vetiquima -

Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela

21994 83 00

100 mg

Powder for oral suspension

Oral

Portugal

| Medicamed - |
| --- |
| Produtos Médicos e Farmacêuticos, S.A. Av. D. Afonso Henriques, 1462 - Edifício Olympus 4450-013 Matosinhos |

Medicamed -

Produtos Médicos e Farmacêuticos, S.A. Av. D. Afonso Henriques, 1462 - Edifício Olympus 4450-013 Matosinhos

Nimesulida Medicamed 100 mg Comprimidos

100 mg

Coated tablet

Oral

Portugal

| Medineo - Comercialização |
| --- |
| de Produtos Farmacêuticos, Lda. Rua Teófilo Braga, 14 2775-290 Parede |

Medineo - Comercialização

de Produtos Farmacêuticos, Lda. Rua Teófilo Braga, 14 2775-290 Parede

Nimesulida Medineo 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Mepha - Investigação, |
| --- |
| Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora |

Mepha - Investigação,

Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora

Nimesulida Mepha 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Mepha - Investigação, |
| --- |
| Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora |

Mepha - Investigação,

Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora

Nimesulida Mepha 100 mg Granulado para Suspensão Oral

100 mg

Powder for oral suspension

Oral

Portugal

Merck Genéricos - Produtos Farmacêuticos, Lda. Rua Alfredo da Silva, 3 C - 4o 1300-040 Lisboa

100 mg

Tablet

Oral

Portugal

Merck Genéricos - Produtos Farmacêuticos, Lda. Rua Alfredo da Silva, 3 C - 4o 1300-040 Lisboa

Nimesulida Merck Genéricos 100 mg Granulado para solução oral

100 mg

Powder for oral solution

Oral

Portugal

Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho

Nimesulida Neuride 100 mg Comprimidos

100 mg

Coated tablet

Oral

Portugal

Labesfal - Laboratórios Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Nilmide 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

Labesfal - Laboratórios Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Nilmide 100 mg Granulado Para Suspensão Oral

100 mg

Powder for oral suspension

Oral

Portugal

| Pharmakern Portugal - |
| --- |
| Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Av. José Gomes Ferreira, 11 - 3o, Sala 31 - Edifício Atlas II 1495-139 Miraflores - Algés |

Pharmakern Portugal -

Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Av. José Gomes Ferreira, 11 - 3o, Sala 31 - Edifício Atlas II 1495-139 Miraflores - Algés

Nimesulida Pharmakern 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Ranbaxy Portugal - |
| --- |
| Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto |

Ranbaxy Portugal -

Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto

Nimesulida Ranbaxy

100 mg

Tablet

Oral

Portugal

| Ranbaxy Portugal - |
| --- |
| Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto |

Ranbaxy Portugal -

Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto

Nimesulida Ranbaxy

100 mg

Powder for oral suspension

Oral

Portugal

| Ratiopharm - Comércio e |
| --- |
| Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide |

Ratiopharm - Comércio e

Indústria de Produtos Farmacêuticos, Lda. Rua Quinta do Pinheiro - Edifício Tejo - 6o Piso 2790-143 Carnaxide

Nimesulida Ratiopharm 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

| Quiraus - Comércio |
| --- |
| Produtos Químicos e Tecnologia Farmacêutica, Lda. Av. Salvador Allende, 12 - 1o 2780-163 Oeiras |

Quiraus - Comércio

Produtos Químicos e Tecnologia Farmacêutica, Lda. Av. Salvador Allende, 12 - 1o 2780-163 Oeiras

Nimesulida Reumesul 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

Sandoz Farmacêutica, Lda. Rua do Centro Empresarial - Edifício 3 - Loja 1 - Quinta da Beloura 2710-693 Sintra

Nimesulida Sandoz 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

Decafarma - Comércio de Produtos Farmacêuticos, Lda Centro Empresarial Sintra Estoril, V, Armazém E 3 2710-144 Sintra

Nimesulida Sulimed 100 mg Comprimidos

100 mg

Tablet

Oral

Portugal

Laboratórios Atral, S.A Vala do Carregado 2600-726 Castanheira do Ribatejo

Ribantil

100 mg

Coated tablet

Oral

Portugal

| Pharmout - Farmacêutica |
| --- |
| Internacional, Lda. Rua da Quinta das Romeiras, 104 - 7o 1495-236 Algés |

Pharmout - Farmacêutica

Internacional, Lda. Rua da Quinta das Romeiras, 104 - 7o 1495-236 Algés

Vitolide

100 mg

Tablet

Oral

Romania

Faran Laboratories SA/Imedica SA, Sos. Bucuresti – Ploiesti Nr. 141D Sector 1, Bucuresti

AFLOGEN

100 mg

Tablet

oral use

Romania

Medochemie LTD, Str. Prof. Dr. Ion Cantacuzino nr. 5, sector 1, Bucuresti

Aponil

100 mg

Tablet

oral use

Romania

C.S.C. PHARMACEUTICALS, Drumul Sarii nr. 108, sector 6 Bucuresti

Aulin

100 mg

granules for oral suspension

oral use

Romania

C.S.C. PHARMACEUTICALS, Drumul Sarii nr. 108, sector 6 Bucuresti

Aulin

100 mg

Tablet

oral use

Romania

Zentiva AS, B-dul Theodor Pallady nr. 50, 032266 Bucuresti

Coxtral

100 mg

Tablet

oral use

Romania

ANFARM HELLAS SA/Imedica, Sos. Bucuresti – Ploiesti Nr. 141D Sector 1, Bucuresti

Lemesil

100 mg

Tablet

oral use

Romania

| LABORATORI GUIDOTTI S.p.A., Via Livornese 897, |
| --- |
| I - 56010 La Vettola, PISA, Italy |

LABORATORI GUIDOTTI S.p.A., Via Livornese 897,

I - 56010 La Vettola, PISA, Italy

Nimesil

100 mg

granules for oral suspension

oral use

Romania

Terapia SA, Str. Fabricii Nr. 124, 3400 Cluj Napoca, Jud. Cluj

Nimesulid

100 mg

Tablet

oral use

Romania

LABORMED PHARMA SRL,Splaiul Independentei Nr. 319, Sector 6, Bucuresti

Nimesulid LPH 100 mg

100 mg

Tablet

oral use

Romania

MAGISTRA C & C, Str. Aviator Belghiru Nr. 9, 8700 Constanta, Jud. Constanta

Nimesulid 100 mg

100 mg

Tablet

oral use

Romania

ARENA GROUP SA, Str. Stefan Mihaileanu Nr.31, Sector 2, 73101 Bucuresti

Nimesulid Arena 100 mg

100 mg

Tablet

oral use

Romania

SLAVIA PHARM SRL, Str. Stirbei Voda Nr.53-55, Sector 1, Bucuresti

Nimesulid Slavia

100 mg

Tablet

oral use

Romania

FARMACEUTICI DAMUR SPA, Calea Dorobantilor Nr.113 Ap.35, Cluj, Jud. Cluj

Sulidamor

100 mg

Powder for oral suspension

powder for oral suspension

Slovak Republic

Medicom International s.r.o., Brno, Czech Republik

AULIN 100 mg granulát

100 mg

Granules for oral use

oral use

Slovak Republic

Medicom International s.r.o., Brno, Czech Republik

AULIN 100 mg tablety

100 mg

Tablet

oral use

Slovak Republic

Zentiva a.s. , Praha, Czech Republik

COXTRAL

100 mg

Tablet

oral use

Slovak Republic

CSC Pharmaceuticals Handels GmbH, Wien, Austria

MESULID

100 mg

Tablet

oral use

Slovak Republic

Medicom International s.r.o., Brno, Czech Republik

NIMED

100 mg

Tablet

oral use

Slovak Republic

Laboratori Guidotti S. P. A., Via Livornese 897, La Vettola, 56010 Pisa, Italy

Nimesil

100 mg

Granules for oral suspension

oral use

Slovenia

CSC Pharma d.o.o. JANA HUSA 1a, SI-1000 Ljubljana Slovenia

Aulin

100 mg

Tablet

oral

Slovenia

CSC Pharma d.o.o. JANA HUSA 1a, SI-1000 Ljubljana Slovenia

Aulin

100 mg

Powder for oral suspension

oral

Spain

HELSINN BIREX PHARMACEUTICALS LTD Damastown Mulhuddart, County Dublin,15 Ireland

GUAXAN 100 mg comprimidos

100 mg

Tablet

oral use

---

ANNEX X

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 | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Wien |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) name

Strength

Pharmaceutical Form

Route of administration

Content

(concentration)

Austria

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

Augmentin intravenös 550 mg – Trockenstechampullen

500/50 mg

Powder for solution for injection or infusion

Intravenous use

500 mg: 50 mg/vial

Augmentin intravenös 1,1 g - Trockensubstanz zur Infusionsbereitung

1 000/100 mg

Powder for solution for infusion

Intravenous use

1 000 mg: 100 mg/vial

Augmentin intravenös 2,2 g - Trockensubstanz zur Infusionsbereitung

2 000/200 mg

Powder for solution for infusion

Intravenous use

2 000 mg: 200 mg/vial

Augmentin 625 mg - lösliche Tabletten

500/125 mg

Dispersible tablet

Oral use

Augmentin

625 mg – Filmtabletten

500/125 mg

Film-coated Tablet

Oral use

Augmentin 1 g – Filmtabletten

875/125 mg

Film-coated Tablet

Oral use

Augmentin 457 mg/5 ml – Trockensaft

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

| Sandoz GmbH, Biochemiestr. 10, |
| --- |
| A - 6250 Kundl |

Sandoz GmbH, Biochemiestr. 10,

A - 6250 Kundl

Clavamox intravenös 550 mg – Trockenstechampullen

500/50 mg

Powder for solution for injection or infusion

Intravenous use

500 mg: 50mg/10,5 ml

Clavamox intravenös 1,1 g - Trockensubstanz zur Infusionsbereitung

1 000/100 mg

Powder for solution for infusion

Intravenous use

1 000 mg: 100 mg/100 ml

Clavamox intravenös 2,2 g - Trockensubstanz zur Infusionsbereitung

2 000/200 mg

Powder for solution for infusion

Intravenous use

2 000 mg: 200 mg/100 ml

Clavamox 625 mg - lösliche Tabletten

500/125 mg

Dispersible tablet

Oral use

Clavamox 625 mg – Filmtabletten

500/125 mg

Film-coated Tablet

Oral use

Clavamox 1 g – Filmtabletten

875/125 mg

Film-coated Tablet

Oral use

Clavamox 156,25 mg/5 ml – Trockensaft

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125/31,25 mg/5 ml

Clavamox 312,5 mg/5 ml – Trockensaft

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250/62,5 mg/5 ml

Clavamox Duo – Trockensaft

400/57 mg/5 ml

Powder for oral suspension

Oral use

400/57 mg/5 ml

Belgium

| GlaxoSmithKline s.a./n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |

GlaxoSmithKline s.a./n.v.

Rue du Tilleul 13

1332 Genval

Augmentin P

500/50 mg

Powder for injection or infusion

Intravenous use

500 mg: 50 mg/10,5 ml or 25 ml

Augmentin P

1 000/100 mg

Powder for infusion

Intravenous use

1 000 mg:100 mg/50 ml

Augmentin

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20 ml

Augmentin

2 000/200 mg

Powder for infusion

Intravenous use

2 000 mg: 200 mg/100 ml

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Augmentin

500/125 mg

Powder for oral suspension

Oral use

Augmentin Retard

1 000/62,5 mg

Modified release tablet

Oral use

Bulgaria

| GlaxoSmithKline EOOD |
| --- |
| Ivan Vasov Complex |
| Dimitar Manov street, bl.10, 1408 Sofia, Bulgaria |

GlaxoSmithKline EOOD

Ivan Vasov Complex

Dimitar Manov street, bl.10, 1408 Sofia, Bulgaria

Augmentin

250/125 mg

Film-coated tablet

Oral use

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Prolonged release tablet

Oral use

Cyprus

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| UK |

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

UK

Augmentin

500/100 mg

Powder for injection or infusion

Intravenous use

500 mg: 100 mg/10,5 ml or 60 ml

Augmentin

1 000/200 mg

Powder for injection or infusion

Intravenous use

1 000 mg: 200 mg/20,9 ml or 120 ml

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Film-coated tablet

Oral use

| Laboratórios BIAL |
| --- |
| À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado |
| Portugal |

Laboratórios BIAL

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

Portugal

Noprilam

500/125 mg

Film-coated tablet

Oral use

Noprilam DT

875/125 mg

Film-coated tablet

Oral use

Noprilam

156,23 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,23 mg/5 ml

Noprilam

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg:62,5 mg/5 ml

Noprilam DT

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Czech Republic

| SmithKline Beecham plc trading as |
| --- |
| SmithKline Beecham Pharmaceuticals |
| 980 Great West Road, |
| Brentford, Middlesex |
| TW8 9GS |
| United Kingdom |

SmithKline Beecham plc trading as

SmithKline Beecham Pharmaceuticals

980 Great West Road,

Brentford, Middlesex

TW8 9GS

United Kingdom

Augmentin 600 mg

500/100 mg

Powder for injection or infusion

Intravenous use

500 mg: 100 mg/10,5 ml or 60 ml

Augmentin 1,2 g

1 000/200 mg

Powder for injection or infusion

Intravenous use

1 000 mg: 200 mg/20,9 ml or 120 ml

| SmithKline Beecham plc trading as |
| --- |
| SmithKline Beecham Pharmaceuticals |
| 980 Great West Road, |
| Brentford, Middlesex |
| TW8 9GS |
| United Kingdom |

SmithKline Beecham plc trading as

SmithKline Beecham Pharmaceuticals

980 Great West Road,

Brentford, Middlesex

TW8 9GS

United Kingdom

Augmentin 375 mg

250/125 mg

Film-coated tablet

Oral use

Augmentin 625 mg

500/125 mg

Film-coated tablet

Oral use

Augmentin 1 g

875/125 mg

Film-coated tablet

Oral use

Augmentin 156 mg/5 ml

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin 312 mg/5 ml

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Augmentin Duo

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin SR

1 000/62,5 mg

modified-release tablet

Oral use

Denmark

| Meda AS |
| --- |
| Solvang 8 |
| DK-3450 Allerød |
| Denmark |

Meda AS

Solvang 8

DK-3450 Allerød

Denmark

Spektramox

500/125 mg

Film-coated tablet

Oral use

Spektramox

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Spektramox

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Spektramox 2:1

250/125 mg

Film-coated tablet

Oral use

Spektraforte

875/125 mg

Film-coated tablet

Oral use

Estonia

| SmithKline Beecham plc. |
| --- |
| 980 Great West Road, Brentford |
| Middlesex TW8 9GS |
| United Kingdom |

SmithKline Beecham plc.

980 Great West Road, Brentford

Middlesex TW8 9GS

United Kingdom

Augmentin

1 000/200 mg

Powder for injection or infusion

Intravenous use

1 000 mg: 200 mg/20,9 ml or 120 ml

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Finland

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford, Middlesex TW8 9GS |
| UK |

SmithKline Beecham plc

980 Great West Road

Brentford, Middlesex TW8 9GS

UK

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin (80/11.97 mg/ml)

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Orion-yhtymä Oyj, Orionintie 1, 02200 Espoo

Clavurion

875/125 mg

Film-coated tablet

Oral use

Clavurion

200/28,5 mg/5 ml

Powder for oral suspension

Oral use

200 mg:28,5 mg/5 ml

Clavurion

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

Augmentin IV

ENFANTS

NOURRISSONS

500/50 mg

Powder for solution for injection

AND Powder and solvent for solution for injection

Intravenous use

500 mg: 50 mg

Augmentin IV

ADULTES

500/100 mg

Powder for solution for injection

Intravenous use

500 mg:100 mg

Augmentin IV

ENFANTS

1 000/100 mg

Powder for solution for injection

Intravenous use

1 000 mg: 100 mg

Augmentin IV

ADULTES

1 000/200 mg

Powder for solution for injection

AND Powder and solvent for solution for injection

Intravenous use

1 000 mg: 200 mg

Augmentin IV

ADULTES

2 000/200 mg

Powder for solution for injection

Intravenous use

2 000 mg: 200 mg

Augmentin

ADULTES

500/62,5 mg

Film-coated tablet

Oral use

Augmentin

ENFANTS

100/12,5 mg/ml

Powder for oral suspension

Oral use

100 mg: 12,5 mg/ml

Augmentin

NOURRISSONS

100/12,5 mg/ml

Powder for oral suspension

Oral use

100 mg/12,5 mg/ml

Augmentin

NOURRISSONS

250/31,25 mg

Powder for oral suspension

Oral use

Augmentin

ENFANTS

500/62,5 mg

Powder for oral suspension

Oral use

Augmentin

ADULTES

1 000/125 mg

Powder for oral suspension

Oral use

Duamentin

ADULTES

1 000/62,5 mg

Film-coated tablet

Oral use

Germany

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Theresienhöhe 11 |
| 80339 München |

GlaxoSmithKline GmbH & Co. KG

Theresienhöhe 11

80339 München

Augmentan i.v. pro infantibus 275 mg

250/25 mg

Powder for solution for infusion

Intravenous use

250 mg: 25 mg

Augmentan i.v. 600 mg

500/100 mg

Powder for solution for injection or infusion

Intravenous use

500 mg: 100 mg

Augmentan i.v. 1,2 g

1 000/200 mg

Powder for solution for infusion or infusion

Intravenous use

1 000 mg: 200 mg

Augmentan i.v. 2,2 g

2 000/200 mg

Powder for solution for infusion

Intravenous use

2 000 mg: 200 mg

Augmentan Tabs Tabletten

500/125 mg

Dispersible tablet

Oral use

Augmentan Filmtabletten 875/125 mg

875/125 mg

Film-coated tablet

Oral use

Augmentan Tropfen 50 mg/12,5 mg pro ml für Säuglinge

50/12,5 mg/ml

Powder for oral suspension

Oral use

50 mg: 12,5 mg/ml

Augmentan Trockensaft 25 mg/6,25 mg pro ml

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentan forte Trockensaft 50 mg/12,5 mg pro ml

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Augmentan Kindersaft

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Greece

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

Augmentin

500/100 mg

Powder for injection

Intravenous use

500 mg: 100 mg/10,5 ml

Augmentin

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

500/125 mg

Dispersible tablet

Oral use

Augmentin

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin SR

1 000/62,5 mg

Film-coated tablet

Oral use

Augmentin ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43 |
| Hungary |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43

Hungary

Augmentin

500/100 mg

Powder for injection

Intravenous use

500 mg: 100 mg/10,5 ml

Augmentin

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin

250/125 mg

Film-coated tablet

Oral use

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

Augmentin Duo

875/125 mg

Film-coated tablet

Oral use

Augmentin Duo

500/125 mg

Film-coated tablet

Oral use

Augmentin Duo

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin Extra

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

Augmentin Extra

1 000/62,5 mg

Film-coated tablet

Oral use

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Þverholti 14 |
| 105 Reykjavík. |

GlaxoSmithKline ehf.

Þverholti 14

105 Reykjavík.

Augmentin IV

500/100 mg

Powder for injection

Intravenous use

500 mg: 100 mg/10,5 ml

Augmentin IV

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin

500/125 mg

tablet

Oral use

Augmentin

875/125 mg

tablet

Oral use

Augmentin

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

Augmentin

Intravenous 500 mg/100 mg Powder for Solution for Injection or Infusion

500/100 mg

Powder for solution for injection or infusion

Intravenous use

500 mg: 100 mg/10,5 ml

Augmentin

Intravenous 1 000 mg/200 mg Powder for Solution for Injection or Infusion

1 000/200 mg

Powder for solution for injection or infusion

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin Tablets 250 mg/125 mg

250/125 mg

Film-coated tablet

Oral use

Augmentin Dispersible Tablets 250 mg/125 mg

250/125 mg

Dispersible Tablet

Oral use

Augmentin Duo Tablets 500/125 mg

500/125 mg

Film-coated tablet

Oral use

Augmentin 500/125 mg Film-Coated Tablets

500/125 mg

Film-coated tablet

Oral use

Augmentin

875 mg/125 mg Film Coated Tablets

875/125 mg

Film-coated tablet

Oral use

Augmentin

Paediatric Suspension

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin

Junior Suspension

125/62,5 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 62,5 mg/5 ml

Augmentin Duo

Suspension 400 mg/57 mg

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

| Clonmel Healthcare Limited |
| --- |
| Waterford Road |
| Clonmel |
| Tipperary |
| Ireland |

Clonmel Healthcare Limited

Waterford Road

Clonmel

Tipperary

Ireland

Clavamel 250 mg/125 mg Tablets

250/125 mg

Film-coated tablet

Oral use

Clavamel 125 mg/31.25 mg Paediatric Powder for Oral Suspension

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Clavamel 125 mg/62,5 mg Junior Powder for Oral Suspension

125/62,5 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 62,5 mg/5 ml

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

Augmentin

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20 ml

Augmentin

2 000/200 mg

Powder for infusion

Intravenous use

2 000 mg: 200 mg

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin

400/57 mg

Powder for oral suspension

Oral use

Augmentin

875/125 mg

Powder for oral suspension

Oral use

| Valeas S.p.A. |
| --- |
| via Vallisneri 10 |
| 20133 Milano |

Valeas S.p.A.

via Vallisneri 10

20133 Milano

Neoduplamox

875/125 mg

Film-coated tablet

Oral use

Neoduplamox

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Neoduplamox

400/57 mg

Powder for oral suspension

Oral use

Neoduplamox

875/125 mg

Powder for oral suspension

Oral use

| Solvay Pharma S.p.A. |
| --- |
| Via della Libertà, 30 |
| 10095 Grugliasco (TO) |

Solvay Pharma S.p.A.

Via della Libertà, 30

10095 Grugliasco (TO)

Clavulin

875/125 mg

Film-coated tablet

Oral use

Clavulin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Clavulin

400/57 mg

Powder for oral suspension

Oral use

Clavulin

875/125 mg

Powder for oral suspension

Oral use

Latvia

| GlaxoSmithKline Latvia SIA |
| --- |
| Bruninieku 5, Riga, LV-1001, Latvia |

GlaxoSmithKline Latvia SIA

Bruninieku 5, Riga, LV-1001, Latvia

Augmentin

1 000/200 mg

Powder for solution for injection

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Film-coated tablet

Oral use

Lithuania

| Beecham Group plc. |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| United Kingdom |

Beecham Group plc.

980 Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

200/28,5 mg/5 ml

Powder for oral suspension

Oral use

200 mg/28,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg/57 mg/5 ml

| UAB „GlaxoSmithKline Lietuva“ |
| --- |
| A. Goštauto g. 40A |
| LT-01112 Vilnius, Lithuania |

UAB „GlaxoSmithKline Lietuva“

A. Goštauto g. 40A

LT-01112 Vilnius, Lithuania

Augmentin ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg/42,9 mg/5 ml

Luxembourg

| GlaxoSmithKline s.a. / n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |

GlaxoSmithKline s.a. / n.v.

Rue du Tilleul 13

1332 Genval

Augmentin P

500/50 mg

Powder for injection or infusion

Intravenous use

500 mg/50 mg/10,5 ml or 25 ml

Augmentin P

1 000/100 mg

Powder for infusion

Intravenous use

1 000 mg/100 mg/50 ml

Augmentin

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg/200 mg/20 ml

Augmentin

2 000/200 mg

Powder for infusion

Intravenous use

2 000 mg/200 mg/100 ml

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Augmentin

500/125 mg

Powder for oral suspension

Oral use

Augmentin Retard,

1 000/62,5 mg

Modified release tablet

Oral use

Malta

| Beecham Group plc |
| --- |
| 980 Great West Road, |
| Brentford, Middlesex |
| TW8 9GS |
| United Kingdom |

Beecham Group plc

980 Great West Road,

Brentford, Middlesex

TW8 9GS

United Kingdom

Augmentin Intravenous 600 mg

500/100 mg

Powder for solution for injection or infusion

Intravenous use

500 mg: 100 mg/10,5 ml

Augmentin Intravenous 1,2 g

1 000/200 mg

Powder for solution for injection or infusion

Intravenous use

1 000 mg: 200 mg/20,9 ml

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham |
| Dublin 16 |
| Ireland |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham

Dublin 16

Ireland

Augmentin 250/125 mg

250/125 mg

Film-coated tablet

Oral use

Augmentin Duo 500/125 tablets

500/125 mg

Film-coated tablet

Oral use

Augmentin 875/125 mg tablets

875/125 mg

Film-coated tablet

Oral use

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex |
| TW8 9GS |

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

Augmentin Duo 400/57

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

| Laboratórios BIAL |
| --- |
| Portela & Ca, S.A. |
| À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado |
| Portugal |

Laboratórios BIAL

Portela & Ca, S.A.

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

Portugal

Noprilam

500/125 mg

Coated tablet

Oral use

Noprilam DT

875/125 mg

Coated tablet

Oral use

Noprilam DT

400/57 mg/5 ml

Powder for oral suspension

Oral use

400/57 mg/5 ml

Netherlands

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| THE NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

THE NETHERLANDS

Augmentin

250/25 mg

Powder for injection

Intravenous use

250 mg: 25 mg/5,2 ml

Augmentin

500/50 mg

Powder for injection

Intravenous use

500 mg: 50 mg/10,5 ml

Augmentin

500/100 mg

Powder for injection

Intravenous use

500 mg: 100 mg/10,5 ml

Augmentin

1 000/100 mg

Powder for injection

Intravenous use

1 000 mg: 100 mg/20,9 ml

Augmentin

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin

2 000/200 mg

Powder for infusion

Intravenous use

2 000 mg: 200 mg/120 ml

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

100/12,5 mg/ml

Powder for oral suspension

Oral use

100 mg: 12,5 mg/ml

Augmentin

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| THE NETHERLANDS |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

THE NETHERLANDS

amoxicilline/clavulaanzuur

250/62,5 mg

Powder for oral suspension

Oral use

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| UK |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

UK

Augmentin

500/100 mg

Powder for injection

Intravenous use

500 mg: 100 mg/10,5 ml

Augmentin

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin

2 000/200 mg

Powder for infusion

Intravenous use

2 000 mg: 200 mg/120 ml

Augmentin

250/125 mg

Film-coated tablet

Oral use

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin

875/125 mg

Film-coated tablet

Oral use

Augmentin

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg:31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg:62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Prolonged release tablet

Oral use

Portugal

| GlaxoSmithKline – Produtos Farmacêuticos Lda |
| --- |
| Rua Dr. António Loureiro Borges, 3 |
| Aquiparque – Miraflores |
| 1495 – 131 Algés |

GlaxoSmithKline – Produtos Farmacêuticos Lda

Rua Dr. António Loureiro Borges, 3

Aquiparque – Miraflores

1495 – 131 Algés

Augmentin

500/125 mg

Film-coated tablet

Oral use

Augmentin Duo

875/125 mg

Film-coated tablet

Oral use

Augmentin

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin Forte

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg:62,5 mg/5 ml

Augmentin Duo

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

| Bial - Portela & Ca, S.A |
| --- |
| À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado |
| Portugal |

Bial - Portela & Ca, S.A

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

Portugal

Clavamox 125

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Clavamox 250

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Clavamox 500

500/125 mg

Film-coated tablet

Oral use

Clavamox DT

875/125 mg

Film-coated tablet

Oral use

Clavamox DT 400

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Clavamox ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

Noprilam

500/125 mg

Film-coated tablet

Oral use

Noprilam

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Noprilam

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Noprilam DT

875/125 mg

Film-coated tablet

Oral use

| Laboratórios Vitória, S.A. Rua Elias Garcia, 28 – Venda Nova |
| --- |
| 2700-327 Amadora |
| (Sob licença GlaxoSmithKline – Produtos Farmacêuticos, Lda.) |

Laboratórios Vitória, S.A. Rua Elias Garcia, 28 – Venda Nova

2700-327 Amadora

(Sob licença GlaxoSmithKline – Produtos Farmacêuticos, Lda.)

Penilan

500/125 mg

Film-coated tablet

Oral use

Penilan

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Penilan DT

875/125 mg

Film-coated tablet

Oral use

Penilan Forte

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Romania

| Beecham Group PLC |
| --- |
| 980 Great West Road, Brentford, Middlesex TW8 9GS |
| United Kingdom |

Beecham Group PLC

980 Great West Road, Brentford, Middlesex TW8 9GS

United Kingdom

Augmentin

intravenos 1,2 g

1 000/200 mg

Powder for injection/infusion

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin

Intravenos 2,2 g

2 000/200 mg

Powder for infusion

Intravenous use

2 000 mg: 200 mg/120 ml

Augmentin 625 mg

500/125 mg

Film-coated tablet

Oral use

Augmentin 1 g

875/125 mg

Film-coated tablet

Oral use

Augmentin BIS

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Prolonged release film-coated tablet

Oral use

Slovak Republic

GlaxoSmithKline Slovakia sro., Galvaniho7/A, 82104 Bratislava, Slovakia

Augmentin 375 mg

250/125 mg

Film-coated tablet

Oral use

Augmentin 625 mg

500/125 mg

Film-coated tablet

Oral use

Augmentin 1 g

875/125 mg

Film-coated tablet

Oral use

Augmentin DUO

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Powder for oral suspension

Oral use

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Prolonged-release tablet

Oral use

Slovenia

| GSK d.o.o., Ljubljana |
| --- |
| Knezov štradon 90 |
| SI-1000 Ljubljana |
| Slovenija |

GSK d.o.o., Ljubljana

Knezov štradon 90

SI-1000 Ljubljana

Slovenija

Augmentin Augmentin 0,6 g prašek za raztopino za injiciranje ali infundiranje

500/100 mg

Powder for injection

Intravenous use

500 mg: 100 mg/10,5 ml

Augmentin 1,2 g prašek za raztopino za injiciranje ali infundiranje

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin 625 mg filmsko obložene tablete

500/125 mg

Film-coated tablet

Oral use

Augmentin 1 000 mg filmsko obložene tablete

875/125 mg

Film-coated tablet

Oral use

Augmentin 457 mg/5 ml prašek za peroralno suspenzijo

400/57 mg/5 ml

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

Augmentin SR 1 000 mg/62,5 mg filmsko obložene tablete s podaljšanim sproščanjem

1 000/62,5 mg

Film-coated tablet

Oral use

Spain

| GlaxoSmithKline, S.A. |
| --- |
| P.T.M.- C/Severo Ochoa, 2 |
| 28760 Tres Cantos (Madrid). |

GlaxoSmithKline, S.A.

P.T.M.- C/Severo Ochoa, 2

28760 Tres Cantos (Madrid).

Augmentine Intravenoso

500/50 mg

Powder for injection

Intravenous use

500 mg: 50 mg/10,5 ml

Augmentine Intravenoso

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentine Intravenoso

2 000/200 mg

Powder for infusion

Intravenous use

2 000 mg: 200 mg/120 ml

Augmentine

500/125 mg

Film-coated tablet

Oral use

Augmentine

875/125 mg

Film-coated tablet

Oral use

Augmentine

100/12,5 mg/ml

Powder for oral suspension

Oral use

100 mg: 12,5 mg/ml

Augmentine

500/125 mg

Powder for oral suspension

Oral use

Augmentine

875/125 mg

Powder for oral suspension

Oral use

Augmentine Plus

1 000/62,5 mg

Film-coated tablet

Oral use

| Laboratorios Beecham, S.A. |
| --- |
| P.T.M.- C/Severo Ochoa, 2 |
| 28760 Tres Cantos (Madrid). |

Laboratorios Beecham, S.A.

P.T.M.- C/Severo Ochoa, 2

28760 Tres Cantos (Madrid).

Pangamox

250/62,5 mg

Powder for oral suspension

Oral use

Pangamox

500/125 mg

Powder for oral suspension

Oral use

Pangamox

875/125 mg

Powder for oral suspension

Oral use

| Allen Farmacéutica, S.A.P.T.M.- C/Severo Ochoa, 2 |
| --- |
| 28760 Tres Cantos (Madrid). |

Allen Farmacéutica, S.A.P.T.M.- C/Severo Ochoa, 2

28760 Tres Cantos (Madrid).

Clavepen

500/125 mg

Film-coated tablet

Oral use

Clavumox

500/125 mg

Film-coated tablet

Oral use

Clavumox

875/125 mg

Film-coated tablet

Oral use

Clavumox

125/31,25 mg/5 ml

Oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Clavumox

250/62,5 mg

Powder for oral suspension

Oral use

Clavepen

500/125 mg

Powder for oral suspension

Oral use

Clavumox

500/125 mg

Powder for oral suspension

Oral use

Clavumox

875/125 mg

Powder for oral suspension

Oral use

Amoxicilina/Ác. Clavulanico ALLEN

875/125 mg

Powder for oral suspension

Oral use

Sweden

| Meda AB |
| --- |
| Box 906 |
| 170 09 Sverige (SWE) |
| Sweden |

Meda AB

Box 906

170 09 Sverige (SWE)

Sweden

Spektramox

250/125 mg

(Amoxicillin: 250 mg)

Film-coated tablet

Oral use

Spektramox

500/125 mg

(Amoxicillin: 500 mg)

Film-coated tablet

Oral use

Spektramox

875/125 mg

(Amoxicillin 875 mg)

Film-coated tablet

Oral use

Spektramox

125/31,25 mg/5 ml

(Amoxicillin 25 mg/ml)

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Spektramox

125/31,25 mg

(Amoxicillin: 125 mg)

Powder for oral suspension

Oral use

Spektramox

250/62,5 mg/5 ml

(Amoxicillin: 50 mg/ml)

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Spektramox

400/57 mg/5 ml

(Amoxicillin: 80 mg/ml)

Powder for oral suspension

Oral use

400 mg: 57 mg/5 ml

United Kingdom

| Beecham Group PLC |
| --- |
| SB House |
| Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| United Kingdom |

Beecham Group PLC

SB House

Great West Road

Brentford

Middlesex TW8 9GS

United Kingdom

Augmentin Intravenous 600 mg & 1,2 gm

500/100 mg

Powder for injection

Intravenous use

500 mg: 100 mg/10,5 ml

Augmentin Intravenous 600 mg & 1,2 gm

1 000/200 mg

Powder for injection

Intravenous use

1 000 mg: 200 mg/20,9 ml

Augmentin 375 mg Tablets

250/125 mg

Film-coated tablet

Oral use

Augmentin 375 mg dispersible tablets

250/125 mg

Dispersible tablets

Oral use

Augmentin 1 g Tablets

875/125 mg

Film-coated tablet

Oral use

Augmentin 625 mg Tablets

500/125 mg

Film-coated tablet

Oral use

Augmentin 250/62 SF Suspension

250/62,5 mg/5 ml

Powder for oral suspension

Oral use

250 mg: 62,5 mg/5 ml

Augmentin 125/31 SF Sachet

125/31,25 mg

Powder for oral suspension

Oral use

Augmentin 125/31 SF Suspension

125/31,25 mg/5 ml

Powder for oral suspension

Oral use

125 mg: 31,25 mg/5 ml

Augmentin Duo

200/28,5 mg/5 ml

Powder for oral suspension

Oral use

200 mg: 28,5 mg/5 ml

---

ANNEX XI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | STADA Arzneimittel AG Stadastrasse 2-18 |
| 61118 Bad Vilbel, |
| Germany |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Denmark

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel,

Germany

Fentrans Depotplaster

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Germany

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, |
| 61118 Bad Vilbel, |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel,

Germany

Fentanyl-GRY

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

---

ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | STADA Arzneimittel AG |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Denmark

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Matripain Depotplaster

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Germany

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentanyl AL

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

---

ANNEX XIII

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

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | Teva Pharma B.V. |
| 3640 AE Mijdrecht, Industrieweg 23, P.O. Box 217 |
| The Netherlands |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Teva Pharma B.V.

3640 AE Mijdrecht, Industrieweg 23, P.O. Box 217

The Netherlands

Fentanyl TEVA transdermales Pflaster

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Belgium

| TEVA Pharma Belgium N.V |
| --- |
| B-2610 Wilrijk; Laarstraat 16, |
| Belgium |

TEVA Pharma Belgium N.V

B-2610 Wilrijk; Laarstraat 16,

Belgium

Fentanyl TEVA Pleister voor transdermaal gebruik

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Czech Republic

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Radlická 3185/1C |
| Praha 5 |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1C

Praha 5

Czech Republic

Fentanyl - TEVA

25 μg/h

25 μg/h

Transdermal patch

Transdermal use

Fentanyl - TEVA

50 μg/h

50 μg/h

Fentanyl - TEVA

75 μg/h

75 μg/h

Fentanyl - TEVA

100 μg/h

100 μg/h

Denmark

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel

Germany

Matrigesic Depotplaster

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Estonia

| Teva Pharmaceuticals Europe B.V. |
| --- |
| 3641 RK Mijdrecht, Indrustrieweg 23 |
| The Netherlands |

Teva Pharmaceuticals Europe B.V.

3641 RK Mijdrecht, Indrustrieweg 23

The Netherlands

Fentanyl - TEVA transdermalpatch

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Finland

| TEVA Sweden AB |
| --- |
| PO Box 1070; |
| 251 10 Helsingborg, |
| Sweden |

TEVA Sweden AB

PO Box 1070;

251 10 Helsingborg,

Sweden

Fentanyl TEVA

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

France

| Société TEVA CLASSICS Immeuble Le Palatin 1; |
| --- |
| 1, Cours du Triangle; 92936 Paris La Défense Cedex, |
| France |

Société TEVA CLASSICS Immeuble Le Palatin 1;

1, Cours du Triangle; 92936 Paris La Défense Cedex,

France

Fentanyl TEVA dispositif transdermique

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Hungary

| TEVA Magyarország Rt. Rákóczi út. 70- 72, H-1074 Budapest |
| --- |
| Hungary |

TEVA Magyarország Rt. Rákóczi út. 70- 72, H-1074 Budapest

Hungary

Fentanyl – Teva tapasz

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Italy

| TEVA Pharma Italia S.r.l. |
| --- |
| Via Giulio Richard, 7 20143 Milan |
| Italy |

TEVA Pharma Italia S.r.l.

Via Giulio Richard, 7 20143 Milan

Italy

Fentanil Teva cerotti transdermici

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Latvia

| Teva Pharmaceuticals Europe B.V. |
| --- |
| 3641 RK Mijdrecht, Indrustrieweg 23 |
| The Netherlands |

Teva Pharmaceuticals Europe B.V.

3641 RK Mijdrecht, Indrustrieweg 23

The Netherlands

Fentanyl - TEVA transdermālie plāksteri

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Lithuania

| Teva Pharmaceuticals Europe B.V. |
| --- |
| Industrieweg 23, 3641 RK Mijdrecht |
| The Netherlands |

Teva Pharmaceuticals Europe B.V.

Industrieweg 23, 3641 RK Mijdrecht

The Netherlands

Fentanyl - TEVA

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Luxembourg

| TEVA Pharma Belgium N.V |
| --- |
| B-2610 Wilrijk; Laarstraat 16, |
| Belgium |

TEVA Pharma Belgium N.V

B-2610 Wilrijk; Laarstraat 16,

Belgium

Fentanyl TEVA Dispositif transdermique

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

The Netherlands

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentanyl 25 microgram/uur PCH, pleister voor transdermaal gebruik

25 μg/h

Transdermal patch

Transdermal use

Fentanyl 50 microgram/uur PCH, pleister voor transdermaal gebruik

50 μg/h

Fentanyl 75 microgram/uur PCH, pleister voor transdermaal gebruik

75 μg/h

Fentanyl 100 microgram/uur PCH, pleister voor transdermaal gebruik

100 μg/h

Norway

| TEVA Sweden AB |
| --- |
| PO Box 1070; |
| 251 10 Helsingborg |
| Sweden |

TEVA Sweden AB

PO Box 1070;

251 10 Helsingborg

Sweden

Fentanyl TEVA

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Poland

| TEVA PHARMACEUTICALS Polska Sp. Z.o.o. |
| --- |
| Emilii Plater 53, 00-113 |
| Warsaw |
| Poland |

TEVA PHARMACEUTICALS Polska Sp. Z.o.o.

Emilii Plater 53, 00-113

Warsaw

Poland

Fentanyl TEVA system transdermalny

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Portugal

| Teva Pharma - Produtos Farmaceuticos, Lda Lagoas Park, Edifício 1, Piso 3, 2740 - 264 Porto Salvo |
| --- |
| Portugal |

Teva Pharma - Produtos Farmaceuticos, Lda Lagoas Park, Edifício 1, Piso 3, 2740 - 264 Porto Salvo

Portugal

Fentanilo Teva

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Slovak Republic

| Teva Pharmaceuticals CR, s.r.o |
| --- |
| Drazni 7; |
| 627 00 Brno |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o

Drazni 7;

627 00 Brno

Czech Republic

Fentanyl – TEVA

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Slovenia

| Teva Pharmaceuticals Europe B.V. |
| --- |
| 3641 RK Mijdrecht, Indrustrieweg 23 |
| The Netherlands |

Teva Pharmaceuticals Europe B.V.

3641 RK Mijdrecht, Indrustrieweg 23

The Netherlands

Fentanil TEVA transdermalni obliž

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Spain

| TEVA GENERICOS ESPAÑOLA, S.L. |
| --- |
| Guzman el Bueno; 133. Edif. Britannia |
| 28003 Madrid |
| Spain |

TEVA GENERICOS ESPAÑOLA, S.L.

Guzman el Bueno; 133. Edif. Britannia

28003 Madrid

Spain

Fentanilo TEVA parches transdermicos EFG

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Sweden

| TEVA Sweden AB |
| --- |
| PO Box 1070; |
| 251 10 Helsingborg, |
| Sweden |

TEVA Sweden AB

PO Box 1070;

251 10 Helsingborg,

Sweden

Matrigesic transdermal patch

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

United Kingdom

| TEVA UK Limited |
| --- |
| Brampton Road; Hampden Park; Eastbourne; East Sussex |
| BN22 9AG |
| United Kingdom |

TEVA UK Limited

Brampton Road; Hampden Park; Eastbourne; East Sussex

BN22 9AG

United Kingdom

Fentanyl Transdermal Patch

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

---

ANNEX XIV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT AND MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES

| Member State | Marketing Authorisation Holder | Applicant | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Denmark | STADA Arzneimittel AG |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Member State

Marketing Authorisation Holder

Applicant

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Denmark

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentador

Depotplaster

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Germany

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, |
| 61118 Bad Vilbel, |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel,

Germany

Fentador

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

---

ANNEX XV

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

| Member State | Marketing Authorisation Holder | Applicant/MAH | (Invented) Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | | STADA Arzneimittel GmbH |
| Muthgasse 36/2 |
| 1190 Wien |
| Austria |

Member State

Marketing Authorisation Holder

Applicant/MAH

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Austria

Fentanyl STADA Depotpflaster

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Belgium

| Eurogenerics N.V., Heizel Esplanade Heysel b22 |
| --- |
| 1020 Brussels |
| Belgium |

Eurogenerics N.V., Heizel Esplanade Heysel b22

1020 Brussels

Belgium

Fentanyl EG Pleister voor transdermaal gebruik

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Czech Republic

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentanyl STADA

25 μg/h

25 μg/h

Transdermal patch

Transdermal use

Fentanyl STADA

50 μg/h

50 μg/h

Fentanyl STADA

75 μg/h

75 μg/h

Fentanyl STADA

100 μg/h

100 μg/h

Denmark

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentastad depotplaster

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Estonia

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentaderm transdermal patch

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Finland

| STADA Arzneimittel AG Stadastrasse 2-18, |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18,

61118 Bad Vilbel

Germany

Fentanyl STADA

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

France

| EGLABO |
| --- |
| Le Quintet-Bat A |
| 12 rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EGLABO

Le Quintet-Bat A

12 rue Danjou

92517 Boulogne Billancourt Cedex

France

Fentanyl EG LABO, dispositif transdermique

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Hungary

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentanyl STADA tapasz

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Italy

| EG S.p.A. |
| --- |
| Via D. Scarlatti, 31 |
| 20124 Milano |
| Italy |

EG S.p.A.

Via D. Scarlatti, 31

20124 Milano

Italy

Nilafen cerotti transdermici

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Latvia

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentastad transdermālie plāksteri

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Lithuania

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentaderm

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Luxembourg

| Eurogenerics N.V., Heizel Esplanade Heysel b22, |
| --- |
| 1020 Brussels |
| Belgium |

Eurogenerics N.V., Heizel Esplanade Heysel b22,

1020 Brussels

Belgium

Fentanyl EG pleister voor transdermal gebruik

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

The Netherlands

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentanyl CF 25 microgram/uur, pleister voor transdermaal gebruik

25 μg/h

Transdermal patch

Transdermal use

Fentanyl CF50 microgram/uur, pleister voor transdermaal gebruik

50 μg/h

Fentanyl CF 75 microgram/uur, pleister voor transdermaal gebruik

75 μg/h

Fentanyl CF 100 microgram/uur, pleister voor transdermaal gebruik

100 μg/h

Poland

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentanyl STADA

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Portugal

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor Câmara, no 2, Edifício D. Amélia - Piso 1, Ala B, 2770-229 Paço de Arcos |
| Portugal |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, no 2, Edifício D. Amélia - Piso 1, Ala B, 2770-229 Paço de Arcos

Portugal

Fentanilo Ciclum

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Slovak Republic

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentanyl STADA transdermálna náplasť

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Spain

| Lab. STADA |
| --- |
| Frederic Mompou,5 |
| 08960 Sant Just Desvern, Barcelona |
| Spain |

Lab. STADA

Frederic Mompou,5

08960 Sant Just Desvern, Barcelona

Spain

Fentanilo STADA parches transdermicos EFG

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

Sweden

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Germany

Fentanyl STADA transdermal patch

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

United Kingdom

| Genus Pharmaceuticals Ltd. |
| --- |
| (trading as Genus Pharmaceuticals) |
| Benham, Valence, Newbury |
| Berkshire, RG20 8LU |
| United Kingdom |

Genus Pharmaceuticals Ltd.

(trading as Genus Pharmaceuticals)

Benham, Valence, Newbury

Berkshire, RG20 8LU

United Kingdom

Fentanyl Transdermal Patch

25 μg/h

Transdermal patch

Transdermal use

50 μg/h

75 μg/h

100 μg/h

---