# Official Journal C 128/2011

| | ISSN 1725-2423
  doi:10.3000/17252423.C_2011.128.eng |
| --- | --- |
| Official Journal
  of the European Union | C 128 |
| | |
| English edition | Information and Notices | Volume 5429 April 2011 |

ISSN 1725-2423

doi:10.3000/17252423.C_2011.128.eng

Official Journal

of the European Union

C 128

English edition

Information and Notices

Volume 5429 April 2011

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2011/C 128/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 1 |
| 2011/C 128/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 19 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2011/C 128/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011(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

2011/C 128/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

or Article 38 of Directive 2001/82/EC

)

19

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

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 29.4.2011 | EN | Official Journal of the European Union | C 128/1 |
| --- | --- | --- | --- |

29.4.2011

EN

Official Journal of the European Union

C 128/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011

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

2011/C 128/01

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 6.1.2011 | Potactasol | topotecan | Actavis Group PTC ehf. |
| Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland |

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

6.1.2011

Potactasol

topotecan

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

EU/1/10/660/001-002

powder for concentrate for solution for infusion

L01XX17

10.1.2011

21.1.2011

Docetaxel Teva Pharma

Docetaxel

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

Teva Pharma B.V.

Computerweg 10, DR Utrecht 3542, Nederland

EU/1/10/662/001-002

Concentrate and solvent for solution for infusion

L01CD02

26.1.2011

21.1.2011

Iasibon

Ibandronic acid

| Pharmathen S.A. |
| --- |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659/001-010

Concentrate for solution for infusion

Film-coated tablet

M05BA06

25.1.2011

27.1.2011

Fluenz

influenza vaccine (live attenuated, nasal)

| MedImmune, LLC |
| --- |
| Lagelandseweg 78, 6545 CG Nijmegen, Nederland |

MedImmune, LLC

Lagelandseweg 78, 6545 CG Nijmegen, Nederland

EU/1/10/661/001-002

Nasal spray, suspension

J07BB03

1.2.2011

18.2.2011

Entacapone Teva

entacapone

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/665/001-004

Film-coated tablet

N04BX02

22.2.2011

28.2.2011

Daliresp

roflumilast

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/668/001-003

Film-coated tablet

R03DX07

2.3.2011

28.2.2011

Esbriet

Pirfenidone

| InterMune Europe Ltd |
| --- |
| Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom |

InterMune Europe Ltd

Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom

EU/1/11/667/001-003

Capsule, hard

L04AX05

2.3.2011

28.2.2011

Lamivudine / Zidovudine Teva

Lamivudine/Zidovudine

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/10/663/001-002

Film-coated tablet

J05AR01

2.3.2011

28.2.2011

Libertek

roflumilast

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/11/666/001-003

Film-coated tablet

R03DX07

2.3.2011

28.2.2011

Xiapex

collagenase clostridium histolyticum

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/1/11/671/001

Powder and solvent for solution for injection

M09AB02

2.3.2011

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.1.2011 | Invirase | Roche Registration Limited |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |

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

6.1.2011

Invirase

Roche Registration Limited

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

EU/1/96/026/001-002

10.1.2011

6.1.2011

Irbesartan HCT Winthrop

| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC |
| --- |
| 174 avenue de France, F- 75013 Paris, France |

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174 avenue de France, F- 75013 Paris, France

EU/1/06/377/001-028

11.1.2011

6.1.2011

Irbesartan Winthrop

| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC |
| --- |
| 174 avenue de France, F- 75013 Paris, France |

SANOFI PHARMA BRISTOL MYERS SQUIBB SNC

174 avenue de France, F- 75013 Paris, France

EU/1/06/376/001-033

11.1.2011

6.1.2011

Lucentis

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

Novartis Europharm Limited

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

EU/1/06/374/001

11.1.2011

6.1.2011

Rapamune

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Limited

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

EU/1/01/171/001

EU/1/01/171/007-010

EU/1/01/171/013-014

11.1.2011

6.1.2011

Resolor

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

Movetis NV

Veedijk 58, B-2300 Turnhout, België

EU/1/09/581/001-008

11.1.2011

6.1.2011

Tepadina

| ADIENNE S.r.l. |
| --- |
| via Broseta, 64/B, 24128 Bergamo, Italia |

ADIENNE S.r.l.

via Broseta, 64/B, 24128 Bergamo, Italia

EU/1/10/622/001-002

11.1.2011

6.1.2011

Yttriga

| Eckert & Ziegler Nuclitec GmbH |
| --- |
| Gieselweg 1, Braunschweig 38110, Deutschland |

Eckert & Ziegler Nuclitec GmbH

Gieselweg 1, Braunschweig 38110, Deutschland

EU/1/05/322/001

10.1.2011

11.1.2011

IntronA

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

Schering Plough Europe

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

EU/1/99/127/011-039

EU/1/99/127/041-044

18.1.2011

11.1.2011

Pantoloc Control

| Nycomed GmbH |
| --- |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |

Nycomed GmbH

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/519/001-004

13.1.2011

11.1.2011

Rapiscan

| Gilead Sciences International Limited |
| --- |
| Cambridge CB21 6GT United Kingdom |

Gilead Sciences International Limited

Cambridge CB21 6GT United Kingdom

EU/1/10/643/001

13.1.2010

13.1.2011

Clopidogrel Winthrop

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

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

EU/1/08/465/001-020

17.1.2011

13.1.2011

Copalia

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

Novartis Europharm Limited

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

EU/1/06/372/037-039

17.1.2010

13.1.2011

INOmax

| INO Therapeutics AB |
| --- |
| SE-181 81 Lidingö, Sverige |

INO Therapeutics AB

SE-181 81 Lidingö, Sverige

EU/1/01/194/001-002

18.1.2011

13.1.2011

Iscover

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

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

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

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

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

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

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

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

EU/1/98/070/008-010

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

EU/1/98/070/012

17.1.2011

13.1.2011

Nimvastid

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

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/525/001-050

17.1.2011

13.1.2011

Plavix

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 avenue de France - 75013 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

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

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

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

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

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

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

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

EU/1/98/069/008-010

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

EU/1/98/069/012

17.1.2011

17.1.2011

Cancidas

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

Merck Sharp & Dohme Ltd

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

EU/1/01/196/001

EU/1/01/196/003

19.1.2011

17.1.2011

Kuvan

| Merck KGaA |
| --- |
| Frankfurter Straße 250, 64293 Darmstadt, Deutschland |

Merck KGaA

Frankfurter Straße 250, 64293 Darmstadt, Deutschland

EU/1/08/481/001-003

19.1.2011

17.1.2011

Nevanac

| Alcon Laboratories (UK) Ltd. |
| --- |
| Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |

Alcon Laboratories (UK) Ltd.

Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom

EU/1/07/433/001

19.1.2011

21.1.2011

Abilify

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

25.1.2011

21.1.2011

Adenuric

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

Menarini International Operations Luxembourg S.A.

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

EU/1/08/447/001-004

25.1.2011

21.1.2011

Arzerra

| Glaxo Group Ltd |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

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

EU/1/10/625/001-002

26.1.2011

21.1.2011

Cubicin

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

Novartis Europharm Limited

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

EU/1/05/328/001-004

25.1.2011

21.1.2011

Enbrel

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Limited

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

EU/1/99/126/001-021

25.1.2011

21.1.2011

Humira

| Abbott Laboratories |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom |

Abbott Laboratories

Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom

EU/1/03/256/001-010

25.1.2011

21.1.2011

INOmax

| INO Therapeutics AB |
| --- |
| SE-181 81 Lidingö, Sverige |

INO Therapeutics AB

SE-181 81 Lidingö, Sverige

EU/1/01/194/001-002

25.1.2011

21.1.2011

Karvea

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/97/049/001-039

26.1.2011

21.1.2011

Kuvan

| Merck KGaA |
| --- |
| Frankfurter Straße 250, 64293 Darmstadt, Deutschland |

Merck KGaA

Frankfurter Straße 250, 64293 Darmstadt, Deutschland

EU/1/08/481/001-003

25.1.2011

21.1.2011

Mixtard

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/231/001-023

EU/1/02/231/036-037

25.1.2011

21.1.2011

Multaq

| Sanofi-Aventis |
| --- |
| 174, avenue de France, F-75013 Paris, France |

Sanofi-Aventis

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

EU/1/09/591/001-004

25.1.2011

21.1.2011

Olazax Disperzi

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

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

EU/1/09/592/001-005

25.1.2011

21.1.2011

Pandemrix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

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

EU/1/08/452/001

26.1.2011

21.1.2011

Pradaxa

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

Boehringer Ingelheim International GmbH

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

EU/1/08/442/001-008

25.1.2011

21.1.2011

Rapamune

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Limited

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

EU/1/01/171/001

EU/1/01/171/007-010

EU/1/01/171/013-014

26.1.2011

21.1.2011

Rasilez

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

Novartis Europharm Limited

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

EU/1/07/405/001-040

25.1.2011

21.1.2011

Revatio

| Pfizer Limited |
| --- |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited

Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/05/318/002

25.1.2011

21.1.2011

Revlimid

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

Celgene Europe Limited

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

EU/1/07/391/001-004

26.1.2011

21.1.2011

RotaTeq

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

26.1.2011

21.1.2011

Sprimeo

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

Novartis Europharm Limited

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

EU/1/07/407/001-020

26.1.2011

21.1.2011

Temomedac

| medac Gesellschaft für klinische Spezialpräparate mbH |
| --- |
| Fehlandtstrasse 3, D-20354 Hamburg - Deutschland |

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstrasse 3, D-20354 Hamburg - Deutschland

EU/1/09/605/001-012

26.1.2011

21.1.2011

Thymanax

| Servier (Ireland) Industries Limited |
| --- |
| Gorey Road, Arklow, Co. Wicklow, Ireland |

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498/001-008

25.1.2011

21.1.2011

Valdoxan

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

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/08/499/001-008

26.1.2011

21.1.2011

Yentreve

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/280/001-008

25.1.2011

24.1.2011

Apidra

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/04/285/001-036

27.1.2011

24.1.2011

Ceplene

| EpiCept GmbH |
| --- |
| Goethestrasse 4, D-80336 München, Deutschland |

EpiCept GmbH

Goethestrasse 4, D-80336 München, Deutschland

EU/1/08/477/001

27.1.2011

24.1.2011

Dafiro

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

Novartis Europharm Limited

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

EU/1/06/371/001-039

27.1.2011

24.1.2011

Eucreas

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

Novartis Europharm Limited

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

EU/1/07/425/001-018

27.1.2011

24.1.2011

Galvus

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

Novartis Europharm Limited

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

EU/1/07/414/001-010

EU/1/07/414/018

27.1.2011

24.1.2011

Isentress

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/07/436/001-002

27.1.2011

24.1.2011

Jalra

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

Novartis Europharm Limited

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

EU/1/08/485/001-011

27.1.2011

24.1.2011

Lantus

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134/001-037

27.1.2011

24.1.2011

NutropinAq

| Ipsen Pharma |
| --- |
| 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

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

EU/1/00/164/003-005

27.1.2011

24.1.2011

Olanzapine Glenmark

| Glenmark Generics (Europe) Limited |
| --- |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |

Glenmark Generics (Europe) Limited

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

EU/1/09/587/001-017

27.1.2011

24.1.2011

Olanzapine Glenmark Europe

| Glenmark Generics (Europe) Limited |
| --- |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |

Glenmark Generics (Europe) Limited

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

EU/1/09/588/001-012

27.1.2011

24.1.2011

Optisulin

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133/001-032

27.1.2011

24.1.2011

Pelzont

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

Merck Sharp & Dohme Ltd

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

EU/1/08/460/009-011

EU/1/08/460/013-014

26.1.2011

24.1.2011

Rotarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, Rixensart, B-1330 Belgique |

GlaxoSmithKline Biologicals S.A.

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

EU/1/05/330/001-011

27.1.2011

24.1.2011

SonoVue

| Bracco International B.V. |
| --- |
| Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland |

Bracco International B.V.

Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland

EU/1/01/177/002

27.1.2011

24.1.2011

Synflorix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/508/001-010

27.1.2011

24.1.2011

Torisel

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

Wyeth Europa Ltd

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

EU/1/07/424/001

27.1.2011

24.1.2011

Tredaptive

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

Merck Sharp & Dohme Ltd

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

EU/1/08/459/009-011

EU/1/08/459/013-014

26.1.2011

24.1.2011

Trevaclyn

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

Merck Sharp & Dohme Ltd

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

EU/1/08/458/009-011

EU/1/08/458/013-014

26.1.2011

24.1.2011

Vistide

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

Gilead Sciences International Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/97/037/001

27.1.2011

24.1.2011

Xarelto

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/08/472/001-010

27.1.2011

24.1.2011

Xiliarx

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

Novartis Europharm Limited

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

EU/1/08/486/001-011

27.1.2011

26.1.2011

Naglazyme

| BioMarin Europe Ltd |
| --- |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/05/324/001-002

27.1.2011

27.1.2011

Adrovance

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

Merck Sharp & Dohme Ltd

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

EU/1/06/364/001-009

1.2.2011

27.1.2011

Alimta

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/290/001-002

1.2.2011

27.1.2011

Cymbalta

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/296/001-009

31.1.2011

27.1.2011

Herceptin

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

Roche Registration Limited

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

EU/1/00/145/001

1.2.2011

27.1.2011

Icandra

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

Novartis Europharm Limited

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

EU/1/08/484/001-018

1.2.2011

27.1.2011

Menveo

| Novartis Vaccines and Diagnostics S.r.l. |
| --- |
| Via Fiorentina, 1, 53100 Siena, Italia |

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/614/001

31.1.2011

27.1.2011

Nonafact

| Sanquin |
| --- |
| Plesmanlaan 125, Amsterdam 1066 CX, Nederland |

Sanquin

Plesmanlaan 125, Amsterdam 1066 CX, Nederland

EU/1/01/186/001-002

1.2.2011

27.1.2011

Orgalutran

| N.V. Organon |
| --- |
| P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland |

N.V. Organon

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

EU/1/00/130/001-002

31.1.2011

27.1.2011

Ranexa

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

Menarini International Operations Luxembourg S.A.

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

EU/1/08/462/001-012

1.2.2011

27.1.2011

Rasilez HCT

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

Novartis Europharm Limited

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

EU/1/08/491/001-080

1.2.2011

27.1.2011

Regranex

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/99/101/001

31.1.2011

27.1.2011

Remicade

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

Centocor B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

1.2.2011

27.1.2011

Ribavirin Mylan

| Three Rivers Global Pharma Limited |
| --- |
| 20-22 Bedford Row, London WC1R4JS, United Kingdom |

Three Rivers Global Pharma Limited

20-22 Bedford Row, London WC1R4JS, United Kingdom

EU/1/10/634/001-004

23.2.2011

27.1.2011

RotaTeq

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

1.2.2011

27.1.2011

Sebivo

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

Novartis Europharm Limited

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

EU/1/07/388/001-003

1.2.2011

27.1.2011

Simponi

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

Centocor B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546/001-004

31.1.2011

27.1.2011

Xeristar

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/297/001-008

1.2.2011

27.1.2011

Zomarist

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

Novartis Europharm Limited

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

EU/1/08/483/001-018

1.2.2011

1.2.2011

Ariclaim

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/283/008-012

3.2.2011

1.2.2011

Emend

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

Merck Sharp & Dohme Ltd

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

EU/1/03/262/001-008

3.2.2011

1.2.2011

Exforge

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

Novartis Europharm Limited

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

EU/1/06/370/001-039

3.2.2011

1.2.2011

Fosavance

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

Merck Sharp & Dohme Ltd

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

EU/1/05/310/001-009

3.2.2011

1.2.2011

Imprida

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

Novartis Europharm Limited

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

EU/1/06/373/001-039

3.2.2011

1.2.2011

INCRELEX

| Ipsen Pharma |
| --- |
| 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France |

Ipsen Pharma

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

EU/1/07/402/001

3.2.2011

1.2.2011

Insulin Human Winthrop

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368/001-168

3.2.2011

1.2.2011

Insuman

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

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/97/030/028-195

3.2.2011

1.2.2011

Irbesartan Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/576/001-039

3.2.2011

1.2.2011

Nivestim

| Hospira UK Limited |
| --- |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |

Hospira UK Limited

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

EU/1/10/631/001-009

3.2.2011

1.2.2011

Orfadin

| Swedish Orphan Biovitrum International AB |
| --- |
| SE-112 76 Stockholm, Sweden |

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sweden

EU/1/04/303/001-003

3.2.2011

1.2.2011

Riprazo

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

Novartis Europharm Limited

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

EU/1/07/409/001-020

3.2.2011

1.2.2011

Votrient

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

Glaxo Group Limited

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

EU/1/10/628/001-004

3.2.2011

2.2.2011

Nplate

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

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/08/497/001-008

4.2.2011

2.2.2011

Prevenar

| Wyeth-Lederle Vaccines S.A. |
| --- |
| Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium |

Wyeth-Lederle Vaccines S.A.

Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium

EU/1/00/167/001-008

4.2.2011

2.2.2011

Prolia

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618/001-004

4.2.2011

2.2.2011

Replagal

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, 182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, 182 33 Danderyd, Sverige

EU/1/01/189/001-006

4.2.2011

2.2.2011

Vantavo

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

Merck Sharp & Dohme Ltd.

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

EU/1/09/572/001-009

4.2.2011

8.2.2011

Biopoin

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

CT Arzneimittel GmbH

Lengeder Straße 42a, D-13407 Berlin, Deutschland

EU/1/09/565/001-028

10.2.2011

8.2.2011

Temodal

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

Schering Plough Europe

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

EU/1/98/096/001-025

14.2.2011

9.2.2011

Cimzia

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

UCB Pharma SA.

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

EU/1/09/544/001-002

11.2.2011

9.2.2011

Karvezide

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/085/001-034

11.2.2011

9.2.2011

Olazax

| Glenmark Pharmaceuticals s.r.o. |
| --- |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |

Glenmark Pharmaceuticals s.r.o.

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

EU/1/09/597/001-005

11.2.2011

9.2.2011

Peyona

| CHIESI FARMACEUTICI SpA |
| --- |
| Via Palermo 26/A, I-43100 Parma, ITALIA |

CHIESI FARMACEUTICI SpA

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

EU/1/09/528/001-002

11.2.2011

9.2.2011

Tesavel

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

Merck Sharp & Dohme Ltd

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

EU/1/07/435/001-018

11.2.2011

9.2.2011

Xelevia

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

Merck Sharp & Dohme Ltd

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

EU/1/07/382/001-018

11.2.2011

11.2.2011

Aprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 avenue de France - 75013 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/97/046/001-039

15.2.2011

11.2.2011

Azarga

| Alcon Laboratories (UK) Ltd. |
| --- |
| Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |

Alcon Laboratories (UK) Ltd.

Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom

EU/1/08/482/001-002

15.2.2011

11.2.2011

Brinavess

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/10/645/001-002

15.2.2011

11.2.2011

Clopidogrel Krka

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

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556/001-011

15.2.2011

11.2.2011

CoAprovel

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 174 avenue de France - 75013 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

174 avenue de France - 75013 Paris, France

EU/1/98/086/001-034

15.2.2011

11.2.2011

Crixivan

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

Merck Sharp & Dohme Ltd

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

EU/1/96/024/001-005

EU/1/96/024/008

EU/1/96/024/010

15.2.2011

11.2.2011

Eporatio

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

ratiopharm GmbH

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

EU/1/09/573/001-028

15.2.2011

11.2.2011

Januvia

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

Merck Sharp & Dohme Ltd

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

EU/1/07/383/001-018

15.2.2011

11.2.2011

Rilonacept Regeneron

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

Regeneron UK Limited

40 Bank Street, E14 5DS London, United Kingdom

EU/1/09/582/001

15.2.2011

11.2.2011

Zutectra

| Biotest Pharma GmbH |
| --- |
| Landsteinerstr.5, 63303 Dreieich, Deutschland |

Biotest Pharma GmbH

Landsteinerstr.5, 63303 Dreieich, Deutschland

EU/1/09/600/001

15.2.2011

11.2.2011

Zyllt

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

KRKA, d.d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553/001-010

15.2.2011

18.2.2011

Actrapid

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/230/001-007

EU/1/02/230/016-017

22.2.2011

18.2.2011

Elaprase

| Shire Human Genetic Therapies AB |
| --- |
| Svärdvägen 11D, 182 33 Danderyd, Sverige |

Shire Human Genetic Therapies AB

Svärdvägen 11D, 182 33 Danderyd, Sverige

EU/1/06/365/001-003

22.2.2011

18.2.2011

Keppra

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

UCB Pharma SA.

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

EU/1/00/146/001-032

22.2.2011

18.2.2011

Mimpara

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/04/292/001-012

22.2.2011

18.2.2011

Optaflu

| Novartis Vaccines and Diagnostics GmbH |
| --- |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland |

Novartis Vaccines and Diagnostics GmbH

Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland

EU/1/07/394/001-009

22.2.2011

18.2.2011

Renagel

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/123/005-013

22.2.2011

21.2.2011

Arzerra

| Glaxo Group Ltd |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

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

EU/1/10/625/001-003

25.2.2011

21.2.2011

Baraclude

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/343/001-007

28.2.2011

21.2.2011

Cervarix

| GlaxoSmithKline Biologicals S.A. |
| --- |
| rue de l'Institut 89, 1330 Rixensart, Belgique |

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419/001-012

25.2.2011

21.2.2011

Cialis

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/02/237/001-009

23.2.2011

21.2.2011

Clopidogrel Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/540/001-016

24.2.2011

21.2.2011

Competact

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych, London WC2B 4AE, United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/06/354/001-011

23.2.2011

21.2.2011

Conbriza

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

Pfizer Limited

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

EU/1/09/511/001-005

23.2.2011

21.2.2011

Dukoral

| Crucell Sweden AB |
| --- |
| SE-105 21 Stockholm, Sweden |

Crucell Sweden AB

SE-105 21 Stockholm, Sweden

EU/1/03/263/001-003

1.3.2011

21.2.2011

Dynastat

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

Pfizer Ltd

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

EU/1/02/209/001-008

23.2.2011

21.2.2011

Efficib

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

Merck Sharp & Dohme Ltd.

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

EU/1/08/457/001-016

24.2.2011

21.2.2011

Enbrel

| Wyeth Europa Limited |
| --- |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |

Wyeth Europa Limited

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

EU/1/99/126/001-021

25.2.2011

21.2.2011

Firazyr

| Jerini AG |
| --- |
| Invalidenstr. 130, D-10115 Berlin, Deutschland |

Jerini AG

Invalidenstr. 130, D-10115 Berlin, Deutschland

EU/1/08/461/001-002

24.2.2011

21.2.2011

Glivec

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

Novartis Europharm Limited

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

EU/1/01/198/001-013

28.2.2011

21.2.2011

Humira

| Abbott Laboratories Ltd |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom |

Abbott Laboratories Ltd

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

EU/1/03/256/001-010

23.2.2011

21.2.2011

Insulatard

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233/005-007

25.2.2011

21.2.2011

Intanza

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

Sanofi Pasteur MSD SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/08/505/001-006

23.2.2011

21.2.2011

Ivemend

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

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

EU/1/07/437/001-004

24.2.2011

21.2.2011

Janumet

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

Merck Sharp & Dohme Ltd.

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

EU/1/08/455/001-016

24.2.2011

21.2.2011

Kineret

| Swedish Orphan Biovitrum AB (publ) |
| --- |
| SE-112 76, Stockholm, Sverige |

Swedish Orphan Biovitrum AB (publ)

SE-112 76, Stockholm, Sverige

EU/1/02/203/001-004

25.2.2011

21.2.2011

Levemir

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278/001-003

28.2.2011

21.2.2011

Myozyme

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/333/001-003

28.2.2011

21.2.2011

Neupro

| Schwarz Pharma Ltd |
| --- |
| Shannon, Industrial Estate, Co.Clare, Ireland |

Schwarz Pharma Ltd

Shannon, Industrial Estate, Co.Clare, Ireland

EU/1/05/331/001-055

25.2.2011

21.2.2011

Pritor

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/98/089/001-022

25.2.2011

21.2.2011

PritorPlus

| Bayer Schering Pharma AG |
| --- |
| 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

13342 Berlin, Deutschland

EU/1/02/215/001-021

28.2.2011

21.2.2011

Protaphane

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234/005-007

25.2.2011

21.2.2011

Protopic

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland

EU/1/02/201/001-006

28.2.2011

21.2.2011

Qutenza

| Astellas Pharma Europe B.V. |
| --- |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland |

Astellas Pharma Europe B.V.

Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/09/524/001-002

25.2.2011

21.2.2011

Ranexa

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

Menarini International Operations Luxembourg S.A.

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

EU/1/08/462/001-012

25.2.2011

21.2.2011

Rasilez

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

Novartis Europharm Limited

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

EU/1/07/405/001-040

25.2.2011

21.2.2011

Rasilez HCT

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

Novartis Europharm Limited

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

EU/1/08/491/001-080

25.2.2011

21.2.2011

Remicade

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, 2333 CB Leiden, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-005

25.2.2011

21.2.2011

Ribavirin Teva

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/509/001-004

24.2.2011

21.2.2011

Ribavirin Teva Pharma BV

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

Teva Pharma B.V.

Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/527/001-016

24.2.2011

21.2.2011

Riprazo

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

Novartis Europharm Limited

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

EU/1/07/409/001-020

28.2.2011

21.2.2011

Ristaben

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

Merck Sharp & Dohme Ltd.

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

EU/1/10/621/001-018

24.2.2011

21.2.2011

Ristfor

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

Merck Sharp & Dohme Ltd.

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

EU/1/10/620/001-016

24.2.2011

21.2.2011

Simponi

| Janssen Biologics B.V. |
| --- |
| Einsteinweg 101, CB Leiden 2333, Nederland |

Janssen Biologics B.V.

Einsteinweg 101, CB Leiden 2333, Nederland

EU/1/09/546/001-004

23.2.2011

21.2.2011

Sprimeo

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

Novartis Europharm Limited

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

EU/1/07/407/001-020

28.3.2011

21.2.2011

Stocrin

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

Merck Sharp & Dohme Ltd

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

EU/1/99/111/001-005

EU/1/99/111/008-011

25.2.2011

21.2.2011

Tamiflu

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

Roche Registration Limited

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

EU/1/02/222/001-004

23.2.2011

21.2.2011

Tysabri

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

Elan Pharma International Ltd.

Monksland, Athlone, County Westmeath, Ireland

EU/1/06/346/001

23.2.2011

21.2.2011

Velmetia

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

Merck Sharp & Dohme Ltd.

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

EU/1/08/456/001-016

24.2.2011

21.2.2011

Ventavis

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, D - 13342 Berlin, Deutschland |

Bayer Schering Pharma AG

Müllerstrasse 170-178, D - 13342 Berlin, Deutschland

EU/1/03/255/001-008

23.2.2011

21.2.2011

Volibris

| Glaxo Group Ltd |
| --- |
| Greenford, Middlesex UB6 0NN, United Kingdom |

Glaxo Group Ltd

Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/08/451/001-004

2.3.2011

21.2.2011

Zylagren

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

KRKA, d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/558/001-010

28.2.2011

21.2.2011

Zyprexa

| Eli Lilly Nederland B.V. |
| --- |
| Grootslag 1-5, 3991 RA Houten, Nederland |

Eli Lilly Nederland B.V.

Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/96/022/016-017

23.2.2011

28.2.2011

Altargo

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

Glaxo Group Limited

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

EU/1/07/390/001-004

4.3.2011

28.2.2011

Aranesp

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

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185/001-022

EU/1/01/185/031-111

4.3.2011

28.2.2011

Arixtra

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

Glaxo Group Ltd.

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

EU/1/02/206/001-035

2.3.2011

28.2.2011

Avastin

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

Roche Registration Limited

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

EU/1/04/300/001-002

4.3.2011

28.2.2011

Baraclude

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

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/343/001-007

3.3.2011

28.2.2011

Clopidogrel Qualimed

| Qualimed |
| --- |
| 117, Allée des Parcs, 69800 Saint Priest, France |

Qualimed

117, Allée des Parcs, 69800 Saint Priest, France

EU/1/09/557/001-010

4.3.2011

28.2.2011

Clopidogrel TAD

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland |

TAD Pharma GmbH

Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland

EU/1/09/555/001-009

4.3.2011

28.2.2011

Fabrazyme

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/188/001-006

4.3.2011

28.2.2011

Firazyr

| Jerini AG |
| --- |
| Invalidenstr. 130, D-10115 Berlin, Deutschland |

Jerini AG

Invalidenstr. 130, D-10115 Berlin, Deutschland

EU/1/08/461/001-002

4.3.2011

28.2.2011

IDflu

| Sanofi Pasteur SA |
| --- |
| 2, avenue Pont Pasteur, F-69007 Lyon, France |

Sanofi Pasteur SA

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

EU/1/08/507/001-006

3.3.2011

28.2.2011

Ilaris

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

Novartis Europharm Limited

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

EU/1/09/564/001-002

4.3.2011

28.2.2011

Invanz

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

Merck Sharp & Dohme Ltd

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

EU/1/02/216/001-002

3.3.2011

28.2.2011

Kaletra

| Abbott Laboratories |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom |

Abbott Laboratories

Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom

EU/1/01/172/001-008

4.3.2011

28.2.2011

Kinzalkomb

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214/001-015

2.3.2011

28.2.2011

Kinzalmono

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Schering Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/091/001-014

2.3.2011

28.2.2011

Micardis

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

Boehringer Ingelheim International GmbH

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

EU/1/98/090/001-020

2.3.2011

28.2.2011

MicardisPlus

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

Boehringer Ingelheim International GmbH

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

EU/1/02/213/001-023

3.3.2011

28.2.2011

NovoMix

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

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/142/004-005

EU/1/00/142/009-025

3.3.2011

28.2.2011

Omnitrope

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10, Kundl 6250, Österreich |

Sandoz GmbH

Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/06/332/001-009

2.3.2011

28.2.2011

Onglyza

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

Bristol Myers Squibb/AstraZeneca EEIG

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

EU/1/09/545/011-015

3.3.2011

28.2.2011

Onglyza

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

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

3.3.2011

28.2.2011

Osigraft

| Howmedica International S. de R.L. |
| --- |
| Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland |

Howmedica International S. de R.L.

Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland

EU/1/01/179/001

4.3.2011

28.2.2011

Osseor

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

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/287/001-006

4.3.2011

28.2.2011

PegIntron

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

Schering Plough Europe

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

EU/1/00/131/001-050

3.3.2011

28.2.2011

PREZISTA

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

Janssen-Cilag International NV

Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/06/380/001-005

4.3.2011

28.2.2011

ProQuad

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, 69007 Lyon, France

EU/1/05/323/001-013

2.3.2011

28.2.2011

Protelos

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

Les Laboratoires Servier

22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/288/001-006

4.3.2011

28.2.2011

Quadramet

| CIS bio international |
| --- |
| Boite Postale 32 - F-91192 Gif-sur-Yvette - France |

CIS bio international

Boite Postale 32 - F-91192 Gif-sur-Yvette - France

EU/1/97/057/001

4.4.2011

28.2.2011

RotaTeq

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

Sanofi Pasteur MSD, SNC

8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

3.3.2011

28.2.2011

Siklos

| ADDMEDICA |
| --- |
| 101, rue Saint Lazare, Paris 75009, France |

ADDMEDICA

101, rue Saint Lazare, Paris 75009, France

EU/1/07/397/001-004

3.3.2011

28.2.2011

Tracleer

| Actelion Registration Ltd |
| --- |
| BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |

Actelion Registration Ltd

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

EU/1/02/220/001-006

3.3.2011

28.2.2011

Vedrop

| Orphan Europe SARL |
| --- |
| Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92800 Puteaux - France |

Orphan Europe SARL

Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92800 Puteaux - France

EU/1/09/533/001-003

3.3.2011

28.2.2011

Ytracis

| CIS bio international |
| --- |
| Boite Postale 32 - F-91192 Gif-sur-Yvette Cedex- France |

CIS bio international

Boite Postale 32 - F-91192 Gif-sur-Yvette Cedex- France

EU/1/03/250/001

4.3.2011

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.1.2011 | Thelin | Pfizer Limited |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |

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

6.1.2011

Thelin

Pfizer Limited

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

EU/1/06/353/001-005

11.1.2011

1.2.2011

Clopidogrel 1A Pharma

| Acino Pharma GmbH |
| --- |
| Am Windfeld 35, 83714 Miesbach, Deutschland |

Acino Pharma GmbH

Am Windfeld 35, 83714 Miesbach, Deutschland

EU/1/09/542/001-007

3.2.2011

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (2)
  ): Accepted

| Date of the Décision | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 27.1.2011 | Hiprabovis IBR Marker Live | Live gE<sup>-</sup> tk<sup>-</sup> double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL | Laboratorios Hipra, S.A. |
| Avda. La Selva, 135, 17170- Amer (Girona), España |

Date of the Décision

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

27.1.2011

Hiprabovis IBR Marker Live

Live gE<sup>-</sup> tk<sup>-</sup> double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL

Laboratorios Hipra, S.A.

Avda. La Selva, 135, 17170- Amer (Girona), España

EU/2/10/114/001-002

Lyophilisate for suspension

QI02AD01

1.2.2011

11.2.2011

Comfortis

Spinosad

| Eli Lilly and Company Ltd |
| --- |
| Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |

Eli Lilly and Company Ltd

Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom

EU/2/10/115/001-010

Chewable tablet

QP53BX03

15.2.2011

18.2.2011

Activyl

Indoxacarb

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

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/10/118/001-014

Spot-on solution

QP53AX27

22.2.2011

18.2.2011

Cimalgex

Cimicoxib

| Vétoquinol SA |
| --- |
| Magny-Vernois - 70200 LURE - France |

Vétoquinol SA

Magny-Vernois - 70200 LURE - France

EU/2/10/119/001-012

Tablet

QM01AH93

24.2.2011

18.2.2011

Purevax Rabies

Rabies recombinant canarypox virus (vCP65)

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

MERIAL

29 avenue Tony Garnier, 69007 LYON, France

EU/2/10/117/001-002

Suspension for injection

QI06AX

22.2.2011

21.2.2011

Melosus

Meloxicam

| CP-Pharma Handelsgesellschaft mbH |
| --- |
| Ostlandring 13, D-31303 Burgdorf, Deutschland |

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, D-31303 Burgdorf, Deutschland

EU/2/10/116/001-004

Oral suspension

QM01AC06

24.2.2011

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.1.2011 | Econor | Novartis Animal Health Austria GmbH |
| Biochemiestrasse 10, 6250 Kundl, Österreich |

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

6.1.2011

Econor

Novartis Animal Health Austria GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/2/98/010/004-006

EU/2/98/010/017-018

EU/2/98/010/021-025

11.1.2011

13.1.2011

Duvaxyn WNV

| Fort Dodge Animal Health Ltd |
| --- |
| Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom |

Fort Dodge Animal Health Ltd

Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom

EU/2/08/086/001-003

18.1.2011

13.1.2011

Palladia

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

Pfizer Ltd

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

EU/2/09/100/001-003

17.1.2011

17.1.2011

Zolvix

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172, DK-2100 Copenhagen, Denmark |

Novartis Healthcare A/S

Lyngbyvej 172, DK-2100 Copenhagen, Denmark

EU/2/09/101/001-010

19.1.2011

21.1.2011

Dicural

| Fort Dodge Animal Health Holland |
| --- |
| C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland |

Fort Dodge Animal Health Holland

C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland

EU/2/97/003/001-018

25.1.2011

21.1.2011

Zulvac 8 Ovis

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

Pfizer Limited

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

EU/2/09/104/001-002

26.1.2011

24.1.2011

Poulvac FluFend H5N3 RG

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

Pfizer Limited

Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom

EU/2/06/060/001-002

27.1.2011

24.1.2011

Rheumocam

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

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, IRELAND

EU/2/07/078/001-010

26.1.2011

27.1.2011

Ingelvac CircoFLEX

| Boehringer Ingelheim Vetmedica GmbH |
| --- |
| 55216 Ingelheim am Rhein, Deutschland |

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim am Rhein, Deutschland

EU/2/07/079/001-004

1.2.2011

27.1.2011

Meloxidyl

| CEVA SANTE ANIMALE |
| --- |
| 10 avenue de la Ballastière, 33500 Libourne, France |

CEVA SANTE ANIMALE

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/06/070/005-007

1.2.2011

11.2.2011

SevoFlo

| Abbott Laboratories Limited |
| --- |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM |

Abbott Laboratories Limited

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

EU/2/02/035/007

15.2.2011

—   Suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 24.1.2011 | Acticam | Ecuphar NV |
| Legeweg 157-I, B-8020 Oostkamp, Belgïe |

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

24.1.2011

Acticam

Ecuphar NV

Legeweg 157-I, B-8020 Oostkamp, Belgïe

EU/2/08/088/001-003

26.1.2011

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

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4H

---

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

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

---

| 29.4.2011 | EN | Official Journal of the European Union | C 128/19 |
| --- | --- | --- | --- |

29.4.2011

EN

Official Journal of the European Union

C 128/19

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2011 to 28 February 2011

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

2011/C 128/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 21.2.2011 | Tazocin | See Annex I | See Annex I | 23.2.2011 |
| 13.1.2011 | Fortum and associated names | See Annex II | See Annex II | 17.1.2011 |
| 21.1.2011 | Vascace plus and associated names | See Annex III | See Annex III | 24.1.2011 |
| 28.2.2011 | fenofibrate, bezafibrate, ciprofibrate, gemfibrozil | See Annex IV | See Annex IV | 1.3.2011 |
| 27.1.2011 | Modafinil containing medicinal products | See Annex V | See Annex V | 31.1.2011 |
| 6.1.2011 | Lucentis | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | These Decisions are addressed to the Member States | 10.1.2011 |
| 28.2.2011 | Xiapex | Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | These Decisions are addressed to the Member States | 1.3.2011 |
| 21.1.2011 | Revatio | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | These Decisions are addressed to the Member States | 25.1.2011 |
| 28.2.2011 | Daliresp | Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | These Decisions are addressed to the Member States | 1.3.2011 |
| 28.2.2011 | Esbriet | InterMune Europe Ltd, Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom | These Decisions are addressed to the Member States | 1.3.2011 |
| 28.2.2011 | Libertek | Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | These Decisions are addressed to the Member States | 1.3.2011 |
| 28.1.2011 | Siklos | ADDMEDICA, 101, rue Saint Lazare, Paris 75009, France | These Decisions are addressed to the Member States | 4.3.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

21.2.2011

Tazocin

See Annex I

See Annex I

23.2.2011

13.1.2011

Fortum and associated names

See Annex II

See Annex II

17.1.2011

21.1.2011

Vascace plus and associated names

See Annex III

See Annex III

24.1.2011

28.2.2011

fenofibrate, bezafibrate, ciprofibrate, gemfibrozil

See Annex IV

See Annex IV

1.3.2011

27.1.2011

Modafinil containing medicinal products

See Annex V

See Annex V

31.1.2011

6.1.2011

Lucentis

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

These Decisions are addressed to the Member States

10.1.2011

28.2.2011

Xiapex

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

These Decisions are addressed to the Member States

1.3.2011

21.1.2011

Revatio

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

These Decisions are addressed to the Member States

25.1.2011

28.2.2011

Daliresp

Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

These Decisions are addressed to the Member States

1.3.2011

28.2.2011

Esbriet

InterMune Europe Ltd, Wellesley House, Duke of Wellington Avenue, Royal Arsenal, London SE18 6SS, United Kingdom

These Decisions are addressed to the Member States

1.3.2011

28.2.2011

Libertek

Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

These Decisions are addressed to the Member States

1.3.2011

28.1.2011

Siklos

ADDMEDICA, 101, rue Saint Lazare, Paris 75009, France

These Decisions are addressed to the Member States

4.3.2011

—   Refusal 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 |
| --- | --- | --- | --- | --- |
| 21.2.2011 | Galantamine STADA and ass. names | See Annex VI | See Annex VI | 24.2.2011 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

21.2.2011

Galantamine STADA and ass. names

See Annex VI

See Annex VI

24.2.2011

---

(1)  OJ L 311, 28.11.01, p. 67.

(2)  OJ L 311, 28.11.01, p. 1.

---

ANNEX I

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

| Member State EU/EEA | Marketing Authorisation Holder | (Invented) Name | Strength | Pharmaceutical Form | Route of administration | Content (concentration) |
| --- | --- | --- | --- | --- | --- | --- |
| Austria | Pfizer Corporation Austria Ges.m.b.H |
| Floridsdorfer |
| Hauptstraße 1, |
| A-1210 Wien |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Content (concentration)

Austria

Pfizer Corporation Austria Ges.m.b.H

Floridsdorfer

Hauptstraße 1,

A-1210 Wien

Austria

Tazonam 4,0 g/0,5 g - Trockenstechampullen

4,0 g/0,5 g

Lyophilisate for solution for injection or infusion

Intravenous

1 injection vial contains piperacillin sodium equivalent to 4,0 g of piperacillin and tazobactam sodium equivalent to 0,5g of tazobactam.

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Brussels |
| Belgium |

Pfizer S.A.

Boulevard de la Plaine 17

1050 Brussels

Belgium

Tazocin 2 g/250 mg

poudre pour solution injectable

2 g/250 mg

Powder for solution for injection

Intravenous

2,085 g sodium piperacillin + 268,30 mg sodium tazobactam

Belgium

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Brussels |
| Belgium |

Pfizer S.A.

Boulevard de la Plaine 17

1050 Brussels

Belgium

Tazocin 4g/500 mg

poudre pour solution injectable

4 g/500 mg

Powder for solution for injection

Intravenous

4,170 g sodium piperacillin + 536,60 mg sodium tazobactam

Bulgaria

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, |
| Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich,

Kent,

CT13 9NJ,

United Kingdom

(TAZOCIN 4 g/0,5 g

powder for solution for injection/infusion Piperacillin/Tazobactam)

4 g/0,5 g

powder for solution for injection/infusion

Intravenous

4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam.

Cyprus

| Pfizer Hellas A.E. |
| --- |
| 243 Messoghion Avenue 154 51 |
| Neo Psychico |
| Greece |

Pfizer Hellas A.E.

243 Messoghion Avenue 154 51

Neo Psychico

Greece

TAZOCIN® EF

2,25 G/VIAL

Powder for solution for injection

Intravenous use

2,085 g sodium piperacillin equivalent to 2 g piperacillin and 0,2683 g sodium tazobactam equivalent to 0,250 g tazobactam.

Cyprus

| Pfizer Hellas A.E. |
| --- |
| 243 Messoghion Avenue 154 51 |
| Neo Psychico |
| Greece |

Pfizer Hellas A.E.

243 Messoghion Avenue 154 51

Neo Psychico

Greece

TAZOCIN® EF

4,5 G/VIAL

Powder for solution for injection

Intravenous use

4,17 g sodium piperacillin equivalent to 4 g piperacillin and 0,5366 g sodium tazobactam equivalent to 0,5 g tazobactam.

Czech Republic

| Pfizer spol. s r.o. |
| --- |
| Stroupežnického 3191/17, |
| 150 00 Praha Smíchov, |
| Czech Republic |

Pfizer spol. s r.o.

Stroupežnického 3191/17,

150 00 Praha Smíchov,

Czech Republic

Tazocin 2,25 g

2,25 g

Powder for solution for injection

Intravenous use

2 g piperacillinum/0,25 g tazobactamum

Czech Republic

| Pfizer spol. s r.o. |
| --- |
| Stroupežnického 3191/17, |
| 150 00 Praha Smíchov |
| Czech Republic |

Pfizer spol. s r.o.

Stroupežnického 3191/17,

150 00 Praha Smíchov

Czech Republic

Tazocin 4,5 g

4,5 g

Powder for solution for injection

Intravenous use

4 g piperacillinum/0,5 g tazobactamum

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| 2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Tazocin

2 g/0,25 g

Powder for solution for injection/infusion

Intravenous

Piperacillin sodium corresponding to piperacillin 2 g, tazobactam sodium corresponding to tazobactam 0,25 g.

Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| 2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Tazocin

4 g/0,5 g

Powder for solution for injection/infusion

Intravenous

Piperacillin sodium corresponding to piperacillin 4 g, tazobactam sodium corresponding to tazobactam 0,5 g

Estonia

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

TAZOCIN 4,5G

4 000 m g+500 mg g

Powder for solution for injection or infusion

Intravenous

4,170 g piperacillin sodium equivalent to 4 000 mg of piperacillin and 0,5366 g tazobactam sodium equivalent to 500 mg of tazobactam.

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4,00330 Helsinki, |
| Finland |

Pfizer Oy

Tietokuja 4,00330 Helsinki,

Finland

Tazocin

2 g/0,25 g

Powder for solution for injection/infusion

Intravenous

Piperacillin. sodium 2,085 g

Tazobactam.sodium 0,2683 g

Finland

| Pfizer Oy |
| --- |
| Tietokuja 4,00330 Helsinki, |
| Finland |

Pfizer Oy

Tietokuja 4,00330 Helsinki,

Finland

Tazocin

4 g/0,5 g

Powder for solution for injection/infusion

Intravenous

Piperacillin. sodium 4,170 g

Tazobactam.sodium 0,5366 g

France

| Pfizer, Coeur Défense - Tour A – La Défense 4 |
| --- |
| 92931 PARIS LA DEFENSE Cedex |
| France |

Pfizer, Coeur Défense - Tour A – La Défense 4

92931 PARIS LA DEFENSE Cedex

France

TAZOCILLINE 2 g/250 mg,

poudre pour solution pour perfusion

2 g/250 mg

Powder for solution for infusion

Infusion

Sodium piperacillin 2,085 g

sodium tazobactam 268,300 mg

France

| Pfizer, Coeur Défense - Tour A – La Défense 4 |
| --- |
| 92931 PARIS LA DEFENSE Cedex |
| France |

Pfizer, Coeur Défense - Tour A – La Défense 4

92931 PARIS LA DEFENSE Cedex

France

TAZOCILLINE 4 g/500 mg,

poudre pour solution pour perfusion

4 g/500 mg

Powder for solution for infusion

Infusion

Sodium piperacillin 4,170 g

sodium tazobactam 536,600 mg

Germany

| Pfizer Pharma GmbH |
| --- |
| Linkstr. 10 |
| 10785 Berlin |
| Germany |

Pfizer Pharma GmbH

Linkstr. 10

10785 Berlin

Germany

Tazobac EF 4 g/0,5 g

4 g/0,5 g

Lyophilisate for injection or infusion

Intravenous (Infusion, Injection)

4 g piperacillin equivalent to 4,17 g piperacillin sodium

0,5 g tazobactam equivalent to 0,5366 g tazobactam sodium

Greece

| Pfizer Hellas A.E. |
| --- |
| 243 Messoghion Avenue 154 51 |
| Neo Psychico |
| Greece |

Pfizer Hellas A.E.

243 Messoghion Avenue 154 51

Neo Psychico

Greece

TAZOCIN® EF

2 + 0,250 G/VIAL

Powder for solution for injection

Intravenous use

2,085 g sodium piperacillin equivalent to 2 g piperacillin and 0,2683 g sodium tazobactam equivalent to 0,250 g tazobactam.

Greece

| Pfizer Hellas A.E. |
| --- |
| 243 Messoghion Avenue 154 51 |
| Neo Psychico |
| Greece |

Pfizer Hellas A.E.

243 Messoghion Avenue 154 51

Neo Psychico

Greece

TAZOCIN® EF

4 + 0,500 G/VIAL

Powder for solution for injection

Intravenous use

4,17 g sodium piperacillin equivalent to 4 g piperacillin and 0,5366 g sodium tazobactam equivalent to 0,5 g tazobactam.

Hungary

| Wyeth Whitehall Export GmbH |
| --- |
| Storchengasse 1 A-1150 Vienna |
| Austria |

Wyeth Whitehall Export GmbH

Storchengasse 1 A-1150 Vienna

Austria

Tazocin 4,5 g injekció

4,5 g

Powder for solution for injection or infusion

Intravenous

0,5366 g tazobactam sodium equivalent to 0,500 g tazobactam and 4,170 g piperacillin sodium equivalent to 4,00 g piperacillin

Ireland

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow, Maidenhead, |
| Berks, SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow, Maidenhead,

Berks, SL6 0PH

United Kingdom

Tazocin2 g/0,25 g

Powder for Solution for Injection or Infusion

2 g/0,25 g

Powder for Solution for Injection or Infusion

Intravenous

2 g piperacillin and 0,25 g tazobactam (both present as sodium salts).

Ireland

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow, Maidenhead, |
| Berks, SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow, Maidenhead,

Berks, SL6 0PH

United Kingdom

Tazocin4 g/0,5 g

Powder for Solution for Injection or Infusion

4 g/0,5 g

Powder for Solution for Injection or Infusion

Intravenous

4 g piperacillin and 0,5 g tazobactam (both present as sodium salts).

Italy

| Wyeth Lederle S.p.A. |
| --- |
| Via Nettunense, 90 |
| Aprilia (LT), 04011, |
| Italy |

Wyeth Lederle S.p.A.

Via Nettunense, 90

Aprilia (LT), 04011,

Italy

TAZOCIN

2 g + 0,250 g

Powder for solution for infusion

Intravenous use

Piperacillin sodium (equiv. to piperacillin 2 g) 2 085 mg

Tazobactam sodium (equiv. to tazobactam 250 mg) 268,3 mg

Italy

| Wyeth Lederle S.p.A. |
| --- |
| Via Nettunense, 90 |
| Aprilia (LT), 04011, |
| Italy |

Wyeth Lederle S.p.A.

Via Nettunense, 90

Aprilia (LT), 04011,

Italy

TAZOCIN

4 g + 0,500 g

Powder for solution for infusion

Intravenous use

Piperacillin sodium (equiv. to piperacillin 4 g) 4 170 mg

Tazobactam sodium (equiv. to tazobactam 500 mg) 536,6 mg

Latvia

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

TAZOCIN 4,0 g/0,5 g

pulveris injekciju vai infūziju šķīduma pagatavošanai

4,0 g/0,500 mg

Powder for solution for injection or infusion

Intravenous

4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam

Lithuania

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

TAZOCIN

4,0 g/0,5 g

Powder for solution for injection or infusion

Intravenous

4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam

Luxembourg

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Brussels |
| Belgium |

Pfizer S.A.

Boulevard de la Plaine 17

1050 Brussels

Belgium

Tazocin 2 g/250 mg

poudre pour solution injectable

2 g/250 mg

Powder for Solution for Injection or Infusion

Intravenous

2,085 g sodium piperacillin + 268,30 mg sodium tazobactam

Luxembourg

| Pfizer S.A. |
| --- |
| Boulevard de la Plaine 17 |
| 1050 Brussels |
| Belgium |

Pfizer S.A.

Boulevard de la Plaine 17

1050 Brussels

Belgium

Tazocin 4g/500 mg

poudre pour solution injectable

4g/500 mg

Powder for Solution for Injection or Infusion

Intravenous

4,170 g sodium piperacillin + 536,60 mg sodium tazobactam

Malta

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

Tazocin 2 g/0,25 g

Powder for Solution for Injection or Infusion

2 g/0,25 g

Powder for Solution for Injection or Infusion

Intravenous

TAZOCIN 2 g/0,25 g contains 2 active ingredients; piperacillin 2 g and tazobactam 0,25 g both present as sodium salts.

Malta

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

TAZOCIN 4 g/0,5 g

Powder for Solution for Injection or Infusion

4 g/0,5 g

Powder for Solution for Injection or Infusion

Intravenous

TAZOCIN 4 g/0,5 g contains 2 active ingredients; piperacillin 4 g and tazobactam 0,5 g both present as sodium salts.

Netherlands

| Pfizer B.V. |
| --- |
| Rivium westlaan 142 2909 LD Capelle a/d Ijssel |
| The Netherlands |

Pfizer B.V.

Rivium westlaan 142 2909 LD Capelle a/d Ijssel

The Netherlands

Tazocin® 2 g/250 mg

2 g/250 mg

Powder for solution for injection

Intravenous

Sodium piperacillin and sodium tazobactam, equivalent to 2 g piperacillin and 250 mg tazobactam.

Netherlands

| Pfizer B.V. |
| --- |
| Rivium westlaan 142 2909 LD Capelle a/d Ijssel |
| The Netherlands |

Pfizer B.V.

Rivium westlaan 142 2909 LD Capelle a/d Ijssel

The Netherlands

Tazocin® 4 g/500 mg

4 g/500 mg

Powder for solution for injection

Intravenous

Sodium piperacillin and sodium tazobactam, equivalent to 4 g piperacillin and 500 mg tazobactam

Norway

| Pfizer AS |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Postboks 3

1324 Lysaker

Norway

Tazocin

2 g/0,25 g

Powder for solution for injection/infusion

Intravenous

Piperacillin sodium corresponding to piperacillin 2 g, tazobactam sodium corresponding to tazobactam. 0,25 g

Norway

| Pfizer AS |
| --- |
| Postboks 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Postboks 3

1324 Lysaker

Norway

Tazocin

4 g/0,5 g

Powder for solution for injection/infusion

Intravenous

Piperacillin sodium corresponding to piperacillin 4 g, tazobactam sodium corresponding to tazobactam 0,5 g.

Poland

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

Tazocin

2 g + 0,25 g

Powder for solution for injection or infusion

Intravenous

2 g piperacillin (in form of piperacillin sodium) and 0,25 g tazobactam (in form of tazobactam sodium).

Poland

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

Tazocin

4 g + 0,5 g

Powder for solution for injection or infusion

Intravenous

4 g piperacillin (in form of piperacillin sodium) and 0,5 g tazobactam (in form of tazobactam sodium).

Portugal

| Instituto Pasteur de Lisboa, S.A. |
| --- |
| Rua Dr. António Loureiro Borges, 2 |
| Arquiparque - Miraflores |
| 1495-131 ALGÉS |
| Portugal |

Instituto Pasteur de Lisboa, S.A.

Rua Dr. António Loureiro Borges, 2

Arquiparque - Miraflores

1495-131 ALGÉS

Portugal

Tazobac

2 000 mg + 250 mg

Powder for solution for injection

Intravenous use

2,085 g of piperacillin sodium equivalent to 2 g of piperacillin and 0,2683 g of tazobactam sodium equivalent to 250 mg of tazobactam

Portugal

| Instituto Pasteur de Lisboa, S.A. |
| --- |
| Rua Dr. António Loureiro Borges, 2 |
| Arquiparque - Miraflores |
| 1495-131 ALGÉS |
| Portugal |

Instituto Pasteur de Lisboa, S.A.

Rua Dr. António Loureiro Borges, 2

Arquiparque - Miraflores

1495-131 ALGÉS

Portugal

Tazobac

4 000 mg + 500 mg

Powder for solution for injection

Intravenous use

4,170 g of piperacillin sodium equivalent to 4 g of piperacillin and 0,5366 g of tazobactam sodium equivalent to 500 mg of tazobactam

Romania

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

Tazocin 2,25 g,

liofilizat pentru soluție injectabilă/perfuzabilă

2,00/0,25 g

Lyophilised powder for solution for injection or infusion

Intravenous

Piperacillin 2,00 g as piperacillin sodium and tazobactam 0,25 g as tazobactam sodium.

Romania

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

Tazocin 4,5 g,

liofilizat pentru soluție injectabilă/perfuzabilă

4,00/0,5 g

Lyophilised powder for solution for injection or infusion

Intravenous

Piperacillin 4,00 g as piperacillin sodium and tazobactam 0,5 g as tazobactam sodium.

Slovak Republic

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

Tazocin 2,25 g

2,25 g

Powder for solution for injection and infusion

Intravenous

contains 2,085 g piperacillin sodium equivalent to 2 g piperacillin and 0,2683 g tazobactam sodium equivalent to 250 milligrams tazobactam

Slovak Republic

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

Tazocin 4,5 g

4,5 g

Powder for solution for injection and infusion

Intravenous

contains 4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 milligrams tazobactam

Slovenia

| Pfizer Europe MA EEIG |
| --- |
| Ramsgate Road, Sandwich, Kent, |
| CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG

Ramsgate Road, Sandwich, Kent,

CT13 9NJ,

United Kingdom

TAZOCIN 4,5 g

prašek za raztopino za injiciranje ali infundiranje

4,0 g/0,5 g

Powder for solution for injection or infusion.

Intravenous

4,170 g piperacillin sodium equivalent to 4 g piperacillin and 0,5366 g tazobactam sodium equivalent to 500 mg tazobactam.

Spain

| Wyeth Farma S.A. |
| --- |
| Ctra. Burgos, Km 23 - Desvío Algete Km 1 |
| 28700 San Sebastián de los Reyes (Madrid) |
| Spain |

Wyeth Farma S.A.

Ctra. Burgos, Km 23 - Desvío Algete Km 1

28700 San Sebastián de los Reyes (Madrid)

Spain

Tazocel 2/0,25 g

Polvo para solución inyectable

2/0,25 g

Powder for injectable solution

Intravenous

Piperacillin (in the form of piperacillin sodium) 2 g

Tazobactam (in the form of tazobactam sodium) 0,25 g

Spain

| Wyeth Farma S.A. |
| --- |
| Ctra. Burgos, Km 23 - Desvío Algete Km 1 |
| 28700 San Sebastián de los Reyes (Madrid), |
| Spain |

Wyeth Farma S.A.

Ctra. Burgos, Km 23 - Desvío Algete Km 1

28700 San Sebastián de los Reyes (Madrid),

Spain

Tazocel 4/0,5 g

Polvo para solución inyectable

4/0,5 g

Powder for injectable solution

Intravenous

Piperacillin (in the form of piperacillin sodium) 4 g

Tazobactam (in the form of tazobactam sodium) 0,50 g

Sweden

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna, |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna,

Sweden

Tazocin

2 g/0,25 g

Powder for solution for injection/infusion

Intravenous

Piperacillin sodium corresponding to piperacillin 2 g and tazobactam sodium corresponding to tazobactam 0,25 g

Sweden

| Pfizer AB |
| --- |
| Vetenskapsvägen 10 |
| 191 90 Sollentuna, |
| Sweden |

Pfizer AB

Vetenskapsvägen 10

191 90 Sollentuna,

Sweden

Tazocin

4 g/0,5 g

Powder for solution for injection/infusion

Intravenous

Piperacillin sodium corresponding to piperacillin 4 g and tazobactam sodium corresponding to tazobactam 0,5 g

United Kingdom

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

TAZOCIN 2 g/0,25 g

Powder for Solution for Injection or Infusion

2,25 g

Powder for Solution for Injection or Infusion

Intravenous

Piperacillin 2 g and tazobactam 250 mg both present as sodium salts.

United Kingdom

| John Wyeth & Brother Limited |
| --- |
| (trading as Wyeth Pharmaceuticals) |
| Huntercombe Lane South |
| Taplow |
| Maidenhead |
| Berkshire SL6 0PH |
| United Kingdom |

John Wyeth & Brother Limited

(trading as Wyeth Pharmaceuticals)

Huntercombe Lane South

Taplow

Maidenhead

Berkshire SL6 0PH

United Kingdom

TAZOCIN 4 g/0,5 g

Powder for Solution for Injection or Infusion

4,5 g

Powder for Solution for Injection or Infusion

Intravenous

Piperacillin 4 g and tazobactam 500 mg both present as sodium salts.

---

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 | 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

Fortum 0,5 g - Trockenstechampullen

500mg

Powder for injection

Intravenous or intramuscular use

Fortum 1 g - Trockenstechampullen

1g

Powder for injection

Intravenous or intramuscular use

Fortum 2 g - Trockenstechampullen

2 g

Powder for injection/infusion

Intravenous use

Belgium

| GlaxoSmithKline s.a. / n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |
| Belgium |

GlaxoSmithKline s.a. / n.v.

Rue du Tilleul 13

1332 Genval

Belgium

Glazidim

500 mg

Powder for solution for Injection

For Intravenous or Intramuscular use

Glazidim

1 g

Powder for solution for Infusion

For intravenous use

Glazidim

1 g

Powder for solution for Injection

For Intravenous or Intramuscular use

Glazidim

2 g

Powder for solution for infusion

For intravenous use

Glazidim

2 g

Powder for solution for injection

For intravenous use

Bulgaria

| Glaxo Group Ltd. |
| --- |
| Glaxo Wellcome House, |
| Berkeley avenue, Greenford, |
| Middlesex UB6 0NN, |
| England |

Glaxo Group Ltd.

Glaxo Wellcome House,

Berkeley avenue, Greenford,

Middlesex UB6 0NN,

England

Fortum

1 g

Powder for solution for Injection

For intravenous or intramuscular use

Cyprus

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlex UB6 0NN |
| United Kingdom |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlex UB6 0NN

United Kingdom

Fortum

1 g

Powder for Injection

For intravenous use

Vials contain 1g ceftazidime (as pentahydrate)

Czech Republic

| Glaxo Group Ltd., |
| --- |
| Glaxo Welcome House, |
| Berkeley avenue, Greenford, |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Group Ltd.,

Glaxo Welcome House,

Berkeley avenue, Greenford,

Middlesex UB6 0NN

United Kingdom

Fortum 500mg

500 mg

Powder for solution for injection

For intravenous use

Fortum 1g

1 g

Powder for solution for injection

For intravenous use

Fortum 2g

2 g

Powder for solution for injection

For intravenous use

Denmark

| GlaxoSmithKline Pharma A/S |
| --- |
| Nykaer 68, 2605 Broendby |
| Denmark |

GlaxoSmithKline Pharma A/S

Nykaer 68, 2605 Broendby

Denmark

Fortum

500 mg

Powder for Injection

For intravenous use

Fortum

1 g

Powder for Injection

For intravenous use

Fortum

2 g

Powder for Injection

For intravenous use

Estonia

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

Glaxo Wellcome Operations,

Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex, UB6 0NN

United Kingdom

Fortum

1 g

Powder for solution for injection /infusion

For intramuscular or intravenous use

1g

Finland

| Glaxo Operations UK Ltd, Glaxo Wellcome House, |
| --- |
| Berkeley Avenue, Greenford, |
| Middlesex UB6 0NN |
| England |

Glaxo Operations UK Ltd, Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex UB6 0NN

England

Glazidim

500 mg

Powder for solution for Injection

For intramuscular or intravenous use

Vials contain 500 mg ceftazidime (as pentahydrate)

| Glaxo Operations UK Ltd, Glaxo Wellcome House, |
| --- |
| Berkeley Avenue, Greenford, |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Operations UK Ltd, Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex UB6 0NN

United Kingdom

Glazidim

1 g

Powder for solution for injection

For intramuscular or intravenous use

Vials contain 1 g ceftazidime (as pentahydrate)

| GlaxoSmithKline Oy, |
| --- |
| PB 24, 02231 Espoo |

GlaxoSmithKline Oy,

PB 24, 02231 Espoo

Glazidim

1 g

Powder for solution for injection/infusion

For intramuscular or intravenous use

Vials contain 1 g ceftazidime (as pentahydrate)

| GlaxoSmithKline Oy, |
| --- |
| PB 24, 02231 Espoo |
| Finland |

GlaxoSmithKline Oy,

PB 24, 02231 Espoo

Finland

Glazidim

2 g

Powder for solution for injection/infusion

For intramuscular or intravenous use

Vials contain 2 g ceftazidime (as pentahydrate)

| GlaxoSmithKline Oy, |
| --- |
| PB 24, 02231 Espoo |
| Finland |

GlaxoSmithKline Oy,

PB 24, 02231 Espoo

Finland

Glazidim

3 g

Powder for solution for injection/infusion

For intramuscular or intravenous use

Vials contain 3 g ceftazidime (as pentahydrate)

France

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |
| France |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

France

Fortum enfants et nourrisons

250 mg

Powder for solution for injection

For intravenous or intramuscular use

295 mg

Fortum enfants et nourrisons

500 mg

Powder for solution for injection

For intravenous or intramuscular use

591 mg

Fortumset

1 g

Powder for solution for infusion (IV)

For intravenous use

1 182 mg

Fortum

1 g

Powder for solution for Injection

For intravenous or intramuscular use

1 182mg

Fortumset

2 g

Powder for solution for infusion (IV)

For intravenous use

2 364 mg

Fortum

2 g

Powder for solution for injection (IV)

For intravenous use

2 364 mg

Germany

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Theresienhöhe 11 |
| 80339 München |
| Germany |

GlaxoSmithKline GmbH & Co. KG

Theresienhöhe 11

80339 München

Germany

Fortum

500 mg

Powder for solution for injection or infusion

For intravenous and intramuscular use

Fortum

1 g

Powder for solution for injection or infusion

For intravenous and intramuscular use

Fortum

2 g

Powder for solution for injection or infusion

For intravenous use

Greece

| GlaxoSmithKline a.e.b.e, Leof. |
| --- |
| Kifissias 266, |
| 152 32 Halandri, Athens |
| Greece |

GlaxoSmithKline a.e.b.e, Leof.

Kifissias 266,

152 32 Halandri, Athens

Greece

Solvetan

1 g

Powder for injection

For intramuscular or intravenous use

Solvetan

2 g

Powder for injection

For intravenous use

Hungary

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |
| Hungary |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

Hungary

Fortum

500 mg

Powder for injection

For intravenous use

Fortum

1 g

Powder for injection

For intravenous use

Fortum

2 g

Powder for infusion

For intravenous use

Iceland

| GlaxoSmithKline ehf. |
| --- |
| Thverholt 14 |
| 105 Reykjavík |
| Iceland |

GlaxoSmithKline ehf.

Thverholt 14

105 Reykjavík

Iceland

Fortum

1 g

Powder for solution for injection

For intravenous or intramuscular use

Fortum

2 g

Powder for solution for infusion

For intravenous use

Ireland

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |
| Ireland |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

Ireland

Fortum

500 mg

Powder for solution for injection

For intravenous or intramuscular injection

Reconstituted solution contains 500mg ceftazidime

Fortum

1 g

Powder for solution for injection or infusion, vial

For intravenous or intramuscular injection or infusion

Reconstituted solution contains 1g ceftazidime

Fortum

1 g

Powder for infusion, monovial

For infusion

Reconstituted solution contains 1g ceftazidime

Fortum

2 g

Powder for solution for injection or infusion, vial

For intravenous or intramuscular injection or infusion

Reconstituted solution contains 2g ceftazidime

Fortum

2 g

Powder for infusion, monovial

For infusion

Reconstituted solution contains 2g ceftazidime

Italy

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |
| Italy |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

Italy

Glazidim

250 mg/ml

Powder and solvent for solution for injection

For intramuscular use

Glazidim

500 mg/1,5 ml

Powder and solvent for solution for injection

For intramuscular use

Glazidim

1 g/3 ml

Powder and solvent for solution for injection

For intramuscular use

Glazidim

1 g/10 ml

Powder and solvent for solution for injection

For intravenous use

Glazidim

2 g

Powder for solution for infusion

For intravenous use

Glazidim

1 g/100 ml

Powder and solvent for solution for infusion (Monovial)

For intravenous use

Glazidim

2 g/100 ml

Powder and solvent for solution for infusion (Monovial)

For intravenous use

Glazidim

1 g

Powder for solution for infusion (Monovial)

For intravenous use

Glazidim

2 g

Powder for solution for infusion (Monovial)

For intravenous use

| Glaxo Allen S.p.A |
| --- |
| Via Fleming, 2 |
| Verona |
| Italy |

Glaxo Allen S.p.A

Via Fleming, 2

Verona

Italy

Panzid

1 g/3 ml

Powder and solvent for solution for injection

For intramuscular use

Latvia

| GlaxoSmithKline Latvia SIA |
| --- |
| Bruninieku 5, Riga, LV-1001, |
| Latvia |

GlaxoSmithKline Latvia SIA

Bruninieku 5, Riga, LV-1001,

Latvia

Fortum 1 g powder for solution for injection or infusion

1 g

Powder for solution for injection or infusion

For intravenous use or intramuscular use

1 g ceftazidime (as ceftazidime pentahydrate)

Lithuania

| UAB „GlaxoSmithKline Lietuva“, |
| --- |
| A. Goštauto g. 40A, |
| LT-01112 Vilnius, Lithuania |

UAB „GlaxoSmithKline Lietuva“,

A. Goštauto g. 40A,

LT-01112 Vilnius, Lithuania

Fortum

500 mg

Powder and solvent for solution for injection

Intravenous use or intramuscular use

Fortum

1 g

Powder and solvent for solution for injection

Intravenous use or intramuscular use

Fortum

2 g

Powder for solution for injection or infusion

Intravenous use

Fortum

3 g

Powder for solution for injection or infusion

Intravenous use

Luxembourg

| GlaxoSmithKline s.a. / n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |
| Belgium |

GlaxoSmithKline s.a. / n.v.

Rue du Tilleul 13

1332 Genval

Belgium

Glazidim

500 mg

Powder for solution for injection

For Intravenous or Intramuscular use

Glazidim

1 g

Powder for solution for infusion

For intravenous use

Glazidim

1 g

Powder for solution for injection

For Intravenous or Intramuscular use

Glazidim

2 g

Powder for solution for infusion

For intravenous use

Glazidim

2 g

Powder for solution for injection

For intravenous use

Malta

| Glaxo Operations UK Limited |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex UB6 0NN |
| United Kingdom |

Glaxo Operations UK Limited

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex UB6 0NN

United Kingdom

Fortum

1g per vial

Powder for solution for injection

For intravenous or Intramuscular use

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

Fortum

500 mg

Powder for solution for injection

For intravenous or intramuscular use

Fortum

1 g

Powder for solution for injection

For intravenous or intramuscular use

Fortum

2 g

Powder for solution for injection

For intravenous use

Norway

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo |
| Norway |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo

Norway

Fortum

500 mg

Powder for infusion/injection

For intravenous or intramuscular use

Fortum

1 g

Powder for infusion/injection

For intravenous or intramuscular use

Fortum

2 g

Powder for infusion/injection

For intravenous use

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| United Kingdom |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

United Kingdom

Fortum

250 mg

Powder for solution for injection

For intramuscular or intravenous use

Fortum

500 mg

Powder for solution for injection

For intramuscular or intravenous use

Fortum

1 g

Powder for solution for injection and infusion

For intramuscular or intravenous use

Fortum

2 g

Powder solution for injection and infusion

For intravenous use

Portugal

| Glaxo Wellcome Farmacêutica, Lda. |
| --- |
| Rua Dr. António Loureiro Borges, 3 |
| Aquiparque – Miraflores |
| 1495 – 131 Algés |
| Portugal |

Glaxo Wellcome Farmacêutica, Lda.

Rua Dr. António Loureiro Borges, 3

Aquiparque – Miraflores

1495 – 131 Algés

Portugal

Cefortam

500 mg/1,5 ml

Powder and solvent for solution for injection

For intravenous or intramuscular use

Cefortam

1 g/3 ml

Powder and solvent for solution for injection

For intravenous or intramuscular use

Cefortam

2 g

Powder for solution for injection

For intravenous use

Romania

| Glaxo Wellcome UK Limited, Glaxo Wellcome House, |
| --- |
| Berkeley Avenue, Greenford, |
| Middlesex, UB6 0NN |
| United Kingdom |

Glaxo Wellcome UK Limited, Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex, UB6 0NN

United Kingdom

Fortum

500 mg

Powder for injection

For intravenous or intramuscular use

Fortum

1 g

Powder for injection

For intravenous or intramuscular use

Fortum

1 g

Powder for injection

For intravenous or intramuscular use

Fortum

1 g

Powder for injection

For intravenous or intramuscular use

Fortum

2 g

Powder for injection or infusion

For intravenous or intramuscular use

Slovak Republic

| GlaxoSmithKline Slovakia sro., |
| --- |
| Galvaniho7/A, 82104 Bratislava, |
| Slovakia. |

GlaxoSmithKline Slovakia sro.,

Galvaniho7/A, 82104 Bratislava,

Slovakia.

Fortum

500 mg

Powder for injection

For intravenous use

Fortum

1 g

Powder for infusion

For intravenous use

Fortum

2 g

Powder for infusion

For intravenous 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

Fortum

1 g

Powder for injection or infusion

For intravenous use

Fortum Monovial

1 g

Powder for infusion

For intravenous use

Spain

| GlaxoSmithKline, S.A. |
| --- |
| P.T.M.- C/Severo Ochoa, 2 |
| 28760 Tres Cantos (Madrid) |
| Spain |

GlaxoSmithKline, S.A.

P.T.M.- C/Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Spain

Fortam IM/IV

500 mg

Powder for injection

For intravenous use/IM

Fortam IV

1 g

Powder for injection

For intravenous use

Fortam 1 g

1 g

Powder for injection

For intravenous use/IM

Fortam IV

2 g

Powder for infusion

For intravenous use

Sweden

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna |
| Sweden |

GlaxoSmithKline AB

Box 516

169 29 Solna

Sweden

Fortum

250 mg

Powder for solution for injection

For intramuscular or intravenous use

250 mg ceftazidime (as pentahydrate)

Fortum

500 mg

Powder for solution for injection

For intramuscular or intravenous use

500 mg ceftazidime (as pentahydrate)

Fortum

1 g

Powder for solution for injection

For intramuscular or intravenous use

1 g ceftazidime (as pentahydrate)

Fortum

1 g

Powder for solution for infusion

For intravenous use

1 g ceftazidime (as pentahydrate)

Fortum

1 g Monovial

Powder for solution for infusion

For intravenous use

1 g ceftazidime (as pentahydrate)

Fortum

2 g Monovial

Powder for solution for infusion

For intravenous use

2 g ceftazidime (as pentahydrate)

Fortum

2 g

Powder for solution for injection/infusion

For intravenous use

2 g ceftazidime (as pentahydrate)

United Kingdom

| Glaxo Operations UK Ltd, |
| --- |
| Glaxo Wellcome House, |
| Berkeley Avenue, Greenford Road, |
| Middlesex, UB6 0NN |
| United Kingdom |

Glaxo Operations UK Ltd,

Glaxo Wellcome House,

Berkeley Avenue, Greenford Road,

Middlesex, UB6 0NN

United Kingdom

Fortum

250 mg

Powder for injection

intravenous use and intramuscular use

118 mg per gram of ceftazidime

Fortum

500 mg

Powder for injection

intravenous use and intramuscular use

118 mg per gram of ceftazidime

Fortum

1 g

Powder for injection

intravenous use and intramuscular use

118 mg per gram of ceftazidime

Fortum

2 g and 3 g + 2 g Monovial

Powder for infusion

intravenous use and intramuscular use

118 mg per gram of ceftazidime

---

ANNEX III

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 | Roche Austria GmbH, |
| Engelhorngasse 3, |
| A - 1211 Vienna |
| Austria |

Member State EU/EEA

Marketing Authorisation Holder

(Invented) Name

Strength

Pharmaceutical Form

Route of administration

Austria

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 Vienna

Austria

Inhibace plus «Roche» - Filmtabletten

5 mg/12,5 mg

Film-coated tablets

Oral use

Belgium

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Co-Inhibace

5 mg/12,5 mg

Film-coated tablets

Oral use

Czech Republic

| Roche s.r.o. |
| --- |
| Dukelskych hrdinu 567/52 |
| 170 00 / Praha 7 |
| Czech Republic |

Roche s.r.o.

Dukelskych hrdinu 567/52

170 00 / Praha 7

Czech Republic

Inhibace Plus

5 mg/12,5 mg

Film-coated tablets

Oral use

Germany

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Germany |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Germany

Dynorm Plus

5 mg/12,5 mg

Film-coated tablets

Oral use

Greece

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Greece |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Greece

Vascace Plus

5 mg/12,5 mg

Film-coated tablets

Oral use

Hungary

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| Hungary |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

Hungary

Inhibace Plus

5 mg/12,5 mg

Film-coated tablets

Oral use

Italy

| Roche S.p.A |
| --- |
| Via G.B Stucchi 110 |
| 20052/Monza |
| Italy |

Roche S.p.A

Via G.B Stucchi 110

20052/Monza

Italy

Inibace Plus

5 mg/12,5 mg

Film-coated tablets

Oral use

Luxembourg

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgium |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgium

Co-Inhibace

5 mg/12,5 mg

Film-coated tablets

Oral use

Poland

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Poland |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Poland

Inhibace Plus

5 mg/12,5 mg

Film-coated tablets

Oral use

Portugal

| Roche Farmacêutica Química, Lda |
| --- |
| Estrada Nacional 249-1 |
| 2720-413 / Amadora |
| Portugal |

Roche Farmacêutica Química, Lda

Estrada Nacional 249-1

2720-413 / Amadora

Portugal

Inibace Plus

5 mg/12,5 mg

Film-coated tablets

Oral use

Spain

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spain |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spain

Inhibace Plus

5 mg/12,5 mg

Film-coated tablets

Oral use

---

ANNEX IV

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

Fenofibrate containing medicinal products with Marketing Authorisation in the European Union

| Member State (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Solvay Pharma GmbH |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Austria |

Member State (EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

AT - Austria

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Austria

Apteor 160 mg - Filmtabletten

160 mg

film-coated tablet

oral

AT - Austria

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| A-8502 Lannach |
| Austria |

G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Fenolip retard 250 mg - Kapseln

250 mg

prolonged release capsule, hard

oral

AT - Austria

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Austria |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Austria

Lipanthyl Nanopartikel 145 mg - Filmtabletten

145 mg

film-coated tablet

oral

AT - Austria

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Austria |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Austria

Lipanthyl supra 160 mg - Filmtabletten

160 mg

film-coated tablet

oral

AT - Austria

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Austria |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Austria

Lipcor 200 mg - Kapseln

200 mg

capsule, hard

oral

AT - Austria

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Austria |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Austria

Lipsin 100 mg - Kapseln

100 mg

capsule, hard

oral

AT - Austria

| Solvay Pharma GmbH |
| --- |
| Dresdner Straße 91/C2/Top 12 |
| A- 1200 Wien |
| Austria |

Solvay Pharma GmbH

Dresdner Straße 91/C2/Top 12

A- 1200 Wien

Austria

Lipsin retard 250 mg - Kapseln

250 mg

prolonged release capsule, hard

oral

BE - Belgium

| DOCPHARMA N.V. |
| --- |
| Ambachtenlaan 13H |
| 3001 Leuven |
| Belgium |

DOCPHARMA N.V.

Ambachtenlaan 13H

3001 Leuven

Belgium

DOCFENOFI 200

200 mg

CAPSULES

oral

BE - Belgium

| EUROGENERICS N.V. AFGEKORT „E.G.” |
| --- |
| Heizel Esplanade b22 |
| 1020 Laeken |
| Belgium |

EUROGENERICS N.V. AFGEKORT „E.G.”

Heizel Esplanade b22

1020 Laeken

Belgium

FENOFIBRAAT EG 200 MG

200 mg

CAPSULES

oral

BE - Belgium

| EUROGENERICS N.V. AFGEKORT „E.G.” |
| --- |
| Heizel Esplanade b22 |
| 1020 Laeken |
| Belgium |

EUROGENERICS N.V. AFGEKORT „E.G.”

Heizel Esplanade b22

1020 Laeken

Belgium

FENOFIBRAAT EG 100 MG

100 mg

CAPSULES

oral

BE - Belgium

| EUROGENERICS N.V. AFGEKORT „E.G.” |
| --- |
| Heizel Esplanade b22 |
| 1020 Laeken |
| Belgium |

EUROGENERICS N.V. AFGEKORT „E.G.”

Heizel Esplanade b22

1020 Laeken

Belgium

FENOFIBRAAT EG 200 MG

200 mg

CAPSULES

oral

BE - Belgium

| JUBILANT PHARMACEUTICALS NV |
| --- |
| Axxes Business Park |
| Guldensporenpark 22 - Block C |
| 9820 Merelbeke |
| Belgium |

JUBILANT PHARMACEUTICALS NV

Axxes Business Park

Guldensporenpark 22 - Block C

9820 Merelbeke

Belgium

FENOFIBRAAT JUBILANT 200 MG CAPSULES

200 mg

CAPSULES

oral

BE - Belgium

| APOTEX NV |
| --- |
| Av. du Bourg. |
| Etienne Demunter 5 box 8 |
| 1090 Jette |
| Belgium |

APOTEX NV

Av. du Bourg.

Etienne Demunter 5 box 8

1090 Jette

Belgium

FENOFIBRATE APOTEX 200 MG

200 mg

CAPSULES

oral

BE - Belgium

| MYLAN BVBA/SPRL |
| --- |
| Terhulpsesteenweg 6A |
| 1560 Hoeilaart |
| Belgium |

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgium

FENOFIBRATE MYLAN 200 MG MICRONISED

200 mg

Capsule, hard

oral

BE - Belgium

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgium |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgium

FENOFIBRATE SANDOZ 200 MG

200 mg

CAPSULES

oral

BE - Belgium

| LABORATOIRES S.M.B. S.A. |
| --- |
| Rue De La Pastorale 26-28 |
| 1080 Bruxelles |
| Belgium |

LABORATOIRES S.M.B. S.A.

Rue De La Pastorale 26-28

1080 Bruxelles

Belgium

FENOGAL 200 LIDOSE

200 mg

capsule, hard

oral

BE - Belgium

| LABORATOIRES S.M.B. S.A. |
| --- |
| Rue De La Pastorale 26-28 |
| 1080 Bruxelles |
| Belgium |

LABORATOIRES S.M.B. S.A.

Rue De La Pastorale 26-28

1080 Bruxelles

Belgium

FENOGAL 267 MG LIDOSE

267 mg

capsule hard

oral

BE - Belgium

| S.M.B. TECHNOLOGY S.A. |
| --- |
| Rue du Parc Industriel 39 |
| 6900 Marche-en-Famenne |
| Belgium |

S.M.B. TECHNOLOGY S.A.

Rue du Parc Industriel 39

6900 Marche-en-Famenne

Belgium

FENOSUP LIDOSE 160 MG

160 mg

capsule hard

oral

BE - Belgium

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgium |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgium

LIPANTHYL 200 MICRONISED

200 mg

capsule, hard

oral

BE - Belgium

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgium |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgium

LIPANTHYL 267 MICRONISED

267 mg

capsule, hard

oral

BE - Belgium

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgium |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgium

LIPANTHYL 67 MICRONISED

67 mg

capsule, hard

oral

BE - Belgium

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgium |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgium

LIPANTHYL SUPRA 215MG

215 mg

film-coated tablet

oral

BE - Belgium

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgium |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgium

LIPANTHYL SUPRA 160 MG

160 mg

film-coated tablet

oral

BE - Belgium

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgium |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgium

LIPANTHYLNANO 145MG

145 mg

film-coated tablet

oral

BE - Belgium

| SOLVAY PHARMA S.A.-N.V. |
| --- |
| Blue Planet Building |
| Av. Brg. E. Demunterlaan 3 |
| 1090 Bruxelles |
| Belgium |

SOLVAY PHARMA S.A.-N.V.

Blue Planet Building

Av. Brg. E. Demunterlaan 3

1090 Bruxelles

Belgium

LIPERIAL 145MG

145 mg

film-coated tablet

oral

BG - Bulgaria

| Laboratoires Fournier SA |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| France |

Laboratoires Fournier SA

28 Boulevard Clemenceau

21000 Dijon

France

Lipanthyl Supra

160 mg

Modified-release tablet

Oral use

BG - Bulgaria

| Laboratoires Fournier SA |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| France |

Laboratoires Fournier SA

28 Boulevard Clemenceau

21000 Dijon

France

Lipanthyl 200 M

200 mg

Capsule, hard

Oral use

BG - Bulgaria

| Laboratoires Fournier SA |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| France |

Laboratoires Fournier SA

28 Boulevard Clemenceau

21000 Dijon

France

Lipanthyl 267 M

267 mg

Capsule, hard

Oral use

CY - Cyprus

| Varnavas Hadjipanayis Ltd |
| --- |
| 7 Androcleous street |
| P.O.Box 21229 |
| 1504 Lefkosia |
| Cyprus |

Varnavas Hadjipanayis Ltd

7 Androcleous street

P.O.Box 21229

1504 Lefkosia

Cyprus

LIPIDIL MICRONISED HARD CAPSULES 267mg

267 mg

capsules

oral

CY - Cyprus

| Varnavas Hadjipanayis Ltd, |
| --- |
| 7 Androcleous street |
| P.O.Box 21229 |
| 1504 Lefkosia |
| Cyprus |

Varnavas Hadjipanayis Ltd,

7 Androcleous street

P.O.Box 21229

1504 Lefkosia

Cyprus

LIPIDIL MICRONISED HARD CAPSULES 200mg

200 mg

capsules

oral

CZ - Czech Republic

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| France |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

France

LIPANTHYL 267 M

267 mg

capsule, hard

oral use

CZ - Czech Republic

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| France |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

France

LIPANTHYL NT 145 MG

145 MG

Film-coated tablet

oral use

CZ - Czech Republic

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| France |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

France

LIPANTHYL SUPRA 160 MG

160 MG

Modified-release tablet

oral use

CZ - Czech Republic

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| France |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

France

LIPANTHYL 200 M

200 MG

capsule, hard

oral use

CZ - Czech Republic

| Laboratoires Fournier S.A. |
| --- |
| 28Bd Clemenceau |
| 21 000 Dijon |
| France |

Laboratoires Fournier S.A.

28Bd Clemenceau

21 000 Dijon

France

LIPANTHYL S 215 MG

215 MG

Film-coated tablet

oral use

CZ - Czech Republic

| HEXAL AG |
| --- |
| Industriestraße 25 |
| 83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestraße 25

83607 Holzkirchen

Germany

LIPOHEXAL 250 RETARD

250 MG

Modified-release capsule,hard

oral use

CZ - Czech Republic

| Ingers Industrial Solutions s.r.o. |
| --- |
| Slunná 16 |
| 617 00 Brno |
| Czech Republic |

Ingers Industrial Solutions s.r.o.

Slunná 16

617 00 Brno

Czech Republic

FENOFIX 267 MG

267 MG

capsule, hard

oral use

CZ - Czech Republic

| Ingers Industrial Solutions s.r.o. |
| --- |
| Slunná 16 |
| 617 00 Brno |
| Czech Republic |

Ingers Industrial Solutions s.r.o.

Slunná 16

617 00 Brno

Czech Republic

FENOFIX 200 MG

200 MG

capsule, hard

oral use

CZ - Czech Republic

| Zentiva a.s. |
| --- |
| Nitrianska 100 |
| 920 27 Hlohovec |
| Slovac Republic |

Zentiva a.s.

Nitrianska 100

920 27 Hlohovec

Slovac Republic

FEBIRA 200

200 MG

capsule, hard

oral use

CZ - Czech Republic

| sanofi-aventis s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

sanofi-aventis s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

LIPIREX 267 MG

267 MG

capsule, hard

oral use

CZ - Czech Republic

| sanofi-aventis s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

sanofi-aventis s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

LIPIREX 200MG

200 MG

capsule, hard

oral use

CZ - Czech Republic

| PharmaSwiss Česká Republika s.r.o., Jankovcova 1569/2c |
| --- |
| 17000 Praha 7 |
| Czech Republic |

PharmaSwiss Česká Republika s.r.o., Jankovcova 1569/2c

17000 Praha 7

Czech Republic

SUPRELIP

200 MG

capsule, hard

oral use

CZ - Czech Republic

| APOTEX (ČR), spol. s r.o. |
| --- |
| Palladium, Na Poříčí 1079/3a |
| 110 00 Praha – 1 |
| Czech Republic |

APOTEX (ČR), spol. s r.o.

Palladium, Na Poříčí 1079/3a

110 00 Praha – 1

Czech Republic

APO-FENO

200 MG

capsule, hard

oral use

DE - Germany

| AbZ-Pharma GmbH |
| --- |
| Dr.Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Fenofibrat AbZ 100mg Hartkapseln

100 mg

Capsule, hard

oral

DE - Germany

| AbZ-Pharma GmbH |
| --- |
| Dr.Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Fenofibrat AbZ 250 mg Retardkapseln

250 mg

Prolonged-release capsule, hard

oral

DE - Germany

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

Fenofibrat AL 250 retard

250 mg

Prolonged-release capsule, hard

oral

DE - Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

Fenobeta 250 retard

250 mg

Prolonged-release capsule, hard

oral

DE - Germany

| CHEPLAPHARM Arzneimittel GmbH |
| --- |
| Bahnhofstr. 1a |
| D-17498 Mesekenhagen |
| Germany |

CHEPLAPHARM Arzneimittel GmbH

Bahnhofstr. 1a

D-17498 Mesekenhagen

Germany

Normalip pro

200 mg

Capsule, hard

oral

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Fenofibrat-CT 100mg Hartkapseln

100 mg

Capsule

oral

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Fenofibrat-CT 250mg Retardkapseln

250 mg

Prolonged-release capsule, hard

oral

DE - Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Fenofibrat 200 Heumann

200 mg

Capsule, hard

oral

DE - Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Fenofibrat 250 retard Heumann

250 mg

Prolonged-release capsule, hard

oral

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

FENOFIBRAT HEXAL 160 mg Hartkapseln

160 mg

Capsule, hard

oral

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Fenofibrat Hexal 200 mg Hartkapseln

200 mg

Capsule, hard

oral

DE - Germany

| Juta Pharma GmbH |
| --- |
| Gutenbergstr. 13 |
| D-24941 Flensburg |
| Germany |

Juta Pharma GmbH

Gutenbergstr. 13

D-24941 Flensburg

Germany

Fenofanton 250 mg Hartkapseln, retardiert

250 mg

Prolonged-release capsule, hard

oral

DE - Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| D-64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Germany

Durafenat

100 mg

Capsule, hard

oral

DE - Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| D-64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Germany

durafenat MF 200 mg

200 mg

Modified-release capsule, hard

oral

DE - Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| D-64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

D-64295 Darmstadt

Germany

durafenat retard

250 mg

Prolonged-release capsule, hard

oral

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Fenofibrat-ratiopharm 250 mg Retardkapseln

250 mg

Prolonged-release capsule, hard

oral

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Fenofibrat-ratiopharm 100 mg Hartkapseln

100 mg

Capsule, hard

oral

DE - Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

Fenofibrat Sandoz 200mg Hartkapseln

200 mg

Capsule, hard

oral

DE - Germany

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

Apteor 160 mg Filmtablette

160 mg

Film-coated tablet

oral

DE - Germany

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

Elipsia 145 mg Filmtabletten

145 mg

Film-coated tablet

oral

DE - Germany

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

Liperial 145 mg Filmtablette

145 mg

Film-coated tablet

oral

DE - Germany

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

Lipidil - Ter 160 mg Filmtablette

160 mg

Film-coated tablet

oral

DE - Germany

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

Lipidil 145 ONE

145 mg

Film-coated tablet

oral

DE - Germany

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

Lipidil 200mg

200 mg

Capsule, hard

oral

DE - Germany

| Abbott Arzneimittel GmbH |
| --- |
| Hans-Boeckler-Allee 20 |
| D-30173 Hannover |
| Germany |

Abbott Arzneimittel GmbH

Hans-Boeckler-Allee 20

D-30173 Hannover

Germany

Xafenor 145 mg Filmtablette

145 mg

Film-coated tablet

oral

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Fenofibrat STADA 250 mg Hartkapseln, retardiert

250 mg

Prolonged-release capsule, hard

oral

DE - Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| D-56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

D-56218 Mülheim-Kärlich

Germany

CiL 160 mg

160 mg

Capsule, hard

oral

DE - Germany

| Winthrop Arzneimittel GmbH |
| --- |
| Urmitzer Str. 5 |
| D-56218 Mülheim-Kärlich |
| Germany |

Winthrop Arzneimittel GmbH

Urmitzer Str. 5

D-56218 Mülheim-Kärlich

Germany

CIL 200 mg

200 mg

Capsule

oral

EL - Greece

| SOLVAY PHARMA Μ.Ε.Π.Ε |
| --- |
| Agiou DIMITRIOU 63 |
| Alimos 17456 |
| Greece |

SOLVAY PHARMA Μ.Ε.Π.Ε

Agiou DIMITRIOU 63

Alimos 17456

Greece

LIPIDIL

200 MG/CAP

HARD CAPSULES

ORAL

EL - Greece

| SOLVAY PHARMA Μ.Ε.Π.Ε |
| --- |
| Agiou DIMITRIOU 63 |
| Alimos |
| Greece 17456 |

SOLVAY PHARMA Μ.Ε.Π.Ε

Agiou DIMITRIOU 63

Alimos

Greece 17456

LIPIDIL (NT)

145 MG/TAB

Film-coated tablet

ORAL

EL - Greece

| LABORATOIRES SMB S.A., BELGIUM |
| --- |
| 26-28 rue de la Pastorale |
| B-1080, Brussels |
| Belgium |

LABORATOIRES SMB S.A., BELGIUM

26-28 rue de la Pastorale

B-1080, Brussels

Belgium

FENOBRAT

160 MG/CAP

HARD CAPSULES

ORAL

ES - Spain

| SOLVAY PHARMA |
| --- |
| S.A.Avda. Diagonal |
| 507 Barcelona |
| Spain |

SOLVAY PHARMA

S.A.Avda. Diagonal

507 Barcelona

Spain

APTEOR

145 mg

film coated tablets

oral

ES - Spain

| SOLVAY PHARMA, |
| --- |
| S.A.Avda. Diagonal |
| 507 Barcelona |
| Spain |

SOLVAY PHARMA,

S.A.Avda. Diagonal

507 Barcelona

Spain

APTEOR

160 mg

film coated tablets

oral

ES - Spain

| KERN PHARMA |
| --- |
| S.L. Venus, 72. |
| Poligono Industrial Colon II.Terrassa |
| Spain |

KERN PHARMA

S.L. Venus, 72.

Poligono Industrial Colon II.Terrassa

Spain

Fenofibrato KernPharma

160 mg

capsules

oral

ES - Spain

| LABORATORIOS RANBAXY |
| --- |
| S.L.Passeig de Gracia |
| 9 Barcelona |
| Spain |

LABORATORIOS RANBAXY

S.L.Passeig de Gracia

9 Barcelona

Spain

FENOFIBRATO RANBAXY

160 mg

film coated tablets

oral

ES - Spain

| LABORATORIOS RANBAXY S.L.Passeig de Gracia |
| --- |
| 9 Barcelona |

LABORATORIOS RANBAXY S.L.Passeig de Gracia

9 Barcelona

FENOFIBRATO RANBAXY

200 mg

capsules

oral

ES - Spain

| LABORATORIOS RANBAXY S.L.Passeig de Gracia |
| --- |
| 9 Barcelona |
| Spain |

LABORATORIOS RANBAXY S.L.Passeig de Gracia

9 Barcelona

Spain

FENOFIBRATO RANBAXYGEN

200 mg

capsules

oral

ES - Spain

| NOVARTIS FARMACEUTICA, S.A. |
| --- |
| Gran Via de les Corts Catalanes |
| 764 Barcelona |
| Spain |

NOVARTIS FARMACEUTICA, S.A.

Gran Via de les Corts Catalanes

764 Barcelona

Spain

Liparison Retard

250 mg

capsules

oral

ES - Spain

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Spain |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Spain

PANLIPAL

145 mg

film coated tablets

oral

ES - Spain

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Spain |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Spain

SECALIP

145 mg

film coated tablets

oral

ES - Spain

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Spain |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Spain

SECALIP

200 mg

capsules

oral

ES - Spain

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Spain |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Spain

SECALIP

250 mg

capsules

oral

ES - Spain

| SOLVAY PHARMA S.A. |
| --- |
| Avda. Diagonal |
| 507 BARCELONA |
| Spain |

SOLVAY PHARMA S.A.

Avda. Diagonal

507 BARCELONA

Spain

SECALIP SUPRA

160 mg

film coated tablets

oral

ET - Estonia

| Laboratoires Fournier S.A. |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| France |

Laboratoires Fournier S.A.

28 Boulevard Clemenceau

21000 Dijon

France

LIPANTHYL

200 mg

capsule

oral use

ET - Estonia

| Pharmaswiss Eesti OÜ |
| --- |
| Tammsaare tee 47 |
| 11316 Tallinn |
| ESTONIA |

Pharmaswiss Eesti OÜ

Tammsaare tee 47

11316 Tallinn

ESTONIA

FENOLIP

160 mg

capsule, hard

oral use

FI - Finland

| Laboratoires SMB S.A. |
| --- |
| Rue de la Pastorale 26-28 |
| 1080 Brussels |
| Belgium |

Laboratoires SMB S.A.

Rue de la Pastorale 26-28

1080 Brussels

Belgium

CIL

160 mg

capsules, hard

Oral use

FI - Finland

| Laboratoires SMB S.A. |
| --- |
| Rue de la Pastorale 26-28 |
| 1080 Brussels |
| Belgium |

Laboratoires SMB S.A.

Rue de la Pastorale 26-28

1080 Brussels

Belgium

FENOSUP LIDOSE

160 mg

capsules, hard

Oral use

FI - Finland

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clémenceau |
| BP 27912 |
| 21079 Dijon Cedex |
| France |

Laboratoires Fournier SA

28 boulevard Clémenceau

BP 27912

21079 Dijon Cedex

France

LIPANTHYL PENTA

145 mg

film-coated tablet

Oral use

FI - Finland

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clémenceau |
| BP 27912 |
| 21079 Dijon Cedex |
| France |

Laboratoires Fournier SA

28 boulevard Clémenceau

BP 27912

21079 Dijon Cedex

France

LIPANTHYL SUPRA

160 mg

film-coated tablet

Oral use

FI - Finland

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clémenceau |
| BP 27912 |
| 21079 Dijon Cedex |
| France |

Laboratoires Fournier SA

28 boulevard Clémenceau

BP 27912

21079 Dijon Cedex

France

LIPANTHYL SUPRA

215 mg

film-coated tablet

Oral use

FR - France

| Société FERLUX SA |
| --- |
| 24, avenue d'Aubière |
| BP 151 |
| 63804 Cournon d'Auvergne Cedex |
| FRANCE |

Société FERLUX SA

24, avenue d'Aubière

BP 151

63804 Cournon d'Auvergne Cedex

FRANCE

CENCARAN 140 mg, gélule

140 mg

capsule

oral use

FR - France

| Société FERLUX SA |
| --- |
| 24, avenue d'Aubière |
| BP 151 |
| 63804 Cournon d'Auvergne Cedex |
| France |

Société FERLUX SA

24, avenue d'Aubière

BP 151

63804 Cournon d'Auvergne Cedex

France

CENCARAN 67 mg, gélule

67 mg

capsule

oral use

FR - France

| Laboratoires LEURQUIN MEDIOLANUM |
| --- |
| 68-88, rue Louis Ampère |
| ZI des Chanoux |
| 93330 Neuilly-sur-Marne |
| FRANCE |

Laboratoires LEURQUIN MEDIOLANUM

68-88, rue Louis Ampère

ZI des Chanoux

93330 Neuilly-sur-Marne

FRANCE

FEGENOR 140 mg, gélule

140 mg

capsule

oral use

FR - France

| Laboratoires LEURQUIN MEDIOLANUM |
| --- |
| 68-88, rue Louis Ampère |
| ZI des Chanoux |
| 93330 Neuilly-sur-Marne |
| France |

Laboratoires LEURQUIN MEDIOLANUM

68-88, rue Louis Ampère

ZI des Chanoux

93330 Neuilly-sur-Marne

France

FEGENOR 200 mg, gélule

200 mg

capsule

oral use

FR - France

| Laboratoires LEURQUIN MEDIOLANUM |
| --- |
| 68-88, rue Louis Ampère |
| ZI des Chanoux |
| 93330 Neuilly-sur-Marne |
| France |

Laboratoires LEURQUIN MEDIOLANUM

68-88, rue Louis Ampère

ZI des Chanoux

93330 Neuilly-sur-Marne

France

FEGENOR 67 mg, gélule

67 mg

capsule

oral use

FR - France

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| FRANCE |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

FRANCE

FENATHOL 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| Laboratoires LEURQUIN MEDIOLANUM |
| --- |
| 68-88, rue Louis Ampère |
| ZI des Chanoux |
| 93330 Neuilly-sur-Marne |
| France |

Laboratoires LEURQUIN MEDIOLANUM

68-88, rue Louis Ampère

ZI des Chanoux

93330 Neuilly-sur-Marne

France

FENOCOR 100 mg, gélule

100 mg

capsule

oral use

FR - France

| ACTAVIS France |
| --- |
| La Boursidière Centre d'Affaires |
| 92357 Le Plessis Robinson |
| FRANCE |

ACTAVIS France

La Boursidière Centre d'Affaires

92357 Le Plessis Robinson

FRANCE

FENOFIBRATE ACTAVIS 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| FRANCE |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

FRANCE

FENOFIBRATE ALMUS 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

FENOFIBRATE ALMUS 200 mg, gélule

200 mg

capsule

oral use

FR - France

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

FENOFIBRATE ALMUS 67 mg, gélule

67 mg

capsule

oral use

FR - France

| LABORATOIRES ALTER |
| --- |
| 3, avenue de la Baltique |
| ZI de Courtaboeuf |
| 91140 Villebon Sur Yvette |
| France |

LABORATOIRES ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette

France

FENOFIBRATE ALTER 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| LABORATOIRES ALTER |
| --- |
| 3, avenue de la Baltique |
| ZI de Courtaboeuf |
| 91140 Villebon Sur Yvette |
| FRANCE |

LABORATOIRES ALTER

3, avenue de la Baltique

ZI de Courtaboeuf

91140 Villebon Sur Yvette

FRANCE

FENOFIBRATE ALTER 300 mg, gélule

300 mg

capsule

oral use

FR - France

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| FRANCE |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

FRANCE

FENOFIBRATE ARROW 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

FENOFIBRATE ARROW 200 mg, gélule

200 mg

capsule

oral use

FR - France

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

France

FENOFIBRATE ARROW 67 mg, gélule

67 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| FRANCE |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

FRANCE

FENOFIBRATE BIOGARAN 100 mg, gélule

100 mg

capsule

oral use

FR - France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

France

FENOFIBRATE BIOGARAN 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE BIOGARAN 200 mg, gélule

200 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE BIOGARAN 300 mg, gélule

300 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE BIOGARAN 67 mg, gélule

67 mg

capsule

oral use

FR - France

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| FRANCE |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

FRANCE

FENOFIBRATE CEHEL PHARMA 140 mg, gélule

140 mg

capsule

oral use

FR - France

| CRISTERS |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| FRANCE |

CRISTERS

22 quai Gallieni

92150 Suresnes

FRANCE

FENOFIBRATE CRISTERS 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| CRISTERS |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| France |

CRISTERS

22 quai Gallieni

92150 Suresnes

France

FENOFIBRATE CRISTERS 200 mg, gélule

200 mg

capsule

oral use

FR - France

| CRISTERS |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| France |

CRISTERS

22 quai Gallieni

92150 Suresnes

France

FENOFIBRATE CRISTERS 67 mg, gélule

67 mg

capsule

oral use

FR - France

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| France |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

France

FENOFIBRATE DCI PHARMA 200 mg, gélule

200 mg

capsule

oral use

FR - France

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| France |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

France

FENOFIBRATE DCI PHARMA 67 mg, gélule

67 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE DEBAT CARDIO 140 mg, gélule

140 mg

capsule

oral use

FR - France

| EG LABO - Laboratoires EuroGenerics |
| --- |
| «Le Quintet» - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - Laboratoires EuroGenerics

«Le Quintet» - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

FENOFIBRATE EG 145 mg, comprimé

145 mg

tablet

oral use

FR - France

| EG LABO - Laboratoires EuroGenerics |
| --- |
| «Le Quintet» - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - Laboratoires EuroGenerics

«Le Quintet» - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

FENOFIBRATE EG 160 mg, comprimé pelliculé

160 mg

tablet

oral use

FR - France

| EG LABO - Laboratoires EuroGenerics |
| --- |
| «Le Quintet» - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - Laboratoires EuroGenerics

«Le Quintet» - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

FENOFIBRATE EG 200 mg, gélule

200 mg

capsule

oral use

FR - France

| EG LABO - Laboratoires EuroGenerics |
| --- |
| «Le Quintet» - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG LABO - Laboratoires EuroGenerics

«Le Quintet» - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

FENOFIBRATE EG 67 mg, gélule

67 mg

capsule

oral use

FR - France

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

FENOFIBRATE ENIREX 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| FRANCE |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

FRANCE

FENOFIBRATE TEVA 145 mg, comprimé

145 mg pour 1 comprimé

tablet

oral use

FR - France

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline |
| Bâtiment D |
| 92213 Saint-Cloud Cedex |
| France |

ETHYPHARM

194, Bureaux de la Colline

Bâtiment D

92213 Saint-Cloud Cedex

France

FENOFIBRATE ETHYPHARM 200 mg, gélule

200 mg

capsule

oral use

FR - France

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline |
| Bâtiment D |
| 92213 Saint-Cloud Cedex |
| France |

ETHYPHARM

194, Bureaux de la Colline

Bâtiment D

92213 Saint-Cloud Cedex

France

FENOFIBRATE ETHYPHARM 67 mg, gélule

67 mg

capsule

oral use

FR - France

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| FRANCE |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

FRANCE

FENOFIBRATE EXPANPHARM 200 mg, comprimé

200 mg

tablet

oral use

FR - France

| AJC INVEST |
| --- |
| 6, rue de la Rochefoucauld |
| 16000 Angoulême |
| FRANCE |

AJC INVEST

6, rue de la Rochefoucauld

16000 Angoulême

FRANCE

FENOFIBRATE EXPANPHARM 200 mg, gélule

200 mg

capsule

oral use

FR - France

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| FRANCE |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

FRANCE

FENOFIBRATE EXPANPHARM 67 mg, comprimé

67 mg

tablet

oral use

FR - France

| AJC INVEST |
| --- |
| 6, rue de la Rochefoucauld |
| 16000 Angoulême |
| FRANCE |

AJC INVEST

6, rue de la Rochefoucauld

16000 Angoulême

FRANCE

FENOFIBRATE EXPANPHARM 67 mg, gélule

67 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE FOURNIER 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE FOURNIER 145 mg, comprimé pelliculé

145 mg

film-coated tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE FOURNIER 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE FOURNIER 200 MICRONISE, gélule

200 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE FOURNIER 300 mg, gélule

300 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE FOURNIER 67 MICRONISE, gélule

67 mg

capsule

oral use

FR - France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| FRANCE |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

FRANCE

FENOFIBRATE G GAM 200 mg, gélule

200 mg

capsule

oral use

FR - France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

FENOFIBRATE G GAM 67 mg, gélule

67 mg

capsule

oral use

FR - France

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| France |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

France

FENOFIBRATE GALENIX 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| FRANCE |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

FRANCE

FENOFIBRATE IVAX 100 mg, gélule

100 mg

capsule

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

FENOFIBRATE IVAX 200 mg, gélule

200 mg

capsule

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

FENOFIBRATE IVAX 300 mg, gélule

300 mg

capsule

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

FENOFIBRATE IVAX 67 mg, gélule

67 mg

capsule

oral use

FR - France

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| France |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

France

FENOFIBRATE MILGEN 200 mg, gélule

200 mg

capsule

oral use

FR - France

| CLL PHARMA |
| --- |
| Nice Premier - Arénas |
| 455, Promenade des Anglais |
| 06299 Nice Cedex 03 |
| France |

CLL PHARMA

Nice Premier - Arénas

455, Promenade des Anglais

06299 Nice Cedex 03

France

FENOFIBRATE MILGEN 67 mg, gélule

67 mg

capsule

oral use

FR - France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

FENOFIBRATE MYLAN 100 mg, gélule

100,00 mg

capsule

oral use

FR - France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

FENOFIBRATE MYLAN 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

FENOFIBRATE MYLAN 200 mg, gélule

200 mg

capsule

oral use

FR - France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

FENOFIBRATE MYLAN 300 mg, gélule

300,00 mg

capsule

oral use

FR - France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

FENOFIBRATE MYLAN 67 mg, gélule

67 mg

capsule

oral use

FR - France

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

FRANCE

FENOFIBRATE QUALIMED 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

France

FENOFIBRATE QUALIMED 200 mg, gélule

200 mg

capsule

oral use

FR - France

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

France

FENOFIBRATE QUALIMED 67 mg, gélule

67 mg

capsule

oral use

FR - France

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| FRANCE |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

FRANCE

FENOFIBRATE RANBAXY 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| France |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

France

FENOFIBRATE RANBAXY 200 mg, gélule

200 mg

capsule

oral use

FR - France

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| France |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

France

FENOFIBRATE RANBAXY 300 mg, gélule

300 mg

capsule

oral use

FR - France

| Laboratoire RATIOPHARM |
| --- |
| 19, boulevard Paul Vaillant Couturier |
| 94200 Ivry sur Seine |
| FRANCE |

Laboratoire RATIOPHARM

19, boulevard Paul Vaillant Couturier

94200 Ivry sur Seine

FRANCE

FENOFIBRATE RATIOPHARM 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE RATIOPHARM 200 mg, gélule

200 mg

capsule

oral use

FR - France

| Laboratoire RATIOPHARM |
| --- |
| 19, boulevard Paul Vaillant Couturier |
| 94200 Ivry sur Seine |
| France |

Laboratoire RATIOPHARM

19, boulevard Paul Vaillant Couturier

94200 Ivry sur Seine

France

FENOFIBRATE RATIOPHARM 300 mg, gélule

300 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE RATIOPHARM 67 mg, gélule

67 mg

capsule

oral use

FR - France

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| FRANCE |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

FRANCE

FENOFIBRATE RPG 100 mg, gélule

100,00 mg

capsule

oral use

FR - France

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| FRANCE |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

FRANCE

FENOFIBRATE RPG 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE RPG 200 mg, gélule

200 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOFIBRATE RPG 67 mg, gélule

67 mg

capsule

oral use

FR - France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| FRANCE |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

FRANCE

FENOFIBRATE SANDOZ 100 mg, gélule

100 mg

capsule

oral use

FR - France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

FENOFIBRATE SANDOZ 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

FENOFIBRATE SANDOZ 200 mg, gélule

200 mg

capsule

oral use

FR - France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

FENOFIBRATE SANDOZ 300 mg, gélule

300 mg

capsule

oral use

FR - France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

France

FENOFIBRATE SANDOZ 67 mg, gélule

67 mg

capsule

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

FENOFIBRATE TEVA 100 mg, gélule

100,00 mg

capsule

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

FENOFIBRATE TEVA 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

FENOFIBRATE TEVA 200 mg, gélule

200 mg

capsule

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| FRANCE |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

FRANCE

FENOFIBRATE TEVA 300 mg, gélule

300,00 mg

capsule

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris la Défense Cedex

France

FENOFIBRATE TEVA 67 mg, gélule

67 mg

capsule

oral use

FR - France

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

FENOFIBRATE WINTHROP 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

FENOFIBRATE WINTHROP 200 mg, gélule

200 mg

capsule

oral use

FR - France

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

FENOFIBRATE WINTHROP 67 mg, gélule

67 mg

capsule

oral use

FR - France

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| UNITED KINGDOM |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

UNITED KINGDOM

FENOFIBRATE WYVERN 200 mg, gélule

200 mg

capsule

oral use

FR - France

| WYVERN MEWYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| UNITED KINGDOM |

WYVERN MEWYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

UNITED KINGDOM

FENOFIBRATE WYVERN 67 mg, gélule

67 mg

capsule

oral use

FR - France

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| UNITED KINGDOM |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

UNITED KINGDOM

FENOFIBRATE WYVERN MEDICAL 160 mg, comprimé pelliculé

160,0 mg

film-coated tablet

oral use

FR - France

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| UNITED KINGDOM |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

UNITED KINGDOM

FENOFIBRATE WYVERN MEDICAL 200 mg, gélule

200 mg

capsule

oral use

FR - France

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| UNITED KINGDOM |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

UNITED KINGDOM

FENOFIBRATE WYVERN MEDICAL 67 mg, gélule

67 mg

capsule

oral use

FR - France

| ZYDUS France |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| FRANCE |

ZYDUS France

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

FRANCE

FENOFIBRATE ZYDUS 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| ZYDUS France |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| France |

ZYDUS France

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

France

FENOFIBRATE ZYDUS 200 mg, gélule

200 mg

capsule

oral use

FR - France

| ZYDUS France |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| France |

ZYDUS France

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

France

FENOFIBRATE ZYDUS 300 mg, gélule

300 mg

capsule

oral use

FR - France

| ZYDUS France |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 92000 Nanterre |
| France |

ZYDUS France

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

92000 Nanterre

France

FENOFIBRATE ZYDUS 67 mg, gélule

67 mg

capsule

oral use

FR - France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

FENOFIBRATE WINTHROP 145 mg, comprimé

145 mg

tablet

oral use

FR - France

| QUALIMED |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

QUALIMED

117, allée des Parcs

69800 Saint-Priest

FRANCE

FENOFIBRATE QUALIMED 145 mg, comprimé

145 mg

tablet

oral use

FR - France

| LABORATOIRE RATIOPHARM |
| --- |
| 19, boulevard Paul Vaillant Couturier |
| 94200 Ivry sur Seine |
| FRANCE |

LABORATOIRE RATIOPHARM

19, boulevard Paul Vaillant Couturier

94200 Ivry sur Seine

FRANCE

FENOFIBRATE RATIOPHARM 145 mg, comprimé

145 mg

tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOX 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

FENOX 300 mg, gélule

300 mg

capsule

oral use

FR - France

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| FRANCE |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

FRANCE

FENOFIBRATE SANDOZ 145 mg, comprimé

145 mg

tablet

oral use

FR - France

| GALENIX DEVELOPPEMENT |
| --- |
| Les Palanques |
| 33127 Saint Jean d’Illac |
| France |

GALENIX DEVELOPPEMENT

Les Palanques

33127 Saint Jean d’Illac

France

GENOTHYL 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

LIPANTHYL 140 MICRONISE, gélule

140 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

LIPANTHYL 145 mg, comprimé pelliculé

145 mg

film-coated tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

LIPANTHYL 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

LIPANTHYL 200 micronisé, gélule

200 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

LIPANTHYL 67 Micronisé, gélule

67 mg

capsule

oral use

FR - France

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| FRANCE |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

FRANCE

FENOFIBRATE BIOGARAN 145 mg, comprimé

145 mg

tablet

oral use

FR - France

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline |
| Bâtiment D |
| 92213 Saint-Cloud Cedex |
| France |

ETHYPHARM

194, Bureaux de la Colline

Bâtiment D

92213 Saint-Cloud Cedex

France

LIPILFEN 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| FRANCE |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

FRANCE

FENOFIBRATE MYLAN 145 mg, comprimé

145 mg

tablet

oral use

FR - France

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| FRANCE |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

FRANCE

FENOFIBRATE WINTHROP 160 mg, comprimé

160 mg

tablet

oral use

FR - France

| ETHYPHARM |
| --- |
| 194, Bureaux de la Colline |
| Bâtiment D |
| 92213 Saint-Cloud Cedex |
| France |

ETHYPHARM

194, Bureaux de la Colline

Bâtiment D

92213 Saint-Cloud Cedex

France

LIPIPHARM 145 mg, comprimé

145 mg

tablet

oral use

FR - France

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

LIPIREX 200 mg, gélule

200 mg

capsule

oral use

FR - France

| SANOFI AVENTIS France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

SANOFI AVENTIS France

1-13, boulevard Romain Rolland

75014 Paris

France

LIPIREX 67 mg, gélule

67 mg

capsule

oral use

FR - France

| BOUCHARA RECORDATI |
| --- |
| 68, rue Marjolin |
| BP 67 |
| 92302 Levallois-Perret Cedex |
| FRANCE |

BOUCHARA RECORDATI

68, rue Marjolin

BP 67

92302 Levallois-Perret Cedex

FRANCE

LIVESAN 200 mg, gélule

200 mg

capsule

oral use

FR - France

| BOUCHARA RECORDATI |
| --- |
| 68, rue Marjolin |
| BP 67 |
| 92302 Levallois-Perret Cedex |
| France |

BOUCHARA RECORDATI

68, rue Marjolin

BP 67

92302 Levallois-Perret Cedex

France

LIVESAN 67 mg, gélule

67 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

PANLIPAL 145 mg, comprimé pelliculé

145 mg

film-coated tablet

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

SECALIP 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

SECALIP 200 mg, gélule

200 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

SECALIP 300 mg, gélule

300 mg

capsule

oral use

FR - France

| Laboratoires FOURNIER SA |
| --- |
| 28, boulevard Clémenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER SA

28, boulevard Clémenceau

21000 Dijon

France

SECALIP 67 mg, gélule

67 mg

capsule

oral use

FR - France

| SUBSTIPHARM |
| --- |
| 8, rue Bellini |
| 75116 Paris |
| FRANCE |

SUBSTIPHARM

8, rue Bellini

75116 Paris

FRANCE

SUBSTICHOL 160 mg, comprimé pelliculé

160 mg

film-coated tablet

oral use

FR - France

| WYVERN MEDICAL LTD |
| --- |
| Sterling House - 3A New Street |
| Ledbury |
| HR8 2DX Herefordshire |
| United Kingdom |

WYVERN MEDICAL LTD

Sterling House - 3A New Street

Ledbury

HR8 2DX Herefordshire

United Kingdom

WYVEBRATE 160 mg, comprimé pelliculé

160,0 mg

film-coated tablet

oral use

HU - Hungary

| PharmaSwiss Magyarország Kft. |
| --- |
| Zichy G. u. 5 fszt/1 |
| 1146 Budapest |
| Hungary |

PharmaSwiss Magyarország Kft.

Zichy G. u. 5 fszt/1

1146 Budapest

Hungary

Fenobrat

250 mg

prolonged-release capsule

oral

HU - Hungary

| PharmaSwiss Magyarország Kft. |
| --- |
| Zichy G. u. 5 fszt/1 |
| 1146 Budapest |
| Hungary |

PharmaSwiss Magyarország Kft.

Zichy G. u. 5 fszt/1

1146 Budapest

Hungary

Fenoswiss

160 mg

hard capsule

oral

HU - Hungary

| Laboratoires Fournier SA |
| --- |
| 8 Bd Clemenceau |
| F-21000 Dijon |
| France |

Laboratoires Fournier SA

8 Bd Clemenceau

F-21000 Dijon

France

Lipidil Supra

160 mg

film-coated tablet

oral

HU - Hungary

| Laboratoires Fournier SA |
| --- |
| 8 Bd Clemenceau |
| F-21000 Dijon |
| France |

Laboratoires Fournier SA

8 Bd Clemenceau

F-21000 Dijon

France

Lipidil Supra

215 mg

film-coated tablet

oral

HU - Hungary

| Laboratoires Fournier SA |
| --- |
| 8 Bd Clemenceau |
| F-21000 Dijon |
| France |

Laboratoires Fournier SA

8 Bd Clemenceau

F-21000 Dijon

France

Lipanthyl NT

145 mg

film-coated tablet

oral

HU - Hungary

| Laboratoires Fournier SA |
| --- |
| 8 Bd Clemenceau |
| F-21000 Dijon |
| France |

Laboratoires Fournier SA

8 Bd Clemenceau

F-21000 Dijon

France

Lipidil

267 mg

hard capsule

oral

IE - Ireland

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

Lipantil Micro 67 mg capsules, hard

67 mg

hard capsules

oral use

IE - Ireland

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

Lipantil Micro 200 mg capsules, hard

200 mg

hard capsules

oral use

IE - Ireland

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

Lipantil Micro 267 mg capsules, hard

267 mg

hard capsules

oral use

IE - Ireland

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

Lipantil Supra 145mg film-coated tablets

145 mg

film-coated tablets

oral use

IE - Ireland

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

Lipantil Supra 160mg film-coated tablets

160 mg

film-coated tablets

oral use

IE - Ireland

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road |
| West End |
| Southampton |
| SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road

West End

Southampton

SO18 3JD

United Kingdom

Lipantil Supra 215 mg film-coated tablets

215 mg

film-coated tablets

oral use

IT - Italy

| Farmaceutici Caber Spa Viale Città D'Europa, 681 00100 ROMA |
| --- |
| Italy |

Farmaceutici Caber Spa Viale Città D'Europa, 681 00100 ROMA

Italy

Lipsin

200 mg

Capsule

Oral

IT - Italy

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italy |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italy

Fulcro

200 mg

Capsule

Oral

IT - Italy

| Francia Farmaceutici Industria Farmaco Biologica Srl |
| --- |
| Via dei Pestagalli, 7 |
| 20138 MILANO |
| Italy |

Francia Farmaceutici Industria Farmaco Biologica Srl

Via dei Pestagalli, 7

20138 MILANO

Italy

Tilene

100 mg

Capsule

Oral

IT - Italy

| Salus Researches Spa |
| --- |
| Via Aurelia, 58 |
| 00165 ROMA |
| Italy |

Salus Researches Spa

Via Aurelia, 58

00165 ROMA

Italy

Nolipax

100 mg

Capsule

Oral

IT - Italy

| Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene 27010 Pavia |
| --- |
| Italy |

Teofarma Srl Via Fratelli Cervi, 8 - Valle Salimbene 27010 Pavia

Italy

Lipofene

100 mg

Capsule

Oral

IT - Italy

| Winthrop Pharmaceuticals Italia Srl Viale Bodio, 37/B 20158 MILANO |
| --- |
| Italy |

Winthrop Pharmaceuticals Italia Srl Viale Bodio, 37/B 20158 MILANO

Italy

Fenofibrato Winthrop

200 mg

Capsule

Oral

IT - Italy

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italy |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italy

Fulcrosupra

145 mg

Film-coated tablet

Oral

IT - Italy

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italy |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italy

Fulcrosupra

160 mg

Film-coated tablet

Oral

IT - Italy

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italy |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italy

Fenolibs

145 mg

Film-coated tablet

Oral

IT - Italy

| Solvay Pharma Spa |
| --- |
| Via della Libertà 30 |
| 100 95 Grugliasco |
| Italy |

Solvay Pharma Spa

Via della Libertà 30

100 95 Grugliasco

Italy

Liperial

145 mg

Film-coated tablet

Oral

LT - Lithuania

| UAB PharmaSwiss |
| --- |
| Šeimyniškių 21B |
| LT-09200 Vilnius |
| Lithuania |

UAB PharmaSwiss

Šeimyniškių 21B

LT-09200 Vilnius

Lithuania

Fenolip

160 mg

capsule, hard

oral use

LT - Lithuania

| Laboratoires Fournier S. A. |
| --- |
| 28 Boulevard Clemenceau |
| 21000 Dijon |
| France |

Laboratoires Fournier S. A.

28 Boulevard Clemenceau

21000 Dijon

France

Lipanthyl 200 M

200 mg

capsule, hard

oral use

LU - Luxembourg

| Leurquin Mediolanum Lab. |
| --- |
| 68-88, rue Ampere |
| (Z.I. Chanaux) |
| 93330 Neuilly-sur-Seine |
| France |

Leurquin Mediolanum Lab.

68-88, rue Ampere

(Z.I. Chanaux)

93330 Neuilly-sur-Seine

France

Fegenor

67 mg

capsule, hard

oral

LU - Luxembourg

| Leurquin Mediolanum Lab. |
| --- |
| 68-88, rue Ampere |
| (Z.I. Chanaux) |
| 93330 Neuilly-sur-Seine |
| France |

Leurquin Mediolanum Lab.

68-88, rue Ampere

(Z.I. Chanaux)

93330 Neuilly-sur-Seine

France

Fegenor

200 mg

capsule, hard

oral

LU - Luxembourg

| S.M.B. |
| --- |
| 26-28, rue de la Pastorale |
| B- 1080 Bruxelles |
| Belgium |

S.M.B.

26-28, rue de la Pastorale

B- 1080 Bruxelles

Belgium

Fenogal-200

200 mg

capsule, hard

oral

LU - Luxembourg

| S.M.B. |
| --- |
| 26-28, rue de la Pastorale |
| B- 1080 Bruxelles |
| Belgium |

S.M.B.

26-28, rue de la Pastorale

B- 1080 Bruxelles

Belgium

Fenogal-267

267 mg

capsule, hard

oral

LU - Luxembourg

| Eurogenerics SA |
| --- |
| Esplanade Heysel, B22 |
| B- 1020 Bruxelles |
| Belgium |

Eurogenerics SA

Esplanade Heysel, B22

B- 1020 Bruxelles

Belgium

Fenofibrate EG

67 mg

capsule, hard

oral

LU - Luxembourg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgium |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgium

Lipanthyl 67 Micronised

67 mg

capsule, hard

oral

LU - Luxembourg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgium |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgium

Lipanthyl 200 Micronised

200 mg

capsule, hard

oral

LU - Luxembourg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgium |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgium

Lipanthyl 267 Micronised

267 mg

capsule, hard

oral

LU - Luxembourg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgium |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgium

Lipanthyl Supra

160 mg

film-coated tablet

oral

LU - Luxembourg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgium |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgium

Lipanthyl Supra

215 mg

film-coated tablet

oral

LU - Luxembourg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgium |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgium

Lipanthyl Nano

145 mg

film-coated tablet

oral

LU - Luxembourg

| Solvay Pharma S.A. |
| --- |
| Avenue du Brg. E. Demunter 3 |
| B- 1090 Bruxelles |
| Belgium |

Solvay Pharma S.A.

Avenue du Brg. E. Demunter 3

B- 1090 Bruxelles

Belgium

Liperial

145 mg

film-coated tablet

oral

LV - Latvia

| SIA PharmaSwiss Latvia |
| --- |
| Gertrudes iela 54-5 |
| Riga, LV-1011 |
| Latvia |

SIA PharmaSwiss Latvia

Gertrudes iela 54-5

Riga, LV-1011

Latvia

Fenolip 160 mg hard capsules

160 mg

Capsules, hard

Oral use

LV - Latvia

| Laboratoires Fournier S.A. |
| --- |
| Boulevard Clemenceau 28 |
| 21000 Dijon |
| France |

Laboratoires Fournier S.A.

Boulevard Clemenceau 28

21000 Dijon

France

Lipanthyl 200 mg hard capsules

200 mg

Capsules, hard

Oral use

PL - Poland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| Leiden 2333 CR |
| Netherlands |

Apotex Europe B.V.

Darwinweg 20

Leiden 2333 CR

Netherlands

Apo-Feno 100

100 mg

capsules

oral

PL - Poland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| Leiden |
| 2333 CR |
| Netherlands |

Apotex Europe B.V.

Darwinweg 20

Leiden

2333 CR

Netherlands

Apo-Feno 200M

200 mg

capsules, hard

oral

PL - Poland

| VEDIM Sp. z o.o. |
| --- |
| 8 Kruczkowskiego St., |
| 00-308 Warsaw |
| Poland |

VEDIM Sp. z o.o.

8 Kruczkowskiego St.,

00-308 Warsaw

Poland

Fenardin

267 mg

capsules, hard

oral

PL - Poland

| VEDIM Sp. z o.o. |
| --- |
| 8 Kruczkowskiego st. |
| 00-308 Warsaw |
| Poland |

VEDIM Sp. z o.o.

8 Kruczkowskiego st.

00-308 Warsaw

Poland

Fenardin

160 mg

capsules, hard

oral

PL - Poland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3, Ulm, |
| D-89079 |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3, Ulm,

D-89079

Germany

Fenoratio 100

100 mg

capsules

oral

PL - Poland

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Fenoratio Retard

250 mg

Prolonged-release capsules

oral

PL - Poland

| Grodziskie Zakłady Farmaceutyczne „Polfa” Sp. z o.o. |
| --- |
| 5 ks. J. Poniatowskiego St. |
| 05-825 Grodzisk Mazowiecki |
| Poland |

Grodziskie Zakłady Farmaceutyczne „Polfa” Sp. z o.o.

5 ks. J. Poniatowskiego St.

05-825 Grodzisk Mazowiecki

Poland

Grofibrat

100 mg

capsules

oral

PL - Poland

| Grodziskie Zakłady Farmaceutyczne „Polfa” Sp. z o.o. |
| --- |
| 5 ks. J. Poniatowskiego St., |
| 05-825 Grodzisk Mazowiecki |
| Poland |

Grodziskie Zakłady Farmaceutyczne „Polfa” Sp. z o.o.

5 ks. J. Poniatowskiego St.,

05-825 Grodzisk Mazowiecki

Poland

Grofibrat 200

200 mg

capsules

oral

PL - Poland

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| France |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

France

Lipanthyl

100 mg

capsules

oral

PL - Poland

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| France |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

France

Lipanthyl 200M

200 mg

capsules

oral

PL - Poland

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| France |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

France

Lipanthyl 267M

267 mg

capsules

oral

PL - Poland

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| France |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

France

Lipanthyl NT 145

145 mg

film-coated tablets

oral

PL - Poland

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| France |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

France

Lipanthyl Supra 160

160 mg

film-coated tablets

oral

PL - Poland

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| France |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

France

Lipanthyl Supra 215 mg

215 mg

film-coated tablets

oral

PL - Poland

| Laboratoires Fournier S.A. |
| --- |
| Bd Clemenceau 28 |
| Dijon, F-21000 |
| France |

Laboratoires Fournier S.A.

Bd Clemenceau 28

Dijon, F-21000

France

Xafenor 145

145 mg

film-coated tablets

Oral

PT - Portugal

| Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| --- |
| 2740-298 Porto Salvo |
| Portugal |

Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugal

Catalip

200 mg

capsule

Oral

PT - Portugal

| Laboratórios Vitória, S.A. |
| --- |
| Rua Elias Garcia, 28 - Venda Nova |
| 2700-327 Amadora |
| Portugal |

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28 - Venda Nova

2700-327 Amadora

Portugal

Lipofen

100 mg

capsule

Oral

PT - Portugal

| Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| --- |
| 2740-298 Porto Salvo |
| Portugal |

Abbot II Products, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugal

Supralip 160 mg

160 mg

modified released tablet

Oral

PT - Portugal

| Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| --- |
| 2740-298 Porto Salvo |
| Portugal |

Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugal

Apteor

160 mg

modified released tablet

Oral

PT - Portugal

| Solvay Farma, Lda. |
| --- |
| Empreendimento Lagoas Park. Edifício 5C - 6o |
| 2740-298 Porto Salvo |
| Portugal |

Solvay Farma, Lda.

Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugal

Catalip 267 Micronizado

267 mg

capsule

Oral

PT - Portugal

| Winthrop Farmacêutica Portugal, Lda. Empreendimento Lagoas Park, Edifício 7 - 2o/3o |
| --- |
| 2740-264 Porto Salvo |
| Portugal |

Winthrop Farmacêutica Portugal, Lda. Empreendimento Lagoas Park, Edifício 7 - 2o/3o

2740-264 Porto Salvo

Portugal

Fenofibrato Winthrop 200 mg Cápsulas

200 mg

capsule

Oral

PT - Portugal

| Alpharma ApS |
| --- |
| Rua Virgílio Correia, 11 – A |
| 1600-219 Lisboa |
| Portugal |

Alpharma ApS

Rua Virgílio Correia, 11 – A

1600-219 Lisboa

Portugal

Fenofibrato Alpharma 200 mg Cápsulas

200 mg

capsule

Oral

PT - Portugal

| Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| --- |
| 2740-298 Porto Salvo |
| Portugal |

Solvay Farma, Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugal

Supralip 145 mg

145 mg

Filmcoated tablet

Oral

PT - Portugal

| Solvay Farma |
| --- |
| Lda. Empreendimento Lagoas Park. Edifício 5C - 6o |
| 2740-298 Porto Salvo |
| Portugal |

Solvay Farma

Lda. Empreendimento Lagoas Park. Edifício 5C - 6o

2740-298 Porto Salvo

Portugal

Lipanthyl 145 mg

145 mg

Filmcoated tablet

Oral

PT - Portugal

| Solvay Farma |
| --- |
| Lda. Empreendimento Lagoas Park Edifício 5C - 6o |
| 2740-298 Porto Salvo |
| Portugal |

Solvay Farma

Lda. Empreendimento Lagoas Park Edifício 5C - 6o

2740-298 Porto Salvo

Portugal

Apteor 145 mg

145 mg

Filmcoated tablet

Oral

PT - Portugal

| Winthrop Farmacêutica Portugal |
| --- |
| Lda. Empreendimento Lagoas Park |
| Edifício 7 - 2o/3o |
| 2740-264 Porto Salvo |
| Portugal |

Winthrop Farmacêutica Portugal

Lda. Empreendimento Lagoas Park

Edifício 7 - 2o/3o

2740-264 Porto Salvo

Portugal

Fenofibrato Winthrop 267 mg Cápsulas

267 mg

capsule

Oral

RO - Romania

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clemenceau |
| 21000 Dijon |
| France |

LABORATOIRES FOURNIER S.A.

28 Bd. Clemenceau

21000 Dijon

France

LIPANTHYL® 100

100 mg

capsule

oral use

RO - Romania

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clemenceau |
| 21000 Dijon |
| France |

LABORATOIRES FOURNIER S.A.

28 Bd. Clemenceau

21000 Dijon

France

FENOX 160 mg

160 mg

modified-release film-coated tablets

oral use

RO - Romania

| S.C. VIM SPECTRUM S.R.L., |
| --- |
| Șoseaua Sighișoarei, Nr. 409, Corunca, jud Mureș |
| Romania |

S.C. VIM SPECTRUM S.R.L.,

Șoseaua Sighișoarei, Nr. 409, Corunca, jud Mureș

Romania

LIPIVIM

200 mg

capsules (with micronised powder)

oral use

RO - Romania

| LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau |
| --- |
| 21000 Dijon |
| France |

LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau

21000 Dijon

France

LIPANTHYL 67 M capsule

67 mg

capsules

oral use

RO - Romania

| LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau |
| --- |
| 21000 Dijon |
| France |

LABORATOIRES FOURNIER S.A. 28, Bd. Clemenceau

21000 Dijon

France

LIPANTHYL 267 M capsule

267 mg

capsules

oral use

RO - Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124, |
| Cluj-Napoca |
| România |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124,

Cluj-Napoca

România

LIPOFIB 160 mg

160 mg

capsules

oral use

RO - Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| România |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

România

LIPOFIB 200 mg

200 mg

capsules

oral use

RO - Romania

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clemenceau |
| 21000 Dijon |
| France |

LABORATOIRES FOURNIER S.A.

28 Bd. Clemenceau

21000 Dijon

France

LIPANTHYL PENTA 145 mg

145 mg

film-coated tablets

oral use

RO - Romania

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clemenceau |
| 21000 Dijon, |
| France |

LABORATOIRES FOURNIER S.A.

28 Bd. Clemenceau

21000 Dijon,

France

TRICOR 145 mg

145 mg

film-coated tablets

oral use

RO - Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| Romania |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

Romania

LIPOFIB 67 mg

67 mg

capsules

oral use

RO - Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| Romania |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

Romania

FENOFIBRAT TERAPIA 200 mg

200 mg

capsules

oral use

RO - Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| Romania |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

Romania

LIPOFIB 267 mg

267 mg

capsules

oral use

RO - Romania

| S. C. LABORMED PHARMA S. A. |
| --- |
| Splaiul Independenței nr. 319 E |
| Sector 6 |
| București |
| Romania |

S. C. LABORMED PHARMA S. A.

Splaiul Independenței nr. 319 E

Sector 6

București

Romania

FENOFIBRAT LPH 200 mg

200 mg

capsules (micronised powder)

oral use

RO - Romania

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii Nr. 124 |
| Cluj-Napoca |
| Romania |

S.C. TERAPIA S.A.

Str. Fabricii Nr. 124

Cluj-Napoca

Romania

FENOFIBRAT TERAPIA 160 mg

160 mg

film-coated tablets

oral use

RO - Romania

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clémenceau |
| 21 000 Dijon |
| France |

LABORATOIRES FOURNIER S.A.

28 Bd. Clémenceau

21 000 Dijon

France

LIPANTHYL SUPRA 160 mg

160 mg

modified-release film-coated tablets

oral use

RO - Romania

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clémenceau |
| 21 000 Dijon |
| France |

LABORATOIRES FOURNIER S.A.

28 Bd. Clémenceau

21 000 Dijon

France

LIPANTIL NANO 145 mg

145 mg

film-coated tablets

oral use

RO - Romania

| LABORATOIRES FOURNIER S.A. |
| --- |
| 28 Bd. Clémenceau |
| 21 000 Dijon |
| France |

LABORATOIRES FOURNIER S.A.

28 Bd. Clémenceau

21 000 Dijon

France

Lipanthyl 200 M

200 mg

capsules

oral use

SE - Sweden

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clèmenceau |
| BP 27912 21079 DIJON Cedex |
| France |

Laboratoires Fournier SA

28 boulevard Clèmenceau

BP 27912 21079 DIJON Cedex

France

Lipanthyl®

67 mg

hard capsule

oral

SE - Sweden

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clèmenceau |
| BP 27912 21079 DIJON Cedex |
| France |

Laboratoires Fournier SA

28 boulevard Clèmenceau

BP 27912 21079 DIJON Cedex

France

Lipanthyl®

200 mg

hard capsule

oral

SE - Sweden

| Laboratoires Fournier SA |
| --- |
| 28 boulevard Clèmenceau |
| BP 27912 21079 DIJON Cedex |
| France |

Laboratoires Fournier SA

28 boulevard Clèmenceau

BP 27912 21079 DIJON Cedex

France

Lipanthyl®

267 mg

hard capsule

oral

SI - Slovenia

| Laboratoires Fournier S.A. |
| --- |
| 28 boulevard Clemenceau |
| Dijon |
| France |

Laboratoires Fournier S.A.

28 boulevard Clemenceau

Dijon

France

Katalip 250 mg trde kapsule

250 mg

capsule, hard

oral use

SK - Slovakia

| Zentiva a.s. |
| --- |
| Nitrianska 100 |
| 920 27 Hlohovec |
| Slovakia |

Zentiva a.s.

Nitrianska 100

920 27 Hlohovec

Slovakia

Febira 200

200 mg

Capsule

Oral

SK - Slovakia

| Archie Samuel s.r.o. |
| --- |
| Slunná 271/16 |
| 61700 Brno 17 |
| Czech Republic |

Archie Samuel s.r.o.

Slunná 271/16

61700 Brno 17

Czech Republic

Fenofibrate - AS 267 mg

267 mg

Capsule, hard

Oral

SK - Slovakia

| IVAX Pharmaceuticals s.r.o. |
| --- |
| Ostravská 29 |
| 747 70 Opava-Komárov |
| Czech Republic |

IVAX Pharmaceuticals s.r.o.

Ostravská 29

747 70 Opava-Komárov

Czech Republic

Fenofix 200

200 mg

Capsule

Oral

SK - Slovakia

| LABORATOIRES S.M.B. S.A. |
| --- |
| 26-28 rue de la Pastorale |
| B-1080 Bruxelles |
| Belgium |

LABORATOIRES S.M.B. S.A.

26-28 rue de la Pastorale

B-1080 Bruxelles

Belgium

Fenolip

160 mg

Capsule, hard

Oral

SK - Slovakia

| Laboratoires FOURNIER S.A. |
| --- |
| 28Bd Clemenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER S.A.

28Bd Clemenceau

21000 Dijon

France

LIPANTHYL 200 M

200 mg

Capsule, hard

Oral

SK - Slovakia

| Laboratoires FOURNIER S.A. |
| --- |
| 28Bd Clemenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER S.A.

28Bd Clemenceau

21000 Dijon

France

LIPANTHYL 267 M

267 mg

Capsule, hard

Oral

SK - Slovakia

| Laboratoires FOURNIER S.A. |
| --- |
| 28Bd Clemenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER S.A.

28Bd Clemenceau

21000 Dijon

France

LIPANTHYL NT 145 mg

145 mg

Film coated tablet

Oral

SK - Slovakia

| Laboratoires FOURNIER S.A. |
| --- |
| 28Bd Clemenceau |
| 21000 Dijon |
| France |

Laboratoires FOURNIER S.A.

28Bd Clemenceau

21000 Dijon

France

LIPANTHYL SUPRA 160 mg

160 mg

Film coated tablet

Oral

SK - Slovakia

| Laboratoires FOURNIER S.A. 28Bd Clemenceau 21000 Dijon |
| --- |
| France |

Laboratoires FOURNIER S.A. 28Bd Clemenceau 21000 Dijon

France

LIPANTHYL SUPRA 215 mg

215 mg

Film coated tablet

Oral

SK - Slovakia

| PharmaSwiss Ćeská republika s.r.o. Jankovcova 1569/2c |
| --- |
| 170 00 Prague |
| Czech Republic |

PharmaSwiss Ćeská republika s.r.o. Jankovcova 1569/2c

170 00 Prague

Czech Republic

SUPRELIP

200 mg

Capsule, hard

Oral

UK - United Kingdom

| ACTAVIS UK LIMITED |
| --- |
| WHIDDON VALLEY |
| BARNSTAPLE |
| DEVON EX32 8NS |
| United Kingdom |

ACTAVIS UK LIMITED

WHIDDON VALLEY

BARNSTAPLE

DEVON EX32 8NS

United Kingdom

FENOFIBRATE 67MG CAPSULES

67 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| ACTAVIS UK LIMITED |
| --- |
| WHIDDON VALLEY |
| BARNSTAPLE |
| DEVON EX32 8NS |
| United Kingdom |

ACTAVIS UK LIMITED

WHIDDON VALLEY

BARNSTAPLE

DEVON EX32 8NS

United Kingdom

FENOFIBRATE 200MG CAPSULES

200 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| ETHYPHARM |
| --- |
| 17/21 Rue Saint Matthieu |
| Houdan, F-78550 |
| FRANCE |

ETHYPHARM

17/21 Rue Saint Matthieu

Houdan, F-78550

FRANCE

FENOFIBRATE 200MG CAPSULES

200 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| Genus Pharmaceuticals Limited |
| --- |
| Park View House |
| 65 London Road |
| NEWBURY, BERKS RG14 1JN |
| United Kingdom |

Genus Pharmaceuticals Limited

Park View House

65 London Road

NEWBURY, BERKS RG14 1JN

United Kingdom

FENOGAL 200MG CAPSULES

200 mg

CAPSULE

oral use

UK - United Kingdom

| Pliva Pharma Limited |
| --- |
| Vision House |
| Bedford Road |
| PETERSFIELD, HANTSGU32 3QB |
| United Kingdom |

Pliva Pharma Limited

Vision House

Bedford Road

PETERSFIELD, HANTSGU32 3QB

United Kingdom

FENOFIBRATE MICRO 267MG CAPSULES

267 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| United Kingdom |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

United Kingdom

FENOFIBRATE 67MG CAPSULES

67 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| United Kingdom |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

United Kingdom

FENOFIBRATE 200MG CAPSULES

200 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| United Kingdom |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

United Kingdom

FENOFIBRATE 267MG CAPSULES

267 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| United Kingdom |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

United Kingdom

FENOFIBRATE 67MG CAPSULES

67 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| United Kingdom |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

United Kingdom

FENOFIBRATE 200MG CAPSULES

200 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| Ranbaxy (Uk) Limited |
| --- |
| Cp House |
| 97-107 Uxbridge Road |
| EALING, LONDON W5 5TL |
| United Kingdom |

Ranbaxy (Uk) Limited

Cp House

97-107 Uxbridge Road

EALING, LONDON W5 5TL

United Kingdom

FENOFIBRATE 267MG CAPSULES

267 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road, West End, SOUTHAMPTON SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road, West End, SOUTHAMPTON SO18 3JD

United Kingdom

LIPANTIL MICRO 67

67 mg

CAPSULE

oral use

UK - United Kingdom

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road, West End, SOUTHAMPTON SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road, West End, SOUTHAMPTON SO18 3JD

United Kingdom

SUPRALIP 160 FILM-COATED TABLETS

160 mg

FILM-COATED TABLET

oral use

UK - United Kingdom

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road, West End, SOUTHAMPTON SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road, West End, SOUTHAMPTON SO18 3JD

United Kingdom

LIPANTIL MICRO 200

200 mg

CAPSULE

oral use

UK - United Kingdom

| Solvay Healthcare Limited |
| --- |
| Mansbridge Road, West End, SOUTHAMPTON SO18 3JD |
| United Kingdom |

Solvay Healthcare Limited

Mansbridge Road, West End, SOUTHAMPTON SO18 3JD

United Kingdom

LIPANTIL® MICRO 267

267 mg

CAPSULE

oral use

UK - United Kingdom

| TILLOMED LABORATORIES LIMITED |
| --- |
| 3 Howard Road, Eaton Socon |
| St. Neots, Cambridgeshire |
| PE19 8ET |
| United Kingdom |

TILLOMED LABORATORIES LIMITED

3 Howard Road, Eaton Socon

St. Neots, Cambridgeshire

PE19 8ET

United Kingdom

FENOFIBRATE 200MG CAPSULES

200 mg

CAPSULE, HARD

oral use

UK - United Kingdom

| WINTHROP |
| --- |
| Pharmaceuticals Uk Limited |
| One Onslow Street |
| Guildford, Surrey GU1 4YS |
| United Kingdom |

WINTHROP

Pharmaceuticals Uk Limited

One Onslow Street

Guildford, Surrey GU1 4YS

United Kingdom

FENOFIBRATE 267MG CAPSULES

267 mg

CAPSULE, HARD

oral use

Bezafibrate containing medicinal products with Marketing Authorisation in the European Union

| Member State (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Arcana Arzneimittel GmbH |
| Hütteldorfer Straße 299 |
| A-1140 Wien |
| Austria |

Member State (EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

AT - Austria

Arcana Arzneimittel GmbH

Hütteldorfer Straße 299

A-1140 Wien

Austria

Bezafibrat „Arcana“ retard 400 mg - Filmtabletten

400 mg

film-coated tablet

oral

AT - Austria

| Genericon Pharma GmbH |
| --- |
| Hafnerstraße 211 |
| A-8054 Graz |
| Austria |

Genericon Pharma GmbH

Hafnerstraße 211

A-8054 Graz

Austria

Bezafibrat „Genericon“ 200 mg - Dragees

200 mg

film-coated tablet

oral

AT - Austria

| Genericon Pharma GmbH |
| --- |
| Hafnerstraße 211 |
| A-8054 Graz |
| Austria |

Genericon Pharma GmbH

Hafnerstraße 211

A-8054 Graz

Austria

Bezafibrat „Genericon“ retard 400 mg - Filmtabletten

400 mg

film-coated tablet

oral

AT - Austria

| 1A Pharma GmbH |
| --- |
| Stella-Klein-Löw-Weg 17, A-1020 Wien |
| Austria |

1A Pharma GmbH

Stella-Klein-Löw-Weg 17, A-1020 Wien

Austria

Bezafibrat „1A Pharma“ retard 400 mg - Filmtabletten

400 mg

film-coated tablet

oral

AT - Austria

| Ratiopharm Arzneimittel |
| --- |
| Vertriebs-GmbH |
| Albert-Schweitzer Gasse 3 A |
| 1140 Wien |
| Austria |

Ratiopharm Arzneimittel

Vertriebs-GmbH

Albert-Schweitzer Gasse 3 A

1140 Wien

Austria

Bezafibrat „ratiopharm“ retard 400 mg - Filmtabletten

400 mg

prolonged-release tablet

oral

AT - Austria

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78 |
| IS- 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf

Reykjavikurvegur 76-78

IS- 220 Hafnarfjördur

Iceland

Bezalip 200 mg - Filmtabletten

200 mg

film-coated tablet

oral

AT - Austria

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78 |
| IS- 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf

Reykjavikurvegur 76-78

IS- 220 Hafnarfjördur

Iceland

Bezalip retard 400 mg - Filmtabletten

400 mg

film-coated tablet

oral

AT - Austria

| Genericon Pharma GmbH |
| --- |
| Hafnerstraße 211 |
| A-8054 Graz |
| Austria |

Genericon Pharma GmbH

Hafnerstraße 211

A-8054 Graz

Austria

Bezaretard „Genericon“ 400 mg - Filmtabletten

400 mg

film-coated tablet

oral

AT - Austria

| Stada Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| A-1190 Wien |
| Austria |

Stada Arzneimittel GmbH

Muthgasse 36

A-1190 Wien

Austria

Bezastad 200 mg - Filmtabletten

200 mg

film-coated tablet

oral

AT - Austria

| Stada Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| A-1190 Wien |
| Austria |

Stada Arzneimittel GmbH

Muthgasse 36

A-1190 Wien

Austria

Bezastad retard 400 mg - Filmtabletten

400 mg

film-coated tablet

oral

BE - Belgium

| ACTAVIS GROUP PTC EHF |
| --- |
| Reykjavikuregur 76-78 |
| 220 Hafnarfjordur |
| Iceland |

ACTAVIS GROUP PTC EHF

Reykjavikuregur 76-78

220 Hafnarfjordur

Iceland

CEDUR

200 mg

coated tablet

oral

BE - Belgium

| ACTAVIS GROUP PTC EHF |
| --- |
| Reykjavikuregur 76-78 |
| 220 Hafnarfjordur |
| Iceland |

ACTAVIS GROUP PTC EHF

Reykjavikuregur 76-78

220 Hafnarfjordur

Iceland

EULITOP 400 MG

400 mg

tablet

oral

CY - Cyprus

| REMEDICA LTD |
| --- |
| Aharnon street |
| P.O.Box 51706 |
| 3508 Lemesos |
| Cyprus |

REMEDICA LTD

Aharnon street

P.O.Box 51706

3508 Lemesos

Cyprus

LACROMID 200 FC TABLETS 200 mg

200 mg

tablets

oral

CY - Cyprus

| MEDOCHEMIE LTD |
| --- |
| 1-10 Constantinoupoleos street, P.O. Box 51409 |
| 3505 Lemesos |
| Cyprus |

MEDOCHEMIE LTD

1-10 Constantinoupoleos street, P.O. Box 51409

3505 Lemesos

Cyprus

ZAFIBRAL FC TABLETS 200 mg

200 mg

tablets

oral

DE - Germany

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| D-82041 Oberhaching |
| Germany |

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Germany

Bezafibrat 400 ret-1 A Pharma

400 mg

Prolonged-release tablet

oral

DE - Germany

| AbZ-Pharma GmbH |
| --- |
| Dr.Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Bezafibrat AbZ 200 mg Filmtabletten

200 mg

Film-coated tablet

oral

DE - Germany

| AbZ-Pharma GmbH |
| --- |
| Dr.Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Germany |

AbZ-Pharma GmbH

Dr.Georg-Spohn-Str. 7

D-89143 Blaubeuren

Germany

Bezafibrat AbZ 400 mg Retardtabletten

400 mg

Film-coated tablet

oral

DE - Germany

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78 |
| IS-220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Cedur

200 mg

Film-coated tablet

oral

DE - Germany

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegur 76-78 |
| IS-220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf

Reykjavikurvegur 76-78

IS-220 Hafnarfjördur

Iceland

Cedur retard

400 mg

Prolonged-release tablet

oral

DE - Germany

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

Bezafibrat AL 200

200 mg

Film-coated tablet

oral

DE - Germany

| ALIUD PHARMA GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| D-89150 Laichingen |
| Germany |

ALIUD PHARMA GmbH

Gottlieb-Daimler-Str. 19

D-89150 Laichingen

Germany

Bezafibrat AL 400 retard

400 mg

Prolonged-release tablet

oral

DE - Germany

| Berlin-Chemie AG |
| --- |
| Glienicker Weg 125 |
| D-12489 Berlin |
| Germany |

Berlin-Chemie AG

Glienicker Weg 125

D-12489 Berlin

Germany

Regadrin B

200 mg

Film-coated tablet

oral

DE - Germany

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Germany |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Germany

Bezabeta 400 retard

400 mg

Prolonged-release tablet

oral

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Bezafibrat-CT 200 mg Filmtabletten

200 mg

Film-coated tablet

oral

DE - Germany

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Germany |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Germany

Bezafibrat-CT 400 mg Retardtabletten

400 mg

Prolonged-release tablet

oral

DE - Germany

| DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA |
| --- |
| Greschbachstr. 7 |
| D-76229 Karlsruhe |
| Germany |

DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA

Greschbachstr. 7

D-76229 Karlsruhe

Germany

Bezadoc PB retard 400 mg

400 mg

Prolonged-release tablet

oral

DE - Germany

| DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA |
| --- |
| Greschbachstr. 7 |
| D-76229 Karlsruhe |

DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA

Greschbachstr. 7

D-76229 Karlsruhe

Germany

Bezadoc retard 400 mg

400 mg

Prolonged-release tablet

oral

DE - Germany

| Hennig Arzneimittel GmbH & Co.KG |
| --- |
| Liebigstr. 1-2 |
| D-65439 Floersheim |
| Germany |

Hennig Arzneimittel GmbH & Co.KG

Liebigstr. 1-2

D-65439 Floersheim

Germany

Befibrat 200 mg Dragees

200 mg

Prolonged-release tablet

oral

DE - Germany

| Hennig Arzneimittel GmbH & Co.KG |
| --- |
| Liebigstr. 1-2 |
| D-65439 Floersheim |
| Germany |

Hennig Arzneimittel GmbH & Co.KG

Liebigstr. 1-2

D-65439 Floersheim

Germany

Befibrat 400 mg retard Filmtabletten

400 mg

Film-coated tablet

oral

DE - Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Bezafibrat 200 Heumann

200 mg

Film-coated tablet

oral

DE - Germany

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Germany |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Germany

Bezafibrat 400 retard Heumann

400 mg

Prolonged-release tablet

oral

DE - Germany

| HEXAL AG |
| --- |
| Industriestr. 25 |
| D-83607 Holzkirchen |
| Germany |

HEXAL AG

Industriestr. 25

D-83607 Holzkirchen

Germany

Bezafibrat HEXAL 400 mg retard Retardtabletten

400 mg

Prolonged-release tablet

oral

DE - Germany

| Mylan dura GmbH |
| --- |
| Wittichstr. 6D |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6D

64295 Darmstadt

Germany

Bezafibrat dura 400 mg Retardtabletten

400 mg

Prolonged-release tablet

oral

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Bezafibrat-ratiopharm 200 mg Filmtabletten

200 mg

Film-coated tablet

oral

DE - Germany

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Bezafibrat-ratiopharm 400 mg Retardtabletten

400 mg

Prolonged-release tablet

oral

DE - Germany

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Germany

Bezafibrat Sandoz 400 mg Retardtabletten

400 mg

Prolonged-release tablet

oral

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Bezafibrat Stada 200 mg überzogene Tabletten

200 mg

Film-coated tablet

oral

DE - Germany

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Germany

Bezafibrat Stada 400 mg Retardtabletten

400 mg

Prolonged-release tablet

oral

DE - Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5D |
| 27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5D

27472 Cuxhaven

Germany

Lipox Bezafibrat 400 mg Retardtabletten

400 mg

Prolonged-release tablet

oral

DE - Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Germany

Lipox Bezafibrat 400 mg Retardtabletten

400 mg

Prolonged-release tablet

oral

DE - Germany

| Wörwag Pharma GmbH & Co. KG |
| --- |
| Calwer Str. 7 |
| D-71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co. KG

Calwer Str. 7

D-71034 Böblingen

Germany

Bezagamma 200

200 mg

Film-coated tablet

oral

DE - Germany

| Wörwag Pharma GmbH & Co. KG |
| --- |
| Calwer Str. 7 |
| D-71034 Böblingen |
| Germany |

Wörwag Pharma GmbH & Co. KG

Calwer Str. 7

D-71034 Böblingen

Germany

Bezagamma 400 retard

400 mg

Prolonged-release tablet

oral

EL - Greece

| ACTAVIS GROUP PTC EHF., ICELAND |
| --- |
| Reykjavikurvegur 76-78, |
| 220, Hafnarfjordur |
| Iceland |

ACTAVIS GROUP PTC EHF., ICELAND

Reykjavikurvegur 76-78,

220, Hafnarfjordur

Iceland

BEZALIP

400 MG/TAB

PROLONGED RELEASE TABLETS

oral

ES - Spain

| ACTAVIS SPAIN, S.A. |
| --- |
| Perú 8 |
| 28290 Las Matas |
| Madrid |
| SPAIN |

ACTAVIS SPAIN, S.A.

Perú 8

28290 Las Matas

Madrid

SPAIN

EULITOP

200 mg

tablets

oral

ES - Spain

| ACTAVIS SPAIN |
| --- |
| S.A.Rivera del Loira |
| 46 - Bussines Centre Regus Office 525 Madrid |
| Spain |

ACTAVIS SPAIN

S.A.Rivera del Loira

46 - Bussines Centre Regus Office 525 Madrid

Spain

EULITOP RETARD

400 mg

film coated tablets

oral

ES - Spain

| BIAL INDUSTRIAL FARMACEUTICA S.A. Alameda de Urquijo |
| --- |
| 27 Bilbao |
| Spain |

BIAL INDUSTRIAL FARMACEUTICA S.A. Alameda de Urquijo

27 Bilbao

Spain

DIFATEROL RETARD

400 mg

film coated tablets

oral

FI - Finland

| Actavis |
| --- |
| Actavis Group PTC ehf Reykjavikurvegi 76-78 |
| 220 Hafnarfjordur |
| Iceland |

Actavis

Actavis Group PTC ehf Reykjavikurvegi 76-78

220 Hafnarfjordur

Iceland

BEZALIP

400 mg

prolonged-release tablet

Oral use

FR - France

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

BEFIZAL 200 mg, comprimé pelliculé

200 mg

film-coated tablet

oral use

FR - France

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée

400 mg

Prolonged-release tablet

oral use

FR - France

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Iceland

BEZAFIBRATE ACTAVIS 200 mg, comprimé pelliculé

200 mg

film-coated tablet

oral use

FR - France

| Actavis Group PTC ehf |
| --- |
| Reykjavikurvegi 76-78 |
| 220 Hafnarfjördur |
| Islande |
| Iceland |

Actavis Group PTC ehf

Reykjavikurvegi 76-78

220 Hafnarfjördur

Islande

Iceland

BEZAFIBRATE ACTAVIS L.P. 400 mg, comprimé enrobé à libération prolongée

400 mg

Prolonged-release tablet

oral use

HU - Hungary

| Actavis Group PTC ehf. |
| --- |
| Reykjavikurvegur 76-78. |
| IS-220 |
| Iceland |

Actavis Group PTC ehf.

Reykjavikurvegur 76-78.

IS-220

Iceland

Bezalip

400mg

modified-release film-coated tablet

oral

IT - Italy

| Actavis Italy Spa |
| --- |
| Viale Luigi Pasteur |
| 10 - Nerviano – 20014 |
| MILANO |
| Italy |

Actavis Italy Spa

Viale Luigi Pasteur

10 - Nerviano – 20014

MILANO

Italy

Bezalip

400 mg

Prolonged release coated tablet

Oral

IT - Italy

| Actavis Italy Spa |
| --- |
| Viale Luigi Pasteur, 10 – |
| Nerviano – |
| 20014 MILANO |
| Italy |

Actavis Italy Spa

Viale Luigi Pasteur, 10 –

Nerviano –

20014 MILANO

Italy

Bezalip

200 mg

Film-coated tablet

Oral

IT - Italy

| Eg Spa |
| --- |
| Via Scarlatti Domenico, 31 |
| 20124 MILANO |
| Italy |

Eg Spa

Via Scarlatti Domenico, 31

20124 MILANO

Italy

Bezafibrato Eg

400 mg

Prolonged release tablet

Oral

IT - Italy

| Vecchi & Piam Sapa |
| --- |
| Via Padre Semeria, 5 |
| 16131 GENOVA |
| Italy |

Vecchi & Piam Sapa

Via Padre Semeria, 5

16131 GENOVA

Italy

Hadiel

400 mg

Prolonged release coated tablet

Oral

LU - Luxembourg

| Hexal AG |
| --- |
| Industriestrasse, 25 |
| D- 83607 Holzkirchen |
| Germany |

Hexal AG

Industriestrasse, 25

D- 83607 Holzkirchen

Germany

Benzafibrat Hexal Retard

400 mg

film-coated tablet

oral

LU - Luxembourg

| Actavis Group PLC Reykjavikurvegur 76-78 |
| --- |
| IS- 220 Hafnarfjordur |
| Iceland |

Actavis Group PLC Reykjavikurvegur 76-78

IS- 220 Hafnarfjordur

Iceland

Cedur

200 mg

film-coated tablet

oral

LU - Luxembourg

| Actavis Group PLC |
| --- |
| Reykjavikurvegur 76-78 |
| IS- 220 Hafnarfjordur |
| Iceland |

Actavis Group PLC

Reykjavikurvegur 76-78

IS- 220 Hafnarfjordur

Iceland

Eulitop

400 mg

tablet

oral use

MT - Malta

| Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2 |
| --- |
| 65439 Flörsheim |
| Germany |

Hennig Arzneimittel GmbH & Co. KG Liebigstrasse 1-2

65439 Flörsheim

Germany

Befibrat

400 mg

Retard coated tablets

Oral

NL - Netherlands

| Actavis Group PTC ehf, Reykjavíkurvegi 76-78 |
| --- |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf, Reykjavíkurvegi 76-78

220 Hafnarfjördur

Iceland

Bezalip, tabletten 200 mg, RVG 15982

200 mg

tablets

oral

NL - Netherlands

| Actavis Group PTC ehf, Reykjavíkurvegi 76-78 |
| --- |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf, Reykjavíkurvegi 76-78

220 Hafnarfjördur

Iceland

Bezalip Retard, tabletten met gereguleerde afgifte 400 mg, RVG 18388

400 mg

modified release tablets

oral

PT - Portugal

| Actavis Group PTC ehf., Reykjavíkurvegi, 76-78 |
| --- |
| IS-220 Hafnarfjörour |

Actavis Group PTC ehf., Reykjavíkurvegi, 76-78

IS-220 Hafnarfjörour

Bezalip

200 mg

film-coated tablet

Oral

PT - Portugal

| Actavis Group PTC ehf., Reykjavíkurvegi, 76-78 |
| --- |
| IS-220 Hafnarfjörour |
| Iceland |

Actavis Group PTC ehf., Reykjavíkurvegi, 76-78

IS-220 Hafnarfjörour

Iceland

Bezalip Retard

400 mg

Prolonged-released tablet

Oral

RO - Romania

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Ștefan Mihăileanu Nr.31, |
| Sector 2 |
| București |
| Romania |

S.C. ARENA GROUP S.A.

Str. Ștefan Mihăileanu Nr.31,

Sector 2

București

Romania

BEZAFIBRAT ARENA 200 mg

200 mg

tablets

oral use

RO - Romania

| S.C. SLAVIA PHARM S.R.L. |
| --- |
| B-dul Theodor Pallady nr. 44C |
| Sector 3, București |
| Romania |

S.C. SLAVIA PHARM S.R.L.

B-dul Theodor Pallady nr. 44C

Sector 3, București

Romania

BEZAFIBRAT SLAVIA 200 mg

200 mg

tablets

oral use

RO - Romania

| BERLIN CHEMIE AG |
| --- |
| (MENARINI GROUP) |
| Glienicker Weg 125-127 |
| 12489 Berlin |
| Germany |

BERLIN CHEMIE AG

(MENARINI GROUP)

Glienicker Weg 125-127

12489 Berlin

Germany

REGADRIN® B

200 mg

coated tablets

oral use

SE - Sweden

| Actavis Group PTC ehf., Reykjavikurvegur 76-78 |
| --- |
| 220 Hafnarfjördur |
| Iceland |

Actavis Group PTC ehf., Reykjavikurvegur 76-78

220 Hafnarfjördur

Iceland

Bezalip®

200 mg

filmcoated tablet

oral

SE - Sweden

| Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur |
| --- |
| Iceland |

Actavis Group PTC ehf., Reykjavikurvegur 76-78 220 Hafnarfjördur

Iceland

Bezalip® Retard

400 mg

depo tablet

oral

UK - United Kingdom

| Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 |
| --- |
| Hafnarfirdi, Is-220, |
| Iceland |

Actavis Group Ptc Ehf, Reykjavikurvegi 76-78

Hafnarfirdi, Is-220,

Iceland

BEZALIP

200 mg

COATED TABLET

oral use

UK - United Kingdom

| Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 |
| --- |
| Hafnarfirdi, Is-220 |
| Iceland |

Actavis Group Ptc Ehf, Reykjavikurvegi 76-78

Hafnarfirdi, Is-220

Iceland

BEZALIP MONO

400 mg

MODIFIED-RELEASE TABLET

oral use

UK - United Kingdom

| Archimedes Pharma Uk Limited |
| --- |
| Bishops Weald House |
| Albion Way, Horsham, |
| West Sussex RH12 1AH |
| United Kingdom |

Archimedes Pharma Uk Limited

Bishops Weald House

Albion Way, Horsham,

West Sussex RH12 1AH

United Kingdom

ZIMBACOL XL

400 mg

MODIFIED-RELEASE TABLET

oral use

UK - United Kingdom

| Generics (Uk) Limited |
| --- |
| Station Close |
| Potters Bar, |
| HERTS EN6 1TL |
| United Kingdom |

Generics (Uk) Limited

Station Close

Potters Bar,

HERTS EN6 1TL

United Kingdom

BEZAGEN XL TABLETS 400MG

400 mg

TABLET

oral use

UK - United Kingdom

| Generics (Uk) Limited |
| --- |
| Station Close |
| Potters Bar, |
| HERTS EN6 1TL |
| United Kingdom |

Generics (Uk) Limited

Station Close

Potters Bar,

HERTS EN6 1TL

United Kingdom

BEZAFIBRATE TABLETS 200 MG

200 mg

FILM-COATED TABLET

oral use

UK - United Kingdom

| Pliva Pharma Limited |
| --- |
| Vision House |
| Bedford Road |
| Petersfield |
| HANTS GU32 3QB |
| United Kingdom |

Pliva Pharma Limited

Vision House

Bedford Road

Petersfield

HANTS GU32 3QB

United Kingdom

BEZAFIBRATE TABLETS 200 MG

200 mg

TABLET

oral use

UK - United Kingdom

| RATIOPHARM GMBH |
| --- |
| Graf-Arco Strasse 3 |
| Ulm, D-89079 |
| GERMANY |

RATIOPHARM GMBH

Graf-Arco Strasse 3

Ulm, D-89079

GERMANY

BEZAFIBRATE 200MG TABLETS

200 mg

FILM-COATED TABLET

oral use

UK - United Kingdom

| SANDOZ LIMITED |
| --- |
| 37 Woolmer Way, |
| Borden, Hampshire GU35 9QE |
| United Kingdom |

SANDOZ LIMITED

37 Woolmer Way,

Borden, Hampshire GU35 9QE

United Kingdom

BEZATARD XL 400MG MODIFIED RELEASE TABLETS

400 mg

MODIFIED-RELEASE TABLET

oral use

Ciprofibrate containing medicinal products with Marketing Authorisation in the European Union

| Member State (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| BE - Belgium | SANOFI-AVENTIS BELGIUM N.V. |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Member State (EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

BE - Belgium

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1C

1831 Diegem

Belgium

CIPROFIBRATE MYLAN 100 MG

100 mg

capsule, hard

oral

BE - Belgium

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1C

1831 Diegem

Belgium

HYPERLIPEN 100 MG

100 mg

capsule, hard

oral

BG - Bulgaria

| Sanofi-Aventis |
| --- |
| Bulgaria EOOD |
| Blvd. Alexander Stamboliyski No 103, Office Building Sofia Tower, 8th floor, 1303 Sofia |
| Bulgaria |

Sanofi-Aventis

Bulgaria EOOD

Blvd. Alexander Stamboliyski No 103, Office Building Sofia Tower, 8th floor, 1303 Sofia

Bulgaria

Lipanor

100 mg

Capsule, hard

Oral use

CY - Cyprus

| SANOFI AVENTIS CYPRUS LTD |
| --- |
| Charalambou Mouskou 14 |
| 2015 Strovolos |
| Cyprus |

SANOFI AVENTIS CYPRUS LTD

Charalambou Mouskou 14

2015 Strovolos

Cyprus

MODALIM TABLETS 100 mg

100 mg

tablets

oral

CZ - Czech Republic

| sanofi-aventis s.r.o. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Czech Republic |

sanofi-aventis s.r.o.

Evropská 846/176a

160 00 Praha 6

Czech Republic

LIPANOR

100 MG

capsule, hard

EL - Greece

| Sanofi-Aventis Aebe |
| --- |
| Syngrou Avenue 348, |
| Building A, |
| Kallithea 176 74 |
| Attiki |
| Greece |

Sanofi-Aventis Aebe

Syngrou Avenue 348,

Building A,

Kallithea 176 74

Attiki

Greece

SAVILEN

100 MG/CAP

HARD CAPSULES

ORAL

ET - Estonia

| Sanofi-Aventis |
| --- |
| Estonia |
| OÜ |
| Pärnu mnt 139E/211317 Tallinn |
| Estonia |

Sanofi-Aventis

Estonia

OÜ

Pärnu mnt 139E/211317 Tallinn

Estonia

LIPANOR

100 mg

capsule, hard

oral use

FR - France

| Sanofi Aventis France |
| --- |
| 1-13 Bd Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13 Bd Romain Rolland

75014 Paris

France

LIPANOR 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Biogaran |
| --- |
| 15, bd Charles de Gaulle |
| 92700 Colombes |
| France |

Biogaran

15, bd Charles de Gaulle

92700 Colombes

France

CIPROFIBRATE ALMUS 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Arrow |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

Arrow

26, avenue Tony Garnier

69007 Lyon

France

CIPROFIBRATE ARROW 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Biogaran |
| --- |
| 15, bd Charles de Gaulle |
| 92700 Colombes |
| France |

Biogaran

15, bd Charles de Gaulle

92700 Colombes

France

CIPROFIBRATE BIOGARAN 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Mylan SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint Priest |
| France |

Mylan SAS

117, allée des Parcs

69800 Saint Priest

France

CIPROFIBRATE MYLAN 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Qualimed |
| --- |
| 117, allée des Parcs |
| 69800 Saint Priest |
| France |

Qualimed

117, allée des Parcs

69800 Saint Priest

France

CIPROFIBRATE QUALIMED 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Laboratoire Ratiopharm |
| --- |
| 19, Bd Paul Vaillant Couturier |
| 94200 Ivry sur Seine |
| France |

Laboratoire Ratiopharm

19, Bd Paul Vaillant Couturier

94200 Ivry sur Seine

France

CIPROFIBRATE RATIOPHARM 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Biogaran |
| --- |
| 15 |
| bd Charles de Gaulle |
| 92700 Colombes |
| France |

Biogaran

15

bd Charles de Gaulle

92700 Colombes

France

CIPROFIBRATE REF 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Ranbaxy Pharmacie Génériques |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| France |

Ranbaxy Pharmacie Génériques

11-15 Quai Dion Bouton

92800 Puteaux

France

CIPROFIBRATE RPG 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Sandoz |
| --- |
| 49, av. Pompidou |
| 92300 Levallois-Perret |
| France |

Sandoz

49, av. Pompidou

92300 Levallois-Perret

France

CIPROFIBRATE SANDOZ 100 mg, gélule

100 mg

capsule

oral use

FR - France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1 cours du Triangle |
| 92936 Paris La Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1 cours du Triangle

92936 Paris La Défense Cedex

France

CIPROFIBRATE TEVA 100 mg, gélule

100 mg

capsule

oral use

FR - France

| Sanofi Aventis France |
| --- |
| 1-13 Bd Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13 Bd Romain Rolland

75014 Paris

France

CIPROFIBRATE WINTHROP 100 mg, gélule

100 mg

capsule

oral use

HU - Hungary

| sanofi-aventis zrt. |
| --- |
| Tó u. 1-5. |
| 1045 Budapest |
| Hungary |

sanofi-aventis zrt.

Tó u. 1-5.

1045 Budapest

Hungary

Lipanor

100 mg

hard capsule

oral

LT - Lithuania

| UAB Sanofi - Aventis Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB Sanofi - Aventis Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Lithuania

Lipanor

100 mg

capsule, hard

oral use

LU - Luxembourg

| Sanofi-Synthélabo SA |
| --- |
| Twin Squares, |
| Navona Building |
| B- 1831 Diegem |

Sanofi-Synthélabo SA

Twin Squares,

Navona Building

B- 1831 Diegem

Hyperlipen

100 mg

capsule, hard

oral

LV - Latvia

| Sanofi-aventis Latvia SIA |
| --- |
| Kr.Valdemara Str. 33-8 |
| Riga, LV-1010 |
| Latvia |

Sanofi-aventis Latvia SIA

Kr.Valdemara Str. 33-8

Riga, LV-1010

Latvia

Lipanor 100 mg capsules, hard

100 mg

Capsules, hard

Oral use

NL - Netherlands

| Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E |
| --- |
| 2803 PE Gouda |
| The Nederlands |

Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E

2803 PE Gouda

The Nederlands

Modalim, tabletten 100 mg, RVG 17863

100 mg

tablets

oral

PL - Poland

| Sanofi-Aventis France |
| --- |
| boulevard Romain Rolland 1-13, |
| F-75014 Paris, |
| France |

Sanofi-Aventis France

boulevard Romain Rolland 1-13,

F-75014 Paris,

France

Lipanor

100 mg

capsules

oral

PT - Portugal

| Sanofi-Aventis - Produtos Farmacêuticos, S.A Empreendimento Lagoas Park, Edifício 7 - 3o |
| --- |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos, S.A Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Lipanor

100 mg

capsule

Oral

PT - Portugal

| Winthrop Farmacêutica Portugal, Lda. Empreendimento Lagoas Park |
| --- |
| Edifício 7 - 2o/3o |
| 2740-299 Porto Salvo |
| Portugal |

Winthrop Farmacêutica Portugal, Lda. Empreendimento Lagoas Park

Edifício 7 - 2o/3o

2740-299 Porto Salvo

Portugal

Fibranin

100 mg

capsule

Oral

RO - Romania

| sanofi-aventis france |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

sanofi-aventis france

1-13, boulevard Romain Rolland

75014 Paris

France

LIPANOR® 100 mg

100 mg

capsules

oral use

SK - Slovakia

| sanofi-aventis Slovakia s.r.o. |
| --- |
| Žilinská 7-9 |
| 81105 Bratislava |
| Slovakia |

sanofi-aventis Slovakia s.r.o.

Žilinská 7-9

81105 Bratislava

Slovakia

LIPANOR 100 mg

100 mg

Capsule

Oral

UK - United Kingdom

| Winthrop Pharmaceuticals Uk Limited |
| --- |
| One Onslow Street |
| Guildford, Surrey GU1 4YS |
| United Kingdom |

Winthrop Pharmaceuticals Uk Limited

One Onslow Street

Guildford, Surrey GU1 4YS

United Kingdom

CIPROFIBRATE 100MG TABLETS

100 mg

Tablet

Oral Use

Gemfibrozil containing medicinal products with Marketing Authorisation in the European Union

| Member State (EU/EEA) | Marketing Authorisation Holder | Invented name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| AT - Austria | Pfizer Corporation |
| Austria GmbH |
| Floridsdorfer Hauptstraße 1 |
| A-1210 Wien |
| Austria |

Member State (EU/EEA)

Marketing Authorisation Holder

Invented name

Strength

Pharmaceutical form

Route of administration

AT - Austria

Pfizer Corporation

Austria GmbH

Floridsdorfer Hauptstraße 1

A-1210 Wien

Austria

Gevilon 450 mg - Filmtabletten

450 mg

film-coated tablet

oral

CY - Cyprus

| MEDOCHEMIE LTD |
| --- |
| 1-10 Constantinoupoleos street |
| P.O.Box 51409 |
| 3505 Lemesos |
| Cyprus |

MEDOCHEMIE LTD

1-10 Constantinoupoleos street

P.O.Box 51409

3505 Lemesos

Cyprus

IPOLIPID CAPSULES 300mg

300 mg

capsules

oral

CY - Cyprus

| MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409 |
| --- |
| 3505 Lemesos |
| Cyprus |

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409

3505 Lemesos

Cyprus

IPOLIPID CAPSULES 600mg

600 mg

capsules

oral

CY - Cyprus

| REMEDICA LTD |
| --- |
| Aharnon street |
| P.O.Box 51706 |
| 3508 Lemesos |
| Cyprus |

REMEDICA LTD

Aharnon street

P.O.Box 51706

3508 Lemesos

Cyprus

LIPOFOR CAPSULES 300mg

300 mg

capsules

oral

CY - Cyprus

| REMEDICA LTD |
| --- |
| Aharnon street |
| P.O.Box 51706 |
| 3508 Lemesos |
| Cyprus |

REMEDICA LTD

Aharnon street

P.O.Box 51706

3508 Lemesos

Cyprus

LIPOFOR CAPSULES 600mg

600 mg

capsules

oral

DE - Germany

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| D-82041 Oberhaching |
| Germany |

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Germany

Gemfi 450-1 A Pharma

450 mg

Film-coated tablet

oral

DE - Germany

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| D-82041 Oberhaching |
| Germany |

1 A Pharma GmbH

Keltenring 1 + 3

D-82041 Oberhaching

Germany

Gemif 600-1 A Pharma

600 mg

Film-coated tablet

oral

DE - Germany

| Pfizer Pharma GmbH |
| --- |
| Linkstr. 10 |
| D-10785 Berlin |
| Germany |

Pfizer Pharma GmbH

Linkstr. 10

D-10785 Berlin

Germany

Gevilon 600mg

600 mg

Film-coated tablet

oral

DE - Germany

| Pfizer Pharma GmbH |
| --- |
| Linkstr. 10D |
| D- 10785 Berlin |
| Germany |

Pfizer Pharma GmbH

Linkstr. 10D

D- 10785 Berlin

Germany

Gevilon Uno

900 mg

Film-coated tablet

oral

DE - Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Germany

Lipox Gemfi 450mg

450 mg

Film-coated tablet

oral

DE - Germany

| TAD Pharma GmbH |
| --- |
| Heinz-Lohmann-Str. 5 |
| D-27472 Cuxhaven |
| Germany |

TAD Pharma GmbH

Heinz-Lohmann-Str. 5

D-27472 Cuxhaven

Germany

Lipox Gemfi 600mg

600 mg

Film-coated tablet

oral

DK - Denmark

| Alternova A/S |
| --- |
| Lodhusvej 11 |
| 4230 Skælskør |
| Denmark |

Alternova A/S

Lodhusvej 11

4230 Skælskør

Denmark

Gemfibrozil «Alternova»

600 mg

film coated tablets

oral

DK - Denmark

| Alternova A/S |
| --- |
| Lodhusvej 11 |
| 4230 Skælskør |
| Denmark |

Alternova A/S

Lodhusvej 11

4230 Skælskør

Denmark

Gemfibrozil «Alternova»

900 mg

film coated tablets

oral

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| 2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Lopid

300 mg

Hard capsules

oral

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| 2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Lopid

450 mg

Film coated tablets

oral

DK - Denmark

| Pfizer ApS |
| --- |
| Lautrupvang 8 |
| 2750 Ballerup |
| Denmark |

Pfizer ApS

Lautrupvang 8

2750 Ballerup

Denmark

Lopid

600 mg

Film coated tablets

oral

EL - Greece

| PFIZER HELLAS S.A. |
| --- |
| Messogion Avenue 243 |
| Neo Psychiko 154 51 |
| Greece |

PFIZER HELLAS S.A.

Messogion Avenue 243

Neo Psychiko 154 51

Greece

LOPID

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| PFIZER HELLAS S.A. |
| --- |
| Messogion Avenue 243 |
| Neo Psychiko 154 51 |
| Greece |

PFIZER HELLAS S.A.

Messogion Avenue 243

Neo Psychiko 154 51

Greece

LOPID

900 MG/TAB

Film coated tablet

ORAL

EL - Greece

| FINIXPHARM EPE |
| --- |
| Dervenakion 38 and Sahini str |
| Gerakas Attikis 153 44 |
| Greece |

FINIXPHARM EPE

Dervenakion 38 and Sahini str

Gerakas Attikis 153 44

Greece

HOBATOLEX

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| ANFARM HELLAS S.A. |
| --- |
| Perikleous 53-57 |
| Gerakas Attikis 153 44 |
| Greece |

ANFARM HELLAS S.A.

Perikleous 53-57

Gerakas Attikis 153 44

Greece

FIBROLIP

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| MEDICHROM S.A. |
| --- |
| 6th Km Markopolou-Koropi Avenue |
| Markopoulo Mesogeion 19003 |
| Greece |

MEDICHROM S.A.

6th Km Markopolou-Koropi Avenue

Markopoulo Mesogeion 19003

Greece

GEMLIPID-MEDICHROM

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| COSMOPHARM EPE |
| --- |
| P.O. Box 42 |
| Korinthos 20100 |
| Greece |

COSMOPHARM EPE

P.O. Box 42

Korinthos 20100

Greece

PRELISIN

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| KLEVA AFBEE |
| --- |
| Parnithos Avenue 189 |
| Aharnes Attikis 136 75 |
| Greece |

KLEVA AFBEE

Parnithos Avenue 189

Aharnes Attikis 136 75

Greece

NOXOBRAN

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| KLEVA AFBEE |
| --- |
| Parnithos Avenue 189 |
| Aharnes Attikis 136 75 |
| Greece |

KLEVA AFBEE

Parnithos Avenue 189

Aharnes Attikis 136 75

Greece

NOXOBRAN

900 MG/TAB

Film coated tablet

ORAL

EL - Greece

| GAP S.A. |
| --- |
| Agisilaou 46 |
| Agios Dimitrios 17341 |
| Greece |

GAP S.A.

Agisilaou 46

Agios Dimitrios 17341

Greece

LISOLIP

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| HRISPA ALFA PHARMACEUTICALS S.A. |
| --- |
| (ΧΡΙΣΠΑ ΑΛΦΑ ΦΑΡΜ/ΚΗ Α.Ε.) |
| 16th Km Marathonos Avenue |
| Pallini Attikis 153 44 |
| Greece |

HRISPA ALFA PHARMACEUTICALS S.A.

(ΧΡΙΣΠΑ ΑΛΦΑ ΦΑΡΜ/ΚΗ Α.Ε.)

16th Km Marathonos Avenue

Pallini Attikis 153 44

Greece

TEROSTRANT

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| BIOSPRAY ABEE |
| --- |
| 18th Km Marathonos Avenue |
| Pallini Attikis 153 44 |
| Greece |

BIOSPRAY ABEE

18th Km Marathonos Avenue

Pallini Attikis 153 44

Greece

PARNOXIL

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| SPECIFAR ABEE |
| --- |
| 28th October str 1 |
| Agia Barbara 123 51 |
| Greece |

SPECIFAR ABEE

28th October str 1

Agia Barbara 123 51

Greece

FIBROSPES

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| PHARMACEUTICAL INDUSTRY E.G. KORONIS S.A. |
| --- |
| Dilou str 9 |
| Peristeri 121 34 |
| Greece |

PHARMACEUTICAL INDUSTRY E.G. KORONIS S.A.

Dilou str 9

Peristeri 121 34

Greece

EKLIPID

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| KLEVA AFBEE |
| --- |
| Parnithos Avenue 189 |
| Aharnes Attikis 136 75 |
| Greece |

KLEVA AFBEE

Parnithos Avenue 189

Aharnes Attikis 136 75

Greece

ANTILIPID

600 MG/TAB

Film coated tablet

ORAL

EL - Greece

| MED-ONE AFBEE |
| --- |
| Agiou Petrou 30 and Epameinonda |
| Aharnes 136 75 |
| Greece |

MED-ONE AFBEE

Agiou Petrou 30 and Epameinonda

Aharnes 136 75

Greece

GINETON

600 MG/TAB

Film coated tablet

ORAL

ES - Spain

| BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area BAravaca 28023 (Madrid) |
| --- |
| Spain |

BEXAL FARMACEUTICA, S.A Centro Empresarial Osa Mayor. Avda. Osa Mayor, 4 - Area BAravaca 28023 (Madrid)

Spain

GEMFIBROZILO BEXAL

600 mg

film coated tablets

oral

ES - Spain

| FERMON, S.L.Alfonso XII, |
| --- |
| 587 Badalona |
| 08918 BARCELONA |
| Spain |

FERMON, S.L.Alfonso XII,

587 Badalona

08918 BARCELONA

Spain

GEMFIBROZILO FERMON

600 mg

film coated tablets

oral

ES - Spain

| FERMON, S.L.Alfonso XII, 587 Badalona |
| --- |
| 08918 BARCELONA |
| Spain |

FERMON, S.L.Alfonso XII, 587 Badalona

08918 BARCELONA

Spain

GEMFIBROZILO FERMON

900 mg

film coated tablets

oral

ES - Spain

| LABORATORIO STADA, S.L.Frederic Mompou, |
| --- |
| 5 Sant Just Desvern 08960 BARCELONA |
| Spain |

LABORATORIO STADA, S.L.Frederic Mompou,

5 Sant Just Desvern 08960 BARCELONA

Spain

GEMFIBROZILO STADA

600 mg

film coated tablets

oral

ES - Spain

| LABORATORIO STADA, S.L.Frederic Mompou, |
| --- |
| 5 Sant Just Desvern 08960 BARCELONA |
| Spain |

LABORATORIO STADA, S.L.Frederic Mompou,

5 Sant Just Desvern 08960 BARCELONA

Spain

GEMFIBROZILO STADA

900 mg

film coated tablets

oral

ES - Spain

| USO RACIONAL |
| --- |
| S.L.Ferraz, 10 - 1o Izda. |
| 28008 Madrid |
| Spain |

USO RACIONAL

S.L.Ferraz, 10 - 1o Izda.

28008 Madrid

Spain

GEMFIBROZILO UR

900 mg

film coated tablets

oral

ES - Spain

| USO RACIONAL |
| --- |
| S.L.Ferraz, 10 - 1o Izda. |
| 28008 Madrid |
| Spain |

USO RACIONAL

S.L.Ferraz, 10 - 1o Izda.

28008 Madrid

Spain

GEMFIBROZILO UR

600 mg

film coated tablets

oral

ES - Spain

| PARKE DAVIS |
| --- |
| Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID |
| Spain |

PARKE DAVIS

Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID

Spain

LOPID

600 mg

film coated tablets

oral

ES - Spain

| PARKE DAVIS, Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID |
| --- |
| Spain |

PARKE DAVIS, Avda. de Europa, 20 B. Parque Empresarial La Moraleja Alcobendas MADRID

Spain

LOPID

900 mg

film coated tablets

oral

ES - Spain

| LABORATORIOS MENARINI S.A Alfonso XII |
| --- |
| 587 Badalona |
| 08918 BARCELONA |
| Spain |

LABORATORIOS MENARINI S.A Alfonso XII

587 Badalona

08918 BARCELONA

Spain

TRIALMIN

600 mg

film coated tablets

oral

ES - Spain

| LABORATORIOS MENARINI S.A Alfonso XII, 587 Badalona |
| --- |
| 08918 BARCELONA |
| Spain |

LABORATORIOS MENARINI S.A Alfonso XII, 587 Badalona

08918 BARCELONA

Spain

TRIALMIN

900 mg

film coated tablets

oral

ES - Spain

| QUIMIFAR, S.A.Comadran, |
| --- |
| 37 Barbera del Valles |
| 08210 BARCELONA |
| Spain |

QUIMIFAR, S.A.Comadran,

37 Barbera del Valles

08210 BARCELONA

Spain

PILDER

600 mg

film coated tablets

oral

FI - Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Finland |

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

LOPID

300 mg

capsules, hard

Oral use

FI - Finland

| Pfizer Oy |
| --- |
| Tietokuja 4 |
| 00330 Helsinki |
| Finland |

Pfizer Oy

Tietokuja 4

00330 Helsinki

Finland

LOPID

600 mg

capsules, hard

Oral use

FR - France

| Pfizer Holding France |
| --- |
| 23-25, avenue du Docteur Lannelongue |
| 75014 Paris |
| France |

Pfizer Holding France

23-25, avenue du Docteur Lannelongue

75014 Paris

France

LIPUR 450 mg, comprimé pelliculé

450 mg

film-coated tablet

oral use

HU - Hungary

| TEVA Magyarország zrt. |
| --- |
| Rákóczi út 70-72. |
| 1074 Budapest |
| Hungary |

TEVA Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Hungary

Minilip

600 mg

film-coated tablet

oral

HU - Hungary

| PannonPharma Kft. |
| --- |
| Pannonpharma út 1. |
| 7720 Pécsvárad |
| Hungary |

PannonPharma Kft.

Pannonpharma út 1.

7720 Pécsvárad

Hungary

Innogem

300 mg

hard capsule

oral

HU - Hungary

| PannonPharma Kft. |
| --- |
| Pannonpharma út 1. |
| 7720 Pécsvárad |
| Hungary |

PannonPharma Kft.

Pannonpharma út 1.

7720 Pécsvárad

Hungary

Innogem

600 mg

film-coated tablet

oral

IE - Ireland

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

UK ADDRESS:

| Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, |
| --- |
| UK |

Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS,

UK

Lopid 300 mg capsules

300 mg

hard capsules

oral use

IE - Ireland

| Pfizer Healthcare Ireland |
| --- |
| 9 Riverwalk |
| National Digital Park |
| Citywest Business Campus |
| Dublin 24 |
| Ireland |

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Ireland

UK ADDRESS:

| Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS |
| --- |
| UK |

Pfizer Ltd., Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS

UK

Lopid 600 mg film-coated tablets

600 mg

film-coated tablets

oral use

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Lopid

600 mg

Film-coated tablet

Oral

IS - Iceland

| Pfizer Aps |
| --- |
| Lautrupsvang 8 |
| 2750 Ballerud |
| Denmark |

Pfizer Aps

Lautrupsvang 8

2750 Ballerud

Denmark

Lopid

300 mg

Capsule, hard

Oral

IT - Italy

| Biores Italia Srl |
| --- |
| Via Vittorio Grassi, 13 – |
| La Rustica |
| 00155 ROMA |
| Italy |

Biores Italia Srl

Via Vittorio Grassi, 13 –

La Rustica

00155 ROMA

Italy

Lipogen

900 mg

Tablet

Oral

IT - Italy

| Biores Italia Srl |
| --- |
| Via Vittorio Grassi, 13 – |
| La Rustica |
| 00155 ROMA |
| Italy |

Biores Italia Srl

Via Vittorio Grassi, 13 –

La Rustica

00155 ROMA

Italy

Lipogen

1 200 mg

Granules

Oral

IT - Italy

| Boniscontro & Gazzone Srl |
| --- |
| Via Pavia, 6 |
| 20136 MILANO |
| Italy |

Boniscontro & Gazzone Srl

Via Pavia, 6

20136 MILANO

Italy

Genozil

600 mg

Film coated tablet

Oral

IT - Italy

| Boniscontro & Gazzone Srl |
| --- |
| Via Pavia, 6 |
| 20136 MILANO |
| Italy |

Boniscontro & Gazzone Srl

Via Pavia, 6

20136 MILANO

Italy

Genozil

900 mg

Film coated tablet

Oral

IT - Italy

| C.T. Laboratorio Farmaceutico S |
| --- |
| Strada Solaro, 75/77 |
| Villa Sayonara, Sanremo – IMPERIA |
| Italy |

C.T. Laboratorio Farmaceutico S

Strada Solaro, 75/77

Villa Sayonara, Sanremo – IMPERIA

Italy

Fibrocit

900 mg

Tablet

Oral

IT - Italy

| C.T. Laboratorio Farmaceutico Srl Strada Solaro, 75/77 |
| --- |
| Villa Sayonara, Sanremo – IMPERIA |
| Italy |

C.T. Laboratorio Farmaceutico Srl Strada Solaro, 75/77

Villa Sayonara, Sanremo – IMPERIA

Italy

Fibrocit

600 mg

Tablet

Oral

IT - Italy

| Doc Generici Srl |
| --- |
| Via Manuzio, 7 |
| 20124 MILANO |
| Italy |

Doc Generici Srl

Via Manuzio, 7

20124 MILANO

Italy

Gemfibrozil

900 mg

Tablet

Oral

IT - Italy

| Doc Generici Srl |
| --- |
| Via Manuzio, 7 |
| 20124 MILANO |
| Italy |

Doc Generici Srl

Via Manuzio, 7

20124 MILANO

Italy

Gemfibrozil

600 mg

Tablet

Oral

IT - Italy

| Eg Spa |
| --- |
| Via Scarlatti Domenico, 31 |
| 20124 MILANO |
| Italy |

Eg Spa

Via Scarlatti Domenico, 31

20124 MILANO

Italy

Gemfibrozil Eg

900 mg

Tablet

Oral

IT - Italy

| Eg Spa |
| --- |
| Via Scarlatti Domenico, 31 |
| 20124 MILANO |
| Italy |

Eg Spa

Via Scarlatti Domenico, 31

20124 MILANO

Italy

Gemfibrozil Eg

600 mg

Tablet

Oral

IT - Italy

| Eg Spa |
| --- |
| Via Scarlatti Domenico, 31 |
| 20124 MILANO |
| Italy |

Eg Spa

Via Scarlatti Domenico, 31

20124 MILANO

Italy

Gemfibrozil Eg

1 200 mg

Granules

Oral

IT - Italy

| Get Srl Via Dante Alighieri, 73 18038 Sanremo – IMPERIA |
| --- |
| Italy |

Get Srl Via Dante Alighieri, 73 18038 Sanremo – IMPERIA

Italy

Gemfibrozil

900 mg

Coated tablet

Oral

IT - Italy

| Get Srl |
| --- |
| Via Dante Alighieri, 73 |
| 18038 Sanremo – IMPERIA |
| Italy |

Get Srl

Via Dante Alighieri, 73

18038 Sanremo – IMPERIA

Italy

Gemfibrozil

600 mg

Coated tablet

Oral

IT - Italy

| Pfizer Italia Srl |
| --- |
| Via Isonzo, 71 |
| 04100 – LATINA |
| Italy |

Pfizer Italia Srl

Via Isonzo, 71

04100 – LATINA

Italy

Lopid

900 mg

Coated tablet

Oral

IT - Italy

| Pfizer Italia Srl |
| --- |
| Via Isonzo, 71 |
| 04100 – LATINA |
| Italy |

Pfizer Italia Srl

Via Isonzo, 71

04100 – LATINA

Italy

Lopid

600 mg

Coated tablet

Oral

IT - Italy

| Ratiopharm GmbH |
| --- |
| Graf-Arco Strasse 3 |
| D-89079 ULM – |
| Germany |

Ratiopharm GmbH

Graf-Arco Strasse 3

D-89079 ULM –

Germany

Gemfibrozil

900 mg

Tablet

Oral

IT - Italy

| Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM |
| --- |
| Germany |

Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM

Germany

Gemfibrozil

600 mg

Tablet

Oral

IT - Italy

| Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM |
| --- |
| Germany |

Ratiopharm Gmbh Graf-Arco Strasse 3 D-89079 ULM

Germany

Gemfibrozil

1 200 mg

Granules

Oral

IT - Italy

| Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE |
| --- |
| Italy |

Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE

Italy

Gemfibrozil

900 mg

Tablet

Oral

IT - Italy

| Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE |
| --- |
| Italy |

Sandoz Spa Largo Umberto Boccioni, 1 21040 Origgio – VARESE

Italy

Gemfibrozil

600 mg

Tablet

Oral

IT - Italy

| Teofarma Srl Via Fratelli Cervi, 8 – |
| --- |
| Valle Salimbene |
| 27010 Pavia |
| Italy |

Teofarma Srl Via Fratelli Cervi, 8 –

Valle Salimbene

27010 Pavia

Italy

Genlip

900 mg

Tablet

Oral

IT - Italy

| Teofarma Srl |
| --- |
| Via Fratelli Cervi, 8 – |
| Valle Salimbene |
| 27010 Pavia |
| Italy |

Teofarma Srl

Via Fratelli Cervi, 8 –

Valle Salimbene

27010 Pavia

Italy

Genlip

600 mg

Tablet

Oral

IT - Italy

| Teva Italia Srl |
| --- |
| Via Messina, 38 |
| 20154 MILANO |
| Italy |

Teva Italia Srl

Via Messina, 38

20154 MILANO

Italy

Gemfibrozil

900 mg

Film-coated tablet

Oral

IT - Italy

| Teva Italia Srl |
| --- |
| Via Messina, 38 |
| 20154 MILANO |
| Italy |

Teva Italia Srl

Via Messina, 38

20154 MILANO

Italy

Gemfibrozil

600 mg

Film-coated tablet

Oral

NL - Netherlands

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| The Netherlands |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

The Netherlands

Lopid 300 mg, harde capsules, RVG 32546

300 mg

capsules, hard

oral

NL - Netherlands

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| The Netherlands |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

The Netherlands

Lopid 450 mg, filmomhulde tabletten, RVG 32547

450 mg

filmcoated tablets

oral

NL - Netherlands

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| The Netherlands |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

The Netherlands

Lopid 600, filmomhulde tabletten 600 mg, RVG 13827

600 mg

filmcoated tablets

oral

NL - Netherlands

| Pfizer B.V. |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d Ijssel |
| The Netherlands |

Pfizer B.V.

Rivium Westlaan 142

2909 LD Capelle a/d Ijssel

The Netherlands

Lopid 900, filmomhulde tabletten 900 mg, RVG 16455

900 mg

filmcoated tablets

oral

NL - Netherlands

| Pharmachemie BV |
| --- |
| P.O.Box 552, |
| 2003 RN Haarlem |
| The Netherlands |

Pharmachemie BV

P.O.Box 552,

2003 RN Haarlem

The Netherlands

Gemfibrozil 600 PCH, omhulde tabletten 600 mg, RVG 25031

600 mg

filmcoated tablets

oral

NL - Netherlands

| Pharmachemie BV |
| --- |
| P.O.Box 552, |
| 2003 RN Haarlem |
| The Netherlands |

Pharmachemie BV

P.O.Box 552,

2003 RN Haarlem

The Netherlands

Gemfibrozil 900 PCH, omhulde tabletten 900 mg, RVG 25032

900 mg

filmcoated tablets

oral

NL - Netherlands

| Actavis BV |
| --- |
| P.O. Box 313, |
| 3740 AH Baarn |
| The Netherlands |

Actavis BV

P.O. Box 313,

3740 AH Baarn

The Netherlands

Gemfibrozil Actavis 600 mg tabletten, omhulde tabletten, RVG 26283

600 mg

filmcoated tablets

oral

NL - Netherlands

| Actavis BV |
| --- |
| P.O. Box 313, |
| 3740 AH Baarn, |
| The Netherlands |

Actavis BV

P.O. Box 313,

3740 AH Baarn,

The Netherlands

Gemfibrozil Actavis 900 mg tabletten, omhulde tabletten, RVG 26284

900 mg

filmcoated tablets

oral

NL - Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Gemfibrozil Apotex 600 mg, tabletten, RVG 24878

600 mg

filmcoated tablets

oral

NL - Netherlands

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| The Netherlands |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

The Netherlands

Gemfibrozil Apotex 900 mg, tabletten, RVG 24879

900 mg

filmcoated tablets

oral

NL - Netherlands

| Centrafarm Services B.V. |
| --- |
| Postbus 289 |
| 4870 AG Etten-Leur |
| The Netherlands |

Centrafarm Services B.V.

Postbus 289

4870 AG Etten-Leur

The Netherlands

Gemfibrozil CF 600 mg, omhulde tabletten, RVG 25184

600 mg

filmcoated tablets

oral

NL - Netherlands

| Centrafarm Services B.V., Postbus 289 |
| --- |
| 4870 AG Etten-Leur |
| The Netherlands |

Centrafarm Services B.V., Postbus 289

4870 AG Etten-Leur

The Netherlands

Gemfibrozil CF 900 mg, omhulde tabletten, RVG 25185

900 mg

filmcoated tablets

oral

NL - Netherlands

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Gemfibrozil Mylan 600 mg, tabletten, RVG 29616

600 mg

tablets

oral

NL - Netherlands

| Mylan B.V. |
| --- |
| Dieselweg 25 |
| 3752 LB Bunschoten |
| The Netherlands |

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

The Netherlands

Gemfibrozil Mylan 900 mg, tabletten, RVG 29617

900 mg

tablets

oral

NL - Netherlands

| Ratiopharm Nederland BV |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| The Netherlands |

Ratiopharm Nederland BV

Ronde Tocht 11

1507 CC Zaandam

The Netherlands

Gemfibrozil Ratiopharm 600 mg, omhulde tabletten, RVG 29232

600 mg

filmcoated tablets

oral

NL - Netherlands

| Ratiopharm Nederland BV |
| --- |
| Ronde Tocht 11 |
| 1507 CC Zaandam |
| The Netherlands |

Ratiopharm Nederland BV

Ronde Tocht 11

1507 CC Zaandam

The Netherlands

Gemfibrozil Ratiopharm 900 mg, omhulde tabletten, RVG 29233

900 mg

filmcoated tablets

oral

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Gemfibrozil Sandoz 600 mg, filmomhulde tabletten, RVG 21426

600 mg

filmcoated tablets

oral

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Gemfibrozil Sandoz tablet 600, omhulde tabletten 600 mg, RVG 25182

600 mg

filmcoated tablets

oral

NL - Netherlands

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH Almere |
| The Netherlands |

Sandoz B.V.

Veluwezoom 22

1327 AH Almere

The Netherlands

Gemfibrozil Sandoz tablet 900, omhulde tabletten 900 mg, RVG 25183

900 mg

filmcoated tablets

oral

PT - Portugal

| Angelfarma Lda. |
| --- |
| Rua João Chagas, 53 |
| Piso 3 1495-764 Cruz Quebrada – Dafundo |
| Portugal |

Angelfarma Lda.

Rua João Chagas, 53

Piso 3 1495-764 Cruz Quebrada – Dafundo

Portugal

Lipoite Forte

600 mg

coated tablet

Oral

PT - Portugal

| Laboratórios Pfizer, Lda. |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer, Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Lopid

300 mg

capsule

Oral

PT - Portugal

| Laboratórios Pfizer,Lda. |
| --- |
| Lagoas Park, Edifício 10 |
| 2740-271 Porto Salvo |
| Portugal |

Laboratórios Pfizer,Lda.

Lagoas Park, Edifício 10

2740-271 Porto Salvo

Portugal

Lopid 600

600 mg

film-coated tablet

Oral

PT - Portugal

| Generis Farmacêutica, S.A. Office Park da Beloura |
| --- |
| Edifício 4 |
| Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Generis Farmacêutica, S.A. Office Park da Beloura

Edifício 4

Quinta da Beloura

2710-444 Sintra

Portugal

Gemfibrozil Generis

600 mg

film-coated tablet

Oral

PT - Portugal

| Generis Farmacêutica S.A. Office Park da Beloura |
| --- |
| Edifício 4, Quinta da Belou |
| 2710-444 Sinta |
| Portugal |

Generis Farmacêutica S.A. Office Park da Beloura

Edifício 4, Quinta da Belou

2710-444 Sinta

Portugal

Gemfibrozil Generis

900 mg

film-coated tablet

Oral

SE - Sweden

| Sandoz A/S |
| --- |
| C.F. Tietgens |
| Boulevard 40 |
| DK-5220 Odense SØ |
| Denmark |

Sandoz A/S

C.F. Tietgens

Boulevard 40

DK-5220 Odense SØ

Denmark

Gemfibrozil Sandoz

450 mg

filmcoated tablet

oral

SE - Sweden

| Sandoz A/S |
| --- |
| C.F.Tietgens |
| Boulevard 40 |
| DK-5220 Odense SØ |
| Denmark |

Sandoz A/S

C.F.Tietgens

Boulevard 40

DK-5220 Odense SØ

Denmark

Gemfibrozil Sandoz

600mg

filmcoated tablet

oral

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lopid

300 mg

hard capsule

oral

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lopid

450 mg

filmcoated tablet

oral

SE - Sweden

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lopid

600 mg

filmcoated tablet

oral

SI - Slovenia

| Lek farmacevtska družba d.d., Verovškova 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenia |

Lek farmacevtska družba d.d., Verovškova 57

SI-1000 Ljubljana

Slovenia

Elmogan 450 mg filmsko obložene tablete

450 mg

film-coated tablet

oral use

SK - Slovakia

Medochemie Ltd. 1-10 Constantinoupoleos St. P.O. Box: 51409 3505 Limassol Cyprus

IPOLIPID

300 mg

Capsule

Oral

UK - United Kingdom

| PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS |
| --- |
| United Kingdom, |

PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS

United Kingdom,

LOPID CAPSULES 300 MG

300 mg

CAPSULE

oral use

UK - United Kingdom

| PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS |
| --- |
| United Kingdom |

PFIZER LIMITED. Walton Oaks, Dorking Road, Tadworth, Surrey KT20 7NS

United Kingdom

LOPID TABLETS 600 MG

600 mg

COATED TABLET

oral use

UK - United Kingdom

| TEVA PHARMA BV, Industrieweg 23, PO Box 217, 3640 AE Mijdrecht, |
| --- |
| Netherlands |

TEVA PHARMA BV, Industrieweg 23, PO Box 217, 3640 AE Mijdrecht,

Netherlands

GEMFIBROZIL TABLETS 600 MG

600 mg

COATED TABLET

oral use

UK - United Kingdom

| Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG |
| --- |
| United Kingdom |

Teva Uk Limited, Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG

United Kingdom

GEMFIBROZIL CAPSULES 300 MG

300 mg

CAPSULE

oral use

UK - United Kingdom

| TILLOMED LABORATORIES LIMITED |
| --- |
| 3 Howard Road |
| Eaton Socon |
| St. Neots, Cambridgeshire |
| PE19 8ET |
| United Kingdom |

TILLOMED LABORATORIES LIMITED

3 Howard Road

Eaton Socon

St. Neots, Cambridgeshire

PE19 8ET

United Kingdom

GEMFIBROZIL TABLETS 600 MG

600 mg

FILM-COATED TABLET

oral use

---

ANNEX V

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

| Member State | Marketing Authorisation Holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Cephalon GmbH |
| Landsberger Straße 94 |
| 80339 München, |
| Germany |

Member State

Marketing Authorisation Holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Cephalon GmbH

Landsberger Straße 94

80339 München,

Germany

Modasomil 100 mg - Tabletten

100 mg

tablets

oral use

Austria

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht

The Netherlands

Modafinil TEVA 100 mg Tabletten

100 mg

tablet

oral use

Belgium

| Teva Pharma B.V. |
| --- |
| Computerweg 10, |
| 3542 DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10,

3542 DR Utrecht

The Netherlands

MODAFINIL TEVA 100MG

100 mg

tablets

oral use

Belgium

| N.V. Organon |
| --- |
| Kloosterstraat 6, |
| 5349 AB Oss |
| The Netherlands |

N.V. Organon

Kloosterstraat 6,

5349 AB Oss

The Netherlands

PROVIGIL

100 mg

tablets

oral use

Cyprus

| GENESIS PHARMA (CYPRUS) LTD, |
| --- |
| 2 Amfipoleos, 1st floor, |
| P.O.Box 23638, |
| 2025 Strovolos, Lefkosia, |
| Cyprus |

GENESIS PHARMA (CYPRUS) LTD,

2 Amfipoleos, 1st floor,

P.O.Box 23638,

2025 Strovolos, Lefkosia,

Cyprus

MODIODAL

100 MG

tablets

oral use

Czech Republic

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Anděl City |
| Radlická 1c |
| 150 00 Praha 5 |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o.

Anděl City

Radlická 1c

150 00 Praha 5

Czech Republic

Modafinil-Teva 100 mg

100 mg

tablets

oral use

Czech Republic

| Torrex Chiesi CZ, s.r.o. |
| --- |
| Na Květnici 33 |
| 140 00 Praha 4 |
| Czech Republic |

Torrex Chiesi CZ, s.r.o.

Na Květnici 33

140 00 Praha 4

Czech Republic

Vigil

100 mg

tablets

oral use

Denmark

| Cephalon France, |
| --- |
| 20, rue Charles Matigny, |
| 94700 Maisons-Alfort, |
| France |

Cephalon France,

20, rue Charles Matigny,

94700 Maisons-Alfort,

France

Modiodal

100 mg

tablets

oral use

Denmark

| Teva Denmark A/S, |
| --- |
| Parallelvej 10, |
| 2800 Kongens Lyngby, |
| Denmark |

Teva Denmark A/S,

Parallelvej 10,

2800 Kongens Lyngby,

Denmark

Modafinil ‘Teva’

100 mg

tablets

oral use

Finland

| ORCHID EUROPE LTD |
| --- |
| Building 3, Chiswick park 556, |
| Chiswick High Road |
| London W4 5YA |
| United Kingdom |

ORCHID EUROPE LTD

Building 3, Chiswick park 556,

Chiswick High Road

London W4 5YA

United Kingdom

MODAFINIL

100 mg

tablets

oral use

Finland

| ORCHID EUROPE LTD |
| --- |
| Building 3, Chiswick park 556, |
| Chiswick High Road |
| London W4 5YA |
| United Kingdom |

ORCHID EUROPE LTD

Building 3, Chiswick park 556,

Chiswick High Road

London W4 5YA

United Kingdom

MODAFINIL

200 mg

tablets

oral use

France

| CEPHALON France |
| --- |
| 20, rue Charles Martigny |
| 94701 Maisons-Alfort Cedex |
| France |

CEPHALON France

20, rue Charles Martigny

94701 Maisons-Alfort Cedex

France

MODIODAL 100 mg, comprimé

100 mg

tablets

oral use

France

| CEPHALON France |
| --- |
| 20, rue Charles Martigny |
| 94701 Maisons-Alfort Cedex |
| France |

CEPHALON France

20, rue Charles Martigny

94701 Maisons-Alfort Cedex

France

MODAFINIL LAFON 100 mg, comprimé

100 mg

tablets

oral use

France

| TEVA SANTE |
| --- |
| Le Palatin 1 |
| 1, cours du Triangle |
| 92936 Paris la Défense Cedex |
| France |

TEVA SANTE

Le Palatin 1

1, cours du Triangle

92936 Paris la Défense Cedex

France

MODAFINIL TEVA 100 mg, comprimé

100 mg

tablets

oral use

Germany

| Cephalon Pharma GmbH |
| --- |
| Fraunhoferstr. 9a |
| D-82152 Martinsried |
| Germany |

Cephalon Pharma GmbH

Fraunhoferstr. 9a

D-82152 Martinsried

Germany

Vigil 100 mg Tabletten

100 mg

tablets

oral use

Greece

| GENESIS PHARMA |
| --- |
| Kiffissias Avenue 274 |
| Halandri Athens 152 32 |
| Greece |

GENESIS PHARMA

Kiffissias Avenue 274

Halandri Athens 152 32

Greece

MODIODAL

100 MG/TAB

tablets

oral use

Hungary

| TORREX Chiesi Kft. |
| --- |
| 1052 Budapest |
| Kristóf tér 4. III/1-3. |
| Hungary |

TORREX Chiesi Kft.

1052 Budapest

Kristóf tér 4. III/1-3.

Hungary

VIGIL

100 mg

tablets

oral use

Iceland

| Cephalon France |
| --- |
| 20, rue Charles Martigny |
| 94700 Maisons Alfort |
| France |

Cephalon France

20, rue Charles Martigny

94700 Maisons Alfort

France

Modiodal

100 mg

tablets

oral use

Ireland

| Cephalon UK Limited |
| --- |
| 1 Albany Place Hyde Way |
| Welwyn Garden City |
| Hertfordshire AL7 3BT |
| United Kingdom |

Cephalon UK Limited

1 Albany Place Hyde Way

Welwyn Garden City

Hertfordshire AL7 3BT

United Kingdom

PROVIGIL 100 mg tablets

100 MG

tablets

oral use

Ireland

| Cephalon UK Limited |
| --- |
| 1 Albany Place Hyde Way |
| Welwyn Garden City |
| Hertfordshire AL7 3BT |
| United Kingdom |

Cephalon UK Limited

1 Albany Place Hyde Way

Welwyn Garden City

Hertfordshire AL7 3BT

United Kingdom

PROVIGIL 200 mg tablets

200 MG

tablets

oral use

Ireland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542DR Utrecht |
| The Netherlands |

Teva Pharma B.V.

Computerweg 10

3542DR Utrecht

The Netherlands

Modafinil Teva 100mg tablet

100 MG

tablets

oral use

Italy

| CEPHALON SRL |
| --- |
| Piazza G. Marconi, 25 |
| 00144 ROMA |
| Italia |

CEPHALON SRL

Piazza G. Marconi, 25

00144 ROMA

Italia

PROVIGIL

100 mg

tablets

oral use

Italy

| TEVA ITALIA S.R.L. |
| --- |
| Via Messina, 38 |
| 20154 Milano |
| Italia |

TEVA ITALIA S.R.L.

Via Messina, 38

20154 Milano

Italia

MODAFINIL TEVA

100 mg

tablets

oral use

Luxembourg

| ORGANON N.V |
| --- |
| Kloosterstraat 6 |
| NL-5349 AB Oss |
| The Netherlands |

ORGANON N.V

Kloosterstraat 6

NL-5349 AB Oss

The Netherlands

PROVIGIL

100 mg

tablets

oral use

Netherlands

| Cephalon France, |
| --- |
| 20 rus Charles Martigny, |
| 94700 Maisons-Alfort, |
| France |

Cephalon France,

20 rus Charles Martigny,

94700 Maisons-Alfort,

France

Modiodal, 100 mg tabletten

100 mg

tablets

oral use

Poland

| Torrex Chiesi Pharma GmbH, |
| --- |
| Gonzagagasse 16/16, |
| A-1010 Vienna, |
| Austria |

Torrex Chiesi Pharma GmbH,

Gonzagagasse 16/16,

A-1010 Vienna,

Austria

Vigil

100 mg

tablets

oral use

Portugal

| Cephalon France |
| --- |
| 20, Rue Charles Martigny |
| 94700 Maisons-Alfort |
| France |

Cephalon France

20, Rue Charles Martigny

94700 Maisons-Alfort

France

Modiodal

100 mg

tablets

oral use

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, Edifício 4, |
| Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Generis Farmacêutica, S.A.

Office Park da Beloura, Edifício 4,

Quinta da Beloura

2710-444 Sintra

Portugal

Modafinil Generis

100 mg

tablets

oral use

Slovakia

| Teva Pharmaceuticals CR, s.r.o., |
| --- |
| Radlická 3185/1c |
| 150 00, Prague, |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o.,

Radlická 3185/1c

150 00, Prague,

Czech Republic

Modafinil-Teva 100 mg

100 mg

tablets

oral use

Slovakia

| Torrex Chiesi Pharma GmbH, |
| --- |
| Gonzagagasse 16/16, |
| 1010, Vienna, |
| Austria |

Torrex Chiesi Pharma GmbH,

Gonzagagasse 16/16,

1010, Vienna,

Austria

VIGIL 100 mg

100 mg

tablets

oral use

Spain

| CEPHALON FRANCE, |
| --- |
| 20, Rue Charles Martigny |
| 94700 Maisons Alfort |
| France |

CEPHALON FRANCE,

20, Rue Charles Martigny

94700 Maisons Alfort

France

MODIODAL

100 mg

tablets

oral use

Spain

| TEVA GENERICOS ESPAÑOLA, S.L |
| --- |
| Guzmán el Bueno 133, |
| Edificio Britania 4oIzq.. |
| 28003 Madrid |
| Spain |

TEVA GENERICOS ESPAÑOLA, S.L

Guzmán el Bueno 133,

Edificio Britania 4oIzq..

28003 Madrid

Spain

MODAFINILO TEVA

100 mg

tablets

oral use

Sweden

| Cephalon France, |
| --- |
| 20, rue Charles Martigny |
| 94700 Maisons Alfort |
| France |

Cephalon France,

20, rue Charles Martigny

94700 Maisons Alfort

France

Modiodal®

100 mg

tablets

oral use

Sweden

| Teva Sweden AB, |
| --- |
| Box 1070 |
| 251 10 Helsingborg, |
| Sverige |

Teva Sweden AB,

Box 1070

251 10 Helsingborg,

Sverige

Modafinil Teva

100 mg

tablets

oral use

United Kingdom

| Cephalon UK Limited |
| --- |
| 1 Albany Place Hyde Way |
| Welwyn Garden City |
| Hertfordshire AL7 3BT |
| United Kingdon |

Cephalon UK Limited

1 Albany Place Hyde Way

Welwyn Garden City

Hertfordshire AL7 3BT

United Kingdon

Provigil 100mg Tablets

100mg

tablets

oral use

United Kingdom

| Cephalon UK Limited |
| --- |
| 1 Albany Place Hyde Way |
| Welwyn Garden City |
| Hertfordshire AL7 3BT |
| United Kingdom |

Cephalon UK Limited

1 Albany Place Hyde Way

Welwyn Garden City

Hertfordshire AL7 3BT

United Kingdom

Provigil 200mg Tablets

200 mg

tablets

oral use

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

Modafinil 100mg Tablets

100 mg

tablets

oral use

---

ANNEX VI

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

| Member State EU/EEA | Applicant | Invented Name | Strength | Pharmaceutical Form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | ALFRED E. TIEFENBACHER |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

Member State EU/EEA

Applicant

Invented Name

Strength

Pharmaceutical Form

Route of administration

Austria

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamin STADA 8 mg Retardtabletten

8 mg

Prolonged-release tablet

Oral use

Austria

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamin STADA 16 mg Retardtabletten

16 mg

Prolonged-release tablet

Oral use

Austria

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamin STADA 24 mg Retardtabletten

24 mg

Prolonged-release tablet

Oral use

Czech Republic

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALASTAD 8 mg

8 mg

Prolonged-release tablet

Oral use

Czech Republic

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALASTAD 16 mg

16 mg

Prolonged-release tablet

Oral use

Czech Republic

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALASTAD 24 mg

24 mg

Prolonged-release tablet

Oral use

Denmark

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamin STADA

8 mg

Prolonged-release tablet

Oral use

Denmark

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamin STADA

16 mg

Prolonged-release tablet

Oral use

Denmark

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamin STADA

24 mg

Prolonged-release tablet

Oral use

Finland

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Galantamine Stada

8 mg

Prolonged-release tablet

Oral use

Finland

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Galantamine Stada

16 mg

Prolonged-release tablet

Oral use

Finland

| STADA Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel

Germany

Galantamine Stada

24 mg

Prolonged-release tablet

Oral use

Ireland

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

GALANTAX XL 8 mg prolonged-release tablets

8 mg

Prolonged-release tablet

Oral use

Ireland

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

GALANTAX XL 16 mg prolonged-release tablets

16 mg

Prolonged-release tablet

Oral use

Ireland

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

GALANTAX XL 24 mg prolonged-release tablets

24 mg

Prolonged-release tablet

Oral use

Portugal

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamina Ciclum

8 mg

Prolonged-release tablet

Oral use

Portugal

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamina Ciclum

16 mg

Prolonged-release tablet

Oral use

Portugal

| STADA Arzneimittel GmbH |
| --- |
| Muthgasse 36 |
| 1190 Wien |
| Austria |

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

Galantamina Ciclum

24 mg

Prolonged-release tablet

Oral use

Slovak Republic

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamine Tiefenbacher 8 mg tablety s predĺženým uvoľňovaním

8 mg

Prolonged-release tablet

Oral use

Slovak Republic

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamine Tiefenbacher 16 mg tablety s predĺženým uvoľňovaním

16 mg

Prolonged-release tablet

Oral use

Slovak Republic

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

Galantamine Tiefenbacher 24 mg tablety s predĺženým uvoľňovaním

24 mg

Prolonged-release tablet

Oral use

Spain

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALANTAMINA Tiefenbacher 8 mg comprimidos de liberación prolongada

8 mg

Prolonged-release tablet

Oral use

Spain

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALANTAMINA Tiefenbacher 16 mg comprimidos de liberación prolongada

16 mg

Prolonged-release tablet

Oral use

Spain

| ALFRED E. TIEFENBACHER |
| --- |
| (GmbH & Co. KG) |
| Van-der-Smissen-Strasse 1 |
| 22767 Hamburg |
| Germany |

ALFRED E. TIEFENBACHER

(GmbH & Co. KG)

Van-der-Smissen-Strasse 1

22767 Hamburg

Germany

GALANTAMINA Tiefenbacher 24 mg comprimidos de liberación prolongada

24 mg

Prolonged-release tablet

Oral use

---