# C_2005130EN.01000501.xml

| 27.5.2005 | EN | Official Journal of the European Union | C 130/5 |
| --- | --- | --- | --- |

27.5.2005

EN

Official Journal of the European Union

C 130/5

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Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 April 2005 to 15 May 2005

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) (1)

(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93) (1

(2005/C 130/04)

—   Modification of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 20.4.2005 | Velcade | Janssen-Cilag International NV, Turnhoutseweg, 30 — B-2340 Beerse | EU/1/04/274/001 | 22.4.2005 |
| 20.4.2005 | Viramune | Boehringer Ingelheim International GmbH, Binger Strasse 173 — D-55216 Ingelheim am Rhein | EU/1/97/055/001-002 | 22.4.2005 |
| 20.4.2005 | Paxene | Norton Healthcare Limited, Albert Basin, Royal Docks, London E16 2QJ, United Kingdom | EU/1/99/113/001-004 | 22.4.2005 |
| 25.4.2005 | Zeffix | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/114/001-003 | 27.4.2005 |
| 25.4.2005 | HBVAXPRO | Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, F-69007 Lyon | EU/1/01/183/001-019 | 27.4.2005 |
| 25.4.2005 | Humira | Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/256/001-006 | 27.4.2005 |
| 25.4.2005 | GONAL f | Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/95/001/001-035 | 27.4.2005 |
| 25.4.2005 | Trudexa | Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/257/001-006 | 27.4.2005 |
| 27.4.2005 | Viagra | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077/001-012 | 29.4.2005 |
| 27.4.2005 | Keppra | UCB SA, Allée de la recherche, 60, B-1070 Bruxelles
  Researchdreef, 60, B-1070 Brussel | EU/1/00/146/001-027 | 29.4.2005 |
| 27.4.2005 | Lantus | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/00/134/012 | 29.4.2005 |
| 27.4.2005 | Optisulin | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/00/133/008 | 29.4.2005 |
| 27.4.2005 | Forsteo | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/03/247/001-002 | 29.4.2005 |
| 27.4.2005 | Neupopeg | Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano | EU/1/02/228/001-002 | 29.4.2005 |
| 27.4.2005 | Cellcept | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/96/005/001-006 | 29.4.2005 |
| 27.4.2005 | Carbaglu | Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense | EU/1/02/246/001-003 | 29.4.2005 |
| 28.4.2005 | Herceptin | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/00/145/001 | 3.5.2005 |
| 28.4.2005 | Emend | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/03/262/001-006 | 3.5.2005 |
| 28.4.2005 | Emend | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/03/262/001-006 | 3.5.2005 |
| 28.4.2005 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/006-011 | 3.5.2005 |
| 28.4.2005 | Rapamune | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/01/171/001-012 | 3.5.2005 |
| 29.4.2005 | Neulasta | Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland | EU/1/02/227/001-002 | 3.5.2005 |
| 10.5.2005 | Lyrica | Pfizer Ltd; Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/04/279/001-025 | 13.5.2005 |
| 10.5.2005 | Cancidas | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/01/196/001-003 | 13.5.2005 |
| 13.5.2005 | Apidra | Aventis Pharma Deutschland GmbH, Brueningstraße 50, D-65926 Frankfurt am Main | EU/1/04/285/001-028 | 18.5.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

20.4.2005

Velcade

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

EU/1/04/274/001

22.4.2005

20.4.2005

Viramune

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

EU/1/97/055/001-002

22.4.2005

20.4.2005

Paxene

Norton Healthcare Limited, Albert Basin, Royal Docks, London E16 2QJ, United Kingdom

EU/1/99/113/001-004

22.4.2005

25.4.2005

Zeffix

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

EU/1/99/114/001-003

27.4.2005

25.4.2005

HBVAXPRO

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

EU/1/01/183/001-019

27.4.2005

25.4.2005

Humira

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

EU/1/03/256/001-006

27.4.2005

25.4.2005

GONAL f

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

EU/1/95/001/001-035

27.4.2005

25.4.2005

Trudexa

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

EU/1/03/257/001-006

27.4.2005

27.4.2005

Viagra

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

EU/1/98/077/001-012

29.4.2005

27.4.2005

Keppra

UCB SA, Allée de la recherche, 60, B-1070 Bruxelles

Researchdreef, 60, B-1070 Brussel

EU/1/00/146/001-027

29.4.2005

27.4.2005

Lantus

Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main

EU/1/00/134/012

29.4.2005

27.4.2005

Optisulin

Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main

EU/1/00/133/008

29.4.2005

27.4.2005

Forsteo

Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/03/247/001-002

29.4.2005

27.4.2005

Neupopeg

Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano

EU/1/02/228/001-002

29.4.2005

27.4.2005

Cellcept

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/96/005/001-006

29.4.2005

27.4.2005

Carbaglu

Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense

EU/1/02/246/001-003

29.4.2005

28.4.2005

Herceptin

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/00/145/001

3.5.2005

28.4.2005

Emend

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

EU/1/03/262/001-006

3.5.2005

28.4.2005

Emend

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

EU/1/03/262/001-006

3.5.2005

28.4.2005

Enbrel

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

EU/1/99/126/006-011

3.5.2005

28.4.2005

Rapamune

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

EU/1/01/171/001-012

3.5.2005

29.4.2005

Neulasta

Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227/001-002

3.5.2005

10.5.2005

Lyrica

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

EU/1/04/279/001-025

13.5.2005

10.5.2005

Cancidas

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

EU/1/01/196/001-003

13.5.2005

13.5.2005

Apidra

Aventis Pharma Deutschland GmbH, Brueningstraße 50, D-65926 Frankfurt am Main

EU/1/04/285/001-028

18.5.2005

—   Withdrawal of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 25.4.2005 | Infanrix Hep B | GlaxoSmithKline Biologicals SA, rue de l'Institut 89, B-1330 Rixensart | EU/1/97/048/001-014 | 27.4.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

25.4.2005

Infanrix Hep B

GlaxoSmithKline Biologicals SA, rue de l'Institut 89, B-1330 Rixensart

EU/1/97/048/001-014

27.4.2005

—   Modification of a marketing authorisation (Article 34 of Council Regulation (EEC) No 2309/93): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 18.4.2005 | Bayovac CSF E2 | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
  Bayer AG, Geschäftsbereich Tiergesundheit, D-51368 Leverkusen | EU/2/00/025/001-004 | 20.4.2005 |
| 21.4.2005 | Eurifel FeLV | Merial, 29 Avenue Tony Garnier, F-69007 Lyon | EU/2/00/019/001-003 | 27.4.2005 |
| 27.4.2005 | Ibraxion | Merial, 29 avenue Tony Garnier, F-69007 Lyon | EU/2/99/017/001-006 | 29.4.2005 |
| 27.4.2005 | Metacam | Boehringer Ingelheim Vetmedica GmbH, D-55216 Ingelheim am Rhein | EU/2/97/004/001
  EU/2/97/004/003-010 | 29.4.2005 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

18.4.2005

Bayovac CSF E2

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

Bayer AG, Geschäftsbereich Tiergesundheit, D-51368 Leverkusen

EU/2/00/025/001-004

20.4.2005

21.4.2005

Eurifel FeLV

Merial, 29 Avenue Tony Garnier, F-69007 Lyon

EU/2/00/019/001-003

27.4.2005

27.4.2005

Ibraxion

Merial, 29 avenue Tony Garnier, F-69007 Lyon

EU/2/99/017/001-006

29.4.2005

27.4.2005

Metacam

Boehringer Ingelheim Vetmedica GmbH, D-55216 Ingelheim am Rhein

EU/2/97/004/001

EU/2/97/004/003-010

29.4.2005

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

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| London E14 4HB |
| United Kingdom |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

London E14 4HB

United Kingdom

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(1)  OJ L 214 of 24.8.1993, p. 1.

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