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)
Date: 2005-05-27
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

27.5.2005

EN

Official Journal of the European Union

C 130/5

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)

(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

20.4.2005

Paxene

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

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

EU/1/97/055/001-002

22.4.2005

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

25.4.2005

GONAL f

25.4.2005

Trudexa

Abbott Laboratories Ltd, Queen-
borough, Kent ME11 5EL, United
Kingdom

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

Abbott Laboratories Ltd, Queen-
borough, Kent ME11 5EL, United
Kingdom

EU/1/03/256/001-006

27.4.2005

EU/1/95/001/001-035

27.4.2005

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

27.4.2005

Lantus

27.4.2005

Optisulin

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

Aventis Pharma Deutschland
GmbH, D-65926 Frankfurt am
Main

Aventis Pharma Deutschland
GmbH, D-65926 Frankfurt am
Main

EU/1/00/146/001-027

29.4.2005

EU/1/00/134/012

29.4.2005

EU/1/00/133/008

29.4.2005

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

C 130/6

EN

Official Journal of the European Union

27.5.2005

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

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, Hert-
ford Road, Hoddesdon, Hertford-
shire EN11 9BU, United Kingdom

EU/1/03/262/001-006

3.5.2005

28.4.2005

Emend

Merck Sharp & Dohme Ltd, Hert-
ford Road, Hoddesdon, Hertford-
shire EN11 9BU, United Kingdom

EU/1/03/262/001-006

3.5.2005

28.4.2005

Enbrel

28.4.2005

Rapamune

Wyeth Europa Limited, Hunter-
combe Lane South, Taplow,
Maidenhead, Berkshire, SL6 0PH,
United Kingdom

Wyeth Europa Limited, Hunter-
combe Lane South, Taplow,
Maidenhead, Berkshire, SL6 0PH,
United Kingdom

EU/1/99/126/006-011

3.5.2005

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, Sand-
wich, Kent, CT13 9NJ, United
Kingdom

EU/1/04/279/001-025

13.5.2005

10.5.2005

Cancidas

Merck Sharp & Dohme Ltd, Hert-
ford Road, Hoddesdon, Hertford-
shire 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

27.5.2005

EN

Official Journal of the European Union

C 130/7

— 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

— 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

21.4.2005

Eurifel FeLV

27.4.2005

Ibraxion

27.4.2005

Metacam

Pfizer Limited, Sandwich, Kent,
CT13 9NJ, United Kingdom
Bayer AG, Geschäftsbereich Tierge-
sundheit, D-51368 Leverkusen

Merial, 29 Avenue Tony Garnier,
F-69007 Lyon

Merial, 29 avenue Tony Garnier,
F-69007 Lyon

Boehringer Ingelheim Vetmedica
GmbH, D-55216 Ingelheim am
Rhein

EU/2/00/025/001-004

20.4.2005

EU/2/00/019/001-003

27.4.2005

EU/2/99/017/001-006

29.4.2005

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