Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 June 2004 to 15 July 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93
Date: 2004-07-30
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

C 194/2

EN

Official Journal of the European Union

30.7.2004

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 June 2004 to 15 July 2004

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

(2004/C 194/02)

— Issuing 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

29.6.2004

Erbitux

6.7.2004

Lyrica

12.7.2004

Telzir

Merck KgaA
Frankfurter Straße 250
D-64293 Darmstadt

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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

EU/1/04/281/001

1.7.2004

EU/1/04/279/001-025

8.7.2004

EU/1/04/282/001-002

14.7.2004

— 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

17.6.2004

GONAL-f

17.6.2004

Beromun

17.6.2004

Tractocile

17.6.2004

Tritanrix HepB

23.6.2004

Emtriva

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

Ingelheim International

Boehringer
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

Ferring AB
Soldattorpsvägen 5
Box 30047
S-200 61 Limhamn

GlaxoSmithKline Biologicals sa
Rue de l'Institut 89
B-1330 Rixensart

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/95/001/005-008
EU/1/95/001/013-020

21.6.2004

EU/1/99/097/001

21.6.2004

EU/1/99/124/001-002

21.6.2004

EU/1/96/014/001-003

21.6.2004

EU/1/03/261/001-003

25.6.2004

23.6.2004

Kogenate Bayer

24.6.2004

Helixate NexGen

Bayer AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

EU/1/00/143/001-003

25.6.2004

EU/1/00/144/001-003

28.6.2004

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

30.7.2004

EN

Official Journal of the European Union

C 194/3

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

6.7.2004

Ammonaps

Orphan Europe,
laumet’
F-92046 Paris-La Défense

Immeuble ‘Le Guil-

EU/1/99/120/001-004

8.7.2004

6.7.2004

Cialis

7.7.2004

Novomix 30

12.7.2004

Betaferon

13.7.2004

Aldurazyme

Lilly ICOS Limited
25 New Street Square
London EC4A 3LN
United Kingdom

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Schering AG Pharma
D-13342 Berlin

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

EU/1/02/237/001-004

8.7.2004

EU/1/00/142/004-005
EU/1/00/142/007-010

12.7.2004

EU/1/95/003/001-004

14.7.2004

EU/1/03/253/001-003

15.7.2004

13.7.2004

Viramune

Ingelheim International

Boehringer
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

EU/1/97/055/001-002

15.7.2004

13.7.2004

Avandamet

SmithKline Beecham plc
980 Great West Road
Brentford
Middlesex TW8 9GS
United Kingdom

EU/1/03/258/001-006

15.7.2004

13.7.2004

Axura

Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100-104
D-60318 Frankfurt/Main

EU/1/02/218/001-011

15.7.2004

13.7.2004

Optisulin

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/133/001-008

15.7.2004

13.7.2004

Aldara

13.7.2004

Sustiva

3M Santé
Boulevard de l'Oise
F-95029 Cergy Pontoise Cedex

Bristol-Myers Squibb Pharma EEIG
141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

EU/1/98/080/001

15.7.2004

EU/1/99/110/001-009/

15.7.2004

13.7.2004

Lantus

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/001-021

15.7.2004

13.7.2004

Stocrin

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

EU/1/99/111/001-009

15.7.2004

C 194/4

EN

Official Journal of the European Union

30.7.2004

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

13.7.2004

Keppra

13.7.2004

Zyprexa

13.7.2004

Ebixa

13.7.2004

Zyprexa Velotab

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

EU/1/00/146/001-027

16.7.2004

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

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby

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

EU/1/96/022/002
EU/1/96/022/004
EU/1/96/022/006
EU/1/96/022/008-012
EU/1/96/022/014
EU/1/96/022/016-022

15.7.2004

EU/1/02/219/001-013

15.7.2004

EU/1/99/125/001-004

15.7.2004

— 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

13.7.2004

Taluvian

Abbott SpA
Campoverde di Aprilia
I-04010 Latina

EU/1/01/182/001-010

15.7.2004