Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 October 2004 to 15 November 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-11-26
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

26.11.2004

EN

Official Journal of the European Union

C 289/7

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 October 2004 to 15 November 2004

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

(2004/C 289/07)

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

Date of the
decision

Name of the
medicinal
product

22.10.2004

EMSELEX

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

Novartis Europharm Limited, Wimble-
hurst Road, Horsham, West Sussex
RH12 5AB, United Kingdom

EU/1/04/294/001-012

26.10.2004

22.10.2004 Mimpara

Amgen Europe BV, Minervum 7061,
4817 ZK Breda, The Netherlands

EU/1/04/292/001-012

26.10.2004

22.10.2004

Parareg

Amgen Europe BV, Minervum 7061,
4817 ZK Breda, The Netherlands

EU/1/04/293/001-012

26.10.2004

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

Date of the
decision

Name of the
medicinal
product

20.10.2004

Zeffix

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

Glaxo
Greenford,
Middlesex UB6 0NN, United Kingdom

Group

Ltd,

EU/1/99/114/001-003

22.10.2004

20.10.2004

Puregon

Organon NV, PO box 20, 5340 BH
Oss, The Netherlands

EU/1/96/008/038-039

22.10.2004

20.10.2004

Viracept

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City,
Hertfordshire AL7
3AY, United
Kingdom

EU/1/97/054/001
EU/1/97/054/003-006

22.10.2004

20.10.2004

Taxotere

Aventis
Pharma
Raymond Aron,
Cedex,

20

SA,
avenue
F-92165 Antony

EU/1/95/002/001-002

22.10.2004

20.10.2004

ViraferonPeg

Schering Plough Europe, Rue de Stalle,
73, B-1180 Brussels

EU/1/00/132/001-050

22.10.2004

20.10.2004

PegIntron

Schering Plough Europe, Rue de Stalle,
73, B-1180 Brussels

Stallestraat, 73, B-1180 Brussel

EU/1/00/131/001-050

22.10.2004

22.10.2004

Herceptin

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City,
Hertfordshire AL7
3AY, United
Kingdom

EU/1/00/145/001

26.10.2004

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

C 289/8

EN

Official Journal of the European Union

26.11.2004

Date of the
decision

Name of the
medicinal
product

22.10.2004

EMEND

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

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

EU/1/03/262/001-006

26.10.2004

22.10.2004

Sifrol

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

EU/1/97/050/001-006
EU/1/97/050/009-012

26.10.2004

22.10.2004

Bondronat

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City,
Hertfordshire AL7
3AY, United
Kingdom

EU/1/96/012/001-013

26.10.2004

28.10.2004

Agenerase

28.10.2004

Paxene

28.10.2004

Cancidas

28.10.2004

Ziagen

28.10.2004

Ziagen

Greenford,
Glaxo
Middlesex UB6 0NN, United Kingdom

Group

Ltd,

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

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

Glaxo
Greenford,
Middlesex UB6 0NN, United Kingdom

Group

Ltd,

Greenford,
Glaxo
Middlesex UB6 0NN, United Kingdom

Group

Ltd,

EU/1/00/148/001-004

1.11.2004

EU/1/99/113/001-004

1.11.2004

EU/1/01/196/001-003

1.11.2004

EU/1/99/112/001-002

1.11.2004

EU/1/99/112/001-002

1.11.2004

28.10.2004

Ytracis

CIS bio international, Boite postale 32,
F-91192 Gif-sur-Yvette

EU/1/03/250/001

3.11.2004

28.10.2004 Mirapexin

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

EU/1/97/051/001-006
EU/1/97/051/009-012

1.11.2004

28.10.2004

Viraferon

28.10.2004

CoAprovel

28.10.2004

Karvezide

Schering Plough Europe, Rue de Stalle,
73, B-1180 Brussels
Stallestraat, 73, B-1180 Brussel

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

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

EU/1/99/128/001-008

1.11.2004

EU/1/98/086/001-020

2.11.2004

EU/1/98/085/001-020

1.11.2004

28.10.2004

Viread

Gilead Sciences International Limited,
Cambridge CB1 6GT United Kingdom

EU/1/01/200/001

1.11.2004

28.10.2004

Ammonaps

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

Immeuble ‘Le Guil-

EU/1/99/120/001-004

2.11.2004

28.10.2004

IntronA

Schering Plough Europe, Rue de Stalle,
73, B-1180 Brussels
Stallestraat, 73, B-1180 Brussel

EU/1/99/127/001-010
EU/1/99/127/040

2.11.2004

29.10.2004

PEGASYS

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City,
Hertfordshire AL7
3AY, United
Kingdom

EU/1/02/221/001-010

5.11.2004

26.11.2004

EN

Official Journal of the European Union

C 289/9

Date of the
decision

Name of the
medicinal
product

29.10.2004 MabCampath

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

ILEX Pharmaceutical Ltd, 1 & 3
Frederick Sanger Road, The Surrey
Research Park, Guildford, Surrey GU2
7YD, United Kingdom

EU/1/01/193/002

5.11.2004

29.10.2004

Liprolog

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

EU/1/01/195/001-015

5.11.2004

4.11.2004

Zometa

Novartis Europharm Limited, Wimble-
hurst Road, Horsham, West Sussex
RH12 5AB, United Kingdom

4.11.2004

Zyprexa

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

4.11.2004

4.11.2004

Zyprexa
Velotab

Zyprexa
Velotab

9.11.2004

Vfend

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

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

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

EU/1/01/176/001-006

8.11.2004

8.11.2004

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

EU/1/99/125/001-008

8.11.2004

EU/1/99/125/001-008

8.11.2004

EU/1/02/212/001-026

15.11.2004

12.11.2004

Arixtra

Sanofi-Synthelabo 174 avenue
France, F-75013 Paris

de

EU/1/02/206/009-017

16.11.2004

12.11.2004 Quixidar

N.V. Organon PO box 20, Klooster-
straat 6, 5340 EB Oss, The Nether-
lands

EU/1/02/207/009-017

16.11.2004