Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 September 2004 to 15 October 2004(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-10-29
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

29.10.2004

EN

Official Journal of the European Union

C 266/5

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 September 2004 to 15 October 2004

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

(2004/C 266/04)

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

Date of the
decision

Name of the
medicinal
product

20.9.2004

Angiox

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of notifica-
tion

The Medicines Company UK Ltd, Suite
Park House, 11 Milton Park,
B,
Abingdon, Oxfordshire OX14 4RS,
United Kingdom

EU/1/04/289/001

22.9.2004

20.9.2004

Alimta

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

EU/1/04/290/001

22.9.2004

20.9.2004

Raptiva

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

London

EU/1/04/291/001-002

22.9.2004

21. 9.2004

Protelos

21. 9.2004

Osseor

27. 9.2004

Apidra

Laboratoires

Les
Garnier, F-92200 Neuilly-sur-Seine

Servier, 22,

Laboratoires

Les
Garnier, F-92200 Neuilly-sur-Seine

Servier, 22,

rue

EU/1/04/288/001-006

23.9.2004

rue

EU/1/04/287/001-006

23.9.2004

Aventis Pharma Deutschland GmbH,
Brueningstrasse 50, D-65926 Frank-
furt am Main,

EU/1/04/285/001-020

29. 9.2004

13.10.2004 Wilzin

Orphan Europe SARL,
Guillaumet’ F-92046 Paris-La-Défense

Immeuble ‘Le

EU/1/04/286/001-002

18.10.2004

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

Date of the
decision

Name of the
medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of notifica-
tion

20.9.2004

Remicade

Centocor BV, Einsteinweg 101, 2333
CB Leiden, Nederland

EU/1/99/116/001-003

22.9.2004

20.9.2004

Azomyr

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

EU/1/00/157/014-021

22.9.2004

20.9.2004

Aerius

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

EU/1/00/160/014-021

22.9.2004

20.9.2004

Neoclarityn

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

EU/1/00/161/014-021

22.9.2004

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

C 266/6

EN

Official Journal of the European Union

29.10.2004

Date of the
decision

Name of the
medicinal
product

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of notifica-
tion

20.9.2004

Lantus

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

EU/1/00/134/008-011
EU/1/00/134/018-021

22.9.2004

20.9.2004

Velcade

Ltd,
Millennium Pharmaceuticals,
Building 3, Chiswick Park, 566 Chis-
wick High Road, Chiswick, London,
W4 5YA United Kingdom

EU/1/04/274/001

22.9.2004

20.9.2004

Velcade

Janssen-Cilag International NV, Turn-
houtsewe 30, B–2340 Beerse

EU/1/04/274/001

23.9.2004

20.9.2004

Ovitrelle

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

London

EU/1/00/165/001-007

22.9.2004

21.9.2004

Carbaglu

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

Immeuble ‘Le Guil-

EU/1/02/246/001-002

23.9.2004

21.9.2004

KOGENATE
Bayer

Bayer AG, D-51368
Deutschland

Leverkusen,

EU/1/00/143/004-006

23.9.2004

23.9.2004

Remicade

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

EU/1/99/116/001-003

27.9.2004

24.9.2004

Insuman

Aventis Pharma Deutschland GmbH,
Brueningstrasse 50, D-65926 Frank-
furt am Main,

EU/1/97/030/065-084

29.9.2004

24.9.2004

InductOs

Ltd., Huntercombe
South, Taplow, Maidenhead,

Wyeth Europa
Lane
Berkshire, SL6 0PH, United Kingdom

EU/1/02/226/001

28.9.2004

24.9.2004

Enbrel

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

EU/1/99/126/001-003

28.9.2004

27.9.2004

SonoVue

Bracco International BV, Strawinsky-
1077ZX Amsterdam,
laan
Nederland

3051,

EU/1/01/177/001-002

29.9.2004

27.9.2004

Ceprotin

Baxter AG, Industriesstrasse 67, 1220
Vienna, Österreich

EU/1/01/190/001-002

29.9.2004

27.9.2004

Avonex

Biogen Idec France,
‘Le Capitole’ 55,
avenue des Champs Pierreux, F-92012
Nanterre Cedex

EU/1/97/033/001-003

30. 9.2004

13.10.2004

Revasc

Canyon Pharmaceuticals Ltd, 20-22
Bedford Row - WC1R 4JS London -
United Kingdom

Pharma

Aventis
SA, 20 Avenue
Raymond Aron, Antony Cedex F-
92165

EU/1/97/043/001-002

19.10.2004

18.10.2004

13.10.2004

Arava

Aventis Pharma Deutschland GmbH,
D-65926 Frankfurt am Main

EU/1/99/118/001-010

18.10.2004

29.10.2004

EN

Official Journal of the European Union

C 266/7

Date of the
decision

Name of the
medicinal
product

13.10.2004

Vaniqa

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of notifica-
tion

Shire Pharmaceutical Contracts Ltd,
Hampshire
Business
Park, Chineham, Basingstoke, Hamp-
shire RG24 8EP, United Kingdom

International

EU/1/01/173/001-003

18.10.2004

13.10.2004

NovoRapid

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

EU/1/99/119/001-014

18.10.2004

13.10.2004

Levviax

15.10.2004

Ketek

15.10.2004

Viramune

15.10.2004

Fuzeon

Aventis
Raymond Aron, F-92160 Antony

SA, 20 Avenue

Pharma

Aventis
Raymond Aron, F-92160 Antony

SA, 20 Avenue

Pharma

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

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

EU/1/01/192/001-005

19.10.2004

EU/1/01/191/001-005

19.10.2004

EU/1/97/055/001-002

19.10.2004

EU/1/03/252/001-003

20.10.2004

15.10.2004

NovoRapid

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

EU/1/99/119/001
EU/1/99/119/003
EU/1/99/119/005-014

19.10.2004

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

Date of the
decision

Name of the
medicinal
product

28.9.2004

Ixense

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of notifica-
tion

Europe R&D Centre

Ltd,
Takeda
Savanah House, 11/12 Charles
II
Street, London SW1Y 4QU, United
Kingdom

EU/1/01/181/001-007

30.9.2004