Summary of Community decisions on marketing authorizations in respect of medicinal products from 15/05/2004 to 15/06/2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-06-25
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 166/2

EN

Official Journal of the European Union

25.6.2004

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15/05/2004 to 15/06/2004

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

(2004/C 166/02)

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

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

01.06.2004

Levemir

04.06.2004

Abilifly

08.06.2004

TachoSil

15.06.2004

Oxybutynin

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

Otsuka Pharmaceutical Europe Ltd,
Common-wealth House,
2 Chalkhill Road,
Hammersmith,
London W6 8DW,
United Kingdom

Nycomed Austria GMBH,
St.-Peter-Strasse 25,
A-4020 Linz,

Nicobrand Limited,
189 Casteroe Road,
Coleraine,
Northerne Ireland

Number of the entry in the Community
Register

Date of notification

EU/01/04/278/001-009

04.06.2004

EU/1/04/276/001-020

08.06.2004

EU/1/04/277/001-004

11.06.2004

EU/1/03/270/001-002

18.06.2004

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

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community
Register

Date of notification

EU/1/02/201/001-006

25.05.2004

19.05.2004

Protopic

25.05.2004

Hepsera

26.05.2004

Viagra

26.05.2004

Combivir

26.05.2004

Ziagen

Fujisawa GmbH,
Neumarkter Str. 61,
D-81673 München,

Sciences

Gilead
Limited,
Cambridge CB1 6GT
United Kingdom

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

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

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

International

EU/1/03/251/001

27.05.2004

EU/1/98/077/001-012

01.06.2004

EU/1/98/058/001-002

01.06.2004

EU/1/99/112/001-002

01.06.2004

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C 166/3

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

26.05.2004

Taxotere

Aventis Pharma S.A.,
20 avenue Raymond Aron,
92165 Antony Cedex, France

Number of the entry in the Community
Register

Date of notification

EU/1/95/002/001-002

01.06.2004

26.05.2004

TRIZIVIR

01.06.2004

Vivanza

01.06.2004

Levitra

01.06.2004

Epivir

08.06.2004

Remicade

08.06.2004

Remicade

08.06.2004

Fuzeon

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

Bayer AG,
D-51368 Leverkusen,

Bayer AG,
D-51368 Leverkusen,

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

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

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

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

EU/1/00/156/001-003

01.06.2004

EU/1/03/249/001-012

07.06.2004

EU/1/03/248/001-012

07.06.2004

EU/1/96/015/001-005

07.06.2004

EU/1/99/116/001-003

10.06.2004

EU/1/99/116/001-003

10.06.2004

EU/1/03/252/001-003

10.06.2004

08.06.2004

Arava

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

EU/1/99/118/001-010/

18.06.2004

08.06.2004

Vfend

09.06.2004

Vfend

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

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

EU/1/02/212/001-026

10.06.2004

EU/1/02/212/001-026

11.06.2004

10.06.2004

Arava

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

EU/1/99/118/001-010/

16.06.2004

10.06.2004

Viread

Sciences

Gilead
Limited,
Cambridge CB1 6GT
United Kingdom

International

EU/1/01/200/001

14.06.2004

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25.6.2004

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community
Register

Date of notification

10.06.2004

Viread

10.06.2004

Herceptin

10.06.2004

Humira

10.06.2004

Trudexa

15.06.2004

Xigris

International

EU/1/01/200/001

15.06.2004

Sciences

Gilead
Limited,
Cambridge CB1 6GT
United Kingdom

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

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

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

Eli Lilly Nederland B.V.,
Grootslag 1-5,
3991 RA Houten,
Nederland

EU/1/00/145/001

14.06.2004

EU/1/03/256/001-006

14.06.2004

EU/1/03/257/001-006

14.06.2004

EU/1/02/225/001-002

17.06.2004