25.6.2004

Official Journal of the European Union

C 166/2

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

Number of the entry in the Community Register

Date of notification

01.06.2004

Levemir

Novo Nordisk A/S,

Novo Allé,

DK-2880 Bagsvaerd,

EU/01/04/278/001-009

04.06.2004

Abilifly

Otsuka Pharmaceutical Europe Ltd,

Common-wealth House,

2 Chalkhill Road,

Hammersmith,

London W6 8DW,

United Kingdom

EU/1/04/276/001-020

08.06.2004

TachoSil

Nycomed Austria GMBH,

St.-Peter-Strasse 25,

A-4020 Linz,

EU/1/04/277/001-004

11.06.2004

15.06.2004

Oxybutynin

Nicobrand Limited,

189 Casteroe Road,

Coleraine,

Northerne Ireland

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

19.05.2004

Protopic

Fujisawa GmbH,

Neumarkter Str. 61,

D-81673 München,

EU/1/02/201/001-006

25.05.2004

Hepsera

Gilead Sciences International Limited,

Cambridge CB1 6GT

United Kingdom

EU/1/03/251/001

27.05.2004

26.05.2004

Viagra

Pfizer Limited,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/98/077/001-012

01.06.2004

26.05.2004

Combivir

Glaxo Group Ltd.,

Greenford Road,

Greenford,

Middlesex UB6 0NN

United Kingdom

EU/1/98/058/001-002

01.06.2004

26.05.2004

Ziagen

Glaxo Group Ltd,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/99/112/001-002

01.06.2004

26.05.2004

Taxotere

Aventis Pharma S.A.,

20 avenue Raymond Aron,

92165 Antony Cedex, France

EU/1/95/002/001-002

01.06.2004

26.05.2004

TRIZIVIR

Glaxo Group Ltd,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/00/156/001-003

01.06.2004

Vivanza

Bayer AG,

D-51368 Leverkusen,

EU/1/03/249/001-012

07.06.2004

01.06.2004

Levitra

Bayer AG,

D-51368 Leverkusen,

EU/1/03/248/001-012

07.06.2004

01.06.2004

Epivir

Glaxo Group Ltd.,

Greenford Road,

Greenford,

Middlesex UB6 0NN,

United Kingdom

EU/1/96/015/001-005

07.06.2004

08.06.2004

Remicade

Centocor B.V.,

Einsteinweg 101,

2333 CB Leiden,

Nederland

EU/1/99/116/001-003

10.06.2004

08.06.2004

Remicade

Centocor B.V.,

Einsteinweg 101,

2333 CB Leiden,

Nederland

EU/1/99/116/001-003

10.06.2004

08.06.2004

Fuzeon

Roche Registration Limited,

40 Broadwater Road,

Welwyn Garden City,

Hertfordshire AL7 3AY,

United Kingdom

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

Pfizer Limited,

Sandwich,

Kent CT13 9NJ,

United Kingdom

EU/1/02/212/001-026

10.06.2004

09.06.2004

Vfend

Pfizer Limited,

Sandwich,

Kent CT13 9NJ,

United Kingdom

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

Gilead Sciences International Limited,

Cambridge CB1 6GT

United Kingdom

EU/1/01/200/001

14.06.2004

10.06.2004

Viread

Gilead Sciences International Limited,

Cambridge CB1 6GT

United Kingdom

EU/1/01/200/001

15.06.2004

10.06.2004

Herceptin

Roche Registration Limited,

40 Broadwater Road,

Welwyn Garden City,

Hertfordshire AL7 3AY,

United Kingdom

EU/1/00/145/001

14.06.2004

10.06.2004

Humira

Abbott Laboratories Ltd.,

Queenborough,

Kent ME11 5EL,

United Kingdom

EU/1/03/256/001-006

14.06.2004

10.06.2004

Trudexa

Abbott Laboratories Ltd.,

Queenborough,

Kent ME11 5EL,

United Kingdom

EU/1/03/257/001-006

14.06.2004

15.06.2004

Xigris

Eli Lilly Nederland B.V.,

Grootslag 1-5,

3991 RA Houten,

Nederland

EU/1/02/225/001-002

17.06.2004