Summary of Community decisions on marketing authorization in respect of medicinal products from 15/04/2004 to 15/05/2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93OJ L 214 du 24 August 1993, page 1.)
Date: 2004-07-02
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

C 172/4

EN

Official Journal of the European Union

2.7.2004

Summary of Community decisions on marketing authorization in respect of medicinal products
from 15/04/2004 to 15/05/2004

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

(2004/C 172/03)

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

26.04.2004

Velcade

28.04.2004

Lysodren

28.04.2004

Dukoral

Millenium Pharmaceuticals Ltd
Building 3 Chiswick Park
566 Chiswick High Road
Chiswick
London W4 5YA
United Kingdom

Laboratoire HRA Pharma
19, rue Frédérick Lemaitre
F-75020 Paris

SBL Vaccin AB
S-105 21 Stockholm

EU/1/04/274/001

28.04.2004

EU/1/04/273/001

30.04.2004

EU/1/03/263/001-003

03.05.2004

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

22.04.2004

Onsenal

22.04.2004

Kudeq

22.04.2004

Bextra

22.04.2004

Dynastat

22.04.2004

Rayzon

Pharmacia-Pfizer EEIG
Hillbottom Road
High Wycombe
Bucks HP12 4PX
United Kingdom

Pfizer Limited Sandwich
Kent CT13 9NJ
United Kingdom

Pharmacia-Pfizer EEIG
Hillbottom Road
High Wycombe
Bucks HP12 4PX
United Kingdom

Pharmacia Europe EEIG
Hillbottom Road
High Wycombe
Buckinghamshire HP12 4PX
United Kingdom

Pharmacia Europe EEIG
Hillbottom Road
High Wycombe
Buckinghamshire HP12 4PX
United Kingdom

EU/1/03/259/001-006

04.05.2004

EU/1/02/244/001-024

27.04.2004

EU/1/02/239/001-024

04.05.2004

EU/1/02/209/001-008

04.05.2004

EU/1/02/210/001-008

04.05.2004

(1) OJ L 214 du 24 August 1993, page 1.

2.7.2004

EN

Official Journal of the European Union

C 172/5

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

28.04.2004

Zerit

28.04.2004

Viracept

29.04.2004

Stocrin

29.04.2004

Sustiva

07.05.2004

Ferriprox

10.05.2004

Enbrel

11.05.2004

Cancidas

13.05.2004

Cancidas

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

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

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

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

Apotex Europe Ltd
Rowan House
41 London Street
Reading
Berkshire RG1 4PS
United Kingdom

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

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

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

EU/1/96/009/001-017

30.04.2004

EU/1/97/054/006

30.04.2004

EU/1/99/111/001-009

07.05.2004

EU/1/99/110/001-009

04.05.2004

EU/1/99/108/001

11.05.2004

EU/1/99/126/001-003

12.05.2004

EU/1/01/196/001-003

13.05.2004

EU/1/01/196/001-003

17.05.2004

Issuing of a marketing authorization (Article 34 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

07.05.2004

Equilis StrepE

Intervet International BV
Wim de Körverstraat, 35
5831 AN Boxmeer
Nederland

EU/2/04/043/001

11.05.2004

C 172/6

EN

Official Journal of the European Union

2.7.2004

Modification of a marketing authorization (Article 34 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

28.04.2004

SevoFlo

28.04.2004

Locatim

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Biokema Anstalt
Aeulestrasse 38
9490 Vaduz
Fürstentum Liechtenstein

EU/2/02/035/001-006

30.04.2004

EU/2/99/011/001

29.04.2004

Anyone wishing to consult the public assessment report on the medicinal products in question and the
decisions relating thereto is invited to contact:

The European Agency for the Evaluation of Medicinal products
7, Westferry Circus, Canary Wharf
LONDON E14 4HB
United Kingdom