Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 June 2005 to 30 June 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-07-29
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 186/2

EN

Official Journal of the European Union

29.7.2005

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 June 2005 to 30 June 2005

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

(2005/C 186/02)

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

Accepted

Date of the
decision

Name of the
medicinal
product

16.6.2005

Tracleer

20.6.2005

Abilify

24.6.2005

Vistide

28.6.2005

Taxotere

28.6.2005

Invirase

28.6.2005

Osigraft

28.6.2005

Herceptin

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Actelion Registration Ltd, BSI Building
13th Floor, 389 Chiswick High Road,
London W4 4AL, United Kingdom

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

Pfizer Enterprises SARL, 51, Avenue
Kennedy — Rond Point du Kirchberg,
L-1855 Luxembourg, Grand-Duché de
Luxembourg.

Aventis
Pharma
Raymond Aron,
Cedex, France

S.A., 20 avenue
92165 Antony

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

Howmedica International S. de R.L.,
Corporation,
Division
Stryker
Raheen
Estate, Raheen,
Limerick, Ireland

of
Industrial

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

EU/1/02/220/001-005

20.6.2005

EU/1/04/276/021-032

22.6.2005

EU/1/97/037/001

28.6.2005

EU/1/95/002/001-002

30.6.2005

EU/1/96/026/001-002

30.6.2005

EU/1/01/179/001

4.7.2005

EU/1/00/145/001

30.6.2005

28.6.2005

Remicade

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

EU/1/99/116/001-003

30.6.2005

28.6.2005

Remicade

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

EU/1/99/116/001-003

30.6.2005

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

Date of the
decision

Name of the
medicinal
product

24.6.2005

Valdyn

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

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

EU/1/02/244/001-024

28.6.2005

24.6.2005

Rayzon

Pharmacia Europe EEIG, Sandwich,
Kent, CT13 9NJ, United Kingdom

EU/1/02/210/001-008

29.6.2005

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

29.7.2005

EN

Official Journal of the European Union

C 186/3

— Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93):

Accepted

Date of the
decision

Name of the
medicinal
product

16.6.2005

Aivlosin

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

ECO Animal Health Ltd, 78 Coombe
Road New Malden Surrey KT3 4QS
United Kingdom

EU/2/04/044/001

20.6.2005

21.6.2005

Dexdomitor

Orion Corporation, Orionintie 1, FIN-
02200 Espoo, Suomi

EU/2/02/033/001

23.6.2005

24.6.2005

Dexdomitor

Orion Corporation, Orionintie 1, FIN-
02200 Espoo, Suomi

EU/2/02/033/001

28.6.2005

24.6.2005

DRAXXIN

24.6.2005

Metacam

24.6.2005

Porcilis Pesti

PFIZER Ltd, Ramsgate Road, Sand-
wich, Kent CT 13 9NJ, United
Kingdom

Boehringer
Ingelheim Vetmedica
GmbH, 55216 Ingelheim am Rhein,
Deutschland

International B.V., Wim de
Intervet
Körverstraat 35, 5831 AN Boxmeer,
Nederland

EU/2/03/041/001-005

28.6.2005

EU/2/97/004/001-011

28.6.2005

EU/2/99/016/001-006

28.6.2005

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 Medicines Agency
7, Westferry Circus, Canary Wharf
London E14 4HB
United Kingdom