Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 February 2005 to 15 March 2005 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-03-24
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

24.3.2005

EN

Official Journal of the European Union

C 75/11

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 February 2005 to 15 March 2005

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

(2005/C 75/06)

— Issuing 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 notification

17.2.2005

Quintanrix

21.2.2005

Truvada

21.2.2005

Orfadin

21.2.2005

Azilect

21.2.2005

Prialt

10.3.2005

Zonegran

GlaxoSmithKline Biologicals
s.a., rue de l'Institut 89,
B-1330 Rixensart

Gilead Sciences International
Limited, Granta Park Abington
Cambridge CB1 6GT United
Kingdom

Swedish Orphan International
AB, Drottninggatan 98,
S-111 60 Stockholm

Teva Pharma GmbH, Kandel-
strasse 10, D-79199 Kirch-
zarten

Elan Pharma International Ltd,
WIL House, Shannon Business
Park, Shannon, County Clare,
Ireland

Eisai Limited, 3, Shortlands,
London W6 8EE United
Kingdom

EU/1/04/301/001-005

21.2.2005

EU/1/04/305/001

24.2.2005

EU/1/04/303/001-003

24.2.2005

EU/1/04/304/001-007

24.2.2005

EU/1/04/302/001-003

24.2.2005

EU/1/04/307/001-004

14.3.2005

— 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 notification

17.2.2005

Caelyx

21.2.2005

Reyataz

23.2.2005

Pegasys

23.2.2005

Tamiflu

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

Schering Plough Europe, Rue
de Stalle, 73, B-1180 Bruxelles
– Stallestraat, 73 – B-1180
Brussel

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

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

EU/1/96/011/001-004

21.2.2005

EU/1/03/267/001-005

4.3.2005

EU/1/02/221/001-010

25.2.2005

EU/1/02/222/001-002

25.2.2005

C 75/12

EN

Official Journal of the European Union

24.3.2005

Date of the
decision

Name of the
medicinal product

Holder of the marketing
authorisation

Number of the entry in
the Community Register

Date of notification

23.2.2005

Thyrogen

23.2.2005

Onsenal

28.2.2005

DaTSCAN

Genzyme Europe BV,
Gooimeer 10, Naarden 1411
DD, Nederland

Pharmacia-Pfizer EEIG, Rams-
gate Road, Sanwich, CT13 9NJ,
United Kingdom

Amersham plc, Amersham
Place, Little Chalfont, Bucks,
United Kingdom

EU/1/99/122/001-002

25.2.2005

EU/1/03/259/001-006

25.2.2005

EU/1/00/135/045-056

2.3.2005

28.2.2005

Nespo

Dompé Biotec SpA, Via San
Martino, 12, I-20122 Milano

EU/1/01/184/045-056

2.3.2005

28.2.2005

Aranesp

28.2.2005

NeuroBloc

Amgen Europe BV, Minervum
7061, 4817 ZK Breda, Neder-
land

Elan Pharma International Ltd.,
WIL House, Shannon Business
Park, Shannon, County Clare,
Ireland

EU/1/01/185/045-056

2.3.2005

EU/1/00/166/001-003

3.3.2005

3.3.2005

Replagal

TKT Europe AB, Rinkebyvägen
11B, S-182 36 Danderyd

EU/1/01/189/001-006

7.3.2005

3.3.2005

Emtriva

3.3.2005

Fabrazyme

3.3.2005

Orgalutran

Gilead Sciences International
Limited, Cambridge CB1 6GT
United Kingdom

Genzyme Europe BV,
Gooimeer 10, Naarden 1411
DD, Nederland

NV Organon, PO Box 20,
Kloosterstraat 6, 5340 BH Oss,
Nederland

EU/1/03/261/001-003

7.3.2005

EU/1/01/188/001-006

7.3.2005

EU/1/00/130/001-002

7.3.2005

7.3.2005

Ceprotin

Baxter AG, Industriesstrasse
67, A-1220 Vienna

EU/1/01/190/001-002

9.3.2005

7.3.2005

Ventavis

Schering AG, Müllerstrasse
170-178, D-13342 Berlin

EU/1/03/255/001-003

9.3.2005

7.3.2005

Mabthera

7.3.2005

Ketek

7.3.2005

Levviax

7.3.2005

Stocrin

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

Aventis Pharma SA,
20 Avenue Raymond Aron,
F-92160 Antony

Aventis Pharma SA,
20 Avenue Raymond Aron,
F-92160 Antony

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

EU/1/98/067/001-002

9.3.2005

EU/1/01/191/001-005

9.3.2005

EU/1/01/192/001-005

9.3.2005

EU/1/99/111/001-009

9.3.2005

24.3.2005

EN

Official Journal of the European Union

C 75/13

Date of the
decision

Name of the
medicinal product

Holder of the marketing
authorisation

Number of the entry in
the Community Register

Date of notification

7.3.2005

Sustiva

7.3.2005

Comtess

7.3.2005

Comtan

7.3.2005

Viread

10.3.2005

Enbrel

10.3.2005

Enbrel

10.3.2005

Gonal-f

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

Orion Corporation, Orionintie
1, FIN-02200 Espoo

Novartis Europharm Limited,
Wimblehurst Road, Horsham,
West Sussex RH12 5AB,
United Kingdom

Gilead Sciences International
Limited, Cambridge CB1 6GT
United Kingdom

Wyeth Europa Limited Hunter-
combe Lane South, Taplow,
Maidenhead, Berkshire, SL6
0PH, United Kingdom

Wyeth Europa Limited Hunter-
combe Lane South, Taplow,
Maidenhead, Berkshire, SL6
0PH, United Kingdom

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

EU/1/99/110/001-009

9.3.2005

EU/1/98/082/001-004

9.3.2005

EU/1/98/081/001-004

9.3.2005

EU/1/01/200/001

9.3.2005

EU/1/99/126/001-005

14.3.2005

EU/1/99/126/001-005

14.3.2005

EU/1/95/001/033-035

14.3.2005

— Issuing of a marketing authorisation (Article 34 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 notification

23.2.2005

23.2.2005

Purevax RCPCh
FeLV

Merial, 29 Avenue Tony
Garnier, F-69007 Lyon

Purevax RCP
FeLV

Merial, 29 Avenue Tony
Garnier, F-69007 Lyon

23.2.2005

Purevax RCCh

23.2.2005

Purevax RCPCh

23.2.2005

Purevax RC

23.2.2005

Purevax RCP

Merial, 29 Avenue Tony
Garnier, F-69007 Lyon

Merial, 29 Avenue Tony
Garnier, F-69007 Lyon

Merial, 29 Avenue Tony
Garnier, F-69007 Lyon

Merial, 29 Avenue Tony
Garnier, F-69007 Lyon

EU/2/04/047/001-002

25.2.2005

EU/2/04/048/001-002

25.2.2005

EU/2/04/049/001-002

25.2.2005

EU/2/04/050/001-002

25.2.2005

EU/2/04/051/001-002

25.2.2005

EU/2/04/052/001-002

25.2.2005