Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 March 2003 to 15 April 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-04-25
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

25.4.2003

EN

Official Journal of the European Union

C 99/5

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 March 2003 to 15 April 2003

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

(2003/C 99/04)

— 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

No of the entry in the
Community Register

Date of
notification

24.3.2003

Ytracis

27.3.2003

Bextra

27.3.2003

Kudeq

27.3.2003

Valdyn

CIS bio international
Boîte postale 32
F-91192 Gif-sur-Yvette

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

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

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

EU/1/03/250/001

27.3.2003

EU/1/02/239/001-024

31.3.2003

EU/1/02/244/001-024

31.3.2003

EU/1/02/242/001-024

31.3.2003

— 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

No of the entry in the
Community Register

Date of
notification

27.2.2003

Aranesp

27.2.2003

Nespo

17.3.2003

Optison

17.3.2003

Actos

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

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

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

Amersham Health AS
Nycoveien 1-2
PO Box 4220
Nydalen
N-0401 Oslo

Takeda Europe
R & D Centre Ltd
Savanah House,
11/12 Charles II Street
London SW1Y 4QU
United Kingdom

EU/1/01/185/001-032

24.3.2003

EU/1/01/184/001-032

24.3.2003

EU/1/98/065/001-002

19.3.2003

EU/1/00/150/001-010

19.3.2003

C 99/6

EN

Official Journal of the European Union

25.4.2003

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

No of the entry in the
Community Register

Date of
notification

17.3.2003

Glustin

17.3.2003

Sonata

17.3.2003

ViraferonPeg

17.3.2003

Pegintron

17.3.2003

Caelyx

17.3.2003

Zerene

17.3.2003

Vistide

17.3.2003

NeoRecormon

17.3.2003

Ovitrelle

17.3.2003

Neoclarityn

17.3.2003

Aerius

Takeda Europe
R & D Centre Ltd
Savanah House,
11/12 Charles II Street
London SW1Y 4QU
United Kingdom

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

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

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

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

Wyeth Research (UK) Limited
Huntercombe Lane South
Taplow Maidenhead
Berkshire SL6 0PH
United Kingdom

Pharmacia Enterprises SA
6, Circuit de la Foire Internationale
BP 2507
L-1347 Luxembourg

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

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

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

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

EU/1/00/151/001-008

19.3.2003

EU/1/99/102/001-008

19.3.2003

EU/1/00/132/001-050

19.3.2003

EU/1/00/131/001-050

19.3.2003

EU/1/96/011/001-004

19.3.2003

EU/1/99/099/001-006

19.3.2003

EU/1/97/037/001

19.3.2003

EU/1/97/031/001-013,
EU/1/97/031/019-044

19.3.2003

EU/1/00/165/001-006

19.3.2003

EU/1/00/161/001-034

19.3.2003

EU/1/00/160/001-034

19.3.2003

25.4.2003

EN

Official Journal of the European Union

C 99/7

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

No of the entry in the
Community Register

Date of
notification

17.3.2003

Azomyr

17.3.2003

Allex

17.3.2003

Opulis

17.3.2003

Quadramet

20.3.2003

Arixtra

20.3.2003

Quixidar

20.3.2003

Iscover

24.3.2003

Liprolog

24.3.2003

Zometa

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

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

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

CIS bio international
Boîte postale 32
F-91192 Gif-sur-Yvette

Sanofi-Synthelabo
174, avenue de France
F-75013 Paris

NV Organon
PO Box 20
Kloosterstraat 6
5340 EB Oss
Nederland

EU/1/00/157/001-034

19.3.2003

EU/1/00/159/001-034

19.3.2003

EU/1/00/158/001-034

19.3.2003

EU/1/97/057/001

20.3.2003

EU/1/02/206/001-004

24.3.2003

EU/1/02/207/001-004

24.3.2003

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

EU/1/98/070/004a-004b

24.3.2003

Eli Lilly Nederland BV
Grootslag 1-5
3991 RA Houten
Nederland

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

EU/1/01/195/001-015

27.3.2003

EU/1/01/176/004-006

27.3.2003

24.3.2003

Plavix

Sanofi Pharma Bristol-Myers Squibb
SNC
174, avenue de France
F-75013 Paris

EU/1/98/069/004a-004b

27.3.2003

24.3.2003

Integrelin

24.3.2003

Gonal-f

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

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

EU/1/99/109/001-002

27.3.2003

EU/1/95/001/001-031

27.3.2003

C 99/8

EN

Official Journal of the European Union

25.4.2003

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

No of the entry in the
Community Register

Date of
notification

24.3.2003

SonoVue

24.3.2003

Agenerase

Bracco International BV
Strawinskylaan 3051
1077ZX Amsterdam
Nederland

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/01/177/001-002

27.3.2003

EU/1/00/148/001-004

27.3.2003

27.3.2003

Viread

Gilead Sciences International Limited
Cambridge CB1 6 GT
United Kingdom

EU/1/01/200/001

31.3.2003

8.4.2003

Xapit

8.4.2003

Ziagen

8.4.2003

Fabrazyme

8.4.2003

Osigraft

8.4.2003

MabCampath

9.4.2003

Opatanol

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Genzyme Europe BV
Gooimeer 10
Naarden 1411 DD
Nederland

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

ILEX Pharmaceutical Ltd
1 & 3 Frederick Sanger Road
The Surrey Research Park
Guildford
Surrey GU2 7YD
United Kingdom

Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
Hemel Hempstead
Herts HP2 7UD
United Kingdom

EU/1/02/208/001-008

10.4.2003

EU/1/99/112/002

10.4.2003

EU/1/01/188/001-006

10.4.2003

EU/1/01/179/001

14.4.2003

EU/1/01/193/001

10.4.2003

EU/1/02/217/001-002

11.4.2003

25.4.2003

EN

Official Journal of the European Union

C 99/9

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

No of the entry in the
Community Register

Date of
notification

9.4.2003

Rayzon

9.4.2003

Dynastat

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/1/02/210/001-008

11.4.2003

EU/1/02/209/001-008

11.4.2003

9.4.2003

Daquiran

Dr. Karl Thomae GmbH
Birkendorfferstraße 65
D-88397 Biberach/Riss

EU/1/97/052/001-006,
EU/1/97/052/009-010

11.4.2003

9.4.2003

Cancidas

10.4.2003

Ferriprox

10.4.2003

Infergen

10.4.2003

Panretin

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

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

Yamanouchi Europe BV
Elisabethhof 19
2353 EW Leiderdorp
Nederland

Ligand Pharmaceuticals UK Ltd
Innovis House
108 High Street
Crawley
West Sussex RH10 1BB
United Kingdom

EU/1/01/196/001-003

11.4.2003

EU/1/99/108/001

15.4.2003

EU/1/98/087/001-003

15.4.2003

EU/1/00/149/001

15.4.2003

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

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorisation

No of the entry in the
Community Register

Date of
notification

17.3.2003

Olansek

Eli Lilly UK Ltd
Kingsclere Road
Basingstoke
Hampshire
United Kingdom

EU/1/96/021/001-010

19.3.2003

C 99/10

EN

Official Journal of the European Union

25.4.2003

— 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

No of the entry in the
Community Register

Date of
notification

2.4.2003

Advocate

Bayer AG
D-51368 Leverkusen

EU/2/03/039/001-012

4.4.2003

— Modification 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

No of the entry in the
Community Register

Date of
notification

17.3.2003

Fevaxyn Pentofel

Fort Dodge Laboratories
Ireland
Finisklin Industrial
Estate
Sligo
Ireland

EU/2/96/002/001-003

19.3.2003

17.3.2003

Metacam

20.3.2003

Ibaflin

9.4.2003

Nobivac Bb

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/001,
EU/2/97/004/003-008

19.3.2003

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/00/022/009-012

24.3.2003

EU/2/02/034/001

11.4.2003

9.4.2003

Bayovac CSF E2

Bayer AG
Geschäftsbereich Tiergesundheit
D-51368 Leverkusen

EU/2/00/025/001-004

11.4.2003

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.