Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 August 2004 to 15 September 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-09-24
Institutions: European Commission
Subjects: market approval, medicinal product

C 237/4

EN

Official Journal of the European Union

24.9.2004

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 August 2004 to 15 September 2004

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

(2004/C 237/04)

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

Date of the
decision

Name of the
medicinal
product

7.9.2004

Yondelis

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

Pharma Mar SA Sociedad Unipersonal,
Avda de los Reyes, 1, P.I. La Mina-
Norte
Viejo,
Madrid

Colmenar

E-28770

—

9.9.2004

— 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

17.8.2004

Cetrotide

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

EU/1/99/100/001-003

20.8.2004

18.8.2004

Cystagon

Orphan Europe,
laumet’, F-92046 Paris La Défense

Immeuble ‘Le Guil-

EU/1/97/039/001-004

23.8.2004

18.8.2004

BeneFIX

Europa

Wyeth
Ltd, Huntercombe
Lane, South, Taplow, Maidenhead,
Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-003

23.8.2004

18.8.2004

Ziagen

18.8.2004

Zavesca

Glaxo
Greenford,
Middlesex UB6 0NN, United Kingdom

Group

Ltd,

EU/1/99/112/001-002

23.8.2004

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

EU/1/02/238/001

23.8.2004

23.8.2004

ViraferonPeg

Schering Plough Europe, Rue de Stalle/
Stallestraat, 73, B-1180 Brussels

EU/1/00/132/001-050

25.8.2004

23.8.2004

Tracleer

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

EU/1/02/220/001-005

25.8.2004

23.8.2004

PegIntron

Schering Plough Europe, Rue de Stalle/
Stallestraat, 73, B-1180 Brussels

EU/1/00/131/001-050

25.8.2004

24.8.2004

NovoMix

Novo Nordisk A/S, Novo Allé, DK-
2880 Bagsvaerd

EU/1/00/142/004-005
EU/1/00/142/007-010

26.8.2004

24.8.2004

NovoRapid

Novo Nordisk A/S, Novo Allé, DK-
2880 Bagsvaerd

31.8.2004

Luveris

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

London

EU/1/99/119/001, EU/1/
99/119/003,
EU/1/99/
119/005-014

26.8.2004

EU/1/00/155/001-006

2.9.2004

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

24.9.2004

EN

Official Journal of the European Union

C 237/5

Date of the
decision

Name of the
medicinal
product

31.8.2004

Ixense

31.8.2004

Tasmar

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

Europe R&D Centre

Ltd,
Takeda
Savanah House, 11/12 Charles
II
Street, London SW1Y 4QU, United
Kingdom

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

EU/1/01/181/001-007

2.9.2004

EU/1/97/044/001-006

2.9.2004

31.8.2004

Lantus

Aventis Pharma Deutschland GmbH,
D-65926 Frankfurt am Main

EU/1/00/134/022-029

2.9.2004

31.8.2004

Lantus

Aventis Pharma Deutschland GmbH,
D-65926 Frankfurt am Main

EU/1/00/134/005-007
EU/1/00/134/013-017

2.9.2004

31.8.2004

Optisulin

Aventis Pharma Deutschland GmbH,
D-65926,
am Main,
Deutschland

Frankfurt

EU/1/00/133/005-007

2.9.2004

2.9.2004

Rebetol

Schering Plough Europe, Rue de Stalle/
Stallestraat, 73, B-1180 Brussels

EU/1/99/107/001-003

6.9.2004

2.9.2004

Ferriprox

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

EU/1/99/108/001

6.9.2004

2.9.2004

Avandamet

SmithKline Beecham plc, 980 Great
West Road, Brentford, Middlesex,
TW8 9GS, United Kingdom

EU/1/03/258/007-012

6.9.2004

2.9.2004

Rapamune

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

EU/1/01/171/001-010

6.9.2004

2.9.2004

Integrilin

Schering Plough Europe, Rue de Stalle/
Stallestraat, 73, B-1180 Brussels

EU/1/99/109/001-002

6.9.2004

2.9.2004

Refludan

Park,
Pharmion
Limited, Granta
McClintock Building, Granta
Park,
Great Abington, Cambridge, CB1
6GX, United Kingdom

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

EU/1/97/035/001-004

6.9.2004

9.9.2004

Aranesp

Amgen Europe BV, Minervum 7061,
4817 ZK Breda, Netherlands

EU/1/01/185/001-032

13.9.2004

9.9.2004

Trisenox

Cell Therapeutics (UK) Ltd, 100 Pall
Mall, London SW1Y 5HP, United
Kingdom

EU/1/02/204/001

13.9.2004

9.9.2004

Kaletra

Abbott Laboratories Ltd, Queenbor-
ough,
5EL, United
Kingdom

Kent ME11

EU/1/01/172/001-003

13.9.2004

C 237/6

EN

Official Journal of the European Union

24.9.2004

Date of the
decision

Name of the
medicinal
product

9.9.2004

Kaletra

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

Abbott Laboratories Ltd, Queenbor-
ough,
5EL, United
Kingdom

Kent ME11

EU/1/01/172/001-003

13.9.2004

9.9.2004

Crixivan

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

EU/1/96/024/001-010

13.9.2004

9.9.2004

Nespo

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

EU/1/01/184/001-032

13.9.2004

9.9.2004

Rebetol

Schering Plough Europe, Rue de Stalle/
Stallestraat, 73, B-1180 Brussels

EU/1/99/107/001-003

13.9.2004

9.9.2004

Fortovase

Roche Registration Ltd, 40 Broadwater
Road, Welwyn Garden City, Hertford-
shire AL7 3AY, United Kingdom

EU/1/98/075/001-002

13.9.2004

9.9.2004

Synagis

Abbott Laboratories Ltd, Queenbor-
ough,
5EL, United
Kingdom

Kent ME11

EU/1/99/117/001-002

13.9.2004

10.9.2004

Invirase

Roche Registration Ltd, 40 Broadwater
Road, Welwyn Garden City, Hertford-
shire, AL7 3AY, United Kingdom

EU/1/96/026/001

14.9.2004

13.9.2004

IntronA

Schering Plough Europe, Rue de Stalle/
Stallestraat, 73, B-1180 Brussels

EU/1/99/127/001-044

15.9.2004

13.9.2004

Viraferon

Schering Plough Europe, Rue de Stalle/
Stallestraat, 73, B-1180 Brussels

EU/1/99/128/001-037

15.9.2004

13.9.2004

Tracleer

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

EU/1/02/220/001-005

15.9.2004

15.9.2004

Xenical

Roche Registration Ltd, 40 Broadwater
Road, Welwyn Garden City, Hertford-
shire AL7 3AY, United Kingdom

EU/1/98/071/001-006

17.9.2004

— Issuing of a marketing authorisation (Article 34 of Council Regulation (EEC) No 2309/93): Accepted

Date of the
decision

Name of the
medicinal
product

2.9.2004

Nobivac Piro

Holder of the marketing authorisation

Number of the entry in the
Community Register

Date of
notification

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

EU/2/04/046/001-003

6.9.2004

9.9.2004

Aivlosin

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

EU/2/04/044/001

13.9.2004

13.9.2004

Previcox

Merial SAS. 4 Chemin de Calquet, F-
31300 Toulouse

EU/2/04/045/001-004

15.9.2004

24.9.2004

EN

Official Journal of the European Union

C 237/7

— 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

Number of the entry in the
Community Register

Date of
notification

31.8.2004

DRAXXIN

Pfizer Ltd, Ramsgate Road, Sandwich,
Kent CT 13 9NJ, United Kingdom

EU/2/03/041/001-005

2.9.2004