Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 April to 15 May 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-05-31
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 129/8

EN

Official Journal of the European Communities

31.5.2002

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 April to 15 May 2002

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

(2002/C 129/04)

— Issuing of a marketing authorisation (Article 12 of 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

18.4.2002

Invanz

19.4.2002

MicardisPlus

19.4.2002

BolusacPlus

22.4.2002

PritorPlus

15.5.2002

Tracleer

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

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

Glaxo Group Ltd
Greenford Road
Greenford
Middlesex UB6 0NN
United Kingdom

Actelion Registration Ltd
90 Fetter Lane (ground floor)
London EC4A 7JP
United Kingdom

EU/1/02/216/001

22.4.2002

EU/1/02/213/001-010

23.4.2002

EU/1/02/214/001-010

23.4.2002

EU/1/02/215/001-010

24.4.2002

EU/1/02/220/001-005

17.5.2002

15.5.2002

Ebixa

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby

EU/1/02/219/001-006

17.5.2002

— Modification of a marketing authorisation (Article 12 of 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

12.4.2002

Sustiva

Bristol-Myers Squibb
Pharma (UK) Limited
Wedgwood Way
Stevenage
Herts SG1 4QN
United Kingdom

EU/1/99/110/001-005

24.4.2002

16.4.2002

Taxotere

Aventis Pharma SA
20, avenue Raymond-Aron
F-92165 Antony Cedex

EU/1/95/002/001-002

19.4.2002

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

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C 129/9

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

16.4.2002

Aerius

16.4.2002

Allex

16.4.2002

Azomyr

16.4.2002

Neoclarityn

16.4.2002

Opulis

16.4.2002

Aerius

16.4.2002

Allex

16.4.2002

Azomyr

16.4.2002

Neoclarityn

16.4.2002

Opulis

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

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

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

EU/1/00/160/014-021

18.4.2002

EU/1/00/159/014-021

18.4.2002

EU/1/00/157/014-021

18.4.2002

EU/1/00/161/014-021

18.4.2002

EU/1/00/158/014-021

18.4.2002

EU/1/00/160/022-034

18.4.2002

EU/1/00/159/022-034

18.4.2002

EU/1/00/157/022-034

18.4.2002

EU/1/00/161/022-034

18.4.2002

EU/1/00/158/022-034

18.4.2002

18.4.2002

Mirapexin

Pharmacia Entreprises SA
6, Circuit de la Foire Internationale
L-1347 Luxembourg

EU/1/97/051/001-006
EU/1/97/051/009-012

22.4.2002

18.4.2002

Orgalutran

18.4.2002

Patrex

18.4.2002

Viagra

NV Organon
PO Box 20
Kloosterstraat 6
5340 BH Oss
Nederland

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/00/130/001-002

22.4.2002

EU/1/98/078/001-012

22.4.2002

EU/1/98/077/001-012

22.4.2002

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Official Journal of the European Communities

31.5.2002

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

18.4.2002

Optison

18.4.2002

Ceprotin

18.4.2002

Karvezide

18.4.2002

Fasturtec

19.4.2002

IntronA

19.4.2002

Viraferon

19.4.2002

Coaprovel

19.4.2002

Cetrotide

19.4.2002

Cetrotide

19.4.2002

Integrelin

19.4.2002

Optruma

19.4.2002

Quadramet

23.4.2002

Taxotere

23.4.2002

Sifrol

Mallinckrodt Medical GmbH
Josef-Dietzgen-Straße 1–3
D-53773 Hennef

Baxter AG
Industriestraße 67
A-1220 Wien

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

Sanofi Synthelabo
174, avenue de France
F-75013 Paris

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

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

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

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

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

CIS bio international
BP 32
F-91192 Gif-sur-Yvette Cedex
(CEA-CEN Route Nationale 306,
F-Sarclay)

Aventis Pharma SA
20, avenue Raymond-Aron
F-92165 Antony Cedex

Boehringer Ingelheim International
GmbH
Binger Straße 173
D-55216 Ingelheim am Rhein

EU/1/98/065/001-002

22.4.2002

EU/1/01/190/001-002

22.4.2002

EU/1/98/085/001-010

22.4.2002

EU/1/00/170/002

22.4.2002

EU/1/99/127/001-044

23.4.2002

EU/1/99/128/001-037

23.4.2002

EU/1/98/086/001-010

23.4.2002

EU/1/99/100/001-003

23.4.2002

EU/1/99/100/001-003

23.4.2002

EU/1/99/109/001-002

23.4.2002

EU/1/98/074/001-004

23.4.2002

EU/1/97/057/001

23.4.2002

EU/1/95/002/001-002

25.4.2002

EU/1/97/050/001-006
EU/1/97/050/009-012

29.4.2002

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C 129/11

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

23.4.2002

Helicobacter test
INFAI

25.4.2002

Refludan

29.4.2002

SonoVue

29.4.2002

Ammonaps

29.4.2002

MabCampath

29.4.2002

Optison

2.5.2002

Helicobacter test
INFAI

2.5.2002

Venvia

2.5.2002

Avandia

2.5.2002

Nyracta

7.5.2002

Sustiva

7.5.2002

DaTSCAN

Institut

für biomedizinische

INFAI,
Analytik und NMR-Imaging GmbH
Universitätsstraße 142
D-44799 Bochum

Schering AG
Brüningstraße 50
D-13342 Berlin

Bracco International BV
Strawinskylaan 3051
1077ZX Amsterdam
Nederland

Orphan Europe
Immeuble ‘Le Guillaumet’
F-92046 Paris La Défense

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

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

Institut

für biomedizinische

INFAI,
Analytik und NMR-Imaging GmbH
Universitätsstraße 142
D-44799 Bochum

SmithKline Beecham plc
New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

SmithKline Beecham plc
New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

SmithKline Beecham plc
New Horizons Court
Brentford
Middlesex TW8 9EP
United Kingdom

Bristol-Myers Squibb
Pharma (UK) Limited
Wedgwood Way
Stevenage
Herts SG1 4QN
United Kingdom

Nycomed Amersham plc
Little Chalfont
Buckinhamshire HP7 9NA
United Kingdom

EU/1/97/045/001

25.4.2002

EU/1/97/035/001-004

30.4.2002

EU/1/01/177/001-002

1.5.2002

EU/1/99/120/001-004

2.5.2002

EU/1/01/193/001

1.5.2002

EU/1/98/065/001-002

2.5.2002

EU/1/97/045/002

6.5.2002

EU/1/00/138/001-012

14.5.2002

EU/1/00/137/001-012

7.5.2002

EU/1/00/139/001-012

7.5.2002

EU/1/99/110/001-005

9.5.2002

EU/1/00/135/001-002

9.5.2002

C 129/12

EN

Official Journal of the European Communities

31.5.2002

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

7.5.2002

Pegintron

7.5.2002

Viraferonpeg

7.5.2002

Avonex

7.5.2002

Avonex

15.5.2002

CellCept

15.5.2002

Luveris

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

Biogen France SA
‘Le Capitole’
55, avenue des Champs Pierreux
F-92012 Nanterre Cedex

Biogen France SA
‘Le Capitole’
55, avenue des Champs Pierreux
F-92012 Nanterre Cedex

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

EU/1/00/131/001-050

13.5.2002

EU/1/00/132/001-050

13.5.2002

EU/1/97/033/001-002

13.5.2002

EU/1/97/033/001-002

13.5.2002

EU/1/96/005/001-006

17.5.2002

EU/1/00/155/001-006

17.5.2002

— Modification of a marketing authorisation (Article 34 of 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

26.4.2002

Locatim

Biokema Anstalt
Aeulestraße 38
9490 Vaduz
Fürstentum Liechtenstein

EU/2/99/011/001

30.4.2002

— Lifting of suspension of a marketing authorisation (Article 34 of 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

26.4.2002

Econor

Novartis Animal Health Austria GmbH
Biochemiestraße 10
A-6250 Kundl

EU/2/98/010/001-024

30.4.2002

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.