Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 May to 15 June 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-07-02
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 157/2

EN

Official Journal of the European Communities

2.7.2002

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

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

(2002/C 157/02)

— 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

17.5.2002

Memantine Merz
Pharmaceuticals
GmbH

Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100-104
D-60318 Frankfurt am Main

EU/1/02/218/001-006

22.5.2002

17.5.2002

Opatanol

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

EU/1/02/217/001-002

22.5.2002

— 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

17.5.2002

Rebif

17.5.2002

Agenerase

17.5.2002

Remicade

17.5.2002

Aerius

17.5.2002

Allex

17.5.2002

Azomyr

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

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

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

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

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

EU/1/98/063/001-006

22.5.2002

EU/1/00/148/001-004

22.5.2002

EU/1/99/116/001-003

22.5.2002

EU/1/00/160/001-013

22.5.2002

EU/1/00/159/001-013

22.5.2002

EU/1/00/157/001-013

22.5.2002

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Official Journal of the European Communities

C 157/3

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

17.5.2002

Neoclarityn

17.5.2002

Opulis

17.5.2002

Trisenox

22.5.2002

Herceptin

24.5.2002

Visudyne

24.5.2002

Synagis

24.5.2002

Zenapax

24.5.2002

Glivec

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

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

Cell Therapeutics (UK) Limited
100 Pall Mall
London SW 1Y 5HP
United Kingdom

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

Novartis Ophtalmics Europe Ltd
Delta House
Southwood Crescent
Southwood
Farnborough
Hants GU 14 0NL
United Kingdom

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

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

EU/1/00/161/001-013

22.5.2002

EU/1/00/158/001-013

22.5.2002

EU/1/02/204/001

22.5.2002

EU/1/00/145/001

27.5.2002

EU/1/00/140/001

28.5.2002

EU/1/99/117/001-002

28.5.2002

EU/1/99/098/001-002

28.5.2002

EU/1/01/198/001-006

29.5.2002

30.5.2002

Micardis

30.5.2002

Telmisartan

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

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

EU/1/98/090/001-014

3.6.2002

EU/1/98/091/001-014

3.6.2002

30.5.2002

Pritor

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/98/089/001-016

5.6.2002

C 157/4

EN

Official Journal of the European Communities

2.7.2002

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

30.5.2002

Emadine

4.6.2002

Zyprexa

4.6.2002

Zyprexa Velotab

4.6.2002

Olansek

7.6.2002

Gonal-F

7.6.2002

Gonal-F

7.6.2002

Gonal-F

7.6.2002

Ketek

7.6.2002

Levviax

11.6.2002

Viracept

12.6.2002

Aprovel

12.6.2002

Karvea

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

EU/1/98/095/003-004

5.6.2002

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

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

Eli Lilly UK Ltd
Kingsclere Road
Basingstoke
Hampshire
United Kingdom

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

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

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

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

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

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

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

EU/1/96/022/001-015

6.6.2002

EU/1/99/125/001-004

6.6.2002

EU/1/96/021/001-010

6.6.2002

EU/1/95/001/001-030

13.6.2002

EU/1/95/001/022-030

13.6.2002

EU/1/95/001/031

12.6.2002

EU/1/01/191/001-004

12.6.2002

EU/1/01/192/001-004

12.6.2002

EU/1/97/054/001-005

13.6.2002

EU/1/97/046/001-015

14.6.2002

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

EU/1/97/049/001-015

14.6.2002

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C 157/5

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

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

24.5.2002

NovoRapid

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/99/119/002,
EU/1/99/119/004

28.5.2002

11.6.2002

Orlaam

Sipaco Internacional Lda
Avenida 5 de Outubro 267 — 6.o dto
P-1600 Lisboa

EU/1/97/041/001-002

18.6.2002

11.6.2002

Zartra

3M Santé
Boulevard de l'Oise
F-95029 Cergy Pontoise Cedex

EU/1/98/079/001

13.6.2002

— 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

17.5.2002

Suvaxyn Aujeszky
783 +O/W

Fort Dodge Animal Health Holland
C.J. van Houtenlaan 36
1381 CP Weesp
Nederland

EU/2/98/009/001-006

22.5.2002

22.5.2002

Eurican Herpes 205

22.5.2002

Porcilis Porcoli

Merial
17, rue Bourgelat
F-69002 Lyon

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/01/029/001-002

24.5.2002

EU/2/96/001/003-008

24.5.2002

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.