Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 November to 15 December 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-12-28
Institutions: European Commission
Subjects: market approval, medicinal product

C 371/8

EN

Official Journal of the European Communities

28.12.2001

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 November to 15 December 2001

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

(2001/C 371/06)

(cid:151) 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

27.11.2001

Travatan

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

EU/1/01/199/001-002

29.11.2001

(cid:151) 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

13.11.2001 Mirapexin

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

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

16.11.2001

19.11.2001

Betaferon

Schering AG
D-13342 Berlin

EU/1/95/003/001-004

20.11.2001

20.11.2001

Zyprexa Velotab

20.11.2001 Olansek

20.11.2001

Zyprexa

21.11.2001

Rebif

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

Eli Lilly UK Ltd
Kingsclere Road
Basingstoke
Hampshire
United Kingdom

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

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

EU/1/99/125/001-004

21.11.2001

EU/1/96/021/001-010

21.11.2001

EU/1/96/022/001-018

21.11.2001

EU/1/98/063/001-006

23.11.2001

21.11.2001

Tritanrix

SmithKline Beecham Biologicals
Rue de l’Institut 89
B-1330 Rixensart

EU/1/96/014/001-003

23.11.2001

21.11.2001

Refludan

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/97/035/001-004

11.11.2001

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

28.12.2001

EN

Official Journal of the European Communities

C 371/9

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

21.11.2001

Zerene

21.11.2001

Zerit

21.11.2001

Aldara

21.11.2001

Sonata

21.11.2001

Zartra

21.11.2001

Crixivan

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

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

Laboratoires 3M SantØ
Boulevard de l’Oise
F-95029 Cergy Pontoise
Cedex

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

Laboratoires 3M SantØ
Boulevard de l’Oise
F-95029 Cergy Pontoise
Cedex

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

EU/1/99/099/001-006

23.11.2001

EU/1/96/009/001-009

23.11.2001

EU/1/98/080/001

23.11.2001

EU/1/99/102/001-008

23.11.2001

EU/1/98/079/001

23.11.2001

EU/1/96/024/001-010

23.11.2001

27.11.2001

Arava

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/99/118/001-009

11.12.2001

27.11.2001

Patrex

27.11.2001

Viagra

30.11.2001

Prometax

30.11.2001

Viramune

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

EU/1/98/078/001-012

29.11.2001

EU/1/98/077/001-012

29.11.2001

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex RH12 4AB
United Kingdom

Boehringer Ingelheim International
GmbH
Binger Stra(cid:223)e 173
D-55216 Ingelheim am Rhein

EU/1/98/092/001-013

3.12.2001

EU/1/97/055/001-002

3.12.2001

C 371/10

EN

Official Journal of the European Communities

28.12.2001

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

3.12.2001

Avonex

Biogen France SA
55, avenue des Champs-Pierreux
F-92012 Nanterre Cedex

EU/1/97/033/001-002

5.12.2001

5.12.2001

Humalog

6.12.2001

Cellcept

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

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

EU/1/96/007/019

7.12.2001

EU/1/96/005/001-006

10.12.2001

(cid:151) 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

19.11.2001 Metacam

5.12.2001

Quadrisol

Boehringer Ingelheim Vetmedica
GmbH
D-55216 Ingelheim am Rhein

Intervet International BV
35 Wim de K(cid:246)rverstraat
5831 AN Boxmeer
Nederland

EU/2/97/004/001

20.11.2001

EU/2/97/005/001, 005

7.12.2001

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