Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 October to 15 November 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-11-30
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

30.11.2001

EN

Official Journal of the European Communities

C 336/13

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

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

(2001/C 336/04)

(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

24.10.2001

Foscan

24.10.2001

Caspofungin

7.11.2001

Glivec

Scotia Pharmaceuticals Limited
Scotia House
Castle Business Park
Stirling FK9 4TZ
United Kingdom

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

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

EU/1/01/197/001-002

26.10.2001

EU/1/01/196/001-003

25.10.2001

EU/1/01/198/001-006

12.11.2001

(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

16.10.2001

Nespo

16.10.2001

Rapamune

16.10.2001

Thyrogen

16.10.2001

Viracept

16.10.2001

Pritor

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

DompØ Biotec SpA
Via Santa Lucia 4
I-20122 Milan

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

Genzyme BV
Gooimeer 10
1411 DD Naarden
Nederland

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/01/184/001-030

17.10.2001

EU/1/01/171/001-006

17.10.2001

EU/1/99/122/001-002

17.10.2001

EU/1/97/054/001-003

17.10.2001

EU/1/98/089/015-016

17.10.2001

C 336/14

EN

Official Journal of the European Communities

30.11.2001

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

18.10.2001

Comtan

18.10.2001

Puregon

18.10.2001

Sustiva

19.10.2001 Micardis

19.10.2001

Telmisartan

19.10.2001

Refludan

19.10.2001

Zyprexa

24.10.2001

Ziagen

24.10.2001 Hexavac

24.10.2001 Helixate NexGen

24.10.2001

Kogenate Bayer

24.10.2001

Stocrin

24.10.2001

Comtess

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

NV Organon
Kloosterstraat 6
Postbus 20
5340 BH Oss
Nederland

DuPont Pharmaceuticals Limited
Wedgwood Way
Stevenage
Hertfordshire SG1 4QN
United Kingdom

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

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

EU/1/98/081/001-004

22.10.2001

EU/1/96/008/017-039

19.10.2001

EU/1/99/110/005

19.10.2001

EU/1/98/090/013-014

22.10.2001

EU/1/98/091/013-014

22.10.2001

Hoechst Marion Roussel Deutschland
GmbH
D-65926 Frankfurt am Main

EU/1/97/035/001-004

23.10.2001

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Aventis Pasteur MSD
8, rue Jonas Salk
F-69007 Lyon

Bayer AG
D-51368 Leverkusen

Bayer AG
D-51368 Leverkusen

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

Orion Corporation
Orionintie 1
FIN-02200 Espoo

EU/1/96/022/001-015

22.10.2001

EU/1/99/112/001-002

25.10.2001

EU/1/00/147/001-008

25.10.2001

EU/1/00/144/001-003

25.10.2001

EU/1/00/143/001-003

25.10.2001

EU/1/99/111/005

25.10.2001

EU/1/98/082/001-004

25.10.2001

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Official Journal of the European Communities

C 336/15

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

24.10.2001 Agenerase

29.10.2001 NeuroBloc

31.10.2001 Optruma

31.10.2001

Avandia

31.10.2001

Venvia

31.10.2001

Nyracta

31.10.2001

Xenical

31.10.2001

Evista

7.11.2001

Humaspect

7.11.2001

Gonal F

8.11.2001

Trizivir

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Elan Pharma International Ltd
WIL House
Shannon Business Park
Shannon
County Clare
Ireland

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

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

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

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

Intracel Netherlands BV
Marco Polostraat 27
7825 VM Emmen
Kadastraat
Nederland

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/00/148/001-003

25.10.2001

EU/1/00/166/001-003

30.11.2001

EU/1/98/074/001-004

1.11.2001

EU/1/00/137/001-012

1.11.2001

EU/1/00/138/001-012

1.11.2001

EU/1/00/138/001-012

1.11.2001

EU/1/98/071/001-006

1.11.2001

EU/1/98/073/001-004

1.11.2001

EU/1/98/083/001

9.11.2001

EU/1/95/001/001-021

12.11.2001

EU/1/00/156/001-003

12.11.2001

C 336/16

EN

Official Journal of the European Communities

30.11.2001

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

8.11.2001

Twinrix Adult

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

EU/1/96/020/001-009

12.11.2001

9.11.2001

Humalog

9.11.2001

Epivir

9.11.2001

Prometax

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

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

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

EU/1/96/007/001-008,
010-016

13.11.2001

EU/1/96/015/001-002

15.11.2001

EU/1/98/092/001-012

15.11.2001

9.11.2001

Twinrix Paediatric

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

EU/1/97/029/001-008

14.11.2001

9.11.2001

Rapilysin

12.11.2001

Norvir

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

Abbott Laboratories Limited
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/96/018/001

15.11.2001

EU/1/96/016/001, 003

15.11.2001

12.11.2001 Mirapexin

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

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

16.11.2001

12.11.2001

Invirase

12.11.2001

Prandin

12.11.2001

Cellcept

15.11.2001

Hbvaxpro

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

Novo Nordisk A/S
Novo AllØ
DK-2880 Bagsv(cid:230)rd

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

Aventis Pasteur MSD SNC
8, rue Jonas Salk
F-69007 Lyon

EU/1/96/026/001

14.11.2001

EU/1/00/162/001-018

14.11.2001

EU/1/96/005/001-006

14.11.2001

EU/1/01/183/018

16.11.2001

30.11.2001

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Official Journal of the European Communities

C 336/17

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

15.11.2001

Epivir

15.11.2001

Exelon

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

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

EU/1/96/015/003

16.11.2001

EU/1/98/066/001-012

16.11.2001

(cid:151) Issuing 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

6.11.2001

Virbagen Omega

Virbac SA
1re Avenue
2065 m LID
F-06516 Carros

EU/2/01/030/001-002

8.11.2001

(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

19.10.2001 Dicural

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

EU/2/97/003/004-015

22.10.2001

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