Summary of Community decisions on marketing authorisations in respect of medicinal products for the period from 15 September to 15 October 2001 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2001-10-26
Institutions: European Commission
Subjects: market approval, medicinal product

C 300/28

EN

Official Journal of the European Communities

26.10.2001

Summary of Community decisions on marketing authorisations in respect of medicinal products
for the period from 15 September to 15 October 2001

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

(2001/C 300/08)

(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

18.9.2001

Orgalutran

18.9.2001

Rebif

20.9.2001

Sustiva

20.9.2001

Stocrin

20.9.2001

Cetrotide

20.9.2001

Opulis

20.9.2001

Neoclarityn

20.9.2001

Azomyr

20.9.2001

Allex

20.9.2001

Aerius

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

NV Organon
PO Box 20
Kloosterstraat 6
5349 EB Oss
Nederland

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

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

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

Ares-Serono (Europe) Ltd
24 Gilbert Street
London W1Y 1RJ
United Kingdom

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/1/00/130/001-002

21.9.2001

EU/1/98/063/001-006

21.9.2001

EU/1/99/110/001-004

24.9.2001

EU/1/99/111/001-004

24.9.2001

EU/1/99/100/001-003

25.9.2001

EU/1/00/160/001-013

24.9.2001

EU/1/00/160/001-013

24.9.2001

EU/1/00/157/001-013

24.9.2001

EU/1/00/160/001-013

24.9.2001

EU/1/00/160/001-013

24.9.2001

26.10.2001

EN

Official Journal of the European Communities

C 300/29

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

24.9.2001

Caelyx

1.10.2001

Nespo

3.10.2001

Xenical

3.10.2001

Mabthera

3.10.2001

Rebif

8.10.2001

Karvea

8.10.2001

Karvezide

8.10.2001

Aranesp

8.10.2001

Optison

8.10.2001

Aprovel

8.10.2001

Coaprovel

15.10.2001

Renagel

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

DompØ Biotec SpA
Via Santa Lucia 4
I-20122 Milano

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

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

Bristol-Myers Squibb Pharma EEIG
Swakeleys House
Milton Road
Ickenham UB10 8PU
United Kingdom

Bristol-Myers Squibb Pharma EEIG
Swakeleys House
Milton Road
Ickenham UB10 8PU
United Kingdom

Amgen Europe BV
Minervum 7061
4817 ZK Breda
Nederland

Mallinckrodt Medical GmbH
Josef-Dietzgen-Stra(cid:223)e 1-3
D-53773 Hennef

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

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

Genzyme BV
Gooimeer 10
1411 DD Naarden
Nederland

EU/1/96/011/001-004

25.9.2001

EU/1/01/184/001-030

4.10.2001

EU/1/98/071/001-006

4.10.2001

EU/1/98/067/001-002

4.10.2001

EU/1/98/063/001-006

4.10.2001

EU/1/97/049/010-012

10.10.2001

EU/1/98/085/007-008

10.10.2001

EU/1/01/185/001-030

10.10.2001

EU/1/98/065/001-002

10.10.2001

EU/1/97/046/010-012

10.10.2001

EU/1/98/086/007-008

10.10.2001

EU/1/99/123/011

16.10.2001

C 300/30

EN

Official Journal of the European Communities

26.10.2001

(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

10.9.2001

Porcilis AR-T DF

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

EU/2/00/026/001-002

13.9.2001

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