Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 December 2002 to 15 January 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-01-31
Institutions: European Commission
Subjects: market approval, medicinal product

C 24/14

EN

Official Journal of the European Communities

31.1.2003

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 December 2002 to 15 January 2003

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

(2003/C 24/07)

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

7.12.2002

Theryttrex

MDS Nordion SA
Zoning Industriel
B-6220 Fleurus

EU/1/02/245/001

9.1.2003

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

5.12.2002

Lantus

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/001-012

20.12.2002

5.12.2002

Viread

Gilead Sciences International Limited
Cambridge CB1 6GT
United Kingdom

EU/1/01/200/001

24.12.2002

16.12.2002

Beromun

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

EU/1/99/097/001

19.12.2002

16.12.2002 Humalog

18.12.2002 Myocet

18.12.2002 MabCampath

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

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

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

EU/1/96/007/021-028

19.12.2002

EU/1/00/141/001

23.12.2002

EU/1/01/193/001

24.12.2002

18.12.2002 NutropinAq

Schwarz Pharma AG
Alfred-Nobel-Straße 10
D-40789 Monheim

EU/1/00/164/001-002

23.12.2002

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

31.1.2003

EN

Official Journal of the European Communities

C 24/15

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

18.12.2002

Prometax

19.12.2002 Zeffix

19.12.2002

Infergen

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Yamanouchi Europe BV
Elisabethhof 19
2353 EW Leiderdorp
Nederland

EU/1/98/092/001-013

23.12.2002

EU/1/99/114/001-003

24.12.2002

EU/1/98/087/001-003

24.12.2002

19.12.2002 ReFacto

Genetics Institute of Europe BV
Fraunhoferstraße 15
D-82152 Planegg/Martinsried

EU/1/99/103/004

7.1.2003

19.12.2002 Glivec

7.1.2003

Exelon

9.1.2003

Taxotere

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

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

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

EU/1/01/198/001-006

24.12.2002

EU/1/98/066/001-013

9.1.2003

EU/1/95/002/001-002

13.1.2003

9.1.2003

Betaferon

Schering AG Pharma
D-13342 Berlin

EU/1/95/003/001-004

13.1.2003

10.1.2003

Avonex

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

EU/1/97/033/001-002

14.1.2003

10.1.2003

Rapamune

10.1.2003

Caelyx

14.1.2003

Pegasys

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

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

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

EU/1/01/171/009-010

14.1.2003

EU/1/96/011/001-004

14.1.2003

EU/1/02/221/001-008

16.1.2003

C 24/16

EN

Official Journal of the European Communities

31.1.2003

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

14.1.2003

Hexavac

14.1.2003

Keppra

14.1.2003

Herceptin

14.1.2003

Quixidar

14.1.2003

Visudyne

15.1.2003

Arixtra

15.1.2003

Karvezide

15.1.2003

Cetrotide

15.1.2003

Prandin

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

EU/1/00/147/001-008

16.1.2003

UCB SA
Allée de la recherche/Researchdreef 60
B-1070 Bruxelles/Brussel

EU/1/00/146/001-026

16.1.2003

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

NV Organon
PO Box 20
Kloosterstraat 6
5340 EB Oss
Nederland

Novartis Ophtalmics Europe Ltd
Delta House
Southwood Crescent
Southwood
Farnborough
Hants GU14 0NL
United Kingdom

Sanofi-Synthelabo
174, avenue de France
F-75013 Paris

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

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

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

EU/1/00/145/001

16.1.2003

EU/1/02/207/001-004

16.1.2003

EU/1/00/140/001

17.1.2003

EU/1/02/206/001-004

17.1.2003

EU/1/98/085/001-010

17.1.2003

EU/1/99/100/001-003

17.1.2003

EU/1/00/162/001-018

17.1.2003

15.1.2003

Infanrix HepB

GlaxoSmithKline Biologicals SA
Rue de l'Institut 89
B-1330 Rixensart

EU/1/97/048/001-014

17.1.2003

Suspension of a marketing authorisation (Article 18 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

7.1.2003

Tasmar

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

EU/1/97/044/001-006

9.1.2003

31.1.2003

EN

Official Journal of the European Communities

C 24/17

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

15.1.2003

Quadrisol

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/97/005/001-009

17.1.2003

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.

Notice concerning the anti-dumping duty in force in respect of imports into the Community of
polyester staple fibres (PSF) originating, inter alia, in the Republic of Korea: modification of the
address of a company subject to an individual anti-dumping duty rate

(2003/C 24/08)

Imports of PSF originating, inter alia, in the Republic of Korea are subject to a definitive anti-dumping duty,
imposed by Council Regulation (EC) No 2852/2000 (1).

Sung Lim Co., Ltd, a company located in the Republic of Korea, whose exports to the Community of PSF
are subject to an individual anti-dumping duty rate of 0 % by the aforementioned Regulation, has informed
the Commission that it has changed its address to RM 911, Dae-Young Bldg, 44-1; Youido-Dong, Young-
dungpo-ku, Seoul, Korea.

The Commission has examined the information supplied, which demonstrates that all the company's
activities linked to the manufacturing, sales and exports of PSF are unaffected by the change of address.
Accordingly,
the change of address in no way affects the findings of Council Regulation (EC) No
2852/2000. Therefore, the right of the Company to benefit from the anti-dumping duty rate of 0 %
should remain despite its change of address.

Hence, for clarification purposes, it should be noted that reference to the address of Sung Lim Co., Ltd,
should be read as RM 911, Dae-Young Bldg, 44-1; Youido-Dong, Youngdungpo-ku; Seoul; Korea in Article
1 of Council Regulation (EC) No 2852/2000.

The Taric additional code A154 previously attributed to Sung Lim Co., Ltd under its former address shall
apply to the company with its new address.

(1) OJ L 332, 28.12.2000, p. 17.