Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 September 2002 to 15 October 2002 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2002-10-25
Institutions: European Commission
Subjects: market approval, marketing, medicinal product, pharmaceutical legislation

C 258/2

EN

Official Journal of the European Communities

25.10.2002

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 September 2002 to 15 October 2002

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

(2002/C 258/02)

— Issuing of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93):

Accepted

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

7.10.2002

Actraphane

7.10.2002

Actrapid

7.10.2002

Mixtard

7.10.2002

Velosulin

7.10.2002

Insulatard

7.10.2002

Monotard

7.10.2002

Protaphane

7.10.2002

Ultratard

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd

Number of
the entry in
the Community register

Date of
notification

EU/1/02/229/001-035

9.10.2002

EU/1/02/230/001-015

9.10.2002

EU/1/02/231/001-035

11.10.2002

EU/1/02/232/001-002

9.10.2002

EU/1/02/233/001-015

9.10.2002

EU/1/02/235/001-004

9.10.2002

EU/1/02/234/001-015

10.10.2002

EU/1/02/236/001-004

9.10.2002

— Issuing of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93):

Rejected

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

8.10.2002

Evoxac

Snow Brand France Sàrl
25, rue Louis-Le-Grand
F-75002 Paris

Number of
the entry in
the Community register

Date of
notification

10.10.2002

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

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Official Journal of the European Communities

C 258/3

— Modification of a marketing authorisation (Article 12 of Council Regulation (EEC) No 2309/93):

Accepted

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

17.6.2002

CEA-Scan

17.6.2002

Leukoscan

16.9.2002

Enbrel

16.9.2002

Enbrel

18.9.2002

Leukoscan

18.9.2002

Refacto

18.9.2002

Venvia

18.9.2002

Nyracta

18.9.2002

Avandia

Number of
the entry in
the Community register

Date of
notification

EU/1/96/023/001

17.10.2002

EU/1/97/032/001

17.10.2002

EU/1/99/126/001-002

18.9.2002

EU/1/99/126/003

18.9.2002

EU/1/97/032/001

24.9.2002

Immunomedics Europe
Haarlemmerstraat 30
2181 HC Hillegom
Nederland

Immunomedics Europe
Haarlemmerstraat 30
2181 HC Hillegom
Nederland

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

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

Immunomedics GmbH
Otto-Röhm-Straße 69
D-64293 Darmstadt

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

EU/1/99/103/001-003

23.9.2002

SmithKline Beecham plc
980 Great West Road
Brentford
TW8 9GS
United Kingdom

SmithKline Beecham plc
980 Great West Road
Brentford
TW8 9GS
United Kingdom

SmithKline Beecham plc
980 Great West Road
Brentford
TW8 9GS
United Kingdom

EU/1/00/138/001-012

23.9.2002

EU/1/00/139/001-012

23.9.2002

EU/1/00/137/001-012

23.9.2002

18.9.2002

Metalyse

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

EU/1/00/169/004-006

23.9.2002

18.9.2002

Tenecteplase
Boehringer Ingelheim
Pharma KG

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

EU/1/00/168/004-006

23.9.2002

C 258/4

EN

Official Journal of the European Communities

25.10.2002

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

27.9.2002

Ebixa

30.9.2002

Opulis

30.9.2002

Neoclarityn

30.9.2002

Azomyr

30.9.2002

Allex

30.9.2002

Aerius

30.9.2002

Opulis

30.9.2002

Neoclarityn

30.9.2002

Azomyr

30.9.2002

Allex

30.9.2002

Aerius

30.9.2002

Micardis

30.9.2002

Leukoscan

30.9.2002

Comtan

30.9.2002

Comtess

Number of
the entry in
the Community register

Date of
notification

EU/1/02/219/007-009

1.10.2002

EU/1/00/158/001-013

2.10.2002

EU/1/00/161/001-013

2.10.2002

EU/1/00/157/001-013

2.10.2002

EU/1/00/159/001-013

2.10.2002

EU/1/00/160/001-013

2.10.2002

EU/1/00/158/014-034

2.10.2002

EU/1/00/161/014-034

2.10.2002

EU/1/00/157/014-034

2.10.2002

EU/1/00/159/014-034

2.10.2002

EU/1/00/160/014-034

2.10.2002

H. Lundbeck A/S
Ottiliavej 9
DK-2500 Valby

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

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

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

EU/1/98/090/001-014

2.10.2002

Immunomedics GmbH
Otto-Röhm-Straße 69
D-64293 Darmstadt

Novartis Europharm Limited
Wimblehurst Road
Horsham
RH12 5AB
United Kingdom

Orion Corporation
Orionintie 1
FIN-02200 Espoo

EU/1/97/032/001

4.10.2002

EU/1/98/081/001-004

2.10.2002

EU/1/98/082/001-004

2.10.2002

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C 258/5

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

30.9.2002

Stocrin

30.9.2002

Sustiva

2.10.2002

Ixense

2.10.2002

Axura

2.10.2002

Gonal-f

2.10.2002

Humalog

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

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

Takeda Europe R & D Centre Ltd
Savanah House
11/12 Charles II Street
London SW1Y 4QU
United Kingdom

Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100-104
D-60318 Frankfurt/Main

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

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

Number of
the entry in
the Community register

Date of
notification

EU/1/99/111/001-005

4.10.2002

EU/1/99/110/001-005

2.10.2002

EU/1/01/181/001-007

4.10.2002

EU/1/02/218/007-011

4.10.2002

EU/1/95/001/001-031

4.10.2002

EU/1/96/007/020

4.10.2002

2.10.2002

Telmisartan
Boehringer Ingelheim
Pharma KG

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

EU/1/98/091/001-014

4.10.2002

3.10.2002

CEA-Scan

3.10.2002

Integrilin

3.10.2002

Osigraft

3.10.2002

Pylobactell

3.10.2002

Vfend

3.10.2002

Replagal

Immunomedics GmbH
Otto-Röhm-Straße 69
D-64293 Darmstadt

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

S. de R.L.
Division of Stryker Corporation
Raheen Industrial Estate
Raheen Limerick
Ireland

Torbet Laboratories Limited
Unit 14D
Wendover Road
Rackheath Industrial Estate
Norwich
NR13 6LH
United Kingdom

Pfizer Limited
Ramsgate Road
Sandwich
CT13 9NJ
United Kingdom

TKT Europe-5S AB
Rinkebyvägen 11B
S-182 36 Danderyd

EU/1/96/023/001

9.10.2002

EU/1/99/109/001-002

7.10.2002

EU/1/01/179/001

8.10.2002

EU/1/98/064/001

7.10.2002

EU/1/02/212/001-025

7.10.2002

EU/1/01/189/001-003

7.10.2002

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EN

Official Journal of the European Communities

25.10.2002

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

7.10.2002

Kaletra

7.10.2002

Renagel

8.10.2002

Paxene

8.10.2002

Protopy

8.10.2002

Rapamune

Abbott Laboratories Ltd
Queenborough
ME11 5EL
United Kingdom

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

Norton Healthcare Limited
Albert Basin
Royal Docks
London E16 2QJ
United Kingdom

Fujisawa GmbH
Levelingstr. 12
D-81673 München

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

Number of
the entry in
the Community register

Date of
notification

EU/1/01/172/001-003

9.10.2002

EU/1/99/123/001-011

9.10.2002

EU/1/99/113/001-002

10.10.2002

EU/1/02/202/001-004

10.10.2002

EU/1/01/171/007-008

10.10.2002

8.10.2002

Infanrix penta

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

EU/1/00/153/001-010

10.10.2002

9.10.2002

Protopic

10.10.2002 Cystagon

10.10.2002

Fortovase

10.10.2002

IntronA

10.10.2002

Procomvax

10.10.2002

Tritanrix HepB

10.10.2002 Viraferon

10.10.2002 Helicobacter test

INFAI

Fujisawa GmbH
Levelingstr. 12
D-81673 München

Orphan Europe
Immeuble ‘Le Guillaumet’
F-92046 Paris La Défense

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

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

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

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

INFAI
Institut für biomedizinische Analytic
und NMR Imaging GmbH
Universitätsstraße 142
D-44799 Bochum

EU/1/02/201/001-004

11.10.2002

EU/1/97/039/001-004

14.10.2002

EU/1/98/075/001-002

15.10.2002

EU/1/99/127/031-039

14.10.2002

EU/1/99/104/001

14.10.2002

EU/1/96/014/001-003

14.10.2002

EU/1/99/128/029-037

14.10.2002

EU/1/97/045/003

15.10.2002

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Official Journal of the European Communities

C 258/7

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

11.10.2002 Nespo

14.10.2002 Remicade

Dompé Biotec SpA
Via San Martino, 12
I-20122 Milano

Centocor BV
Einsteinweg 101
2333 CB Leiden
Nederland

Number of
the entry in
the Community register

Date of
notification

EU/1/01/184/001-032

15.10.2002

EU/1/99/116/001-003

16.10.2002

— Modification of a marketing authorisation (Article 34 of Council Regulation (EEC) No 2309/93):

Accepted

Date of
the decision

Name of the
medicinal product

Holder of the marketing
authorisation

30.9.2002

Quadrisol

2.10.2002

Eurican Herpes 205

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Merial
17, rue Bourgelat
F-69002 Lyon

Number of
the entry in
the Community register

Date of
notification

EU/2/97/005/004

2.10.2002

EU/2/01/029/003

4.10.2002

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.

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 September 2002 to 15 October 2002

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) of the European Parliament and of the Council
or Article 38 of Directive 2001/82/EC (2) of the European Parliament and of the Council)

— Issuing, maintenance or modification of a national marketing authorisation

(2002/C 258/03)

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the
marketing authorisation

Member State concerned

Date of
notification

30.9.2002

Actilyse

See Annex

See Annex

2.10.2002

15.10.2002

Sibutramine

See Annex

See Annex

16.10.2002

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1 .