Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 August 2003 to 15 September 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-09-26
Institutions: European Commission
Subjects: market approval, marketing standard, medicinal product, pharmaceutical legislation, public health

26.9.2003

EN

Official Journal of the European Union

C 230/5

Duration: From 26 October 2001 to 31 October 2002

Other information: Re-notification for any extension or
amendment of the aid

The authentic text(s) of the decision, from which all confi-
dential information has been removed, can be found at

http://europa.eu.int/comm/secretariat_general/sgb/state_aids

Date of adoption of the decision: 20.8.2003

Member State: Belgium

Aid No: NN 52/02

service
Objective: Establishment
providers based in Belgium of insurance cover similar to that
existing before 11 September 2001 relating to risks of war and
terrorism

for airlines and airport

Legal basis: Décisions des Conseils des Ministres du 5 octobre

Besluiten van de Ministerraad van 5 oktober

Budget: State-issued insurance

Duration: From 25 November 2001 to 31 October 2002

Other information: Scheme renewed and notified after the
first 30 days in the context of this aid

The authentic text(s) of the decision, from which all confi-
dential information has been removed, can be found at

Title: State-guaranteed scheme to cover aviation risks

http://europa.eu.int/comm/secretariat_general/sgb/state_aids

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 August 2003 to 15 September 2003

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

(2003/C 230/04)

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

Date of
the decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

1.9.2003

Trudexa

8.9.2003

Humira

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

Abbott Laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/03/257/001-006

3.9.2003

EU/1/03/256/001-006

10.9.2003

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

Accepted

Date of
the decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

18.8.2003

Somavert

19.8.2003

Puregon

Pharmacia Enterprises SA
6, Circuit de la Foire Internationale
BP 2507
L-1347 Luxembourg

EU/1/02/240/001-003

20.8.2003

Organon NV
PO Box 20
5340 BH Oss
Nederland

EU/1/96/008/038-039

21.8.2003

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

C 230/6

EN

Official Journal of the European Union

26.9.2003

Date of
the decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

22.8.2003

NovoRapid

22.8.2003

Actrapid

22.8.2003

Mixtard

22.8.2003

Actraphane

22.8.2003

Protaphane

22.8.2003

NovoMix 30

25.8.2003

Insulatard

28.8.2003

Glustin

28.8.2003

Actos

28.8.2003

Avandia

28.8.2003

Nyracta

28.8.2003

Ebixa

28.8.2003

Venvia

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

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

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

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

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

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

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

EU/1/99/119/009-011

26.8.2003

EU/1/02/230/013-015

26.8.2003

EU/1/02/231/033-035

26.8.2003

EU/1/02/229/033-035

26.8.2003

EU/1/02/234/013-015

26.8.2003

EU/1/00/142/009-010

26.8.2003

EU/1/02/233/013-015

27.8.2003

EU/1/00/151/001-008

1.9.2003

EU/1/00/150/001-010

1.9.2003

EU/1/00/137/001-012

1.9.2003

EU/1/00/139/001-012

1.9.2003

EU/1/02/219/010-013

1.9.2003

EU/1/00/138/001-012

1.9.2003

26.9.2003

EN

Official Journal of the European Union

C 230/7

Date of
the decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

28.8.2003

Thyrogen

28.8.2003

Keppra

28.8.2003

Cerezyme

1.9.2003

Rapamune

1.9.2003

Ebixa

1.9.2003

Axura

8.9.2003

Fortovase

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

UCB SA
Allée de la recherche 60
B-1070 Bruxelles

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

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

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

Merz Pharmaceuticals GmbH
Eckenheimer Landstraße 100—104
D-60318 Frankfurt/Main

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

EU/1/99/122/001-002

1.9.2003

EU/1/00/146/006-013

1.9.2003

EU/1/97/053/001-005

1.9.2003

EU/1/01/171/001-010

3.9.2003

EU/1/02/219/001-009

3.9.2003

EU/1/02/218/001-011

3.9.2003

EU/1/98/075/001-002

10.9.2003

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

Accepted

Date of
the decision

Name of the
medicinal product

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

28.8.2003

Quadrisol

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/97/005/001-007

1.9.2003

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.