Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 February 2003 to 15 March 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2003-03-28
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 76/24

EN

Official Journal of the European Union

28.3.2003

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 February 2003 to 15 March 2003

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

(2003/C 76/07)

— 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

Number of the entry in the
Community Register

Date of
notification

4.3.2003

Vivanza

Bayer AG
D-51368 Leverkusen

EU/1/03/249/001-012

6.3.2003

6.3.2003

Levitra

Bayer AG
D-51368 Leverkusen

EU/1/03/248/001-012

10.3.2003

6.3.2003

Hepsera

Gilead Sciences International Ltd
Cambridge CB1 6GT
United Kingdom

EU/1/03/251/001

10.3.2003

— 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

Number of the entry in the
Community Register

Date of
notification

17.2.2003

Viramune

17.2.2003

Zeffix

17.2.2003

Replagal

17.2.2003

Caspofungin MSD

17.2.2003

Evra

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

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

EU/1/97/055/001-002

19.2.2003

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

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

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

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

EU/1/99/114/001-003

19.2.2003

EU/1/01/189/001-003

19.2.2003

EU/1/01/196/001-003

19.2.2003

EU/1/02/223/001-003

19.2.2003

28.3.2003

EN

Official Journal of the European Union

C 76/25

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

17.2.2003

Replagal

24.2.2003

NutropinAq

24.2.2003

Xigris

24.2.2003

Vfend

3.3.2003

Keppra

3.3.2003

Levviax

4.3.2003

Ketek

4.3.2003

Xenical

4.3.2003

Tractocile

4.3.2003

Evra

4.3.2003

Rebif

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

IPSEN Limited
190 Bath Road
Slough
Berkshire SLI 3XE
United Kingdom

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

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

UCB SA
Allée de la recherche 60
B-1070 Bruxelles

Aventis Pharma SA
20, avenue Raymond Aron
F-92160 Antony

Aventis Pharma SA
20, avenue Raymond Aron
F-92160 Antony

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

Ferring AB
Soldattorpsvägen 5
Box 30 047
S-200 61 Limhamn

EU/1/01/189/001-003

19.2.2003

EU/1/00/164/001-002

26.2.2003

EU/1/02/225/001-002

26.2.2003

EU/1/02/212/025

27.2.2003

EU/1/00/146/027

5.3.2003

EU/1/01/192/001-004

5.3.2003

EU/1/01/191/001-004

6.3.2003

EU/1/98/071/001-006

6.3.2003

EU/1/99/124/001-002

6.3.2003

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse

EU/1/02/223/001-003

6.3.2003

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

EU/1/98/063/001-006

6.3.2003

4.3.2003

Lantus

Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main

EU/1/00/134/001-012

7.3.2003

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EN

Official Journal of the European Union

28.3.2003

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

4.3.2003

Renagel

4.3.2003

Luveris

6.3.2003

Cetrotide

6.3.2003

PritorPlus

6.3.2003

Pritor

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Nederland

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

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

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

Glaxo Group Ltd
Greenford
Middlesex UB6 0NN
United Kingdom

EU/1/99/123/001-011

6.3.2003

EU/1/00/155/001-006

6.3.2003

EU/1/99/100/001-003

10.3.2003

EU/1/02/215/001-010

10.3.2003

EU/1/98/089/001-016

10.3.2003

6.3.2003

Temodal

Schering Plough Europe
Rue de Stalle 73
B-1180 Bruxelles

EU/1/98/096/001-008

10.3.2003

7.3.2003

Karvezide

7.3.2003

Karvea

7.3.2003

Aprovel

7.3.2003

CoAprovel

7.3.2003

Simulect

7.3.2003

NeuroBloc

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

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

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

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

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

EU/1/98/085/001-010

11.3.2003

EU/1/97/049/001-015

11.3.2003

EU/1/97/046/001-015

11.3.2003

EU/1/98/086/001-010

11.3.2003

EU/1/98/084/002

11.3.2003

EU/1/00/166/001-003

11.3.2003

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Official Journal of the European Union

C 76/27

— Issuing 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

Number of the entry in the
Community Register

Date of
notification

6.3.2003

ProteqFlu-Te

6.3.2003

ProteqFlu

Merial
17, rue Bourgelat
F-69002 Lyon

Merial
17, rue Bourgelat
F-69002 Lyon

EU/2/03/038/001-004

10.3.2003

EU/2/03/037/001-004

10.3.2003

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.

Authorisation for State aid pursuant to Articles 87 and 88 of the EC Treaty

Cases where the Commission raises no objections

(2003/C 76/08)

(Text with EEA relevance)

Date of adoption of the decision: 11.3.2003.

Member State: Italian Republic.

Aid No: N 19/03.

Title: Extension of a scheme to reduce social charges in the
maritime cabotage sector.

Objective: To promote the competitiveness of shipowners
active in the maritime cabotage sector.

Legal basis: Legge 27 dicembre 2002, n. 289.

Budget: A maximum of EUR 20 million/year.

Aid intensity or amount: 25 %.

Duration: One year.

Other information: Extension of a scheme already approved
by the Commission for the period 1999-2002.

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: 20.12.2002.

Member State: Germany (Lower Saxony).

Aid No: N 559/02.

Title: Guidelines concerning the granting of allocations in the
context of
‘Economy and Environment’
allocated by the funds of business development — ecological
scope.

the programme

Objective: To create more innovative methods of production
which aim at the efficient use of natural resources and the
substitution of environment-impairing materials.