Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 March 2005 to 15 April 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-04-29
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

29.4.2005

EN

Official Journal of the European Union

C 104/15

Summary of Community decisions on marketing authorisations in respect of medicinal products
from 15 March 2005 to 15 April 2005

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

(2005/C 104/04)

— 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

22.3.2005

Aloxi

15.4.2005

Aclasta

Helsinn Birex Pharmaceuticals
Ltd, Damastown, Mulhuddart,
Dublin 15, Republic of Ireland

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

EU/1/04/306/001

24.3.2005

EU/1/05/308/001

19.4.2005

— 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

16.3.2005

Thyrogen

Genzyme Europe B.V.,
Gooimeer 10, Naarden 1411
DD, Nederland

EU/1/99/122/001-002

18.3.2005

22.3.2005

Zometa

22.3.2005

PegIntron

22.3.2005

ViraferonPeg

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

Schering Plough Europe, Rue
de Stalle, 73, 1180 Bruxelles,
Belgique — Stallestraat, 73 —
1180 Brussel, België

Schering Plough Europe, Rue
de Stalle, 73, 1180 Bruxelles,
Belgique — Stallestraat, 73 —
1180 Brussel, België

EU/1/01/176/001-006

24.3.2005

EU/1/00/131/001-050

24.3.2005

EU/1/00/132/001-050

24.3.2005

22.3.2005

Aldurazyme

Genzyme Europe B.V.,
Gooimeer 10, Naarden 1411
DD, Nederland

EU/1/03/253/001-003

24.3.2005

29.3.2005

Foscan

Biolitec pharma (Ireland) Ltd.,
Unit 2, Broomhill Business
Park, Broomhill Road,Tallaght,
Dublin 24, Ireland

EU/1/01/197/001-002

1.4.2005

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

C 104/16

EN

Official Journal of the European Union

29.4.2005

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

29.3.2005

Cialis

29.3.2005

Inductos

Lilly ICOS Limited, St Bride's
House — 10 Salisbury Square
— London EC4Y 8EH —
United Kingdom.

Wyeth Europa Ltd., Hunter-
combe Lane South, Taplow,
Maidenhead, Berkshire, SL6
0PH, United Kingdom

EU/1/02/237/001-005

31.3.2005

EU/1/02/226/001

31.3.2005

29.3.2005

Ammonaps

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

EU/1/99/120/001-004

31.3.2005

29.3.2005

NeuroBloc

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

EU/1/00/166/001-003

4.4.2005

29.3.2005

Levitra

Bayer AG, D-51368 Lever-
kusen, Deutschland

EU/1/03/248/001-012

31.3.2005

29.3.2005

Vivanza

Bayer AG, D-51368 Lever-
kusen, Deutschland

EU/1/03/249/001-012

31.3.2005

29.3.2005

Uprima

Abbott laboratories Ltd,
Queenborough, Kent ME11
5EL, United Kingdom

EU/1/01/180/001-010

31.3.2005

29.3.2005

Viagra

Pfizer Limited, Sandwich, Kent
CT13 9NJ, United Kingdom

EU/1/98/077/001-012

31.3.2005

29.3.2005

Vfend

Pfizer Limited, Sandwich, Kent
CT13 9NJ, United Kingdom

EU/1/02/212/001-026

31.3.2005

29.3.2005

Mirapexin

Boehringer Ingelheim Interna-
tional GmbH, Binger Strasse
173, D-55216 Ingelheim am
Rhein, Deutschland

EU/1/97/051/001-006
EU/1/97/051/009-012

31.3.2005

29.3.2005

Stalevo

Orion Corporation, Orionintie
1, FIN-02200 Espoo, Suomi

EU/1/03/260/001-012

31.3.2005

29.3.2005

Zeffix

Glaxo Group Ltd, Greenford,
Middlesex UB6 0NN, United
Kingdom

EU/1/99/114/001-003

31.3.2005

29.3.2005

Levemir

Novo Nordisk A/S, Novo Allé,
DK-2880 Bagsvaerd, Danmark

EU/1/04/278/001-009

31.3.2005

29.4.2005

EN

Official Journal of the European Union

C 104/17

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

29.3.2005

Visudyne

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

EU/1/00/140/001

31.3.2005

29.3.2005

HBVAXPRO

Aventis Pasteur MSD, 8, rue
Jonas Salk, 69007 Lyon,
France

EU/1/01/183/019

31.3.2005

30.3.2005

Xeloda

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

EU/1/00/163/001-002

1.4.2005

30.3.2005

NovoRapid

Novo Nordisk A/S, Novo Allé,
DK-2880 Bagsvaerd, Danmark

EU/1/99/119/001
EU/1/99/119/003
EU/1/99/119/005-014

1.4.2005

30.3.2005

Glivec

30.3.2005

Bondenza

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

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

EU/1/01/198/001-013

1.4.2005

EU/1/03/266/001-002

1.4.2005

30.3.2005

Sifrol

Boehringer Ingelheim Interna-
tional GmbH, Binger Strasse
173- D — 55216 Ingelheim
am Rhein, Deutschland

EU/1/97/050/001-006
EU/1/97/050/009-012

1.4.2005

30.3.2005

Abilify

30.3.2005

EMEND

Otsuka Pharmaceutical Europe
Ltd, Commonwealth House, 2
Chalkhill Road, Hammersmith,
London W6 8DW, United
Kingdom

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

EU/1/04/276/001-020

1.4.2005

EU/1/03/262/001-006

1.4.2005

11.4.2005

Cerezyme

Genzyme Europe B.V.,
Gooimeer 10, Naarden 1411
DD, Nederland

EU/1/97/053/001-005

13.4.2005

11.4.2005

Fuzeon

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

EU/1/03/252/001-002

13.4.2005

C 104/18

EN

Official Journal of the European Union

29.4.2005

— 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

Number of the entry in
the Community Register

Date of notification

16.3.2005

Eurifel FeLV

11.4.2005

Incurin

11.4.2005

Rabigen SAG2

15.4.2005

Aivlosin

Merial, 29 Avenue Tony
Garnier, 69007 Lyon, France

Intervet International B.V.,
Wim de Körverstraat 35, 5831
AN Boxmeer, Nederland

VIRBAC S.A., 1ere Avenue
2065 m L.I.D. — 06516
Carros — France

ECO Animal Health Ltd, 78
Coombe Road New Malden
Surrey KT3 4QS United
Kingdom

EU/2/00/019/005-007

18.3.2005

EU/2/00/018/001

14.4.2005

EU/2/00/021/001-002

13.4.2005

EU/2/04/044/001

19.4.2005

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 Medicines Agency
7, Westferry Circus, Canary Wharf
UK — London E14 4HB