Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 January 2005 to 15 February 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-02-25
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

C 49/2

EN

Official Journal of the European Union

25.2.2005

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 January 2005 to 15 February 2005

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

(2005/C 49/02)

— Issuing of a marketing authorization (Article 12 of Council 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

2.2.2005

Fendrix

GlaxoSmithKline Biologicals
S.A., rue de l'Institut 89,
B-1330 Rixensart

EU/1/04/299/001-003

4.2.2005

— Modification of a marketing authorization (Article 12 of Council 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

20.1.2005

Norvir

20.1.2005

Zerit

20.1.2005

Avandamet

20.1.2005

Zerit

20.1.2005

Rapamune

25.1.2005

NeupoPeg

25.1.2005

Neulasta

25.1.2005

IntronA

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

EU/1/96/016//001
EU/1/96/016/003

24.1.2005

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

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

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

Wyeth Europa Limited,
Huntercombe Lane South,
Taplow, Maidenhead, Berk-
shire, SL6 0PH, United
Kingdom

Dompé Biotec S.p.A., Via
San Martino, 12, I-20122
Milano

Amgen Europe B.V.,
Minervum 7061, 4817 ZK
Breda, Nederland

Schering Plough Europe,
Rue de Stalle, 73, B-1180
Bruxelles

EU/1/96/009/001-017

24.1.2005

EU/1/03/258/001-012

24.1.2005

EU/1/96/009/001-017

24.1.2005

EU/1/01/171/011-012

24.1.2005

EU/1/02/228/001-002

27.1.2005

EU/1/02/227/001-002

27.1.2005

EU/1/99/127/001-044

28.1.2005

(1) OJ L 214 of 24 August 1993, page 1.

25.2.2005

EN

Official Journal of the European Union

C 49/3

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

25.1.2005

Viraferon

25.1.2005

Xigris

25.1.2005

Trudexa

25.1.2005

Arixtra

25.1.2005

Travatan

25.1.2005

Quixidar

25.1.2005

Humira

25.1.2005

Rebetol

25.1.2005

Rebetol

26.1.2005

Remicade

26.1.2005

Bextra

26.1.2005

Dynastat

26.1.2005

Rayzon

26.1.2005

Prevenar

26.1.2005

Valdyn

Schering Plough Europe,
Rue de Stalle, 73, B-1180
Bruxelles

Eli Lilly Nederland B.V.,
Grootslag 1-5, 3991 RA
Houten, Nederland

Abbott Laboratories Ltd.,
Queenborough, Kent ME11
5EL, United Kingdom

Glaxo Group Ltd, Green-
ford, Middlesex UB6 0NN,
United Kingdom

Alcon Laboratories (UK)
Ltd., Boundary Way, Hemel
Hempstead, Herts HP2
7UD, United Kingdom

Glaxo Group Ltd, Green-
ford, Middlesex UB6 0NN,
United Kingdom

Abbott Laboratories Ltd.,
Queenborough, Kent ME11
5EL, United Kingdom

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

Schering Plough Europe,
Rue de Stalle, 73, B-1180
Bruxelles — Stallestraat, 73,
B–1180 Brussel

Centocor B.V., Einsteinweg
101, 2333 CB Leiden,
Nederland

Pharmacia-Pfizer EEIG,
Sandwich, Kent, CT13 9NJ,
United Kingdom

Pharmacia Europe EEIG,
Sandwich, Kent, CT13 9NJ,
United Kingdom

Pharmacia Europe EEIG,
Sandwich, Kent, CT13 9NJ,
United Kingdom

Wyeth-Lederle Vaccines
S.A., Rue du Bosquet, 15,
B-1348 Louvain-La-Neuve.

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

EU/1/99/128/001-037

28.1.2005

EU/1/02/225/001-002

27.1.2005

EU/1/03/257/001-006

27.1.2005

EU/1/02/206/001-017

27.1.2005

EU/1/01/199/001-002

27.1.2005

EU/1/02/206/001-017

27.1.2005

EU/1/03/256/001-006

27.1.2005

EU/1/99/107/001-004

27.1.2005

EU/1/99/107/004

27.1.2005

EU/1/99/116/001-003

28.1.2005

EU/1/02/239/001-030

1.2.2005

EU/1/02/209/001-008

1.2.2005

EU/1/02/210/001-008

1.2.2005

EU/1/00/167/001-007

28.1.2005

EU/1/02/244/001-024

31.1.2005

C 49/4

EN

Official Journal of the European Union

25.2.2005

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

26.1.2005

Visudyne

26.1.2005

Pegasys

26.1.2005

Renagel

31.1.2005

Tractocile

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

Roche Registration Limited,
40 Broadwater Road,
Welwyn Garden City, Hert-
fordshire AL7 3AY, United
Kingdom

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

Ferring AB, Soldattorps-
vägen 5 — Box 30 047,
Limhamn S-20061

EU/1/00/140/001

31.1.2005

EU/1/02/221/001-008

31.1.2005

EU/1/99/123/001-011

28.1.2005

EU/1/99/124/001-002

2.2.2005

2.2.2005

NovoNorm

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

EU/1/98/076/001-002,
EU/1/98/076/004-009,
EU/1/98/076/011-016
EU/1/98/076/018-021

4.2.2005

4.2.2005

Prandin

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

EU/1/00/162/001-018

8.2.2005

9.2.2005

Zyprexa

9.2.2005

Zyprexa

9.2.2005

Zyprexa Velotab

14.2.2005

Keppra

14.2.2005

Avonex

EU/1/96/022/016-018

11.2.2005

11.2.2005

EU/1/96/022/002,
EU/1/96/022/004,
EU/1/96/022/006,
EU/1/96/022/008-012,
EU/1/96/022/014
EU/1/96/022/016-022

EU/1/99/125/001-008

11.2.2005

EU/1/00/146/001-029

16.2.2005

EU/1/97/033/001-003

16.2.2005

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

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

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

UCB S.A. — Allée de la
recherche, 60, B-1070
Bruxelles — Researchdreef,
60, B-1070 Brussel

Biogen Idec Ltd, 5 Roxbor-
Foundation
ough Way,
Berk-
Park, Maidenhead,
shire,
SL6 3UD, United
Kindgom
Biogen
‘Le
Capitole’ 55, avenue des
Champs Pierreux, F-92012
Nanterre Cedex.

France,

Idec

14.2.2005

Helicobacter Test
INFAI

INFAI, Institut für biomedi-
zinische Analytic und NMR
Imaging GmbH — Universi-
tätsstrasse 142, D-44799
Bochum

EU/1/97/045/001-004

16.2.2005

25.2.2005

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Official Journal of the European Union

C 49/5

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

15.2.2005

Karvea

15.2.2005

Aprovel

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

EU/1/97/049/001-030

17.2.2005

EU/1/97/046/001-030

17.2.2005

— Modification of a marketing authorization (Article 34 of Council 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

31.1.2005

IBAFLIN

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

EU/2/00/022/001a-
001b, 002a
- 002b,
003a-003b, 004a-004b
EU/2/00/022/005-008,

2.2.2005

31.1.2005

METACAM

Boehringer Ingelheim
Vetmedica GmbH, D-55216
Ingelheim am Rhein

EU/2/97/004/007-008

2.2.2005