Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 July 2005 to 31 July 2005(Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-08-26
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

26.8.2005

EN

Official Journal of the European Union

C 209/3

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 1 July 2005 to 31 July 2005

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

(2005/C 209/03)

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

Accepted

Date of the
decision

Name of the
medicinal
product

4.7.2005

Apidra

4.7.2005

Forcaltonin

4.7.2005

Trisenox

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Aventis Pharma Deutschland GmbH,
Brueningstrasse 50, D-65926 Frank-
furt am Main

Unigene UK Limited, 63 High Road,
Bushey Heath, Herts, WD2 1EE,
United Kingdom

Cell Therapeutics (UK) Ltd, 100 Pall
Mall, London SW1Y 5HP, United
Kingdom

EU/1/04/285/001-028

6.7.2005

EU/1/98/093/002

6.7.2005

EU/1/02/204/001

6.7.2005

4.7.2005

Levemir

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

EU/1/04/278/001-009

6.7.2005

4.7.2005

Zerene

4.7.2005

Sonata

Wyeth Research (UK) Limited, Hunter-
combe Lane South, Taplow, Maiden-
head, Berkshire, SL6 0PH, United
Kingdom

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

EU/1/99/099/001-006

6.7.2005

EU/1/99/102/001-008

6.7.2005

4.7.2005

Cymbalta

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

EU/1/04/296/001-006

6.7.2005

4.7.2005

Cymbalta

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

EU/1/04/296/001-006

6.7.2005

4.7.2005

Xeristar

4.7.2005

Xeristar

Boehringer
GmbH,
D-55216 Ingelheim am Rhein

Ingelheim International
173 —

Strasse

Binger

Boehringer
GmbH,
D-55216 Ingelheim am Rhein

Ingelheim International
173 —

Strasse

Binger

EU/1/04/297/001-006

6.7.2005

EU/1/04/297/001-006

6.7.2005

4.7.2005

Visudyne

Novartis Europharm Limited, Wimble-
hurst Road, Horsham, West Sussex
RH12 5AB, United Kingdom

EU/1/00/140/001

6.7.2005

4.7.2005

Xigris

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

EU/1/02/225/001-002

6.7.2005

7.7.2005

Invanz

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

EU/1/02/216/001-002

11.7.2005

7.7.2005

Arixtra

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

Glaxo
Greenford,
Middlesex UB6 0NN, United Kingdom

Group

Ltd,

EU/1/02/206/001-008

11.7.2005

C 209/4

EN

Official Journal of the European Union

26.8.2005

Date of the
decision

Name of the
medicinal
product

7.7.2005

Quixidar

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Glaxo
Greenford,
Middlesex UB6 0NN, United Kingdom

Group

Ltd,

EU/1/02/207/001-008

11.7.2005

7.7.2005

Cystagon

Orphan Europe,
laumet’, F-92046 Paris La Défense

Immeuble ‘Le Guil-

EU/1/97/039/001-004

11.7.2005

8.7.2005

Glivec

Novartis Europharm Limited, Wimble-
hurst Road, Horsham, West Sussex
RH12 5AB, United Kingdom

EU/1/01/198/001-013

12.7.2005

8.7.2005

Aranesp

Amgen Europe BV, Minervum 7061,
4817 ZK Breda, Nederland

EU/1/01/185/001-056

12.7.2005

8.7.2005

Nespo

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

EU/1/01/184/001-056

12.7.2005

8.7.2005

Lyrica

8.7.2005

Fortovase

8.7.2005

AVANDIA

PFIZER Ltd, Ramsgate Road, Sand-
wich, Kent CT 13 9NJ, United
Kingdom

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City,
3AY, United
Hertfordshire AL7
Kingdom

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

8.7.2005

NovoRapid

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

8.7.2005

NeuroBloc

8.7.2005

Simulect

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

Novartis Europharm Limited, Wimble-
hurst Road, Horsham, West Sussex
RH12 5AB, United Kingdom

EU/1/04/279/030-032

12.7.2005

EU/1/98/075/001-002

12.7.2005

EU/1/00/137/001-012

12.7.2005

EU/1/99/119/003
EU/1/99/119/005-007
EU/1/99/119/009-014

12.7.2005

EU/1/00/166/001-003

13.7.2005

EU/1/98/084/001-002

12.7.2005

8.7.2005

Zevalin

Schering AG, Müllerstrasse 170-178,
D-13342 Berlin

EU/1/03/264/001

12.7.2005

8.7.2005

Viread

Gilead Sciences International Limited,
Cambridge CB1 6GT United Kingdom

EU/1/01/200/001

12.7.2005

8.7.2005

Keppra

UCB SA, Allée de la recherche, 60,
B-1070 Bruxelles/Researchdreef, 60,
B-1070 Brussel

EU/1/00/146/001-027

12.7.2005

8.7.2005

Lantus

Aventis Pharma Deutschland GmbH,
D-65926 Frankfurt am Main

EU/1/00/134/001-029

12.7.2005

8.7.2005

Optisulin

Aventis Pharma Deutschland GmbH,
D-65926 Frankfurt am Main

EU/1/00/133/001-008

12.7.2005

13.7.2005

NeoRecormon

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City,
Hertfordshire AL7
3AY, United
Kingdom

EU/1/97/031/001-003
EU/1/97/031/019-046

15.7.2005

26.8.2005

EN

Official Journal of the European Union

C 209/5

Date of the
decision

Name of the
medicinal
product

22.7.2005

Enbrel

22.7.2005

KOGENATE
Bayer

27.7.2005

Vaniqa

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

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

EU/1/99/126/001-011

26.7.2005

Bayer AG, D-51368 Leverkusen

EU/1/00/143/001-006

26.7.2005

Shire Pharmaceutical Contracts Ltd,
Business
Hampshire
Park, Chineham, Basingstoke, Hamp-
shire RG24 8EP, United Kingdom

International

EU/1/01/173/001-003

29.7.2005

27.7.2005

Infergen

Yamanouchi Europe B.V., Elisabethhof
19, 2353 EW Leiderdorp, Nederland

EU/1/98/087/001-003

29.7.2005

27.7.2005

Zevalin

Schering AG, Müllerstrasse 170-178,
D-13342 Berlin

EU/1/03/264/001

29.7.2005

27.7.2005

Replagal

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

EU/1/01/189/001-006

29.7.2005

27.7.2005

Velcade

Janssen-Cilag International NV, Turn-
houtseweg, 30 B-2340 Beerse

EU/1/04/274/001

29.7.2005

27.7.2005

AVANDIA

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

EU/1/00/137/001-012

29.7.2005

27.7.2005

ReFacto

Ltd., Huntercombe
South, Taplow, Maidenhead,

Wyeth Europa
Lane
Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-004

29.7.2005

28.7.2005

Kineret

Amgen Europe BV, Minervum 7061,
4817 ZK Breda, Nederland

EU/1/02/203/001-004

1.8.2005

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

Accepted

Date of the
decision

8.7.2005

Name of the
medicinal
product

Equilis
Prequenza

Holder of the marketing authorization

Number of the entry in
the Community Register

Date of
notification

Intervet
International BV, Wim de
Körverstraat 35, 5831 AN Boxmeer,
Nederland

EU/2/05/056/001-002

12.7.2005

8.7.2005

Equilis
Prequenza Te

Intervet
International BV, Wim de
Körverstraat 35, 5831 AN Boxmeer,
Nederland

EU/2/05/057/001-002

12.7.2005

8.7.2005

Equilis Te

Intervet
International BV, Wim de
Körverstraat 35, 5831 AN Boxmeer,
Nederland

EU/2/05/055/001-002

12.7.2005

27.7.2005

Profender

Bayer Healthcare AG, D-51368
Leverkusen

EU/2/05/054/001-017

29.7.2005

C 209/6

EN

Official Journal of the European Union

26.8.2005

— 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

7.7.2005

Neocolipor

Merial, 29 avenue Tony Garnier,
F-69007 Lyon

EU/2/98/008/001-004

11.7.2005

8.7.2005

Ibaflin

Intervet
International BV, Wim de
Körverstraat 35, 5831 AN Boxmeer,
Nederland

12.7.2005

EU/2/00/022/001a-
001b, 002a-002b,
003a-003b, 004a-
004b,
EU/2/00/022/005-017,

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
London E14 4HB
United Kingdom