Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 July 2004 to 15 August 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-08-27
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

27.8.2004

EN

Official Journal of the European Union

C 215/7

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 July 2004 to 15 August 2004

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

(2004/C 215/05)

— Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1))

Accepted

Date of the
decision

Name of the
medicinal
product

29.7.2004

Pedea

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of notifica-
tion

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

EU/1/04/284/001

2.8.2004

11.8.2004

Yentreve

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

EU/1/04/280/001-006.

13.8.2004

11.8.2004

Ariclaim

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

EU/1/04/283/001-006

13.8.2004

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

93 (1)) Accepted

Date of the
decision

Name of the
medicinal
product

19.7.2004

Reyataz

19.7.2004

Humira

19.7.2004

Trudexa

19.7.2004

Nyracta

19.7.2004

Avandia

19.7.2004

Venvia

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of notifica-
tion

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

Abbott Laboratories Ltd., Queenbor-
ough,
5EL, United
Kingdom

Kent ME11

Abbott Laboratories Ltd., Queenbor-
ough,
5EL, United
Kingdom

Kent ME11

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

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

EU/1/03/267/001-007

21.07.2004

EU/1/03/256/001-006

21.07.2004

EU/1/03/257/001-006

21.07.2004

EU/1/00/139/001-012

21.07.2004

EU/1/00/137/001-012

21.07.2004

EU/1/00/138/001-012

21.07.2004

20.7.2004

Rebif

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

EU/1/98/063/001-006

23.07.2004

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

C 215/8

EN

Official Journal of the European Union

27.8.2004

Date of the
decision

Name of the
medicinal
product

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of notifica-
tion

20.7.2004

Replagal

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

EU/1/01/189/001-003

23.07.2004

20.7.2004

Refacto

Ltd., Huntercombe
South, Taplow, Maidenhead,

Wyeth Europa
Lane
Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-004

23.07.2004

22.7.2004

Mirapexin

Ingelheim International
Boehringer
GmbH, Binger Strasse 173, D-55216
Ingelheim am Rhein, Deutschland
Pfizer Enterprises SARL, 6, Circuit de
la Foire Internationale, 1347 Luxem-
bourg, Grand-Duché du Luxembourg

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

26.07.2004

23.7.2004

Enbrel

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

EU/1/99/126/001-003

27.07.2004

23.7.2004

Enbrel

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

EU/1/99/126/001-003

27.07.2004

29.7.2004

ReFacto

Ltd., Huntercombe
South, Taplow, Maidenhead,

Wyeth Europa
Lane
Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-004

2.8.2004

29.7.2004

Replagal

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

EU/1/01/189/004-006

2.8.2004

2.8.2004

Procomvax

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

rue Jonas

EU/1/99/104/001

4.8.2004

2.8.2004

CoAprovel

Sanofi Pharma Bristol-Myers Squibb
SNC, 174 avenue de France - 75013
Paris, France

EU/1/98/086/001-020

4.8.2004

2.8.2004

Aprovel

Sanofi Pharma Bristol-Myers Squibb
SNC, 174 avenue de France - 75013
Paris, France

EU/1/97/046/001-030

4.8.2004

2.8.2004

Karvezide

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

EU/1/98/085/001-020

4.8.2004

2.8.2004

Karvea

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

EU/1/97/049/001-030

4.8.2004

2.8.2004

MabThera

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

EU/1/98/067/001-002

4.8.2004

2.8.2004

Plavix

Sanofi Pharma Bristol-Myers Squibb
SNC, 174 avenue de France - 75013
Paris, France

EU/1/98/069/001a-001b,
EU/1/98/069/002a-002b,
EU/1/98/069/003a-003b,
EU/1/98/069/004a-004b

4.8.2004

27.8.2004

EN

Official Journal of the European Union

C 215/9

Date of the
decision

Name of the
medicinal
product

2.8.2004

Iscover

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of notifica-
tion

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

EU/1/98/070/001a-001b,
EU/1/98/070/002a-002b,
EU/1/98/070/003a-003b,
EU/1/98/070/004a-004b

4.8.2004

2.8.2004

Prevenar

Wyeth-Lederle Vaccines S.A., Rue du
Bosquet,
Louvain-La-
Neuve - Belgique

15 - 1348

EU/1/00/167/001-007

4.8.2004

2.8.2004

Actrapid

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

EU/1/02/230/001-017

4.8.2004

2.8.2004

Mixtard

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

EU/1/02/231/001-037

4.8.2004

2.8.2004

Insulatard

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

EU/1/02/233/001-017

4.8.2004

2.8.2004

Velosulin

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

EU/1/02/232/001-003

4.8.2004

2.8.2004

Protaphane

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

EU/1/02/234/001-017

4.8.2004

2.8.2004

Puregon

Organon N.V., P.O. Box 20, 5340 BH
Oss, Nederland

EU/1/96/008/038-039

4.8.2004

2.8.2004

Puregon,

Organon N.V., P.O. Box 20, 5340 BH
Oss, Nederland

EU/1/96/008/040-041

4.8.2004

2.8.2004

Viread

Gilead Sciences International Limited,
Cambridge CB1 6GT United Kingdom

EU/1/01/200/001

4.8.2004

2.8.2004

Emtriva

Gilead Sciences International Limited,
Cambridge CB1 6GT United Kingdom

EU/1/03/261/001-003

4.8.2004

2.8.2004

Actraphane

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

EU/1/02/229/001-037

4.8.2004

2.8.2004

Norvir

Abbott
ough, Kent ME11
Kingdom

laboratories Ltd, Queenbor-
5EL, United-

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

4.8.2004

2.8.2004

Starlix

2.8.2004

Cellcept

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

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

EU/1/01/174/001-021

4.8.2004

EU/1/96/005/001-006

4.8.2004

2.8.2004

Protopy

Fujisawa GmbH, Neumarkter Str. 61,
D-81673 München, Deutschland

EU/1/02/202/001-007

4.8.2004

2.8.2004

Inomax

INO Therapeutics AB, SE-181 81
Lidingö, Sverige

EU/1/01/194/001-002

4.8.2004

C 215/10

EN

Official Journal of the European Union

27.8.2004

Date of the
decision

Name of the
medicinal
product

2.8.2004

Trazec

4.8.2004

Insuman

4.8.2004

Somavert

9.8.2004

Fabrazyme

11.8.2004

Vfend

12.8.2004

Infergen

12.8.2004

Optison

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of notifica-
tion

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

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

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

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

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

Yamanouchi Europe B.V., Elisabethhof
19, NL-2353 EW Leiderdorp, Neder-
land

Amersham Health AS, Nycoveien 1-2,
P.O. Box 4220 Nydalen, 0401 Oslo,
Norway

EU/1/01/175/001-021

4.8.2004

6.8.2004

EU/1/97/030/030, EU/1/
97/030/035, EU/1/97/
030/040, EU/1/97/030/
045, EU/1/97/030/050,
EU/1/97/030/055-064

EU/1/02/240/001-004

6.8.2004

EU/1/01/188/001-006

12.8.2004

EU/1/02/212/001-026

13.8.2004

EU/1/98/087/001-003

16.8.2004

EU/1/98/065/001-002

16.8.2004

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

93 (1)) 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 notifica-
tion

23.07.2004

Eurifel RCP
FeL V

Merial, 29 avenue Tony Garnier,
69007 Lyon, France

EU/2/02/031/001-002

27.07.2004

29-07-2004

11-08-2004

Virbagen
Omega

Porcilis
Porcoli

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

EU/2/01/030/001-002

02-08-2004

Intervet International B.V. (NL), Wim
5831 AN
de
Boxmeer, Nederland

Körverstraat

35,

EU/2/96/001/009-010

13-08-2004

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
UK - LONDON E14 4HB