Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 March 2004 to 15 April 2004 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-04-30
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

C 115/20

EN

Official Journal of the European Union

30.4.2004

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 March 2004 to 15 April 2004

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

(2004/C 115/10)

— 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 notifi-
cation

25.3.2004

PhotoBarr

14.4.2004

Litak

Axcan Pharma International BV
Engelenkampstraat 72
6131 JJ Sittard
Nederland

Lipomed GmbH
Schönaugasse 11
D-79713 Bad Säckingen

EU/1/04/272/001-002

29.3.2004

EU/1/04/275/001-002

19.4.2004

— 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 notifi-
cation

16.3.2004

ViraferonPeg

16.3.2004

PegIntron

19.3.2004

Mabthera

19.3.2004

NutropinAq

25.3.2004

Norvir

25.3.2004

Xeloda

25.3.2004

Synagis

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

Schering Plough Europe
Rue de Stalle, 73
1180 Bruxelles

Schering Plough Europe
Rue de Stalle, 73
1180 Bruxelles

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

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

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

Abbott laboratories Ltd
Queenborough
Kent ME11 5EL
United Kingdom

EU/1/00/132/031-050

18.3.2004

EU/1/00/131/031-050

18.3.2004

EU/1/98/067/001-002

23.3.2004

EU/1/00/164/003-005

23.3.2004

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

29.3.2004

EU/1/00/163/001-002

26.3.2004

EU/1/99/117/001-002

29.3.2004

30.4.2004

EN

Official Journal of the European Union

C 115/21

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of notifi-
cation

25.3.2004

Infergen

31.3.2004

Glivec

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

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

31.3.2004

NovoNorm

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsvaerd

31.3.2004

Sonata

31.3.2004

Regranex

31.3.2004

Zerene

31.3.2004

Ambirix

5.4.2004

Prandin

7.4.2004

NovoRapid W28-
29

13.4.2004

Ventavis

14.4.2004

Aranesp

14.4.2004

Nespo

14.4.2004

Zenapax

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

Janssen-Cilag International NV
Turnhoutseweg, 30
B-2340 Beerse

Wyeth Research (UK) Limited
Huntercombe Lane South
Taplow, Maidenhead
Berkshire, SL6 0PH
United Kingdom

GlaxoSmithKline Biologicals s.a.
rue de l'Institut 89
B-1330 Rixensart

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsvaerd

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsvaerd

Schering AG
Müllerstrasse 170-178
D-13342 Berlin

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

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

Roche Registration Ltd
40 Broadwater Road
Welwyn Garden City
Hertfordshire, AL7 3AY

EU/1/98/087/001-003

26.3.2004

EU/1/01/198/001-010

2.4.2004

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

2.4.2004

EU/1/99/102/001-008

2.4.2004

EU/1/99/101/001

2.4.2004

EU/1/99/099/001-006

2.4.2004

EU/1/02/224/001-005

5.4.2004

EU/1/00/162/001-018

7.4.2004

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

14.4.2004

EU/1/03/255/001-003

16.4.2004

EU/1/01/185/001-032

16.4.2004

EU/1/01/184/001-032

16.4.2004

EU/1/99/098/001-002

16.4.2004

C 115/22

EN

Official Journal of the European Union

30.4.2004

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of notifi-
cation

14.4.2004

Forcaltonin

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

EU/1/98/093/002

16.4.2004

15.4.2004

NovoMix 30

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsvaerd

EU/1/00/142/004-005
EU/1/00/142/007-010

19.4.2004

— 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 notifi-
cation

15.3.2004

Suvaxyn Aujeszky
783 +O/W

Fort Dodge Animal Health Holland
36, C. J. van Houtenlaan
1381 CP Weesp
Nederland

EU/2/98/009/001-006

17.3.2004

15.3.2004

Quadrisol

19.3.2004

Gonazon

19.3.2004

Porcilis Pesti

19.3.2004

Nobilis OR inac

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/97/005/001-009

17.3.2004

EU/2/03/040/001

23.3.2004

EU/2/99/016/001-006

23.3.2004

EU/2/02/036/001-002

23.3.2004

19.3.2004

METACAM

Ingelheim Vetmedica

Boehringer
GmbH
D-55216 Ingelheim am Rhein

EU/2/97/004/010

23.3.2004

19.3.2004

Nobivac Bb

25.3.2004

Gallivac HVT IBD

31.3.2004

Econor

7.4.2004

IBAFLIN

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Merial
29 avenue Tony Garnier
F-69007 Lyon

Novartis Animal Health Austria
GmbH
Biochemiestrasse 10
A-6250 Kundl

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/02/034/001

23.3.2004

EU/2/02/032/001

26.3.2004

EU/2/98/010/001-024

2.4.2004

EU/2/00/022/009-012

14.4.2004

30.4.2004

EN

Official Journal of the European Union

C 115/23

Date of the
decision

Name of the medicinal
product

Holder of the marketing authorization

Number of the entry in the
Community Register

Date of notifi-
cation

7.4.2004

Incurin

13.4.2004

Advocate

14.4.2004

Nobilis IB 4-91

14.4.2004

Pruban

14.4.2004

Porcilis AR-T DF

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Bayer Healthcare AG
D-51368 Leverkusen
Bayer AG
D-51368 Leverkusen

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

Intervet International BV
Wim de Körverstraat 35
5831 AN Boxmeer
Nederland

EU/2/00/018/001

14.4.2004

EU/2/03/039/001-018

16.4.2004

EU/2/98/006/001-010

16.4.2004

EU/2/00/024/001

16.4.2004

EU/2/00/026/001-004

16.4.2004

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
London E14 4HB
United Kingdom