Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 November 2003 to 15 December 2003 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2004-01-10
Institutions: European Commission
Subjects: market approval, marketing, medicinal product

C 6/2

EN

Official Journal of the European Union

10.1.2004

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 November 2003 to 15 December 2003

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

(2004/C 6/02)

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

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

1.12.2003

Serostim

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

Number of the
entry in the
Community Register

—

Date of
notification

3.12.2003

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

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

1.12.2003

INOmax

1.12.2003

Invanz

4.12.2003

Karvezide

4.12.2003

CoAprovel

4.12.2003

MacCampath

12.12.2003 Rebetol

12.12.2003 Cotronak

INO Therapeutics AB
S-181 81 Lidingö AGA AB
S-181 81 Lidingö

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

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

ILEX Pharmaceutical Ltd
1 & 3 Frederick Sanger Road
The Surrey Research Park
Guildford
Surrey GU2 7YD
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

Number of the
entry in the
Community Register

Date of
notification

EU/1/01/194/001-002

3.12.2003

EU/1/02/216/001-002

3.12.2003

EU/1/98/085/001-010

9.12.2003

EU/1/98/086/001-010

9.12.2003

EU/1/01/193/001

9.12.2003

EU/1/99/107/001-003

16.12.2003

EU/1/99/106/001-003

16.12.2003

15.12.2003

Twinrix Paedriatric

GlaxoSmithKline Biologicals SA
rue de l'Institut 89
B-1330 Rixensart

EU/1/97/029/001-010

17.12.2003

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

10.1.2004

EN

Official Journal of the European Union

C 6/3

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

Accepted

Date of the
decision

Name of the
medicinal product

Holder of the
marketing authorization

1.12.2003

Doxirobe Gel

1.12.2003

Pirsue

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Pfizer Ltd
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Number of the
entry in the
Community Register

Date of
notification

EU/2/99/012/001-002

3.12.2003

EU/2/00/027/001-003

3.12.2003

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

Summary of Community decisions on marketing authorizations in respect of medicinal products
from 15 November 2003 to 15 December 2003

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

— Issuing, maintenance or modification of a national marketing authorisation

(2004/C 6/03)

Date of the decision

Name(s) of the
medicinal product

Holder(s) of the marketing
authorization

Member State concerned

Date of
notification

1.12.2003

Calcichew D3

See Annex I

See Annex I

3.12.2003

1.12.2003

Calcitugg

See Annex II

See Annex II

3.12.2003

1.12.2003

Fluconazole

See Annex III

See Annex III

3.12.2003

1.12.2003

Beriate P

See Annex IV

See Annex IV

3.12.2003

4.12.2003

Perindopril

See Annex V

See Annex V

8.12.2003

12.12.2003

Mononine

See Annex VI

See Annex VI

16.12.2003

(1) OJ L 311, 28.11.2001, p. 67.
(2) OJ L 311, 28.11.2001, p. 1.