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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

Number of the
Date of the Name of the Holder of the Date of
entry in the
decision medicinal product marketing authorization notification
Community Register

1.12.2003 Serostim Serono Europe Limited — 3.12.2003


56, Marsh Wall
London E14 9TP
United Kingdom

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


Accepted

Number of the
Date of the Name of the Holder of the Date of
entry in the
decision medicinal product marketing authorization notification
Community Register

1.12.2003 INOmax INO Therapeutics AB EU/1/01/194/001-002 3.12.2003


S-181 81 Lidingö AGA AB
S-181 81 Lidingö

1.12.2003 Invanz Merck Sharp & Dohme Ltd EU/1/02/216/001-002 3.12.2003


Hertford Road
Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

4.12.2003 Karvezide Bristol-Myers Squibb Pharma EEIG EU/1/98/085/001-010 9.12.2003


141-149 Staines Road
Hounslow TW3 3JA
United Kingdom

4.12.2003 CoAprovel Sanofi Pharma Bristol-Myers EU/1/98/086/001-010 9.12.2003


Squibb SNC
174, avenue de France
F-75013 Paris

4.12.2003 MacCampath ILEX Pharmaceutical Ltd EU/1/01/193/001 9.12.2003


1 & 3 Frederick Sanger Road
The Surrey Research Park
Guildford
Surrey GU2 7YD
United Kingdom

12.12.2003 Rebetol Schering Plough Europe EU/1/99/107/001-003 16.12.2003


Rue de Stalle 73
B-1180 Bruxelles
Stallestraat 73
B-1180 Brussel

12.12.2003 Cotronak Schering Plough Europe EU/1/99/106/001-003 16.12.2003


Rue de Stalle 73
B-1180 Bruxelles
Stallestraat 73
B-1180 Brussel

15.12.2003 Twinrix Paedriatric GlaxoSmithKline Biologicals SA EU/1/97/029/001-010 17.12.2003


rue de l'Institut 89
B-1330 Rixensart

(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

Number of the
Date of the Name of the Holder of the Date of
entry in the
decision medicinal product marketing authorization notification
Community Register

1.12.2003 Doxirobe Gel Pfizer Ltd EU/2/99/012/001-002 3.12.2003


Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

1.12.2003 Pirsue Pfizer Ltd EU/2/00/027/001-003 3.12.2003


Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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))

(2004/C 6/03)

— Issuing, maintenance or modification of a national marketing authorisation

Name(s) of the Holder(s) of the marketing Date of


Date of the decision Member State concerned
medicinal product authorization 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.