Summary of Community decisions on marketing authorizations in respect of medicinal products from  1 October 2005  to  31 October 2005 (Published pursuant to Article 12 or Article 34 of Council Regulation (EEC) No 2309/93)
Date: 2005-11-25
Institutions: European Commission
Subjects: market approval, medicinal product, pharmaceutical legislation

25.11.2005

EN

Official Journal of the European Union

C 293/11

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

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

(2005/C 293/06)

— Issuing 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

Number of the entry in
the Community Register

Date of
notification

3.10.2005

Vasovist

Schering AG, Müllerstrasse
DE-13342 Berlin

170-178,

EU/1/05/313/001-009

5.10.2005

13.10.2005 Xyrem

UCB Pharma Ltd., 208 Bath Road, Slough,
Berks, UK-SL1 3WE

EU/1/05/312/001

18.10.2005

25.10.2005 Posaconazole SP

SP Europe, Rue de Stalle, 73, BE-1180
Bruxelles — Stallestraat, 73 — BE-1180
Brussel

EU/1/05/321/001

27.10.2005

25.10.2005 Aptivus

25.10.2005 Xolair

Boehringer
International
Ingelheim
GmbH, Binger Strasse 173 — DE-55216
Ingelheim am Rhein

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

EU/1/05/315/001

27.10.2005

EU/1/05/319/001-002

27.10.2005

25.10.2005 Kepivance

Amgen Europe BV, Minervum 7061,
NL-4817 ZK Breda

EU/1/05/314/001

27.10.2005

25.10.2005 Noxafil

SP Europe, Rue de Stalle, 73, BE-1180
Bruxelles — Stallestraat, 73 — BE-1180
Brussel

EU/1/05/320/001

27.10.2005

25.10.2005 Corlentor

Laboratoires Servier, 22,
FR-92200 Neuilly-sur-Seine

rue Garnier,

EU/1/05/317/001-014

27.10.2005

25.10.2005 Procoralan

Laboratoires Servier, 22,
FR-92200 Neuilly-sur-Seine

rue Garnier,

EU/1/05/316/001-014

27.10.2005

28.10.2005 Revatio

PFIZER Ltd, Ramsgate Road, Sandwich,
Kent, UK-CT 13 9NJ

EU/1/05/318/001

4.11.2005

— 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

Number of the entry in
the Community Register

Date of
notification

5.10.2005 Mixtard

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

EU/1/02/231/011-013
EU/1/02/231/033-035

10.10.2005

5.10.2005

Actraphane

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

EU/1/02/229/011-013
EU/1/02/229/033-035

10.10.2005

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

C 293/12

EN

Official Journal of the European Union

25.11.2005

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

5.10.2005

Insulatard

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

EU/1/02/233/005-007
EU/1/02/233/013-015

10.10.2005

5.10.2005

Protaphane

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

EU/1/02/234/005-007
EU/1/02/234/013-015

10.10.2005

5.10.2005

Actrapid

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

EU/1/02/230/005-007
EU/1/02/230/013-015

10.10.2005

5.10.2005

Prevenar

Wyeth-Lederle Vaccines
du
Bosquet, 15 — BE-1348 Louvain-La-
Neuve

SA, Rue

EU/1/00/167/001-007

7.10.2005

5.10.2005 NovoMix

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

EU/1/00/142/011-016

10.10.2005

5.10.2005

Fuzeon

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City, Hert-
fordshire, UK-AL7 3AY

EU/1/03/252/001-003

7.10.2005

5.10.2005 Onsenal

Pharmacia-Pfizer EEIG, Ramsgate Road,
Sanwich, UK-CT13 9NJ

EU/1/03/259/001-006

7.10.2005

5.10.2005 NovoMix

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

EU/1/00/142/017-022

10.10.2005

5.10.2005 Dynastat

Pharmacia Europe EEIG, Sandwich, Kent,
UK-CT13 9NJ

EU/1/02/209/001-008

7.10.2005

6.10.2005

Trisenox

Cell Therapeutics (UK) Limited, 100 Pall
Mall, London, UK-SW1Y 5HP

EU/1/02/204/001

10.10.2005

13.10.2005 Actos

Takeda Europe R & D Centre Ltd, Savanah
House, 11/12 Charles II Street, London,
UK-SW1Y 4QU

EU/1/00/150/001-015

18.10.2005

13.10.2005 Glustin

Takeda Europe R & D Centre Ltd, Savanah
House, 11/12 Charles II Street, London,
UK-SW1Y 4QU

EU/1/00/151/001-013

18.10.2005

13.10.2005 Procomvax

Sanofi Pasteur MSD, SNC, 8, rue Jonas
Salk, FR-69007 Lyon

EU/1/99/104/001

18.10.2005

13.10.2005 Foscan

Biolitec pharma Ltd. United Drug, House
Magna Drive, IE-Dublin 24

EU/1/01/197/001-002

18.10.2005

19.10.2005 GONAL-f

Serono Europe Limited, 56, Marsh Wall,
London, UK-E14 9TP

21.10.2005

EU/1/95/001/001
EU/1/95/001/003-005
EU/1/95/001/009
EU/1/95/001/012
EU/1/95/001/021-022
EU/1/95/001/025-028
EU/1/95/001/031-035

25.11.2005

EN

Official Journal of the European Union

C 293/13

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

19.10.2005 Tracleer

Actelion Registration Ltd, BSI Building
13th Floor, 389 Chiswick High Road,
London, UK-W4 4AL

EU/1/02/220/001-005

21.10.2005

19.10.2005 NeuroBloc

Solstice Neurosciences
House, Wilton Place, IE-Dublin 2

Ltd,

Fitzwilton

EU/1/02/166/001-003

21.10.2005

19.10.2005 Velcade

Janssen-Cilag International NV,
Turnhoutsewe, 30 — BE-2340 Beerse

EU/1/04/274/001

21.10.2005

25.10.2005 Paxene

Norton Healthcare Limited, Albert Basin,
Royal Docks, London, UK-E16 2QJ

EU/1/99/113/001-004

27.10.2005

25.10.2005 Pegasys

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City, Hert-
fordshire, UK-AL7 3AY

EU/1/02/221/001-010

27.10.2005

25.10.2005 Orgalutran

NV Organon, PO Box 20, Kloosterstraat 6,
NL-5340 BH Oss

EU/1/00/130/001-002

27.10.2005

25.10.2005 Rebetol

Norton Healthcare Limited, Albert Basin,
Royal Docks, London, UK-E16 2QJ

EU/1/99/107/001-004

27.10.2005

25.10.2005 Telzir

Glaxo Group Ltd., Greenford Road, Green-
ford, Middlesex, UK-UB6 0NN

EU/1/04/282/001-002

27.10.2005

25.10.2005 Truvada

Gilead
Granta
UK-CB1 6GT

Sciences
Park

International
Abington

Limited,
Cambridge,

EU/1/04/305/001

27.10.2005

25.10.2005 Viread

Gilead
Sciences
Cambridge, UK-CB1 6GT

International

Limited,

EU/1/01/200/001

27.10.2005

25.10.2005 Ovitrelle

Serono Europe Limited, 56, Marsh Wall,
London, UK-E14 9TP

EU/1/01/200/001-007

27.10.2005

25.10.2005 Stocrin

Merck Sharp & Dohme Ltd, Hertford
Road, Hoddesdon, Hertfordshire,
UK-EN11 9BU

EU/1/99/111/001-009

27.10.2005

25.10.2005 Cialis

Lilly ICOS Limited, St Bride's House — 10
Salisbury Square — London,
UK-EC4Y 8EH

EU/1/02/237/002-005

27.10.2005

C 293/14

EN

Official Journal of the European Union

25.11.2005

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

25.10.2005 Refludan

Pharmion Limited, Riverside House, River-
side Walk, Windsor, UK-SL4 1NA

EU/1/97/035/001-004

27.10.2005

25.10.2005 Sustiva

Squibb

Bristol-Myers
EEIG,
Uxbridge Business Park, Sanderson Road,
Uxbridge, UK-UD8 1DH

Pharma

EU/1/99/110/001-009

27.10.2005

27.10.2005 Vfend

Pfizer Limited, Sandwich, Kent,
UK-CT13 9NJ

EU/1/02/212/001-026

31.10.2005

27.10.2005 IntronA

Schering Plough Europe, Rue de Stalle, 73,
BE-1180 Bruxelles — Stallestraat, 73 —
BE-1180 Brussel

EU/1/99/127/001-044

2.11.2005

27.10.2005 Rapilysin

Roche Registration Limited, 40 Broad-
water Road, Welwyn Garden City, Hert-
fordshire, UK-AL7 3AY

EU/1/96/018/001

31.10.2005

27.10.2005 Prevenar

Wyeth-Lederle Vaccines
du
Bosquet, 15 — BE-1348 Louvain-La-
Neuve

SA, Rue

EU/1/00/167/001-007

31.10.2005

27.10.2005 Betaferon

Schering AG Pharma, Berlin, DE-13342
Berlin

EU/1/95/003/001-004

31.10.2005

27.10.2005 Busilvex

Pierre Fabre Médicament, 45 place Abel
Gance, FR-92654 Boulogne Billancourt
Cedex

EU/1/03/254/001

31.10.2005

27.10.2005 Viraferon

Schering Plough Europe, Rue de Stalle, 73,
BE-1180 Bruxelles — Stallestraat, 73 —
BE-1180 Brussel

EU/1/99/128/001-037

2.11.2005

28.10.2005 Abilify

Pharmaceutical

Otsuka
Ltd,
Commonwealth House, 2 Chalkhill Road,
Hammersmith, London, UK-W6 8DW

Europe

EU/1/04/276/033-035

4.11.2005

28.10.2005 Neupopeg

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

EU/1/02/228/001-003

4.11.2005

28.10.2005 Aldara

3M Santé, Boulevard de l'Oise, FR-95029
Cergy Pontoise Cedex

EU/1/98/080/001

4.11.2005

28.10.2005 Neulasta

Amgen Europe BV, Minervum 7061,
NL-4817 ZK Breda

EU/1/02/227/001-003

4.11.2005

— Suspension of a marketing authorization (Article 18 of Regulation (EEC) No 2309/93)

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

13.10.2005 Bextra

Pharmacia-Pfizer EEIG, Sandwich, Kent,
UK-CT13 9NJ

EU/1/02/239/001-030

19.10.2005