# C_2005293EN.01001101.xml

| 25.11.2005 | EN | Official Journal of the European Union | C 293/11 |
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25.11.2005

EN

Official Journal of the European Union

C 293/11

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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)

(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 170-178, DE-13342 Berlin | 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 | Boehringer Ingelheim International GmbH, Binger Strasse 173 — DE-55216 Ingelheim am Rhein | EU/1/05/315/001 | 27.10.2005 |
| 25.10.2005 | Xolair | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex, UK-RH12 5AB | 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, rue Garnier, FR-92200 Neuilly-sur-Seine | EU/1/05/317/001-014 | 27.10.2005 |
| 25.10.2005 | Procoralan | Laboratoires Servier, 22, rue Garnier, FR-92200 Neuilly-sur-Seine | 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 |

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 170-178, DE-13342 Berlin

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

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

EU/1/05/315/001

27.10.2005

25.10.2005

Xolair

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

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, rue Garnier, FR-92200 Neuilly-sur-Seine

EU/1/05/317/001-014

27.10.2005

25.10.2005

Procoralan

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

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 |
| 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 SA, Rue du Bosquet, 15 — BE-1348 Louvain-La-Neuve | 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 Broadwater Road, Welwyn Garden City, Hertfordshire, 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 | 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 | 21.10.2005 |
| 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 Ltd, Fitzwilton House, Wilton Place, IE-Dublin 2 | 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 Broadwater Road, Welwyn Garden City, Hertfordshire, 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, Greenford, Middlesex, UK-UB6 0NN | EU/1/04/282/001-002 | 27.10.2005 |
| 25.10.2005 | Truvada | Gilead Sciences International Limited, Granta Park Abington Cambridge, UK-CB1 6GT | EU/1/04/305/001 | 27.10.2005 |
| 25.10.2005 | Viread | Gilead Sciences International Limited, Cambridge, UK-CB1 6GT | 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 |
| 25.10.2005 | Refludan | Pharmion Limited, Riverside House, Riverside Walk, Windsor, UK-SL4 1NA | EU/1/97/035/001-004 | 27.10.2005 |
| 25.10.2005 | Sustiva | Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge, UK-UD8 1DH | 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 Broadwater Road, Welwyn Garden City, Hertfordshire, UK-AL7 3AY | EU/1/96/018/001 | 31.10.2005 |
| 27.10.2005 | Prevenar | Wyeth-Lederle Vaccines SA, Rue du Bosquet, 15 — BE-1348 Louvain-La-Neuve | 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 | Otsuka Pharmaceutical Europe Ltd, Commonwealth House, 2 Chalkhill Road, Hammersmith, London, UK-W6 8DW | 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 |

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

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 SA, Rue du Bosquet, 15 — BE-1348 Louvain-La-Neuve

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 Broadwater Road, Welwyn Garden City, Hertfordshire, 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

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

21.10.2005

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 Ltd, Fitzwilton House, Wilton Place, IE-Dublin 2

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 Broadwater Road, Welwyn Garden City, Hertfordshire, 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, Greenford, Middlesex, UK-UB6 0NN

EU/1/04/282/001-002

27.10.2005

25.10.2005

Truvada

Gilead Sciences International Limited, Granta Park Abington Cambridge, UK-CB1 6GT

EU/1/04/305/001

27.10.2005

25.10.2005

Viread

Gilead Sciences International Limited, Cambridge, UK-CB1 6GT

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

25.10.2005

Refludan

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

EU/1/97/035/001-004

27.10.2005

25.10.2005

Sustiva

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

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 Broadwater Road, Welwyn Garden City, Hertfordshire, UK-AL7 3AY

EU/1/96/018/001

31.10.2005

27.10.2005

Prevenar

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

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

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

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 |

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

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

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