# C_2005268EN.01000201.xml

| 28.10.2005 | EN | Official Journal of the European Union | C 268/2 |
| --- | --- | --- | --- |

28.10.2005

EN

Official Journal of the European Union

C 268/2

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 September 2005 to 30 September 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 268/02)

—   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 notification |
| --- | --- | --- | --- | --- |
| 19.9.2005 | Tarceva | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY | EU/1/05/311/001-003 | 21.9.2005 |

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

19.9.2005

Tarceva

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY

EU/1/05/311/001-003

21.9.2005

—   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 notification |
| --- | --- | --- | --- | --- |
| 5.9.2005 | Ventavis | Schering AG, Müllerstraße 170-178, DE-13342 Berlin | EU/1/03/255//001-003 | 8.9.2005 |
| 5.9.2005 | Trazec | Novartis Europharm Limited, Wimblehurst Road, Horsham, UK-West Sussex RH12 5AB | EU/1/01/175/001-021 | 8.9.2005 |
| 5.9.2005 | Forsteo | Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten | EU/1/03/247/001-002 | 7.9.2005 |
| 5.9.2005 | Starlix | Novartis Europharm Limited, Wimblehurst Road, Horsham, UK-West Sussex RH12 5AB | EU/1/01/174/001-021 | 8.9.2005 |
| 7.9.2005 | DaTSCAN | GE Healthcare Limited, UK-Little Chalfont Bucks HP7 9NA | EU/1/00/135/001-002 | 9.9.2005 |
| 7.9.2005 | Emtriva | Gilead Sciences International Limited, UK-Cambridge CB1 6GT | EU/1/03/261/001-003 | 9.9.2005 |
| 7.9.2005 | KOGENATE Bayer | Bayer AG, DE-51368 Leverkusen | EU/1/00/143/001-006 | 9.9.2005 |
| 7.9.2005 | Helixate NexGen | Bayer AG, DE-51368 Leverkusen | EU/1/00/144/001-003 | 9.9.2005 |
| 8.9.2005 | Nespo | Dompé Biotec S.p.A., Via San Martino, 12, IT-20122 Milano | EU/1/01/184/001-056 | 13.9.2005 |
| 8.9.2005 | Herceptin | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY | EU/1/00/145/001 | 13.9.2005 |
| 8.9.2005 | Xagrid | Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP | EU/1/04/295/001 | 13.9.2005 |
| 8.9.2005 | Kivexa | Glaxo Group Ltd, Berkeley Avenue, Greenford, UK-Middlesex UB6 0NN | EU/1/04/298/001-002 | 13.9.2005 |
| 8.9.2005 | Ziagen | Glaxo Group Ltd, Greenford, UK-Middlesex UB6 0NN | EU/1/99/112/001-002 | 13.9.2005 |
| 8.9.2005 | Aranesp | Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda | EU/1/01/185/001-056 | 13.9.2005 |
| 8.9.2005 | Karvezide | Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, UK-Uxbridge UD8 1DH | EU/1/98/085/001-020 | 13.9.2005 |
| 8.9.2005 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris | EU/1/98/086/001-020 | 13.9.2005 |
| 8.9.2005 | PegIntron | Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73, BE-1180 Brussel | EU/1/00/131/001-050 | 13.9.2005 |
| 8.9.2005 | ViraferonPeg | Schering Plough Europe, Rue de Stalle, 73, BE-1180 Bruxelles — Stallestraat, 73, BE-1180 Brussel | EU/1/00/132/001-050 | 13.9.2005 |
| 8.9.2005 | Raptiva | Serono Europe Limited, 56, Marsh Wall, UK-London E14 9TP | EU/1/04/291/001-002 | 14.9.2005 |
| 8.9.2005 | Pylobactell | Torbet Laboratories Limited, Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, UK-Norfolk NR13 6LH | EU/1/98/064/001 | 13.9.2005 |
| 13.9.2005 | Infanrix Hexa | GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, BE-1330 Rixensart | EU/1/00/152/001-018 | 14.9.2005 |
| 13.9.2005 | Somavert | Pfizer Limited, Sandwich, UK-Kent, CT13 9NJ | EU/1/02/240/001-004 | 14.9.2005 |
| 13.9.2005 | Hepsera | Gilead Sciences International Limited, UK-Cambridge CB1 6GT | EU/1/03/251/001 | 15.9.2005 |
| 13.9.2005 | Erbitux | Merck KGaA, Frankfurter Straße 250, DE-64293 Darmstadt | EU/1/04/281/001 | 14.9.2005 |
| 13.9.2005 | Dynepo | Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP
  Aventis Pharma S.A., 20 Avenue Raymond Aron, Antony Cedex FR-92165 | EU/1/02/211/001-009 | 15.9.2005 |
| 13.9.2005 | Infanrix Penta | GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, BE-1330 Rixensart | EU/1/00/153/001-010 | 14.9.2005 |
| 13.9.2005 | Mimpara | Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda | EU/1/04/292/001-012 | 14.9.2005 |
| 13.9.2005 | Avandamet | SmithKline Beecham plc, 980 Great West Road, Brentford, UK-Middlesex TW8 9GS | EU/1/03/258/013-014 | 14.9.2005 |
| 13.9.2005 | Karvea | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA | EU/1/97/049/001-030 | 15.9.2005 |
| 13.9.2005 | Keppra | UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel | EU/1/00/146/001-029 | 16.9.2005 |
| 13.9.2005 | Keppra | UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel | EU/1/00/146/001-027 | 16.9.2005 |
| 13.9.2005 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris | EU/1/97/046/001-030 | 15.9.2005 |
| 15.9.2005 | Hepsera | Gilead Sciences International Limited, UK-Cambridge CB1 6GT | EU/1/03/251/001 | 20.9.2005 |
| 15.9.2005 | Cymbalta | Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten | EU/1/04/296/001-006 | 20.9.2005 |
| 15.9.2005 | Ariclaim | Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein | EU/1/04/283/001-007 | 20.9.2005 |
| 15.9.2005 | Yentreve | Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten | EU/1/04/280/001-007 | 20.9.2005 |
| 15.9.2005 | Xeristar | Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein | EU/1/04/297/001-006 | 20.9.2005 |
| 15.9.2005 | Bonviva | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY | EU/1/03/265/003-004 | 20.9.2005 |
| 15.9.2005 | Bondenza | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY | EU/1/03/266/003-004 | 20.9.2005 |
| 15.9.2005 | Myocet | Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, IE-County Clare | EU/1/00/141/001 | 20.9.2005 |
| 15.9.2005 | NovoMix | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd | EU/1/00/142/004-005
  EU/1/00/142/009-010 | 20.9.2005 |
| 16.9.2005 | REYATAZ | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA | EU/1/03/267/001-007 | 20.9.2005 |
| 19.9.2005 | Ariclaim | Boehringer Ingelheim International GmbH, Binger Straße 173, DE-55216 Ingelheim am Rhein | EU/1/04/283/001-007 | 21.9.2005 |
| 19.9.2005 | Arava | Aventis Pharma Deutschland GmbH, DE-65926 Frankfurt am Main | EU/1/99/118/001-010 | 21.9.2005 |
| 19.9.2005 | Yentreve | Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten | EU/1/04/280/001-007 | 21.9.2005 |
| 19.9.2005 | Hexavac | Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, FR-69007 Lyon | EU/1/00/147/001-012 | 21.9.2005 |
| 22.9.2005 | Iscover | Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, UK-Uxbridge UD8 1DH | EU/1/98/070/001a — 001b
  EU/1/98/070/002a — 002b
  EU/1/98/070/003a — 003b
  EU/1/98/070/004a — 001b | 26.9.2005 |
| 22.9.2005 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris | EU/1/98/069/001a — 001b
  EU/1/98/069/002a — 002b
  EU/1/98/069/003a — 003b
  EU/1/98/069/004a — 001b | 26.9.2005 |
| 29.9.2005 | Remicade | Centocor B.V., Einsteinweg 101, NL-2333 CB Leiden | EU/1/99/116/001-003 | 4.10.2005 |

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

5.9.2005

Ventavis

Schering AG, Müllerstraße 170-178, DE-13342 Berlin

EU/1/03/255//001-003

8.9.2005

5.9.2005

Trazec

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

EU/1/01/175/001-021

8.9.2005

5.9.2005

Forsteo

Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten

EU/1/03/247/001-002

7.9.2005

5.9.2005

Starlix

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

EU/1/01/174/001-021

8.9.2005

7.9.2005

DaTSCAN

GE Healthcare Limited, UK-Little Chalfont Bucks HP7 9NA

EU/1/00/135/001-002

9.9.2005

7.9.2005

Emtriva

Gilead Sciences International Limited, UK-Cambridge CB1 6GT

EU/1/03/261/001-003

9.9.2005

7.9.2005

KOGENATE Bayer

Bayer AG, DE-51368 Leverkusen

EU/1/00/143/001-006

9.9.2005

7.9.2005

Helixate NexGen

Bayer AG, DE-51368 Leverkusen

EU/1/00/144/001-003

9.9.2005

8.9.2005

Nespo

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

EU/1/01/184/001-056

13.9.2005

8.9.2005

Herceptin

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY

EU/1/00/145/001

13.9.2005

8.9.2005

Xagrid

Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP

EU/1/04/295/001

13.9.2005

8.9.2005

Kivexa

Glaxo Group Ltd, Berkeley Avenue, Greenford, UK-Middlesex UB6 0NN

EU/1/04/298/001-002

13.9.2005

8.9.2005

Ziagen

Glaxo Group Ltd, Greenford, UK-Middlesex UB6 0NN

EU/1/99/112/001-002

13.9.2005

8.9.2005

Aranesp

Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda

EU/1/01/185/001-056

13.9.2005

8.9.2005

Karvezide

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

EU/1/98/085/001-020

13.9.2005

8.9.2005

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris

EU/1/98/086/001-020

13.9.2005

8.9.2005

PegIntron

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

EU/1/00/131/001-050

13.9.2005

8.9.2005

ViraferonPeg

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

EU/1/00/132/001-050

13.9.2005

8.9.2005

Raptiva

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

EU/1/04/291/001-002

14.9.2005

8.9.2005

Pylobactell

Torbet Laboratories Limited, Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, UK-Norfolk NR13 6LH

EU/1/98/064/001

13.9.2005

13.9.2005

Infanrix Hexa

GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, BE-1330 Rixensart

EU/1/00/152/001-018

14.9.2005

13.9.2005

Somavert

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

EU/1/02/240/001-004

14.9.2005

13.9.2005

Hepsera

Gilead Sciences International Limited, UK-Cambridge CB1 6GT

EU/1/03/251/001

15.9.2005

13.9.2005

Erbitux

Merck KGaA, Frankfurter Straße 250, DE-64293 Darmstadt

EU/1/04/281/001

14.9.2005

13.9.2005

Dynepo

Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, UK-Hampshire RG24 8EP

Aventis Pharma S.A., 20 Avenue Raymond Aron, Antony Cedex FR-92165

EU/1/02/211/001-009

15.9.2005

13.9.2005

Infanrix Penta

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

EU/1/00/153/001-010

14.9.2005

13.9.2005

Mimpara

Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda

EU/1/04/292/001-012

14.9.2005

13.9.2005

Avandamet

SmithKline Beecham plc, 980 Great West Road, Brentford, UK-Middlesex TW8 9GS

EU/1/03/258/013-014

14.9.2005

13.9.2005

Karvea

Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA

EU/1/97/049/001-030

15.9.2005

13.9.2005

Keppra

UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel

EU/1/00/146/001-029

16.9.2005

13.9.2005

Keppra

UCB S.A., Allée de la recherche, 60, BE-1070 Bruxelles — Researchdreef, 60, BE-1070 Brussel

EU/1/00/146/001-027

16.9.2005

13.9.2005

Aprovel

Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris

EU/1/97/046/001-030

15.9.2005

15.9.2005

Hepsera

Gilead Sciences International Limited, UK-Cambridge CB1 6GT

EU/1/03/251/001

20.9.2005

15.9.2005

Cymbalta

Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten

EU/1/04/296/001-006

20.9.2005

15.9.2005

Ariclaim

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

EU/1/04/283/001-007

20.9.2005

15.9.2005

Yentreve

Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten

EU/1/04/280/001-007

20.9.2005

15.9.2005

Xeristar

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

EU/1/04/297/001-006

20.9.2005

15.9.2005

Bonviva

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY

EU/1/03/265/003-004

20.9.2005

15.9.2005

Bondenza

Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, UK-Hertfordshire AL7 3AY

EU/1/03/266/003-004

20.9.2005

15.9.2005

Myocet

Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, IE-County Clare

EU/1/00/141/001

20.9.2005

15.9.2005

NovoMix

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

EU/1/00/142/004-005

EU/1/00/142/009-010

20.9.2005

16.9.2005

REYATAZ

Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, UK-Hounslow TW3 3JA

EU/1/03/267/001-007

20.9.2005

19.9.2005

Ariclaim

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

EU/1/04/283/001-007

21.9.2005

19.9.2005

Arava

Aventis Pharma Deutschland GmbH, DE-65926 Frankfurt am Main

EU/1/99/118/001-010

21.9.2005

19.9.2005

Yentreve

Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten

EU/1/04/280/001-007

21.9.2005

19.9.2005

Hexavac

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

EU/1/00/147/001-012

21.9.2005

22.9.2005

Iscover

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

EU/1/98/070/001a — 001b

EU/1/98/070/002a — 002b

EU/1/98/070/003a — 003b

EU/1/98/070/004a — 001b

26.9.2005

22.9.2005

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France, FR-75013 Paris

EU/1/98/069/001a — 001b

EU/1/98/069/002a — 002b

EU/1/98/069/003a — 003b

EU/1/98/069/004a — 001b

26.9.2005

29.9.2005

Remicade

Centocor B.V., Einsteinweg 101, NL-2333 CB Leiden

EU/1/99/116/001-003

4.10.2005

—   Withdrawal of a marketing authorization (Article 12 of Council 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 |
| --- | --- | --- | --- | --- |
| 22.9.2005 | CEA-Scan | Immunomedics GmbH, Otto-Röhm-Straße 69, DE-64293 Darmstadt | EU/1/96/023/001 | 27.9.2005 |

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

22.9.2005

CEA-Scan

Immunomedics GmbH, Otto-Röhm-Straße 69, DE-64293 Darmstadt

EU/1/96/023/001

27.9.2005

—   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 notification |
| --- | --- | --- | --- | --- |
| 19.9.2005 | Pirsue | PFIZER Ltd, Ramsgate Road, Sandwich, UK-Kent CT13 9NJ | EU/2/00/027/001-003 | 21.9.2005 |

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

19.9.2005

Pirsue

PFIZER Ltd, Ramsgate Road, Sandwich, UK-Kent CT13 9NJ

EU/2/00/027/001-003

21.9.2005

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 Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK-London E14 4HB |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK-London E14 4HB

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

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