# C_2004237EN.01000401.xml

| 24.9.2004 | EN | Official Journal of the European Union | C 237/4 |
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24.9.2004

EN

Official Journal of the European Union

C 237/4

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Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 August 2004 to 15 September 2004

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

1

(2004/C 237/04)

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.9.2004 | Yondelis | Pharma Mar SA Sociedad Unipersonal, Avda de los Reyes, 1, P.I. La Mina-Norte E-28770 Colmenar Viejo, Madrid | — | 9.9.2004 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

7.9.2004

Yondelis

Pharma Mar SA Sociedad Unipersonal, Avda de los Reyes, 1, P.I. La Mina-Norte E-28770 Colmenar Viejo, Madrid

—

9.9.2004

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 17.8.2004 | Cetrotide | Serono Europe Ltd, 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/99/100/001-003 | 20.8.2004 |
| 18.8.2004 | Cystagon | Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense | EU/1/97/039/001-004 | 23.8.2004 |
| 18.8.2004 | BeneFIX | Wyeth Europa Ltd, Huntercombe Lane, South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-003 | 23.8.2004 |
| 18.8.2004 | Ziagen | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/112/001-002 | 23.8.2004 |
| 18.8.2004 | Zavesca | Actelion Registration Ltd, BSI Building, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/238/001 | 23.8.2004 |
| 23.8.2004 | ViraferonPeg | Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels | EU/1/00/132/001-050 | 25.8.2004 |
| 23.8.2004 | Tracleer | Actelion Registration Ltd, BSI Building, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220/001-005 | 25.8.2004 |
| 23.8.2004 | PegIntron | Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels | EU/1/00/131/001-050 | 25.8.2004 |
| 24.8.2004 | NovoMix | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd | EU/1/00/142/004-005 EU/1/00/142/007-010 | 26.8.2004 |
| 24.8.2004 | NovoRapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd | EU/1/99/119/001, EU/1/99/119/003, EU/1/99/119/005-014 | 26.8.2004 |
| 31.8.2004 | Luveris | Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/00/155/001-006 | 2.9.2004 |
| 31.8.2004 | Ixense | Takeda Europe R&D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom | EU/1/01/181/001-007 | 2.9.2004 |
| 31.8.2004 | Tasmar | Roche Registration Ltd, 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom | EU/1/97/044/001-006 | 2.9.2004 |
| 31.8.2004 | Lantus | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/00/134/022-029 | 2.9.2004 |
| 31.8.2004 | Lantus | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | EU/1/00/134/005-007 EU/1/00/134/013-017 | 2.9.2004 |
| 31.8.2004 | Optisulin | Aventis Pharma Deutschland GmbH, D-65926, Frankfurt am Main, Deutschland | EU/1/00/133/005-007 | 2.9.2004 |
| 2.9.2004 | Rebetol | Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels | EU/1/99/107/001-003 | 6.9.2004 |
| 2.9.2004 | Ferriprox | Apotex Europe Ltd, Rowan House, 41 London Street, Reading, Berkshire, RG1 4PS, United Kingdom | EU/1/99/108/001 | 6.9.2004 |
| 2.9.2004 | Avandamet | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/03/258/007-012 | 6.9.2004 |
| 2.9.2004 | Rapamune | Wyeth Europa Limited, Huntercombe Lane, South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/01/171/001-010 | 6.9.2004 |
| 2.9.2004 | Integrilin | Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels | EU/1/99/109/001-002 | 6.9.2004 |
| 2.9.2004 | Refludan | Pharmion Limited, Granta Park, McClintock Building, Granta Park, Great Abington, Cambridge, CB1 6GX, United KingdomSchering AG, Müllerstrasse 170-178, D-13342 Berlin | EU/1/97/035/001-004 | 6.9.2004 |
| 9.9.2004 | Aranesp | Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Netherlands | EU/1/01/185/001-032 | 13.9.2004 |
| 9.9.2004 | Trisenox | Cell Therapeutics (UK) Ltd, 100 Pall Mall, London SW1Y 5HP, United Kingdom | EU/1/02/204/001 | 13.9.2004 |
| 9.9.2004 | Kaletra | Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/01/172/001-003 | 13.9.2004 |
| 9.9.2004 | Kaletra | Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/01/172/001-003 | 13.9.2004 |
| 9.9.2004 | Crixivan | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/96/024/001-010 | 13.9.2004 |
| 9.9.2004 | Nespo | Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano | EU/1/01/184/001-032 | 13.9.2004 |
| 9.9.2004 | Rebetol | Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels | EU/1/99/107/001-003 | 13.9.2004 |
| 9.9.2004 | Fortovase | Roche Registration Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/98/075/001-002 | 13.9.2004 |
| 9.9.2004 | Synagis | Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/99/117/001-002 | 13.9.2004 |
| 10.9.2004 | Invirase | Roche Registration Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom | EU/1/96/026/001 | 14.9.2004 |
| 13.9.2004 | IntronA | Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels | EU/1/99/127/001-044 | 15.9.2004 |
| 13.9.2004 | Viraferon | Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels | EU/1/99/128/001-037 | 15.9.2004 |
| 13.9.2004 | Tracleer | Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220/001-005 | 15.9.2004 |
| 15.9.2004 | Xenical | Roche Registration Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/98/071/001-006 | 17.9.2004 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

17.8.2004

Cetrotide

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

EU/1/99/100/001-003

20.8.2004

18.8.2004

Cystagon

Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense

EU/1/97/039/001-004

23.8.2004

18.8.2004

BeneFIX

Wyeth Europa Ltd, Huntercombe Lane, South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-003

23.8.2004

18.8.2004

Ziagen

Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/99/112/001-002

23.8.2004

18.8.2004

Zavesca

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

EU/1/02/238/001

23.8.2004

23.8.2004

ViraferonPeg

Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels

EU/1/00/132/001-050

25.8.2004

23.8.2004

Tracleer

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

EU/1/02/220/001-005

25.8.2004

23.8.2004

PegIntron

Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels

EU/1/00/131/001-050

25.8.2004

24.8.2004

NovoMix

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

EU/1/00/142/004-005 EU/1/00/142/007-010

26.8.2004

24.8.2004

NovoRapid

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

EU/1/99/119/001, EU/1/99/119/003, EU/1/99/119/005-014

26.8.2004

31.8.2004

Luveris

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

EU/1/00/155/001-006

2.9.2004

31.8.2004

Ixense

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

EU/1/01/181/001-007

2.9.2004

31.8.2004

Tasmar

Roche Registration Ltd, 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom

EU/1/97/044/001-006

2.9.2004

31.8.2004

Lantus

Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main

EU/1/00/134/022-029

2.9.2004

31.8.2004

Lantus

Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main

EU/1/00/134/005-007 EU/1/00/134/013-017

2.9.2004

31.8.2004

Optisulin

Aventis Pharma Deutschland GmbH, D-65926, Frankfurt am Main, Deutschland

EU/1/00/133/005-007

2.9.2004

2.9.2004

Rebetol

Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels

EU/1/99/107/001-003

6.9.2004

2.9.2004

Ferriprox

Apotex Europe Ltd, Rowan House, 41 London Street, Reading, Berkshire, RG1 4PS, United Kingdom

EU/1/99/108/001

6.9.2004

2.9.2004

Avandamet

SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/03/258/007-012

6.9.2004

2.9.2004

Rapamune

Wyeth Europa Limited, Huntercombe Lane, South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/01/171/001-010

6.9.2004

2.9.2004

Integrilin

Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels

EU/1/99/109/001-002

6.9.2004

2.9.2004

Refludan

Pharmion Limited, Granta Park, McClintock Building, Granta Park, Great Abington, Cambridge, CB1 6GX, United KingdomSchering AG, Müllerstrasse 170-178, D-13342 Berlin

EU/1/97/035/001-004

6.9.2004

9.9.2004

Aranesp

Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Netherlands

EU/1/01/185/001-032

13.9.2004

9.9.2004

Trisenox

Cell Therapeutics (UK) Ltd, 100 Pall Mall, London SW1Y 5HP, United Kingdom

EU/1/02/204/001

13.9.2004

9.9.2004

Kaletra

Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom

EU/1/01/172/001-003

13.9.2004

9.9.2004

Kaletra

Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom

EU/1/01/172/001-003

13.9.2004

9.9.2004

Crixivan

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

EU/1/96/024/001-010

13.9.2004

9.9.2004

Nespo

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

EU/1/01/184/001-032

13.9.2004

9.9.2004

Rebetol

Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels

EU/1/99/107/001-003

13.9.2004

9.9.2004

Fortovase

Roche Registration Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/98/075/001-002

13.9.2004

9.9.2004

Synagis

Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom

EU/1/99/117/001-002

13.9.2004

10.9.2004

Invirase

Roche Registration Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom

EU/1/96/026/001

14.9.2004

13.9.2004

IntronA

Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels

EU/1/99/127/001-044

15.9.2004

13.9.2004

Viraferon

Schering Plough Europe, Rue de Stalle/Stallestraat, 73, B-1180 Brussels

EU/1/99/128/001-037

15.9.2004

13.9.2004

Tracleer

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

EU/1/02/220/001-005

15.9.2004

15.9.2004

Xenical

Roche Registration Ltd, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom

EU/1/98/071/001-006

17.9.2004

—   Issuing of a marketing authorisation (Article 34 of Council Regulation (EEC) No 2309/93): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 2.9.2004 | Nobivac Piro | Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Netherlands | EU/2/04/046/001-003 | 6.9.2004 |
| 9.9.2004 | Aivlosin | ECO Animal Health Ltd, 78 Coombe Road, New Malden, Surrey KT3 4QS, United Kingdom | EU/2/04/044/001 | 13.9.2004 |
| 13.9.2004 | Previcox | Merial SAS. 4 Chemin de Calquet, F-31300 Toulouse | EU/2/04/045/001-004 | 15.9.2004 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

2.9.2004

Nobivac Piro

Intervet International BV, Wim de Körverstraat 35, 5831 AN Boxmeer, Netherlands

EU/2/04/046/001-003

6.9.2004

9.9.2004

Aivlosin

ECO Animal Health Ltd, 78 Coombe Road, New Malden, Surrey KT3 4QS, United Kingdom

EU/2/04/044/001

13.9.2004

13.9.2004

Previcox

Merial SAS. 4 Chemin de Calquet, F-31300 Toulouse

EU/2/04/045/001-004

15.9.2004

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 31.8.2004 | DRAXXIN | Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/03/041/001-005 | 2.9.2004 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

31.8.2004

DRAXXIN

Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/2/03/041/001-005

2.9.2004

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

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