# C_2005075EN.01001101.xml

| 24.3.2005 | EN | Official Journal of the European Union | C 75/11 |
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24.3.2005

EN

Official Journal of the European Union

C 75/11

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Summary of Community decisions on marketing authorisations in respect of medicinal products from 15 February 2005 to 15 March 2005

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

1

(2005/C 75/06)

—   Issuing 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 |
| --- | --- | --- | --- | --- |
| 17.2.2005 | Quintanrix | GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, B-1330 Rixensart | EU/1/04/301/001-005 | 21.2.2005 |
| 21.2.2005 | Truvada | Gilead Sciences International Limited, Granta Park Abington Cambridge CB1 6GT United Kingdom | EU/1/04/305/001 | 24.2.2005 |
| 21.2.2005 | Orfadin | Swedish Orphan International AB, Drottninggatan 98, S-111 60 Stockholm | EU/1/04/303/001-003 | 24.2.2005 |
| 21.2.2005 | Azilect | Teva Pharma GmbH, Kandelstrasse 10, D-79199 Kirchzarten | EU/1/04/304/001-007 | 24.2.2005 |
| 21.2.2005 | Prialt | Elan Pharma International Ltd, WIL House, Shannon Business Park, Shannon, County Clare, Ireland | EU/1/04/302/001-003 | 24.2.2005 |
| 10.3.2005 | Zonegran | Eisai Limited, 3, Shortlands, London W6 8EE United Kingdom | EU/1/04/307/001-004 | 14.3.2005 |

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

17.2.2005

Quintanrix

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

EU/1/04/301/001-005

21.2.2005

21.2.2005

Truvada

Gilead Sciences International Limited, Granta Park Abington Cambridge CB1 6GT United Kingdom

EU/1/04/305/001

24.2.2005

21.2.2005

Orfadin

Swedish Orphan International AB, Drottninggatan 98, S-111 60 Stockholm

EU/1/04/303/001-003

24.2.2005

21.2.2005

Azilect

Teva Pharma GmbH, Kandelstrasse 10, D-79199 Kirchzarten

EU/1/04/304/001-007

24.2.2005

21.2.2005

Prialt

Elan Pharma International Ltd, WIL House, Shannon Business Park, Shannon, County Clare, Ireland

EU/1/04/302/001-003

24.2.2005

10.3.2005

Zonegran

Eisai Limited, 3, Shortlands, London W6 8EE United Kingdom

EU/1/04/307/001-004

14.3.2005

—   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 |
| --- | --- | --- | --- | --- |
| 17.2.2005 | Caelyx | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles – Stallestraat, 73 – B-1180 Brussel | EU/1/96/011/001-004 | 21.2.2005 |
| 21.2.2005 | Reyataz | Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom | EU/1/03/267/001-005 | 4.3.2005 |
| 23.2.2005 | Pegasys | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/02/221/001-010 | 25.2.2005 |
| 23.2.2005 | Tamiflu | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/02/222/001-002 | 25.2.2005 |
| 23.2.2005 | Thyrogen | Genzyme Europe BV, Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/99/122/001-002 | 25.2.2005 |
| 23.2.2005 | Onsenal | Pharmacia-Pfizer EEIG, Ramsgate Road, Sanwich, CT13 9NJ, United Kingdom | EU/1/03/259/001-006 | 25.2.2005 |
| 28.2.2005 | DaTSCAN | Amersham plc, Amersham Place, Little Chalfont, Bucks, United Kingdom | EU/1/00/135/045-056 | 2.3.2005 |
| 28.2.2005 | Nespo | Dompé Biotec SpA, Via San Martino, 12, I-20122 Milano | EU/1/01/184/045-056 | 2.3.2005 |
| 28.2.2005 | Aranesp | Amgen Europe BV, Minervum 7061, 4817 ZK Breda, Nederland | EU/1/01/185/045-056 | 2.3.2005 |
| 28.2.2005 | NeuroBloc | Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland | EU/1/00/166/001-003 | 3.3.2005 |
| 3.3.2005 | Replagal | TKT Europe AB, Rinkebyvägen 11B, S-182 36 Danderyd | EU/1/01/189/001-006 | 7.3.2005 |
| 3.3.2005 | Emtriva | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/03/261/001-003 | 7.3.2005 |
| 3.3.2005 | Fabrazyme | Genzyme Europe BV, Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/01/188/001-006 | 7.3.2005 |
| 3.3.2005 | Orgalutran | NV Organon, PO Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland | EU/1/00/130/001-002 | 7.3.2005 |
| 7.3.2005 | Ceprotin | Baxter AG, Industriesstrasse 67, A-1220 Vienna | EU/1/01/190/001-002 | 9.3.2005 |
| 7.3.2005 | Ventavis | Schering AG, Müllerstrasse 170-178, D-13342 Berlin | EU/1/03/255/001-003 | 9.3.2005 |
| 7.3.2005 | Mabthera | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/98/067/001-002 | 9.3.2005 |
| 7.3.2005 | Ketek | Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony | EU/1/01/191/001-005 | 9.3.2005 |
| 7.3.2005 | Levviax | Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony | EU/1/01/192/001-005 | 9.3.2005 |
| 7.3.2005 | Stocrin | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/111/001-009 | 9.3.2005 |
| 7.3.2005 | Sustiva | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/99/110/001-009 | 9.3.2005 |
| 7.3.2005 | Comtess | Orion Corporation, Orionintie 1, FIN-02200 Espoo | EU/1/98/082/001-004 | 9.3.2005 |
| 7.3.2005 | Comtan | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/081/001-004 | 9.3.2005 |
| 7.3.2005 | Viread | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | EU/1/01/200/001 | 9.3.2005 |
| 10.3.2005 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-005 | 14.3.2005 |
| 10.3.2005 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-005 | 14.3.2005 |
| 10.3.2005 | Gonal-f | Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/95/001/033-035 | 14.3.2005 |

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

17.2.2005

Caelyx

Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles – Stallestraat, 73 – B-1180 Brussel

EU/1/96/011/001-004

21.2.2005

21.2.2005

Reyataz

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

EU/1/03/267/001-005

4.3.2005

23.2.2005

Pegasys

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

EU/1/02/221/001-010

25.2.2005

23.2.2005

Tamiflu

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

EU/1/02/222/001-002

25.2.2005

23.2.2005

Thyrogen

Genzyme Europe BV, Gooimeer 10, Naarden 1411 DD, Nederland

EU/1/99/122/001-002

25.2.2005

23.2.2005

Onsenal

Pharmacia-Pfizer EEIG, Ramsgate Road, Sanwich, CT13 9NJ, United Kingdom

EU/1/03/259/001-006

25.2.2005

28.2.2005

DaTSCAN

Amersham plc, Amersham Place, Little Chalfont, Bucks, United Kingdom

EU/1/00/135/045-056

2.3.2005

28.2.2005

Nespo

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

EU/1/01/184/045-056

2.3.2005

28.2.2005

Aranesp

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

EU/1/01/185/045-056

2.3.2005

28.2.2005

NeuroBloc

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

EU/1/00/166/001-003

3.3.2005

3.3.2005

Replagal

TKT Europe AB, Rinkebyvägen 11B, S-182 36 Danderyd

EU/1/01/189/001-006

7.3.2005

3.3.2005

Emtriva

Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom

EU/1/03/261/001-003

7.3.2005

3.3.2005

Fabrazyme

Genzyme Europe BV, Gooimeer 10, Naarden 1411 DD, Nederland

EU/1/01/188/001-006

7.3.2005

3.3.2005

Orgalutran

NV Organon, PO Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland

EU/1/00/130/001-002

7.3.2005

7.3.2005

Ceprotin

Baxter AG, Industriesstrasse 67, A-1220 Vienna

EU/1/01/190/001-002

9.3.2005

7.3.2005

Ventavis

Schering AG, Müllerstrasse 170-178, D-13342 Berlin

EU/1/03/255/001-003

9.3.2005

7.3.2005

Mabthera

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

EU/1/98/067/001-002

9.3.2005

7.3.2005

Ketek

Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony

EU/1/01/191/001-005

9.3.2005

7.3.2005

Levviax

Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony

EU/1/01/192/001-005

9.3.2005

7.3.2005

Stocrin

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

EU/1/99/111/001-009

9.3.2005

7.3.2005

Sustiva

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

EU/1/99/110/001-009

9.3.2005

7.3.2005

Comtess

Orion Corporation, Orionintie 1, FIN-02200 Espoo

EU/1/98/082/001-004

9.3.2005

7.3.2005

Comtan

Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/081/001-004

9.3.2005

7.3.2005

Viread

Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom

EU/1/01/200/001

9.3.2005

10.3.2005

Enbrel

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

EU/1/99/126/001-005

14.3.2005

10.3.2005

Enbrel

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

EU/1/99/126/001-005

14.3.2005

10.3.2005

Gonal-f

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

EU/1/95/001/033-035

14.3.2005

—   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 |
| --- | --- | --- | --- | --- |
| 23.2.2005 | Purevax RCPCh FeLV | Merial, 29 Avenue Tony Garnier, F-69007 Lyon | EU/2/04/047/001-002 | 25.2.2005 |
| 23.2.2005 | Purevax RCP FeLV | Merial, 29 Avenue Tony Garnier, F-69007 Lyon | EU/2/04/048/001-002 | 25.2.2005 |
| 23.2.2005 | Purevax RCCh | Merial, 29 Avenue Tony Garnier, F-69007 Lyon | EU/2/04/049/001-002 | 25.2.2005 |
| 23.2.2005 | Purevax RCPCh | Merial, 29 Avenue Tony Garnier, F-69007 Lyon | EU/2/04/050/001-002 | 25.2.2005 |
| 23.2.2005 | Purevax RC | Merial, 29 Avenue Tony Garnier, F-69007 Lyon | EU/2/04/051/001-002 | 25.2.2005 |
| 23.2.2005 | Purevax RCP | Merial, 29 Avenue Tony Garnier, F-69007 Lyon | EU/2/04/052/001-002 | 25.2.2005 |

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

23.2.2005

Purevax RCPCh FeLV

Merial, 29 Avenue Tony Garnier, F-69007 Lyon

EU/2/04/047/001-002

25.2.2005

23.2.2005

Purevax RCP FeLV

Merial, 29 Avenue Tony Garnier, F-69007 Lyon

EU/2/04/048/001-002

25.2.2005

23.2.2005

Purevax RCCh

Merial, 29 Avenue Tony Garnier, F-69007 Lyon

EU/2/04/049/001-002

25.2.2005

23.2.2005

Purevax RCPCh

Merial, 29 Avenue Tony Garnier, F-69007 Lyon

EU/2/04/050/001-002

25.2.2005

23.2.2005

Purevax RC

Merial, 29 Avenue Tony Garnier, F-69007 Lyon

EU/2/04/051/001-002

25.2.2005

23.2.2005

Purevax RCP

Merial, 29 Avenue Tony Garnier, F-69007 Lyon

EU/2/04/052/001-002

25.2.2005

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

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