# C_2005153EN.01000301.xml

| 24.6.2005 | EN | Official Journal of the European Union | C 153/3 |
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24.6.2005

EN

Official Journal of the European Union

C 153/3

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 May 2005 to 15 June 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 153/03)

—   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 |
| --- | --- | --- | --- | --- |
| 18.5.2005 | Bonviva | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/03/265/001-002 | 24.5.2005 |
| 23.5.2005 | IntronA | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | EU/1/99/127/001-044 | 25.5.2005 |
| 23.5.2005 | Viraferon | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | EU/1/99/128/001-037 | 25.5.2005 |
| 23.5.2005 | Kentera | Nicobrand Limited, 189 Casteroe Road, Coleraine, Northern Ireland BT51 3 RP | EU/1/03/270/001-003 | 25.5.2005 |
| 23.5.2005 | DepoCyte | SkyePharma PLC, 105 Piccadilly, London W1V 9FN, United Kingdom | EU/1/01/187/001 | 25.5.2005 |
| 25.5.2005 | Invirase | Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom | EU/1/96/026/002 | 27.5.2005 |
| 25.5.2005 | PegIntron | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | EU/1/00/131/001-050 | 27.5.2005 |
| 25.5.2005 | ViraferonPeg | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | EU/1/00/132/001-050 | 27.5.2005 |
| 2.6.2005 | Azopt | Alcon Laboratories (UK) Ltd., Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UK, United Kingdom | EU/1/00/129/001-003 | 6.6.2005 |
| 2.6.2005 | Onsenal | Pharmacia-Pfizer EEIG, Ramsgate Road, Sanwich, CT13 9NJ, United Kingdom | EU/1/03/259/001-006 | 6.6.2005 |
| 2.6.2005 | Glivec | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/198/001-013 | 6.6.2005 |
| 3.6.2005 | Zavesca | Actelion Registration Ltd, BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/238/001 | 7.6.2005 |
| 3.6.2005 | Ariclaim | Boehringer Ingelheim International GmbH, Binger Straße 173, D-5216 Ingelheim am Rhein | EU/1/04/283/001-006 | 7.6.2005 |
| 3.6.2005 | Rebetol | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | EU/1/99/107/001-004 | 7.6.2005 |
| 3.6.2005 | Ketek | Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony | EU/1/01/191/001-005 | 7.6.2005 |
| 3.6.2005 | Levviax | Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony | EU/1/01/192/001-005 | 7.6.2005 |
| 3.6.2005 | Temodal | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73 — B-1180 Brussel | EU/1/98/096/001-008 | 7.6.2005 |
| 3.6.2005 | Valdyn | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/244/001-024 | 7.6.2005 |
| 10.6.2005 | Taxotere | Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex | EU/1/95/002/001-002 | 14.6.2005 |
| 10.6.2005 | Viracept | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/97/054/001
  EU/1/97/054/003-006 | 14.6.2005 |
| 10.6.2005 | Azilect | Teva Pharma GmbH, Kandelstraße 10, D-79199 Kirchzarten | EU/1/04/304/001-007 | 14.6.2005 |
| 10.6.2005 | Angiox | The Medicines Company UK Ltd, Suite B, Park House, 11 Milton Park, Abingdon, Oxfordshire OX14 4RS, United Kingdom | EU/1/04/289/001-002 | 14.6.2005 |
| 10.6.2005 | Rayzon | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/210/001-008 | 14.6.2005 |
| 10.6.2005 | Dynastat | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/209/001-008 | 14.6.2005 |
| 10.6.2005 | TachoSil | Nycomed Austria GmbH, St.-Peter-Straße 25, A-4020 Linz | EU/1/04/277/001-004 | 14.6.2005 |
| 10.6.2005 | Bextra | Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/239/001-030 | 14.6.2005 |
| 10.6.2005 | NovoMix 30 | Novo Nordisk A/S, Novo Allé, DK-880 Bagsværd | EU/1/00/142/004-005
  EU/1/00/142/009-010 | 14.6.2005 |
| 10.6.2005 | Protopy | Fujisawa GmbH, Neumarkter Str. 61, D-81673 München | EU/1/02/202/001-006 | 14.6.2005 |
| 10.6.2005 | Protopic | Fujisawa GmbH, Neumarkter Str. 61, D-81673 München | EU/1/02/201/001-006 | 14.6.2005 |
| 10.6.2005 | Xenical | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/98/071/001-006 | 14.6.2005 |
| 10.6.2005 | Avandia | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | EU/1/00/137/001-012 | 14.6.2005 |

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

18.5.2005

Bonviva

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

EU/1/03/265/001-002

24.5.2005

23.5.2005

IntronA

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

EU/1/99/127/001-044

25.5.2005

23.5.2005

Viraferon

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

EU/1/99/128/001-037

25.5.2005

23.5.2005

Kentera

Nicobrand Limited, 189 Casteroe Road, Coleraine, Northern Ireland BT51 3 RP

EU/1/03/270/001-003

25.5.2005

23.5.2005

DepoCyte

SkyePharma PLC, 105 Piccadilly, London W1V 9FN, United Kingdom

EU/1/01/187/001

25.5.2005

25.5.2005

Invirase

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

EU/1/96/026/002

27.5.2005

25.5.2005

PegIntron

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

EU/1/00/131/001-050

27.5.2005

25.5.2005

ViraferonPeg

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

EU/1/00/132/001-050

27.5.2005

2.6.2005

Azopt

Alcon Laboratories (UK) Ltd., Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UK, United Kingdom

EU/1/00/129/001-003

6.6.2005

2.6.2005

Onsenal

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

EU/1/03/259/001-006

6.6.2005

2.6.2005

Glivec

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

EU/1/01/198/001-013

6.6.2005

3.6.2005

Zavesca

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

EU/1/02/238/001

7.6.2005

3.6.2005

Ariclaim

Boehringer Ingelheim International GmbH, Binger Straße 173, D-5216 Ingelheim am Rhein

EU/1/04/283/001-006

7.6.2005

3.6.2005

Rebetol

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

EU/1/99/107/001-004

7.6.2005

3.6.2005

Ketek

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

EU/1/01/191/001-005

7.6.2005

3.6.2005

Levviax

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

EU/1/01/192/001-005

7.6.2005

3.6.2005

Temodal

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

EU/1/98/096/001-008

7.6.2005

3.6.2005

Valdyn

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/244/001-024

7.6.2005

10.6.2005

Taxotere

Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex

EU/1/95/002/001-002

14.6.2005

10.6.2005

Viracept

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

EU/1/97/054/001

EU/1/97/054/003-006

14.6.2005

10.6.2005

Azilect

Teva Pharma GmbH, Kandelstraße 10, D-79199 Kirchzarten

EU/1/04/304/001-007

14.6.2005

10.6.2005

Angiox

The Medicines Company UK Ltd, Suite B, Park House, 11 Milton Park, Abingdon, Oxfordshire OX14 4RS, United Kingdom

EU/1/04/289/001-002

14.6.2005

10.6.2005

Rayzon

Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/210/001-008

14.6.2005

10.6.2005

Dynastat

Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/209/001-008

14.6.2005

10.6.2005

TachoSil

Nycomed Austria GmbH, St.-Peter-Straße 25, A-4020 Linz

EU/1/04/277/001-004

14.6.2005

10.6.2005

Bextra

Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/02/239/001-030

14.6.2005

10.6.2005

NovoMix 30

Novo Nordisk A/S, Novo Allé, DK-880 Bagsværd

EU/1/00/142/004-005

EU/1/00/142/009-010

14.6.2005

10.6.2005

Protopy

Fujisawa GmbH, Neumarkter Str. 61, D-81673 München

EU/1/02/202/001-006

14.6.2005

10.6.2005

Protopic

Fujisawa GmbH, Neumarkter Str. 61, D-81673 München

EU/1/02/201/001-006

14.6.2005

10.6.2005

Xenical

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

EU/1/98/071/001-006

14.6.2005

10.6.2005

Avandia

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

EU/1/00/137/001-012

14.6.2005

—   Issuing 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 |
| --- | --- | --- | --- | --- |
| 19.5.2005 | Naxcel | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/2/05/053/001 | 24.5.2005 |

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

19.5.2005

Naxcel

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom

EU/2/05/053/001

24.5.2005

—   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 |
| --- | --- | --- | --- | --- |
| 26.5.2005 | Econor | Novartis Animal Health Austria GmbH, Biochemiestraße 10, A-250 Kundl | EU/2/98/010/004-006
  EU/2/98/010/017-018
  EU/2/98/010/021-024 | 30.5.2005 |

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

26.5.2005

Econor

Novartis Animal Health Austria GmbH, Biochemiestraße 10, A-250 Kundl

EU/2/98/010/004-006

EU/2/98/010/017-018

EU/2/98/010/021-024

30.5.2005

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 |
| London E14 4HB |
| United Kingdom |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

London E14 4HB

United Kingdom

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

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