# C_2005049EN.01000201.xml

| 25.2.2005 | EN | Official Journal of the European Union | C 49/2 |
| --- | --- | --- | --- |

25.2.2005

EN

Official Journal of the European Union

C 49/2

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 January 2005 to 15 February 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 49/02)

—   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 |
| --- | --- | --- | --- | --- |
| 2.2.2005 | Fendrix | GlaxoSmithKline Biologicals S.A., rue de l'Institut 89, B-1330 Rixensart | EU/1/04/299/001-003 | 4.2.2005 |

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

2.2.2005

Fendrix

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

EU/1/04/299/001-003

4.2.2005

—   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 |
| --- | --- | --- | --- | --- |
| 20.1.2005 | Norvir | Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/96/016//001
  EU/1/96/016/003 | 24.1.2005 |
| 20.1.2005 | Zerit | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA — United Kingdom | EU/1/96/009/001-017 | 24.1.2005 |
| 20.1.2005 | Avandamet | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex, TW8 9GS — United Kingdom | EU/1/03/258/001-012 | 24.1.2005 |
| 20.1.2005 | Zerit | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA — United Kingdom | EU/1/96/009/001-017 | 24.1.2005 |
| 20.1.2005 | Rapamune | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/01/171/011-012 | 24.1.2005 |
| 25.1.2005 | NeupoPeg | Dompé Biotec S.p.A., Via San Martino, 12, I-20122 Milano | EU/1/02/228/001-002 | 27.1.2005 |
| 25.1.2005 | Neulasta | Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland | EU/1/02/227/001-002 | 27.1.2005 |
| 25.1.2005 | IntronA | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles | EU/1/99/127/001-044 | 28.1.2005 |
| 25.1.2005 | Viraferon | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles | EU/1/99/128/001-037 | 28.1.2005 |
| 25.1.2005 | Xigris | Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/02/225/001-002 | 27.1.2005 |
| 25.1.2005 | Trudexa | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/257/001-006 | 27.1.2005 |
| 25.1.2005 | Arixtra | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/02/206/001-017 | 27.1.2005 |
| 25.1.2005 | Travatan | Alcon Laboratories (UK) Ltd., Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | EU/1/01/199/001-002 | 27.1.2005 |
| 25.1.2005 | Quixidar | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/02/206/001-017 | 27.1.2005 |
| 25.1.2005 | Humira | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/256/001-006 | 27.1.2005 |
| 25.1.2005 | Rebetol | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73, B-1180 Brussel | EU/1/99/107/001-004 | 27.1.2005 |
| 25.1.2005 | Rebetol | Schering Plough Europe, Rue de Stalle, 73, B-1180 Bruxelles — Stallestraat, 73, B–1180 Brussel | EU/1/99/107/004 | 27.1.2005 |
| 26.1.2005 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-003 | 28.1.2005 |
| 26.1.2005 | Bextra | Pharmacia-Pfizer EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/239/001-030 | 1.2.2005 |
| 26.1.2005 | Dynastat | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/209/001-008 | 1.2.2005 |
| 26.1.2005 | Rayzon | Pharmacia Europe EEIG, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/210/001-008 | 1.2.2005 |
| 26.1.2005 | Prevenar | Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15, B-1348 Louvain-La-Neuve. | EU/1/00/167/001-007 | 28.1.2005 |
| 26.1.2005 | Valdyn | Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/02/244/001-024 | 31.1.2005 |
| 26.1.2005 | Visudyne | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom. | EU/1/00/140/001 | 31.1.2005 |
| 26.1.2005 | Pegasys | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/02/221/001-008 | 31.1.2005 |
| 26.1.2005 | Renagel | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/99/123/001-011 | 28.1.2005 |
| 31.1.2005 | Tractocile | Ferring AB, Soldattorpsvägen 5 — Box 30 047, Limhamn S-20061 | EU/1/99/124/001-002 | 2.2.2005 |
| 2.2.2005 | NovoNorm | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd | EU/1/98/076/001-002,
  EU/1/98/076/004-009,
  EU/1/98/076/011-016
  EU/1/98/076/018-021 | 4.2.2005 |
| 4.2.2005 | Prandin | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd | EU/1/00/162/001-018 | 8.2.2005 |
| 9.2.2005 | Zyprexa | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/96/022/016-018 | 11.2.2005 |
| 9.2.2005 | Zyprexa | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/96/022/002,
  EU/1/96/022/004,
  EU/1/96/022/006,
  EU/1/96/022/008-012,
  EU/1/96/022/014
  EU/1/96/022/016-022 | 11.2.2005 |
| 9.2.2005 | Zyprexa Velotab | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/99/125/001-008 | 11.2.2005 |
| 14.2.2005 | Keppra | UCB S.A. — Allée de la recherche, 60, B-1070 Bruxelles — Researchdreef, 60, B-1070 Brussel | EU/1/00/146/001-029 | 16.2.2005 |
| 14.2.2005 | Avonex | Biogen Idec Ltd, 5 Roxborough Way, Foundation Park, Maidenhead, Berkshire, SL6 3UD, United Kindgom
  Biogen Idec France, ‘Le Capitole’ 55, avenue des Champs Pierreux, F-92012 Nanterre Cedex. | EU/1/97/033/001-003 | 16.2.2005 |
| 14.2.2005 | Helicobacter Test INFAI | INFAI, Institut für biomedizinische Analytic und NMR Imaging GmbH — Universitätsstrasse 142, D-44799 Bochum | EU/1/97/045/001-004 | 16.2.2005 |
| 15.2.2005 | Karvea | Bristol-Myers Squibb Pharma EEIG — 141-149 Staines Road, Hounslow TW3 3JA — United Kingdom | EU/1/97/049/001-030 | 17.2.2005 |
| 15.2.2005 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC — 174 avenue de France, F-75013 Paris | EU/1/97/046/001-030 | 17.2.2005 |

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

20.1.2005

Norvir

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

EU/1/96/016//001

EU/1/96/016/003

24.1.2005

20.1.2005

Zerit

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

EU/1/96/009/001-017

24.1.2005

20.1.2005

Avandamet

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

EU/1/03/258/001-012

24.1.2005

20.1.2005

Zerit

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

EU/1/96/009/001-017

24.1.2005

20.1.2005

Rapamune

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

EU/1/01/171/011-012

24.1.2005

25.1.2005

NeupoPeg

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

EU/1/02/228/001-002

27.1.2005

25.1.2005

Neulasta

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland

EU/1/02/227/001-002

27.1.2005

25.1.2005

IntronA

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

EU/1/99/127/001-044

28.1.2005

25.1.2005

Viraferon

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

EU/1/99/128/001-037

28.1.2005

25.1.2005

Xigris

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

EU/1/02/225/001-002

27.1.2005

25.1.2005

Trudexa

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

EU/1/03/257/001-006

27.1.2005

25.1.2005

Arixtra

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

EU/1/02/206/001-017

27.1.2005

25.1.2005

Travatan

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

EU/1/01/199/001-002

27.1.2005

25.1.2005

Quixidar

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

EU/1/02/206/001-017

27.1.2005

25.1.2005

Humira

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

EU/1/03/256/001-006

27.1.2005

25.1.2005

Rebetol

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

EU/1/99/107/001-004

27.1.2005

25.1.2005

Rebetol

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

EU/1/99/107/004

27.1.2005

26.1.2005

Remicade

Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/99/116/001-003

28.1.2005

26.1.2005

Bextra

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

EU/1/02/239/001-030

1.2.2005

26.1.2005

Dynastat

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

EU/1/02/209/001-008

1.2.2005

26.1.2005

Rayzon

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

EU/1/02/210/001-008

1.2.2005

26.1.2005

Prevenar

Wyeth-Lederle Vaccines S.A., Rue du Bosquet, 15, B-1348 Louvain-La-Neuve.

EU/1/00/167/001-007

28.1.2005

26.1.2005

Valdyn

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

EU/1/02/244/001-024

31.1.2005

26.1.2005

Visudyne

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

EU/1/00/140/001

31.1.2005

26.1.2005

Pegasys

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

EU/1/02/221/001-008

31.1.2005

26.1.2005

Renagel

Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland

EU/1/99/123/001-011

28.1.2005

31.1.2005

Tractocile

Ferring AB, Soldattorpsvägen 5 — Box 30 047, Limhamn S-20061

EU/1/99/124/001-002

2.2.2005

2.2.2005

NovoNorm

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

EU/1/98/076/001-002,

EU/1/98/076/004-009,

EU/1/98/076/011-016

EU/1/98/076/018-021

4.2.2005

4.2.2005

Prandin

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

EU/1/00/162/001-018

8.2.2005

9.2.2005

Zyprexa

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

EU/1/96/022/016-018

11.2.2005

9.2.2005

Zyprexa

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

EU/1/96/022/002,

EU/1/96/022/004,

EU/1/96/022/006,

EU/1/96/022/008-012,

EU/1/96/022/014

EU/1/96/022/016-022

11.2.2005

9.2.2005

Zyprexa Velotab

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

EU/1/99/125/001-008

11.2.2005

14.2.2005

Keppra

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

EU/1/00/146/001-029

16.2.2005

14.2.2005

Avonex

Biogen Idec Ltd, 5 Roxborough Way, Foundation Park, Maidenhead, Berkshire, SL6 3UD, United Kindgom

Biogen Idec France, ‘Le Capitole’ 55, avenue des Champs Pierreux, F-92012 Nanterre Cedex.

EU/1/97/033/001-003

16.2.2005

14.2.2005

Helicobacter Test INFAI

INFAI, Institut für biomedizinische Analytic und NMR Imaging GmbH — Universitätsstrasse 142, D-44799 Bochum

EU/1/97/045/001-004

16.2.2005

15.2.2005

Karvea

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

EU/1/97/049/001-030

17.2.2005

15.2.2005

Aprovel

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

EU/1/97/046/001-030

17.2.2005

—   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 |
| --- | --- | --- | --- | --- |
| 31.1.2005 | IBAFLIN | Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/00/022/001a-001b, 002a - 002b, 003a-003b, 004a-004b
  EU/2/00/022/005-008, | 2.2.2005 |
| 31.1.2005 | METACAM | Boehringer Ingelheim Vetmedica GmbH, D-55216 Ingelheim am Rhein | EU/2/97/004/007-008 | 2.2.2005 |

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

31.1.2005

IBAFLIN

Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/00/022/001a-001b, 002a - 002b, 003a-003b, 004a-004b

EU/2/00/022/005-008,

2.2.2005

31.1.2005

METACAM

Boehringer Ingelheim Vetmedica GmbH, D-55216 Ingelheim am Rhein

EU/2/97/004/007-008

2.2.2005

---

(1)  OJ L 214 of 24 August 1993, page 1.

1

---