# C_2005241EN.01000101.xml

| 30.9.2005 | EN | Official Journal of the European Union | C 241/1 |
| --- | --- | --- | --- |

30.9.2005

EN

Official Journal of the European Union

C 241/1

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 August 2005 to 31 August 2005

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

o

1

(2005/C 241/01)

—   Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1)) Accepted

Issuing of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1

| 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 |
| --- | --- | --- | --- | --- |
| 24.08.2005 | FOSAVANCE | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/310/001-005 | 26.08.2005 |

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

24.08.2005

FOSAVANCE

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

EU/1/05/310/001-005

26.08.2005

—   Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1)) Accepted

Modification of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1

| 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 |
| --- | --- | --- | --- | --- |
| 01.08.2005 | Crixivan | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United-Kingdom | EU/1/96/024/001-005
  EU/1/96/024/007-008
  EU/1/96/024/010 | 03.08.2005 |
| 01.08.2005 | Humira | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/256/001-006 | 03.08.2005 |
| 01.08.2005 | Fabrazyme | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/01/188/001-006 | 03.08.2005 |
| 01.08.2005 | Enbrel | Wyeth Europa Limited, Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-011 | 03.08.2005 |
| 01.08.2005 | Trudexa | Abbott Laboratories Ltd., Queenborough, Kent ME11 5EL, United Kingdom | EU/1/03/257/001-006 | 03.08.2005 |
| 01.08.2005 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-003 | 03.08.2005 |
| 01.08.2005 | Fasturtec | Sanofi-Aventis, 174, avenue de France, F-75013 Paris, France | EU/1/00/170/001-002 | 03.08.2005 |
| 01.08.2005 | Comtan | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/081/001-004 | 03.08.2005 |
| 01.08.2005 | Neulasta | Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/02/227/001-002 | 03.08.2005 |
| 01.08.2005 | Neupopeg | Dompé Biotec S.p.A., Via San Martino, 12, I – 20122 Milano, Italia | EU/1/02/228/001-002 | 03.08.2005 |
| 09.08.2005 | Stocrin | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/111/001-009 | 11.08.2005 |
| 09.08.2005 | Sustiva | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/99/110/001-009 | 11.08.2005 |
| 16.08.2005 | Parareg | Dompé Biotec S.p.A., Via San Martino, 12, I - 20122 Milano, Italia Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands | EU/1/04/293/001-012 | 18.08.2005 |
| 16.08.2005 | NeuroBloc | Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland | EU/1/00/166/001-003 | 18.08.2005 |
| 16.08.2005 | MabCampath | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland ILEX Services Limited, 1 & 3 Frederick Sanger Road, The Surrey Research Park, Guildford Surrey, GU2 7YD, United Kingdom | EU/1/01/193/001-002 | 18.08.2005 |
| 16.08.2005 | Vivanza | Bayer AG, D-51368 Leverkusen, Deutschland | EU/1/03/249/001-012 | 18.08.2005 |
| 16.08.2005 | Dukoral | SBL Vaccin AB, S-105 21 Stockholm, Sweden | EU/1/03/263/001-003 | 18.08.2005 |
| 16.08.2005 | Levitra | Bayer AG, D-51368 Leverkusen, Deutschland | EU/1/03/248/001-013 | 18.08.2005 |
| 22.08.2005 | Ferriprox | Apotex Europe Ltd., Rowan House, 41 London Street, Reading, Berkshire, RG1 4PS, United Kingdom | EU/1/99/108/001 | 24.08.2005 |
| 23.08.2005 | BeneFIX | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-003 | 25.08.2005 |
| 24.08.2005 | BeneFIX | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-003 | 26.08.2005 |
| 24.08.2005 | REYATAZ | Bristol - Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom | EU/1/03/267/001-007 | 26.08.2005 |
| 24.08.2005 | Telzir | Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/04/282/001-002 | 26.08.2005 |
| 24.08.2005 | Agenerase | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/00/148/001-004 | 26.08.2005 |
| 24.08.2005 | Kaletra | Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/01/172/001-003 | 26.08.2005 |
| 24.08.2005 | Fortovase | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | EU/1/98/075/001-002 | 26.08.2005 |
| 26.08.2005 | Pedea | Orphan Europe, Immeuble ‘Le Guillaumet’, F-92046 Paris La Défense, France | EU/1/04/284/001 | 31.08.2005 |
| 26.08.2005 | Neurobloc | Solstice Neurosciences Ltd, Fitzwilton House, Wilton Place, Dublin 2, Ireland Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland | EU/1/00/166/001-003 | 01.09.2005 |
| 30.08.2005 | Stalevo | Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi | EU/1/03/260/001-012 | 01.09.2005 |
| 30.08.2005 | Rebetol | Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique – Stallestraat, 73 – 1180 Brussel, België | EU/1/99/107/001-003 | 01.09.2005 |
| 31.08.2005 | Neulasta | Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/02/227/001-002 | 02.09.2005 |
| 31.08.2005 | Renagel | Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland | EU/1/99/123/001-011 | 05.09.2005 |
| 31.08.2005 | Avonex | Biogen Idec Ltd, 5 Roxborough Way, Foundation Park, Maidenhead, Berkshire, SL6 3UD, United Kindgom | EU/1/97/033/001-003 | 02.09.2005 |
| 31.08.2005 | Avonex | Biogen Idec Ltd, 5 Roxborough Way, Foundation Park, Maidenhead, Berkshire, SL6 3UD, United Kindgom | EU/1/97/033/001-003 | 02.09.2005 |
| 31.08.2005 | Norvir | Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United-Kingdom | EU/1/96/016/001
  EU/1/96/016/003 | 02.09.2005 |
| 31.08.2005 | Neupopeg | Dompé Biotec S.p.A., Via San Martino, 12, I – 20122 Milano, Italia | EU/1/02/228/001-002 | 02.09.2005 |
| 31.08.2005 | Invirase | Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom | EU/1/96/026/001-002 | 02.09.2005 |
| 31.08.2005 | Zerit | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA - United Kingdom | EU/1/96/009/001-017 | 02.09.2005 |
| 31.08.2005 | 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 | 02.09.2005 |
| 31.08.2005 | Zyprexa Velotab | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/99/125/001-008 | 02.09.2005 |

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

01.08.2005

Crixivan

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

EU/1/96/024/001-005

EU/1/96/024/007-008

EU/1/96/024/010

03.08.2005

01.08.2005

Humira

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

EU/1/03/256/001-006

03.08.2005

01.08.2005

Fabrazyme

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

EU/1/01/188/001-006

03.08.2005

01.08.2005

Enbrel

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

EU/1/99/126/001-011

03.08.2005

01.08.2005

Trudexa

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

EU/1/03/257/001-006

03.08.2005

01.08.2005

Remicade

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

EU/1/99/116/001-003

03.08.2005

01.08.2005

Fasturtec

Sanofi-Aventis, 174, avenue de France, F-75013 Paris, France

EU/1/00/170/001-002

03.08.2005

01.08.2005

Comtan

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

EU/1/98/081/001-004

03.08.2005

01.08.2005

Neulasta

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

EU/1/02/227/001-002

03.08.2005

01.08.2005

Neupopeg

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

EU/1/02/228/001-002

03.08.2005

09.08.2005

Stocrin

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

EU/1/99/111/001-009

11.08.2005

09.08.2005

Sustiva

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

EU/1/99/110/001-009

11.08.2005

16.08.2005

Parareg

Dompé Biotec S.p.A., Via San Martino, 12, I - 20122 Milano, Italia Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, The Netherlands

EU/1/04/293/001-012

18.08.2005

16.08.2005

NeuroBloc

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

EU/1/00/166/001-003

18.08.2005

16.08.2005

MabCampath

Genzyme Europe B.V., Gooimeer 10, Naarden 1411 DD, Nederland ILEX Services Limited, 1 & 3 Frederick Sanger Road, The Surrey Research Park, Guildford Surrey, GU2 7YD, United Kingdom

EU/1/01/193/001-002

18.08.2005

16.08.2005

Vivanza

Bayer AG, D-51368 Leverkusen, Deutschland

EU/1/03/249/001-012

18.08.2005

16.08.2005

Dukoral

SBL Vaccin AB, S-105 21 Stockholm, Sweden

EU/1/03/263/001-003

18.08.2005

16.08.2005

Levitra

Bayer AG, D-51368 Leverkusen, Deutschland

EU/1/03/248/001-013

18.08.2005

22.08.2005

Ferriprox

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

EU/1/99/108/001

24.08.2005

23.08.2005

BeneFIX

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

EU/1/97/047/001-003

25.08.2005

24.08.2005

BeneFIX

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

EU/1/97/047/001-003

26.08.2005

24.08.2005

REYATAZ

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

EU/1/03/267/001-007

26.08.2005

24.08.2005

Telzir

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

EU/1/04/282/001-002

26.08.2005

24.08.2005

Agenerase

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

EU/1/00/148/001-004

26.08.2005

24.08.2005

Kaletra

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

EU/1/01/172/001-003

26.08.2005

24.08.2005

Fortovase

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

EU/1/98/075/001-002

26.08.2005

26.08.2005

Pedea

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

EU/1/04/284/001

31.08.2005

26.08.2005

Neurobloc

Solstice Neurosciences Ltd, Fitzwilton House, Wilton Place, Dublin 2, Ireland Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland

EU/1/00/166/001-003

01.09.2005

30.08.2005

Stalevo

Orion Corporation, Orionintie 1, FIN-02200 Espoo, Suomi

EU/1/03/260/001-012

01.09.2005

30.08.2005

Rebetol

Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique – Stallestraat, 73 – 1180 Brussel, België

EU/1/99/107/001-003

01.09.2005

31.08.2005

Neulasta

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

EU/1/02/227/001-002

02.09.2005

31.08.2005

Renagel

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

EU/1/99/123/001-011

05.09.2005

31.08.2005

Avonex

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

EU/1/97/033/001-003

02.09.2005

31.08.2005

Avonex

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

EU/1/97/033/001-003

02.09.2005

31.08.2005

Norvir

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

EU/1/96/016/001

EU/1/96/016/003

02.09.2005

31.08.2005

Neupopeg

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

EU/1/02/228/001-002

02.09.2005

31.08.2005

Invirase

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

EU/1/96/026/001-002

02.09.2005

31.08.2005

Zerit

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

EU/1/96/009/001-017

02.09.2005

31.08.2005

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

02.09.2005

31.08.2005

Zyprexa Velotab

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

EU/1/99/125/001-008

02.09.2005

—   Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1))

Withdrawal of a marketing authorization (Article 12 of Council Regulation (EEC) No 2309/93 (1

| 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 |
| --- | --- | --- | --- | --- |
| 09.08.2005 | Tenecteplase Boehringer Ingelheim Pharma GmbH co. KG | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/00/168/001-006 | 11.08.2005 |

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

09.08.2005

Tenecteplase Boehringer Ingelheim Pharma GmbH co. KG

Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/00/168/001-006

11.08.2005

—   Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93 (1)) Accepted

Modification of a marketing authorization (Article 34 of Council Regulation (EEC) No 2309/93 (1

| 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 |
| --- | --- | --- | --- | --- |
| 01.08.2005 | Metacam | Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland | EU/2/97/004/012-013 | 03.08.2005 |
| 18.08.2005 | Quadrisol | Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/97/005/001-003
  EU/2/97/005/005-009 | 22.08.2005 |
| 18.08.2005 | Pirsue | PFIZER Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/00/027/001-003 | 22.08.2005 |
| 25.08.2005 | Novem | Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland | EU/2/04/042/001-002 | 29.08.2005 |
| 26.08.2005 | Virbagen omega | VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/01/030/001-004 | 31.08.2005 |

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

01.08.2005

Metacam

Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/012-013

03.08.2005

18.08.2005

Quadrisol

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

EU/2/97/005/001-003

EU/2/97/005/005-009

22.08.2005

18.08.2005

Pirsue

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

EU/2/00/027/001-003

22.08.2005

25.08.2005

Novem

Boehringer Ingelheim Vetmedica GmbH, 55216 Ingelheim am Rhein, Deutschland

EU/2/04/042/001-002

29.08.2005

26.08.2005

Virbagen omega

VIRBAC S.A., 1ere Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/01/030/001-004

31.08.2005

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

The European Medicines Agency

7, Westferry Circus, Canary Wharf

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4HB

UK - LONDON E14 4HB

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

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