# C_2005023EN.01000201.xml

| 28.1.2005 | EN | Official Journal of the European Union | C 23/2 |
| --------- | -- | -------------------------------------- | ------ |

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Summary of Community decisions on marketing authorizations in respect of medicinal products from 15 December 2004 to 15 January 2005

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

(2005/C 23/02)

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 |
| ---------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 17.12.2004 | Xeristar | Boehringer Ingelheim International GmbH, Binger Straße 173, D-55216 Ingelheim am Rhein | Boehringer Ingelheim International GmbH, | Binger Straße 173, |
| Boehringer Ingelheim International GmbH, | | | | |
| Binger Straße 173, | | | | |
| D-55216 | | | | |
| Ingelheim am Rhein | | | | |
| 17.12.2004 | Cymbalta | Eli Lilly Nederland BV, Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland BV, | Grootslag 1-5, |
| Eli Lilly Nederland BV, | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 17.12.2004 | Kivexa | Glaxo Group Ltd, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd, | Berkeley Avenue, |
| Glaxo Group Ltd, | | | | |
| Berkeley Avenue, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 12.1.2004 | Avastin | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | Roche Registration Limited, | 40 Broadwater Road, |
| Roche Registration Limited, | | | | |
| 40 Broadwater Road, | | | | |
| Welwyn Garden City, | | | | |
| Hertfordshire AL7 3AY, | | | | |
| United Kingdom | | | | |

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 |
| ---------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------- |
| 17.12.2004 | Agenerase | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd, | Greenford, |
| Glaxo Group Ltd, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 17.12.2004 | Fuzeon | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | Roche Registration Limited, | 40 Broadwater Road, |
| Roche Registration Limited, | | | | |
| 40 Broadwater Road, | | | | |
| Welwyn Garden City, | | | | |
| Hertfordshire AL7 3AY, | | | | |
| United Kingdom | | | | |
| 17.12.2004 | Kaletra | Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | Abbott laboratories Ltd, | Queenborough, |
| Abbott laboratories Ltd, | | | | |
| Queenborough, | | | | |
| Kent ME11 5EL, | | | | |
| United Kingdom | | | | |
| 17.12.2004 | Epivir | Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd., | Greenford Road, |
| Glaxo Group Ltd., | | | | |
| Greenford Road, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 17.12.2004 | Telzir | Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd., | Greenford Road, |
| Glaxo Group Ltd., | | | | |
| Greenford Road, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 17.12.2004 | Invirase | Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire, AL7 3AY, United Kingdom | Roche Registration Ltd., | 40, Broadwater Road, |
| Roche Registration Ltd., | | | | |
| 40, Broadwater Road, | | | | |
| Welwyn Garden City, | | | | |
| Hertfordshire, AL7 3AY, | | | | |
| United Kingdom | | | | |
| 17.12.2004 | Emtriva | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited, | Cambridge CB1 6GT |
| Gilead Sciences International Limited, | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 17.12.2004 | NeuroBloc | Elan Pharma International Ltd., WIL House, Shannon Business Park, Shannon, County Clare, Ireland | Elan Pharma International Ltd., | WIL House, |
| Elan Pharma International Ltd., | | | | |
| WIL House, | | | | |
| Shannon Business Park, | | | | |
| Shannon, | | | | |
| County Clare, | | | | |
| Ireland | | | | |
| 17.12.2004 | Reyataz | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA, United Kingdom | Bristol-Myers Squibb Pharma EEIG, | 141-149 Staines Road, |
| Bristol-Myers Squibb Pharma EEIG, | | | | |
| 141-149 Staines Road, | | | | |
| Hounslow TW3 3JA, | | | | |
| United Kingdom | | | | |
| 17.12.2004 | Ziagen | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd, | Greenford, |
| Glaxo Group Ltd, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 17.12.2004 | Rilutek | Aventis Pharma SA, 20 Avenue Raymond Aron, F-92165 Antony Cedex | Aventis Pharma SA, | 20 Avenue Raymond Aron, |
| Aventis Pharma SA, | | | | |
| 20 Avenue Raymond Aron, | | | | |
| F-92165 Antony Cedex | | | | |
| 17.12.2004 | Viracept | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | Roche Registration Limited, | 40 Broadwater Road, |
| Roche Registration Limited, | | | | |
| 40 Broadwater Road, | | | | |
| Welwyn Garden City, | | | | |
| Hertfordshire AL7 3AY, | | | | |
| United Kingdom | | | | |
| 21.12.2004 | Advate | Baxter AG, Industriestraße 67, A-1221 Wien | Baxter AG, | Industriestraße 67, |
| Baxter AG, | | | | |
| Industriestraße 67, | | | | |
| A-1221 Wien | | | | |
| 22.12.2004 | Iscover | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA United Kingdom | Bristol-Myers Squibb Pharma EEIG, | 141-149 Staines Road, |
| Bristol-Myers Squibb Pharma EEIG, | | | | |
| 141-149 Staines Road, | | | | |
| Hounslow TW3 3JA | | | | |
| United Kingdom | | | | |
| 22.12.2004 | Tasmar | Valeant Pharmaceuticals Limited, Cedarwood, Chineham Business Park, Crockford lane, Basingstoke RG24 8WD, United Kingdom Roche Registration Ltd., 40, Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | Valeant Pharmaceuticals Limited, | Cedarwood, |
| Valeant Pharmaceuticals Limited, | | | | |
| Cedarwood, | | | | |
| Chineham Business Park, | | | | |
| Crockford lane, | | | | |
| Basingstoke RG24 8WD, | | | | |
| United Kingdom | | | | |
| Roche Registration Ltd., | | | | |
| 40, Broadwater Road, | | | | |
| Welwyn Garden City, | | | | |
| Hertfordshire AL7 3AY, | | | | |
| United Kingdom | | | | |
| 22.12.2004 | Taxotere | Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex | Aventis Pharma SA, | 20 avenue Raymond Aron, |
| Aventis Pharma SA, | | | | |
| 20 avenue Raymond Aron, | | | | |
| F-92165 Antony Cedex | | | | |
| 5.1.2005 | Crixivan | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd., | Hertford Road, |
| Merck Sharp & Dohme Ltd., | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 5.1.2005 | Caelyx | Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel | Schering Plough Europe, | Rue de Stalle 73/Stallestraat, 73, |
| Schering Plough Europe, | | | | |
| Rue de Stalle 73/Stallestraat, 73, | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 5.1.2005 | Taxotere | Aventis Pharma SA, 20 avenue Raymond Aron, F-92165 Antony Cedex | Aventis Pharma SA, | 20 avenue Raymond Aron, |
| Aventis Pharma SA, | | | | |
| 20 avenue Raymond Aron, | | | | |
| F-92165 Antony Cedex | | | | |
| 5.1.2005 | Glivec | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited, | Wimblehurst Road, |
| Novartis Europharm Limited, | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 5.1.2005 | Sustiva | Bristol-Myers Squibb Pharma EEIG, 141-149 Staines Road, Hounslow TW3 3JA United Kingdom | Bristol-Myers Squibb Pharma EEIG, | 141-149 Staines Road, |
| Bristol-Myers Squibb Pharma EEIG, | | | | |
| 141-149 Staines Road, | | | | |
| Hounslow TW3 3JA | | | | |
| United Kingdom | | | | |
| 5.1.2005 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC, 174 avenue de France F-75013 Paris | Sanofi Pharma Bristol-Myers Squibb SNC, | 174 avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC, | | | | |
| 174 avenue de France | | | | |
| F-75013 Paris | | | | |
| 5.1.2005 | Foscan | Biolitec pharma (Ireland) ltd., Unit 2, Broomhill Business Park, Broomhill Road, Tallaght, Dublin 24, Ireland Biolitec pharma limited, Research Avenue South, Heriot-Watt Research Park, Edinburgh, EH14 4AP, United Kingdom | Biolitec pharma (Ireland) ltd., | Unit 2, |
| Biolitec pharma (Ireland) ltd., | | | | |
| Unit 2, | | | | |
| Broomhill Business Park, | | | | |
| Broomhill Road, | | | | |
| Tallaght, | | | | |
| Dublin 24, | | | | |
| Ireland | | | | |
| Biolitec pharma limited, | | | | |
| Research Avenue South, | | | | |
| Heriot-Watt Research Park, | | | | |
| Edinburgh, | | | | |
| EH14 4AP, | | | | |
| United Kingdom | | | | |
| 5.1.2005 | Stocrin | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd, | Hertford Road, |
| Merck Sharp & Dohme Ltd, | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 5.1.2005 | Trivizir | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd, | Greenford, |
| Glaxo Group Ltd, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 5.1.2005 | Caelyx | Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel | Schering Plough Europe, | Rue de Stalle 73/Stallestraat, 73, |
| Schering Plough Europe, | | | | |
| Rue de Stalle 73/Stallestraat, 73, | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 5.1.2005 | Viramune | Boehringer Ingelheim International GmbH, Binger Straße 173 D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH, | Binger Straße 173 |
| Boehringer Ingelheim International GmbH, | | | | |
| Binger Straße 173 | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 5.1.2005 | Combivir | Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN United Kingdom | Glaxo Group Ltd., | Greenford Road, |
| Glaxo Group Ltd., | | | | |
| Greenford Road, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN | | | | |
| United Kingdom | | | | |
| 10.1.2005 | Azomyr | Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel | Schering Plough Europe, | Rue de Stalle 73/Stallestraat, 73, |
| Schering Plough Europe, | | | | |
| Rue de Stalle 73/Stallestraat, 73, | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 10.1.2005 | Aerius | Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel | Schering Plough Europe, | Rue de Stalle 73/Stallestraat, 73, |
| Schering Plough Europe, | | | | |
| Rue de Stalle 73/Stallestraat, 73, | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 10.1.2005 | Neoclarityn | Schering Plough Europe, Rue de Stalle 73/Stallestraat, 73, B-1180 Bruxelles/Brussel | Schering Plough Europe, | Rue de Stalle 73/Stallestraat, 73, |
| Schering Plough Europe, | | | | |
| Rue de Stalle 73/Stallestraat, 73, | | | | |
| B-1180 Bruxelles/Brussel | | | | |
| 10.1.2005 | Ketek | Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony | Aventis Pharma SA, | 20 Avenue Raymond Aron, |
| Aventis Pharma SA, | | | | |
| 20 Avenue Raymond Aron, | | | | |
| F-92160 Antony | | | | |
| 10.1.2005 | Levviax | Aventis Pharma SA, 20 Avenue Raymond Aron, F-92160 Antony | Aventis Pharma SA, | 20 Avenue Raymond Aron, |
| Aventis Pharma SA, | | | | |
| 20 Avenue Raymond Aron, | | | | |
| F-92160 Antony | | | | |
| 10.1.2005 | Glustin | Takeda Europe R & D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom | Takeda Europe R & D Centre Ltd, | Savanah House, |
| Takeda Europe R & D Centre Ltd, | | | | |
| Savanah House, | | | | |
| 11/12 Charles II Street, | | | | |
| London SW1Y 4QU, | | | | |
| United Kingdom | | | | |
| 10.1.2005 | Actos | Takeda Europe R & D Centre Ltd, Savanah House, 11/12 Charles II Street, London SW1Y 4QU, United Kingdom | Takeda Europe R & D Centre Ltd, | Savanah House, |
| Takeda Europe R & D Centre Ltd, | | | | |
| Savanah House, | | | | |
| 11/12 Charles II Street, | | | | |
| London SW1Y 4QU, | | | | |
| United Kingdom | | | | |
| 10.1.2005 | Optisulin | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | Aventis Pharma Deutschland GmbH, | D-65926 Frankfurt am Main |
| Aventis Pharma Deutschland GmbH, | | | | |
| D-65926 Frankfurt am Main | | | | |
| 10.1.2005 | Fortovase | Roche Registration Limited, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY, United Kingdom | Roche Registration Limited, | 40 Broadwater Road, |
| Roche Registration Limited, | | | | |
| 40 Broadwater Road, | | | | |
| Welwyn Garden City, | | | | |
| Hertfordshire AL7 3AY, | | | | |
| United Kingdom | | | | |
| 10.1.2005 | Remicade | Centocor BV, Einsteinweg 101, 2333 CB Leiden, Nederland | Centocor BV, | Einsteinweg 101, |
| Centocor BV, | | | | |
| Einsteinweg 101, | | | | |
| 2333 CB Leiden, | | | | |
| Nederland | | | | |
| 10.1.2005 | Viread | Gilead Sciences International Limited, Cambridge CB1 6GT United Kingdom | Gilead Sciences International Limited, | Cambridge CB1 6GT |
| Gilead Sciences International Limited, | | | | |
| Cambridge CB1 6GT | | | | |
| United Kingdom | | | | |
| 10.1.2005 | Vfend | Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited, | Sandwich, |
| Pfizer Limited, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 10.1.2005 | Avandia | SmithKline Beecham plc, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom | SmithKline Beecham plc, | 980 Great West Road, |
| SmithKline Beecham plc, | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex TW8 9GS | | | | |
| United Kingdom | | | | |
| 11.1.2005 | Lantus | Aventis Pharma Deutschland GmbH, D-65926 Frankfurt am Main | Aventis Pharma Deutschland GmbH, | D-65926 Frankfurt am Main |
| Aventis Pharma Deutschland GmbH, | | | | |
| D-65926 Frankfurt am Main | | | | |
| 12.1.2004 | Aldurazyme | Genzyme Europe BV, Gooimeer 10, Naarden 1411 DD, Nederland | Genzyme Europe BV, | Gooimeer 10, |
| Genzyme Europe BV, | | | | |
| Gooimeer 10, | | | | |
| Naarden 1411 DD, | | | | |
| Nederland | | | | |
| 12.1.2004 | Quixidar | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom NV Organon, PO Box 20, Kloosterstraat 6, 5340 EB Oss, Nederland | Glaxo Group Ltd, | Greenford, |
| Glaxo Group Ltd, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| NV Organon, | | | | |
| PO Box 20, | | | | |
| Kloosterstraat 6, | | | | |
| 5340 EB Oss, | | | | |
| Nederland | | | | |
| 12.1.2004 | Arixtra | Glaxo Group Ltd, Greenford, Middlesex UB6 0NN, United Kingdom Sanofi-Synthelabo, 174 avenue de France, F-75013 Paris | Glaxo Group Ltd, | Greenford, |
| Glaxo Group Ltd, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| Sanofi-Synthelabo, | | | | |
| 174 avenue de France, | | | | |
| F-75013 Paris | | | | |
| 12.1.2004 | Kaletra | Abbott laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | Abbott laboratories Ltd, | Queenborough, |
| Abbott laboratories Ltd, | | | | |
| Queenborough, | | | | |
| Kent ME11 5EL, | | | | |
| United Kingdom | | | | |

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 |
| ----------------------- | ----------------------------- | -------------------------------------------- | --------------------------------------------- | ----------------------- |
| 5.1.2005 | Advocate | Bayer Healthcare AG, D-51368 Leverkusen | Bayer Healthcare AG, | D-51368 Leverkusen |
| Bayer Healthcare AG, | | | | |
| D-51368 Leverkusen | | | | |
| 5.1.2005 | ProteqFlu Te | Merial, 29 Avenue Tony Garnier, F-69007 Lyon | Merial, | 29 Avenue Tony Garnier, |
| Merial, | | | | |
| 29 Avenue Tony Garnier, | | | | |
| F-69007 Lyon | | | | |

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

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