# C_2010111EN.01000201.xml

| 30.4.2010 | EN | Official Journal of the European Union | C 111/2 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2010 to 28 February 2010

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
( 1 )
)

2010/C 111/02

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | INN
(International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
(Anatomical Therapeutic Chemical Code) | Date of notification |
| ------------------------------- | ----------------------------- | ----------------------------------------- | ----------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- | ------------------------------------------------ | -------------------- |
| 8.1.2010 | Leflunomide Winthrop | leflunomide | Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND | Sanofi-Aventis Deutschland GmbH | 65926 Frankfurt am Main | DEUTSCHLAND | EU/1/09/604/001-010 |
| Sanofi-Aventis Deutschland GmbH | | | | | | | |
| 65926 Frankfurt am Main | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 11.1.2010 | Scintimun | besilesomab | CIS bio international 32 Boite Postale 91192 Gif-sur-Yvette FRANCE | CIS bio international | 32 Boite Postale | 91192 Gif-sur-Yvette | FRANCE |
| CIS bio international | | | | | | | |
| 32 Boite Postale | | | | | | | |
| 91192 Gif-sur-Yvette | | | | | | | |
| FRANCE | | | | | | | |
| 25.1.2010 | Elonva | corifollitropin alfa | N.V. Organon Kloosterstraat 6 5349 AB Oss NEDERLAND | N.V. Organon | Kloosterstraat 6 | 5349 AB Oss | NEDERLAND |
| N.V. Organon | | | | | | | |
| Kloosterstraat 6 | | | | | | | |
| 5349 AB Oss | | | | | | | |
| NEDERLAND | | | | | | | |
| 25.1.2010 | Temomedac | temozolomide | ALFRED E. TIEFENBACHER (GmbH & Co. KG) Van-der-Smissen-Straße 1 22767 Hamburg DEUTSCHLAND | ALFRED E. TIEFENBACHER | (GmbH & Co. KG) | Van-der-Smissen-Straße 1 | 22767 Hamburg |
| ALFRED E. TIEFENBACHER | | | | | | | |
| (GmbH & Co. KG) | | | | | | | |
| Van-der-Smissen-Straße 1 | | | | | | | |
| 22767 Hamburg | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 26.1.2010 | Docetaxel Teva | Docetaxel | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 | 3542 DR Utrecht | NEDERLAND |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| 3542 DR Utrecht | | | | | | | |
| NEDERLAND | | | | | | | |
| 26.1.2010 | Telmisartan Teva | telmisartan | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 | 3542 DR Utrecht | NEDERLAND |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| 3542 DR Utrecht | | | | | | | |
| NEDERLAND | | | | | | | |
| 28.1.2010 | Temozolomide Teva | temozolomide | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 | 3542 DR Utrecht | NEDERLAND |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10 | | | | | | | |
| 3542 DR Utrecht | | | | | | | |
| NEDERLAND | | | | | | | |
| 29.1.2010 | Silodyx | silodosin | Recordati Ireland Ltd Raheens East Ringaskiddy Co. Cork IRELAND | Recordati Ireland Ltd | Raheens East | Ringaskiddy Co. Cork | IRELAND |
| Recordati Ireland Ltd | | | | | | | |
| Raheens East | | | | | | | |
| Ringaskiddy Co. Cork | | | | | | | |
| IRELAND | | | | | | | |
| 29.1.2010 | Urorec | silodosin | Recordati Ireland Ltd Raheens East Ringaskiddy Co. Cork IRELAND | Recordati Ireland Ltd | Raheens East | Ringaskiddy Co. Cork | IRELAND |
| Recordati Ireland Ltd | | | | | | | |
| Raheens East | | | | | | | |
| Ringaskiddy Co. Cork | | | | | | | |
| IRELAND | | | | | | | |

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Rejected

| 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 |
| --------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 29.1.2010 | Gemesis | BioMimetic Therapeutics Ltd Arnold & Porter Tower 42 25 Old Broad Street London EC2N 1HQ UNITED KINGDOM | BioMimetic Therapeutics Ltd | Arnold & Porter |
| BioMimetic Therapeutics Ltd | | | | |
| Arnold & Porter | | | | |
| Tower 42 | | | | |
| 25 Old Broad Street | | | | |
| London | | | | |
| EC2N 1HQ | | | | |
| UNITED KINGDOM | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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 |
| --------------------------------------- | -------------------------------- | ----------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------- |
| 7.1.2010 | Lumigan | Allergan Pharmaceuticals Ireland Castlebar Road Westport Co. Mayo IRELAND | Allergan Pharmaceuticals Ireland | Castlebar Road |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road | | | | |
| Westport | | | | |
| Co. Mayo | | | | |
| IRELAND | | | | |
| 8.1.2010 | Kaletra | Abbott Laboratories Ltd Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE UNITED KINGDOM | Abbott Laboratories Ltd | Abbott House |
| Abbott Laboratories Ltd | | | | |
| Abbott House | | | | |
| Vanwall Business Park | | | | |
| Vanwall Road | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 4XE | | | | |
| UNITED KINGDOM | | | | |
| 8.1.2010 | Osseor | Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE | Les Laboratoires Servier | 22 rue Garnier |
| Les Laboratoires Servier | | | | |
| 22 rue Garnier | | | | |
| 92200 Neuilly-sur-Seine | | | | |
| FRANCE | | | | |
| 8.1.2010 | Protelos | Les Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE | Les Laboratoires Servier | 22 rue Garnier |
| Les Laboratoires Servier | | | | |
| 22 rue Garnier | | | | |
| 92200 Neuilly-sur-Seine | | | | |
| FRANCE | | | | |
| 8.1.2010 | Ratiograstim | ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm DEUTSCHLAND | ratiopharm GmbH | Graf-Arco-Straße 3 |
| ratiopharm GmbH | | | | |
| Graf-Arco-Straße 3 | | | | |
| 89079 Ulm | | | | |
| DEUTSCHLAND | | | | |
| 8.1.2010 | Revlimid | Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM | Celgene Europe Limited | Riverside House |
| Celgene Europe Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor | | | | |
| Berkshire | | | | |
| SL4 1NA | | | | |
| UNITED KINGDOM | | | | |
| 11.1.2010 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France | | | | |
| 75013 Paris | | | | |
| FRANCE | | | | |
| 11.1.2010 | Nplate | Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND | Amgen Europe B.V. | Minervum 7061 |
| Amgen Europe B.V. | | | | |
| Minervum 7061 | | | | |
| 4817 ZK Breda | | | | |
| NEDERLAND | | | | |
| 12.1.2010 | Apidra | Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND | Sanofi-Aventis Deutschland GmbH | 65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| 65926 Frankfurt am Main | | | | |
| DEUTSCHLAND | | | | |
| 12.1.2010 | EMEND | 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 | | | | |
| 12.1.2010 | Prialt | Eisai Limited European Knowledge Centre Mosquito Way Hatfield Herts AL10 9SN UNITED KINGDOM | Eisai Limited | European Knowledge Centre |
| Eisai Limited | | | | |
| European Knowledge Centre | | | | |
| Mosquito Way | | | | |
| Hatfield | | | | |
| Herts | | | | |
| AL10 9SN | | | | |
| UNITED KINGDOM | | | | |
| 12.1.2010 | Revlimid | Celgene Europe Limited Riverside House Riverside Walk Windsor Berkshire SL4 1NA UNITED KINGDOM | Celgene Europe Limited | Riverside House |
| Celgene Europe Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor | | | | |
| Berkshire | | | | |
| SL4 1NA | | | | |
| UNITED KINGDOM | | | | |
| 15.1.2010 | Thyrogen | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| NEDERLAND | | | | |
| 19.1.2010 | Gardasil | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 19.1.2010 | Herceptin | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 19.1.2010 | IRESSA | AstraZeneca AB SE-151 85 Sodertalje SVERIGE | AstraZeneca AB | SE-151 85 Sodertalje |
| AstraZeneca AB | | | | |
| SE-151 85 Sodertalje | | | | |
| SVERIGE | | | | |
| 19.1.2010 | M-M-RVAXPRO | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 19.1.2010 | Orfadin | Swedish Orphan International AB Drottninggatan 98 SE-111 60 Stockholm SVERIGE | Swedish Orphan International AB | Drottninggatan 98 |
| Swedish Orphan International AB | | | | |
| Drottninggatan 98 | | | | |
| SE-111 60 Stockholm | | | | |
| SVERIGE | | | | |
| 19.1.2010 | ProQuad | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 20.1.2010 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37 58638 Iserlohn DEUTSCHLAND | Medice Arzneimittel Pütter GmbH & Co KG | Kuhloweg 37 |
| Medice Arzneimittel Pütter GmbH & Co KG | | | | |
| Kuhloweg 37 | | | | |
| 58638 Iserlohn | | | | |
| DEUTSCHLAND | | | | |
| 20.1.2010 | Arixtra | 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 | | | | |
| 20.1.2010 | Atriance | Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Limited | Berkeley Avenue |
| Glaxo Group Limited | | | | |
| Berkeley Avenue | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Avaglim | SmithKline Beecham Ltd 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM | SmithKline Beecham Ltd | 980 Great West Road |
| SmithKline Beecham Ltd | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex | | | | |
| TW8 9GS | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Avandamet | SmithKline Beecham Ltd 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM | SmithKline Beecham Ltd | 980 Great West Road |
| SmithKline Beecham Ltd | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex | | | | |
| TW8 9GS | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | AVANDIA | SmithKline Beecham Ltd 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM | SmithKline Beecham Ltd | 980 Great West Road |
| SmithKline Beecham Ltd | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex | | | | |
| TW8 9GS | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Binocrit | Sandoz GmbH Biochemiestrasse 10 6250 Kundl ÖSTERREICH | Sandoz GmbH | Biochemiestrasse 10 |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10 | | | | |
| 6250 Kundl | | | | |
| ÖSTERREICH | | | | |
| 20.1.2010 | Elaprase | Shire Human Genetic Therapies AB Svärdvägen 11D SE-182 33 Danderyd SVERIGE | Shire Human Genetic Therapies AB | Svärdvägen 11D |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D | | | | |
| SE-182 33 Danderyd | | | | |
| SVERIGE | | | | |
| 20.1.2010 | Epoetin alfa Hexal | Hexal AG. Industriestraße 25 83607 Holzkirchen DEUTSCHLAND | Hexal AG. | Industriestraße 25 |
| Hexal AG. | | | | |
| Industriestraße 25 | | | | |
| 83607 Holzkirchen | | | | |
| DEUTSCHLAND | | | | |
| 20.1.2010 | HBVAXPRO | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 20.1.2010 | Hycamtin | SmithKline Beecham Ltd 980 Great West Road Brentford Middlesex TW8 9GS UNITED KINGDOM | SmithKline Beecham Ltd | 980 Great West Road |
| SmithKline Beecham Ltd | | | | |
| 980 Great West Road | | | | |
| Brentford | | | | |
| Middlesex | | | | |
| TW8 9GS | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Integrilin | Glaxo Group Ltd Greenford Middlesex UB6 ONN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 ONN | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | NeoRecormon | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | ORENCIA | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge | | | | |
| UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Orgalutran | N.V. Organon P.O. Box 20 Kloosterstraat 6 5340 BH Oss NEDERLAND | N.V. Organon | P.O. Box 20 |
| N.V. Organon | | | | |
| P.O. Box 20 | | | | |
| Kloosterstraat 6 | | | | |
| 5340 BH Oss | | | | |
| NEDERLAND | | | | |
| 20.1.2010 | RotaTeq | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 20.1.2010 | Tamiflu | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | 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 | | | | |
| 20.1.2010 | Thyrogen | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| NEDERLAND | | | | |
| 20.1.2010 | Tracleer | Actelion Registration Ltd BSI Building 13th Floor 389 Chiswick High London W4 4AL UNITED KINGDOM | Actelion Registration Ltd | BSI Building 13th Floor |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor | | | | |
| 389 Chiswick High | | | | |
| London | | | | |
| W4 4AL | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM | Gilead Sciences International Limited | Cambridge |
| Gilead Sciences International Limited | | | | |
| Cambridge | | | | |
| CB21 6GT | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Tyverb | Glaxo Group Limited Berkeley Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Limited | Berkeley Avenue |
| Glaxo Group Limited | | | | |
| Berkeley Avenue | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Viracept | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Volibris | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Ziagen | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Zostavax | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 25.1.2010 | Alisade | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 25.1.2010 | Altargo | Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Limited | Glaxo Wellcome House |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House | | | | |
| Berkeley Avenue | | | | |
| Greenford, Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 25.1.2010 | Avamys | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 25.1.2010 | Betaferon | Bayer Schering Pharma AG Müllerstraße 170—178 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | Müllerstraße 170—178 |
| Bayer Schering Pharma AG | | | | |
| Müllerstraße 170—178 | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 25.1.2010 | Bondronat | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 25.1.2010 | 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 | | | | |
| 25.1.2010 | Fabrazyme | Genzyme Europe B.V. Gooimeer 10 1411 DD Naarden NEDERLAND | Genzyme Europe B.V. | Gooimeer 10 |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| NEDERLAND | | | | |
| 25.1.2010 | Kiovig | Baxter AG Industriesstrasse 67 1220 Wien ÖSTERREICH | Baxter AG | Industriesstrasse 67 |
| Baxter AG | | | | |
| Industriesstrasse 67 | | | | |
| 1220 Wien | | | | |
| ÖSTERREICH | | | | |
| 25.1.2010 | Norvir | Abbott Laboratories Ltd Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE UNITED KINGDOM | Abbott Laboratories Ltd | Abbott House |
| Abbott Laboratories Ltd | | | | |
| Abbott House | | | | |
| Vanwall Business Park | | | | |
| Vanwall Road | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 4XE | | | | |
| UNITED KINGDOM | | | | |
| 25.1.2010 | Pelzont | 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 | | | | |
| 25.1.2010 | Qutenza | Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND | Astellas Pharma Europe B.V. | Elisabethhof 19 |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19 | | | | |
| 2353 EW Leiderdorp | | | | |
| NEDERLAND | | | | |
| 25.1.2010 | Sebivo | 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 | | | | |
| 25.1.2010 | Somavert | Pfizer Ltd Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 25.1.2010 | TORISEL | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Ltd | Huntercombe Lane South |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 25.1.2010 | Tredaptive | 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 | | | | |
| 25.1.2010 | Trevaclyn | 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 | | | | |
| 25.1.2010 | Xolair | 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 | | | | |
| 25.1.2010 | Zometa | 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 | | | | |
| 27.1.2010 | Arava | Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main DEUTSCHLAND | Sanofi-Aventis Deutschland GmbH | 65926 Frankfurt am Main |
| Sanofi-Aventis Deutschland GmbH | | | | |
| 65926 Frankfurt am Main | | | | |
| DEUTSCHLAND | | | | |
| 27.1.2010 | Privigen | CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg DEUTSCHLAND | CSL Behring GmbH | Emil-von-Behring-Straße 76 |
| CSL Behring GmbH | | | | |
| Emil-von-Behring-Straße 76 | | | | |
| 35041 Marburg | | | | |
| DEUTSCHLAND | | | | |
| 27.1.2010 | Rivastigmine Teva | Teva Pharma B.V. Computerweg 10 3542 DR Utrecht NEDERLAND | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| 3542 DR Utrecht | | | | |
| NEDERLAND | | | | |
| 27.1.2010 | Sonata | Meda AB Pipers väg 2A SE-170 09 Solna SVERIGE | Meda AB | Pipers väg 2A |
| Meda AB | | | | |
| Pipers väg 2A | | | | |
| SE-170 09 Solna | | | | |
| SVERIGE | | | | |
| 27.1.2010 | Zerene | Meda AB Pipers väg 2A SE-170 09 Solna SVERIGE | Meda AB | Pipers väg 2A |
| Meda AB | | | | |
| Pipers väg 2A | | | | |
| SE-170 09 Solna | | | | |
| SVERIGE | | | | |
| 28.1.2010 | Rapamune | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Limited | Huntercombe Lane South |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 29.1.2010 | Azopt | Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD UNITED KINGDOM | Alcon Laboratories (UK) Ltd | Pentagon Park |
| Alcon Laboratories (UK) Ltd | | | | |
| Pentagon Park | | | | |
| Boundary Way | | | | |
| Hemel Hempstead | | | | |
| Herts | | | | |
| HP2 7UD | | | | |
| UNITED KINGDOM | | | | |
| 29.1.2010 | Clopidogrel Winthrop | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France | | | | |
| 75013 Paris | | | | |
| FRANCE | | | | |
| 29.1.2010 | INTANZA | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk |
| Sanofi Pasteur MSD SNC | | | | |
| 8 rue Jonas Salk | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 2.2.2010 | Yttriga | Eckert & Ziegler Nuclitec GmbH Gieselweg 1 38110 Braunschweig DEUTSCHLAND | Eckert & Ziegler Nuclitec GmbH | Gieselweg 1 |
| Eckert & Ziegler Nuclitec GmbH | | | | |
| Gieselweg 1 | | | | |
| 38110 Braunschweig | | | | |
| DEUTSCHLAND | | | | |
| 3.2.2010 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France 75013 Paris FRANCE | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France | | | | |
| 75013 Paris | | | | |
| FRANCE | | | | |
| 3.2.2010 | Karvezide | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH UNITED KINGDOM | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park | | | | |
| Sanderson Road | | | | |
| Uxbridge | | | | |
| UB8 1DH | | | | |
| UNITED KINGDOM | | | | |
| 3.2.2010 | Temodal | Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Schering Plough Europe | Rue de Stalle 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |
| 4.2.2010 | Irbesartan HCT Winthrop | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France 75013 Paris FRANCE | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | 174 avenue de France |
| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | | | | |
| 174 avenue de France | | | | |
| 75013 Paris | | | | |
| FRANCE | | | | |
| 8.2.2010 | Bondenza (Ibandronic Acid Roche) | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 8.2.2010 | Bonviva | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 8.2.2010 | Pandemrix | GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89 1330 Rixensart BELGIQUE | GlaxoSmithKline Biologicals s.a. | Rue de l'Institut 89 |
| GlaxoSmithKline Biologicals s.a. | | | | |
| Rue de l'Institut 89 | | | | |
| 1330 Rixensart | | | | |
| BELGIQUE | | | | |
| 8.2.2010 | ReFacto AF | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Ltd | Huntercombe Lane South |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South | | | | |
| Taplow | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 8.2.2010 | TOVIAZ | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road |
| Pfizer Limited | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 9.2.2010 | Bridion | N.V. Organon Kloosterstraat 6 5349 AB Oss NEDERLAND | N.V. Organon | Kloosterstraat 6 |
| N.V. Organon | | | | |
| Kloosterstraat 6 | | | | |
| 5349 AB Oss | | | | |
| NEDERLAND | | | | |
| 9.2.2010 | Cialis | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND | Eli Lilly Nederland B.V. | Grootslag 1-5 |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5 | | | | |
| 3991 RA Houten | | | | |
| NEDERLAND | | | | |
| 9.2.2010 | Clopidogrel 1A Pharma | Acino Pharma GmbH Am Windfeld 35 83714 Miesbach DEUTSCHLAND | Acino Pharma GmbH | Am Windfeld 35 |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35 | | | | |
| 83714 Miesbach | | | | |
| DEUTSCHLAND | | | | |
| 9.2.2010 | Exforge | 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 | | | | |
| 9.2.2010 | Fertavid | SP Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE | SP Europe | Rue de Stalle 73 |
| SP Europe | | | | |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| 9.2.2010 | Imprida | 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 | | | | |
| 9.2.2010 | Kaletra | Abbott Laboratories Limited Abbott House Vanwall Business Park Vanwall Road Maidenhead Berkshire SL6 4XE UNITED KINGDOM | Abbott Laboratories Limited | Abbott House |
| Abbott Laboratories Limited | | | | |
| Abbott House | | | | |
| Vanwall Business Park | | | | |
| Vanwall Road | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 4XE | | | | |
| UNITED KINGDOM | | | | |
| 9.2.2010 | Kineret | Biovitrum AB (publ) SE-112 76 Stockholm SVERIGE | Biovitrum AB (publ) | SE-112 76 Stockholm |
| Biovitrum AB (publ) | | | | |
| SE-112 76 Stockholm | | | | |
| SVERIGE | | | | |
| 9.2.2010 | NovoSeven | Novo Nordisk A/S Novo Allé 2880 Bagsvaerd DANMARK | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| 2880 Bagsvaerd | | | | |
| DANMARK | | | | |
| 9.2.2010 | Temodal | Schering Plough Europe Rue de Stalle 73 1180 Bruxelles BELGIQUE Stallestraat 73 1180 Brussel BELGIË | Schering Plough Europe | Rue de Stalle 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle 73 | | | | |
| 1180 Bruxelles | | | | |
| BELGIQUE | | | | |
| Stallestraat 73 | | | | |
| 1180 Brussel | | | | |
| BELGIË | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): Rejected

| 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 |
| ------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------- |
| 20.1.2010 | Avastin | Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW UNITED KINGDOM | Roche Registration Limited | 6 Falcon Way |
| Roche Registration Limited | | | | |
| 6 Falcon Way | | | | |
| Shire Park | | | | |
| Welwyn Garden City | | | | |
| AL7 1TW | | | | |
| UNITED KINGDOM | | | | |
| 20.1.2010 | Erbitux | Merck KGaA Frankfurter Straße 250 64271 Darmstadt DEUTSCHLAND | Merck KGaA | Frankfurter Straße 250 |
| Merck KGaA | | | | |
| Frankfurter Straße 250 | | | | |
| 64271 Darmstadt | | | | |
| DEUTSCHLAND | | | | |
| 9.2.2010 | EVICEL | OMRIX biopharmaceuticals S.A./N.V. Chaussée de Waterloo/Waterloosesteenweg 200 1640 Rhode-St-Genèse/Sint-Genesius-Rode BELGIQUE/BELGIË | OMRIX biopharmaceuticals S.A./N.V. | Chaussée de Waterloo/Waterloosesteenweg 200 |
| OMRIX biopharmaceuticals S.A./N.V. | | | | |
| Chaussée de Waterloo/Waterloosesteenweg 200 | | | | |
| 1640 Rhode-St-Genèse/Sint-Genesius-Rode | | | | |
| BELGIQUE/BELGIË | | | | |

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004
( 2 )
): Accepted

| Date of the decision | Name of the medicinal product | INN
(International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code
(Anatomical Therapeutic Chemical Code) | Date of notification |
| ---------------------------- | ----------------------------- | ----------------------------------------------------------------- | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- | ------------------------------------------------ | -------------------- |
| 14.1.2010 | Gripovac 3 | Inactivated vaccine against swine influenza in pigs | MERIAL 29 avenue Tony Garnier 69007 Lyon FRANCE | MERIAL | 29 avenue Tony Garnier | 69007 Lyon | FRANCE |
| MERIAL | | | | | | | |
| 29 avenue Tony Garnier | | | | | | | |
| 69007 Lyon | | | | | | | |
| FRANCE | | | | | | | |
| 14.1.2010 | RESPIPORC FLU3 | Inactivated vaccine against swine influenza in pigs | IDT Biologika GmbH Am Pharmapark 06861 Dessau-Rosslau DEUTSCHLAND | IDT Biologika GmbH | Am Pharmapark | 06861 Dessau-Rosslau | DEUTSCHLAND |
| IDT Biologika GmbH | | | | | | | |
| Am Pharmapark | | | | | | | |
| 06861 Dessau-Rosslau | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 15.1.2010 | Zulvac 8 Bovis | Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02 | Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH UNITED KINGDOM | Fort Dodge Animal Health Ltd | Flanders Road | Hedge End | Southampton |
| Fort Dodge Animal Health Ltd | | | | | | | |
| Flanders Road | | | | | | | |
| Hedge End | | | | | | | |
| Southampton | | | | | | | |
| SO30 4QH | | | | | | | |
| UNITED KINGDOM | | | | | | | |
| 15.1.2010 | Zulvac 8 Ovis | Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02 | Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH UNITED KINGDOM | Fort Dodge Animal Health Ltd | Flanders Road | Hedge End | Southampton |
| Fort Dodge Animal Health Ltd | | | | | | | |
| Flanders Road | | | | | | | |
| Hedge End | | | | | | | |
| Southampton | | | | | | | |
| SO30 4QH | | | | | | | |
| UNITED KINGDOM | | | | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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 |
| ----------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------ |
| 12.1.2010 | BTVPUR Alsap 8 | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 12.1.2010 | METACAM | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim Vetmedica GmbH | 55216 Ingelheim am Rhein |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 12.1.2010 | Porcilis PCV | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| NEDERLAND | | | | |
| 12.1.2010 | Previcox | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 14.1.2010 | Poulvac FluFend H5N3 RG | Fort Dodge Animal Health Ltd Flanders Road Hedge End Southampton SO30 4QH UNITED KINGDOM | Fort Dodge Animal Health Ltd | Flanders Road |
| Fort Dodge Animal Health Ltd | | | | |
| Flanders Road | | | | |
| Hedge End | | | | |
| Southampton | | | | |
| SO30 4QH | | | | |
| UNITED KINGDOM | | | | |
| 14.1.2010 | Purevax RCPCh | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 15.1.2010 | Convenia | Pfizer Ltd Ramsgate Road Sandwich Kent CT 13 9NJ UNITED KINGDOM | Pfizer Ltd | Ramsgate Road |
| Pfizer Ltd | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT 13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 15.1.2010 | Purevax RC | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 15.1.2010 | Purevax RCCh | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 15.1.2010 | Purevax RCPCh FeLV | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 15.1.2010 | Purevax RCP FeLV | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 25.1.2010 | Purevax RCP | Merial 29 avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 avenue Tony Garnier |
| Merial | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 29.1.2010 | Quadrisol | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND | Intervet International B.V. | Wim de Körverstraat 35 |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35 | | | | |
| 5831 AN Boxmeer | | | | |
| NEDERLAND | | | | |

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 4H |
| UNITED KINGDOM |

---

( 1 )  OJ L 136, 30.4.2004, p. 1.

( 2 )  See footnote 1.

---