# C_2009073EN.01000501.xml

| 27.3.2009 | EN | Official Journal of the European Union | C 73/5 |
| --------- | -- | -------------------------------------- | ------ |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 February 2009 to 28 February 2009

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

(2009/C 73/03)

—   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 |
| ------------------------------------ | ----------------------------- | --------------------------------------------- | -------------------------------------------------------------------------- | --------------------------------------------- | -------------------- | ------------------------------------------------ | -------------------- |
| 4.2.2009 | Nplate | Romiplostim | Amgen Europe B.V. Minervum 7061 4817 ZK Breda NEDERLAND | Amgen Europe B.V. | Minervum 7061 | 4817 ZK Breda | NEDERLAND |
| Amgen Europe B.V. | | | | | | | |
| Minervum 7061 | | | | | | | |
| 4817 ZK Breda | | | | | | | |
| NEDERLAND | | | | | | | |
| 6.2.2009 | Zarzio | Filgrastim | Sandoz GmbH Biochemiestraße 10 6250 Kundl ÖSTERREICH | Sandoz GmbH | Biochemiestraße 10 | 6250 Kundl | ÖSTERREICH |
| Sandoz GmbH | | | | | | | |
| Biochemiestraße 10 | | | | | | | |
| 6250 Kundl | | | | | | | |
| ÖSTERREICH | | | | | | | |
| 6.2.2009 | Filgrastim Hexal | Filgrastim | HEXAL AG Industriestraße 25 83607 Holzkirchen DEUTSCHLAND | HEXAL AG | Industriestraße 25 | 83607 Holzkirchen | DEUTSCHLAND |
| HEXAL AG | | | | | | | |
| Industriestraße 25 | | | | | | | |
| 83607 Holzkirchen | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 17.2.2009 | FIRMAGON | Degarelix (as acetate) | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 Copenhagen S 2300 DANMARK | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11 | Copenhagen S 2300 | DANMARK |
| Ferring Pharmaceuticals A/S | | | | | | | |
| Kay Fiskers Plads 11 | | | | | | | |
| Copenhagen S 2300 | | | | | | | |
| DANMARK | | | | | | | |
| 19.2.2009 | Thymanax | Agomelatine | Servier (Ireland) Industries Limited Gorey Road Arklow Co. Wicklow IRELAND | Servier (Ireland) Industries Limited | Gorey Road | Arklow | Co. Wicklow |
| Servier (Ireland) Industries Limited | | | | | | | |
| Gorey Road | | | | | | | |
| Arklow | | | | | | | |
| Co. Wicklow | | | | | | | |
| IRELAND | | | | | | | |
| 19.2.2009 | Opgenra | Eptotermin alfa | Howmedica International S. de R. L. Raheen Business Park Limerick IRELAND | Howmedica International S. de R. L. | Raheen Business Park | Limerick | IRELAND |
| Howmedica International S. de R. L. | | | | | | | |
| Raheen Business Park | | | | | | | |
| Limerick | | | | | | | |
| IRELAND | | | | | | | |
| 19.2.2009 | Valdoxan | Agomelatine | Laboratoires Servier 22 rue Garnier 92200 Neuilly-sur-Seine FRANCE | Laboratoires Servier | 22 rue Garnier | 92200 Neuilly-sur-Seine | FRANCE |
| Laboratoires Servier | | | | | | | |
| 22 rue Garnier | | | | | | | |
| 92200 Neuilly-sur-Seine | | | | | | | |
| FRANCE | | | | | | | |
| 24.2.2009 | FABLYN | Lasofoxifene | Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Ramsgate Road | Sandwich | Kent CT13 9NJ |
| Pfizer Limited | | | | | | | |
| Ramsgate Road | | | | | | | |
| Sandwich | | | | | | | |
| Kent CT13 9NJ | | | | | | | |
| UNITED KINGDOM | | | | | | | |
| 24.2.2009 | INTANZA | Influenza Vaccine (split virion, inactivated) | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk | 69007 Lyon | FRANCE |
| Sanofi Pasteur MSD SNC | | | | | | | |
| 8 rue Jonas Salk | | | | | | | |
| 69007 Lyon | | | | | | | |
| FRANCE | | | | | | | |
| 24.2.2009 | IDflu | Influenza Vaccine (split virion, inactivated) | Sanofi Pasteur MSD SNC 8 rue Jonas Salk 69007 Lyon FRANCE | Sanofi Pasteur MSD SNC | 8 rue Jonas Salk | 69007 Lyon | FRANCE |
| Sanofi Pasteur MSD SNC | | | | | | | |
| 8 rue Jonas Salk | | | | | | | |
| 69007 Lyon | | | | | | | |
| FRANCE | | | | | | | |
| 25.2.2009 | Efient | Prasugrel | Eli Lilly Nederland B.V. Grootslag 1-5 3991 RA Houten NEDERLAND | Eli Lilly Nederland B.V. | Grootslag 1-5 | 3991 RA Houten | NEDERLAND |
| Eli Lilly Nederland B.V. | | | | | | | |
| Grootslag 1-5 | | | | | | | |
| 3991 RA Houten | | | | | | | |
| NEDERLAND | | | | | | | |

—   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 |
| ------------------------------------------------------------------------------------------------------------------- | ------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------- | ----------------------------------------------- |
| 2.2.2009 | Vfend | 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 | | | | |
| 2.2.2009 | 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 | | | | |
| 2.2.2009 | Silgard | 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 | | | | |
| 2.2.2009 | Vimpat | UCB Pharma S.A. Allée de la Recherche 60 1070 Bruxelles BELGIQUE | UCB Pharma S.A. | Allée de la Recherche 60 |
| UCB Pharma S.A. | | | | |
| Allée de la Recherche 60 | | | | |
| 1070 Bruxelles | | | | |
| BELGIQUE | | | | |
| 2.2.2009 | DuoTrav | 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 | | | | |
| 4.2.2009 | Elaprase | Shire Human Genetic Therapies AB Svardvagen 11D 182 33 Danderyd SVERIGE | Shire Human Genetic Therapies AB | Svardvagen 11D |
| Shire Human Genetic Therapies AB | | | | |
| Svardvagen 11D | | | | |
| 182 33 Danderyd | | | | |
| SVERIGE | | | | |
| 6.2.2009 | REYATAZ | 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 | | | | |
| 6.2.2009 | Extavia | 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 | | | | |
| 10.2.2009 | Pradaxa | Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Straße 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173 | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 10.2.2009 | SUTENT | 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 | | | | |
| 10.2.2009 | Baraclude | 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 | | | | |
| 10.2.2009 | Sprycel | 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 | | | | |
| 10.2.2009 | 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 | | | | |
| 10.2.2009 | TachoSil | Nycomed Austria GmbH St.-Peter-Straße 25 4020 Linz ÖSTERREICH | Nycomed Austria GmbH | St.-Peter-Straße 25 |
| Nycomed Austria GmbH | | | | |
| St.-Peter-Straße 25 | | | | |
| 4020 Linz | | | | |
| ÖSTERREICH | | | | |
| 10.2.2009 | Abraxane | Abraxis BioSciences Limited 2nd floor Titan Court 3 Bishops Sq Hatfield AL 10 9NA UNITED KINGDOM | Abraxis BioSciences Limited | 2nd floor Titan Court 3 Bishops Sq |
| Abraxis BioSciences Limited | | | | |
| 2nd floor Titan Court 3 Bishops Sq | | | | |
| Hatfield AL 10 9NA | | | | |
| UNITED KINGDOM | | | | |
| 10.2.2009 | 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 | | | | |
| 10.2.2009 | IVEMEND | Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Limited | Hertford Road |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 11.2.2009 | Zonegran | Eisai Limited 3 Shortlands London W6 8EE UNITED KINGDOM | Eisai Limited | 3 Shortlands |
| Eisai Limited | | | | |
| 3 Shortlands | | | | |
| London W6 8EE | | | | |
| UNITED KINGDOM | | | | |
| 13.2.2009 | 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 | | | | |
| 13.2.2009 | Clopidogrel BMS | 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 | | | | |
| 13.2.2009 | Dafiro | 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 | | | | |
| 13.2.2009 | Lyrica | 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 | | | | |
| 13.2.2009 | Copalia | 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 | | | | |
| 13.2.2009 | 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 | | | | |
| 13.2.2009 | Tasmar | Meda Actiebolag Pipers väg 2A Box 906 170 09 Solna SVERIGE | Meda Actiebolag | Pipers väg 2A |
| Meda Actiebolag | | | | |
| Pipers väg 2A | | | | |
| Box 906 | | | | |
| 170 09 Solna | | | | |
| SVERIGE | | | | |
| Valeant Pharmaceuticals Limited Cedarwood Chineham Business Park Crockford Lane Basingstoke RG24 8WD UNITED KINGDOM | Valeant Pharmaceuticals Limited | Cedarwood | Chineham Business Park | Crockford Lane |
| Valeant Pharmaceuticals Limited | | | | |
| Cedarwood | | | | |
| Chineham Business Park | | | | |
| Crockford Lane | | | | |
| Basingstoke RG24 8WD | | | | |
| UNITED KINGDOM | | | | |
| 13.2.2009 | 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 | | | | |
| 17.2.2009 | Temodal | Schering Plough Europe Rue de Stalle, 73/Stallestraat, 73 1180 Bruxelles/1180 Brussel BELGIQUE/BELGIË | Schering Plough Europe | Rue de Stalle, 73/Stallestraat, 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73/Stallestraat, 73 | | | | |
| 1180 Bruxelles/1180 Brussel | | | | |
| BELGIQUE/BELGIË | | | | |
| 19.2.2009 | Zerene | Meda AB Pipers väg 2A 170 09 Solna SVERIGE | Meda AB | Pipers väg 2A |
| Meda AB | | | | |
| Pipers väg 2A | | | | |
| 170 09 Solna | | | | |
| SVERIGE | | | | |
| 19.2.2009 | Insuman | 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 | | | | |
| 19.2.2009 | Sonata | Meda AB Pipers väg 2A 170 09 Solna SVERIGE | Meda AB | Pipers väg 2A |
| Meda AB | | | | |
| Pipers väg 2A | | | | |
| 170 09 Solna | | | | |
| SVERIGE | | | | |
| 19.2.2009 | Insulin Human Winthrop | 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 | | | | |
| 20.2.2009 | Myozyme | 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 | | | | |
| 20.2.2009 | Evoltra | 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 | | | | |
| 20.2.2009 | Luminity | Bristol-Myers Squibb Pharma Belgium Sprl Chaussée de la Hulpe, 185/Terhulpsesteenweg 185 1170 Bruxelles/1180 Brussel BELGIQUE/BELGIË | Bristol-Myers Squibb Pharma Belgium Sprl | Chaussée de la Hulpe, 185/Terhulpsesteenweg 185 |
| Bristol-Myers Squibb Pharma Belgium Sprl | | | | |
| Chaussée de la Hulpe, 185/Terhulpsesteenweg 185 | | | | |
| 1170 Bruxelles/1180 Brussel | | | | |
| BELGIQUE/BELGIË | | | | |
| 20.2.2009 | Bondenza | 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 | | | | |
| 23.2.2009 | Myozyme | 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 | | | | |
| 23.2.2009 | BeneFIX | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Ltd | Huntercombe Lane |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane | | | | |
| South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 23.2.2009 | 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 | | | | |
| 23.2.2009 | Mabthera | 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 | | | | |
| 24.2.2009 | Thalidomide Celgene | Celgene Europe Limited Riverside House Riverside Walk Windsor SL4 1NA UNITED KINGDOM | Celgene Europe Limited | Riverside House |
| Celgene Europe Limited | | | | |
| Riverside House | | | | |
| Riverside Walk | | | | |
| Windsor SL4 1NA | | | | |
| UNITED KINGDOM | | | | |
| 24.2.2009 | Irbesartan HCT BMS | 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 | | | | |
| 24.2.2009 | 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 | | | | |
| 24.2.2009 | 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 | | | | |
| 24.2.2009 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House Highbridge Business Park Oxford Road Uxbridge Middlesex UB8 1HU UNITED KINGDOM | Otsuka Pharmaceutical Europe Ltd | Hunton House |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House | | | | |
| Highbridge Business Park | | | | |
| Oxford Road | | | | |
| Uxbridge | | | | |
| Middlesex UB8 1HU | | | | |
| UNITED KINGDOM | | | | |
| 25.2.2009 | 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 | | | | |
| 25.2.2009 | Dynastat | 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 | | | | |
| 25.2.2009 | Levitra | Bayer AG 51368 Leverkusen DEUTSCHLAND | Bayer AG | 51368 Leverkusen |
| Bayer AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 25.2.2009 | Forsteo | 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 | | | | |
| 25.2.2009 | Zerit | 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 | | | | |
| 25.2.2009 | Irbesartan 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 | | | | |
| 25.2.2009 | HUMIRA | Abbott Laboratories Ltd Queenborough Kent ME11 5EL UNITED KINGDOM | Abbott Laboratories Ltd | Queenborough |
| Abbott Laboratories Ltd | | | | |
| Queenborough | | | | |
| Kent ME11 5EL | | | | |
| UNITED KINGDOM | | | | |
| 25.2.2009 | Vivanza | Bayer AG 51368 Leverkusen DEUTSCHLAND | Bayer AG | 51368 Leverkusen |
| Bayer AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 25.2.2009 | Advagraf | 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 | | | | |
| 25.2.2009 | Ranexa | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare L-1611 Luxembourg Luxembourg | Menarini International Operations Luxembourg S.A. | 1, Avenue de la Gare |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, Avenue de la Gare | | | | |
| L-1611 Luxembourg | | | | |
| Luxembourg | | | | |
| CV Therapeutics Europe Limited 15 Meadway Court Rutherford Close Stevenage Hertfordshire SG1 2EF UNITED KINGDOM | CV Therapeutics Europe Limited | 15 Meadway Court | Rutherford Close | Stevenage |
| CV Therapeutics Europe Limited | | | | |
| 15 Meadway Court | | | | |
| Rutherford Close | | | | |
| Stevenage | | | | |
| Hertfordshire SG1 2EF | | | | |
| UNITED KINGDOM | | | | |
| 26.2.2009 | Advate | Baxter AG Industriesstraße 67 1220 Vienna ÖSTERREICH | Baxter AG | Industriesstraße 67 |
| Baxter AG | | | | |
| Industriesstraße 67 | | | | |
| 1220 Vienna | | | | |
| ÖSTERREICH | | | | |
| 26.2.2009 | ReFacto AF | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Ltd | Huntercombe Lane |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane | | | | |
| South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 26.2.2009 | Myfenax | Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 NEDERLAND | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| DR Utrecht 3542 | | | | |
| NEDERLAND | | | | |
| 26.2.2009 | Fasturtec | Sanofi-Aventis 174 avenue de France 75013 Paris FRANCE | Sanofi-Aventis | 174 avenue de France |
| Sanofi-Aventis | | | | |
| 174 avenue de France | | | | |
| 75013 Paris | | | | |
| FRANCE | | | | |
| 26.2.2009 | Mycophenolate mofetil Teva | Teva Pharma B.V. Computerweg 10 DR Utrecht 3542 NEDERLAND | Teva Pharma B.V. | Computerweg 10 |
| Teva Pharma B.V. | | | | |
| Computerweg 10 | | | | |
| DR Utrecht 3542 | | | | |
| NEDERLAND | | | | |
| 26.2.2009 | Pradaxa | Boehringer IngelheimInternational GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer IngelheimInternational GmbH | Binger Straße 173 |
| Boehringer IngelheimInternational GmbH | | | | |
| Binger Straße 173 | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 26.2.2009 | Protopic | Astellas Pharma GmbH Neumarkter Str. 61 81673 München DEUTSCHLAND | Astellas Pharma GmbH | Neumarkter Str. 61 |
| Astellas Pharma GmbH | | | | |
| Neumarkter Str. 61 | | | | |
| 81673 München | | | | |
| DEUTSCHLAND | | | | |
| 26.2.2009 | Volibris | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 26.2.2009 | 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 | | | | |
| 26.2.2009 | Xeristar | Boehringer Ingelheim International GmbH Binger Straße 173 55216 Ingelheim am Rhein DEUTSCHLAND | Boehringer Ingelheim International GmbH | Binger Straße 173 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Straße 173 | | | | |
| 55216 Ingelheim am Rhein | | | | |
| DEUTSCHLAND | | | | |
| 26.2.2009 | 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 | | | | |
| 26.2.2009 | Karvea | 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 | | | | |
| 26.2.2009 | 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 | | | | |
| 26.2.2009 | Oprymea | KRKA, d. d. Novo mesto Šmarješka cesta 6 SI-8501 Novo mesto SLOVENIJA | KRKA, d. d. | Novo mesto |
| KRKA, d. d. | | | | |
| Novo mesto | | | | |
| Šmarješka cesta 6 | | | | |
| SI-8501 Novo mesto | | | | |
| SLOVENIJA | | | | |
| 26.2.2009 | Aprovel | 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 | | | | |
| 26.2.2009 | Tasigna | 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 | | | | |
| 26.2.2009 | Baraclude | 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 | | | | |
| 26.2.2009 | REYATAZ | 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 | | | | |
| 26.2.2009 | Sprycel | 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 | | | | |
| 26.2.2009 | 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 | | | | |
| 26.2.2009 | Xagrid | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP UNITED KINGDOM | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park | | | | |
| Chineham | | | | |
| Basingstoke | | | | |
| Hampshire RG24 8EP | | | | |
| UNITED KINGDOM | | | | |
| 27.2.2009 | Ariclaim | 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 | | | | |

—   Issuing of a marketing authorization (Article 38 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 |
| ----------------------------- | ----------------------------- | ---------------------------------------------------------------- | ---------------------------------------------------------------------------------- | --------------------------------------------- | ------------------- | ------------------------------------------------ | -------------------- |
| 10.2.2009 | Loxicom | Meloxicam | Norbrook Laboratories Limited Station Works Newry Co. Down BT35 6JP UNITED KINDGOM | Norbrook Laboratories Limited | Station Works | Newry | Co. Down BT35 6JP |
| Norbrook Laboratories Limited | | | | | | | |
| Station Works | | | | | | | |
| Newry | | | | | | | |
| Co. Down BT35 6JP | | | | | | | |
| UNITED KINDGOM | | | | | | | |
| EU/2/08/090/006-008 | Solution for Injection | | | | | | |
| 11.2.2009 | STARTVAC | Escherichia coli J5: > 50 RED60
Staph. Aureus (CP8): > 50 RED80 | Laboratorios Hipra, S.A. Avda. La Selva, 135 17170 Amer (Girona) ESPAÑA | Laboratorios Hipra, S.A. | Avda. La Selva, 135 | 17170 Amer (Girona) | ESPAÑA |
| Laboratorios Hipra, S.A. | | | | | | | |
| Avda. La Selva, 135 | | | | | | | |
| 17170 Amer (Girona) | | | | | | | |
| ESPAÑA | | | | | | | |

—   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 |
| -------------------------------- | ----------------------------- | ------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 12.2.2009 | Purevax RCCh | Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 Avenue Tony Garnier |
| Merial | | | | |
| 29 Avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 13.2.2009 | Purevax RCP FeLV | Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 Avenue Tony Garnier |
| Merial | | | | |
| 29 Avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 13.2.2009 | Purevax RCPCh FeLV | Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 Avenue Tony Garnier |
| Merial | | | | |
| 29 Avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 17.2.2009 | Purevax RCPCh | Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 Avenue Tony Garnier |
| Merial | | | | |
| 29 Avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 17.2.2009 | ProMeris Duo | Fort Dodge Animal Health Holland C.J. van Houtenlaan 36 1381 CP Weesp NEDERLAND | Fort Dodge Animal Health Holland | C.J. van Houtenlaan 36 |
| Fort Dodge Animal Health Holland | | | | |
| C.J. van Houtenlaan 36 | | | | |
| 1381 CP Weesp | | | | |
| NEDERLAND | | | | |
| 17.2.2009 | Purevax RC | Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 Avenue Tony Garnier |
| Merial | | | | |
| 29 Avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 17.2.2009 | Purevax RCP | Merial 29 Avenue Tony Garnier 69007 Lyon FRANCE | Merial | 29 Avenue Tony Garnier |
| Merial | | | | |
| 29 Avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |

—   Suspension of a marketing authorization (Article 45 of Regulation (EC) No 726/2004)

| 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 |
| --------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 20.2.2009 | Porcilis Pesti | 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 4HB |
| UNITED KINGDOM |

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

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