# C_2009121EN.01000301.xml

| 29.5.2009 | EN | Official Journal of the European Union | C 121/3 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorisations in respect of medicinal products

from 1 April 2009 to 30 April 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 121/03

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ------------------------------ | ----------------------------- | ---------------------------------------- | ---------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------- | ----------------------------------------------- | -------------------- |
| 17.4.2009 | Rivastigmine Teva | Rivastigmine | 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 | | | | | | | |
| 17.4.2009 | CONBRIZA | Bazedoxifene | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Limited | Huntercombe Lane | South Taplow | Maidenhead |
| Wyeth Europa Limited | | | | | | | |
| Huntercombe Lane | | | | | | | |
| South Taplow | | | | | | | |
| Maidenhead | | | | | | | |
| Berkshire | | | | | | | |
| SL6 0PH | | | | | | | |
| UNITED KINGDOM | | | | | | | |
| 20.4.2009 | Removab | Catumaxomab | Fresenius Biotech GmbH Am Haag 6-7 82166 Graefelfing DEUTSCHLAND | Fresenius Biotech GmbH | Am Haag 6-7 | 82166 Graefelfing | DEUTSCHLAND |
| Fresenius Biotech GmbH | | | | | | | |
| Am Haag 6-7 | | | | | | | |
| 82166 Graefelfing | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 21.4.2009 | Exalief | Eslicarbazepine acetate | BIAL - Portela & Ca, SA, A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado PORTUGAL | BIAL - Portela & Ca, SA, A | Av. da Siderurgia Nacional | 4745-457 S. Mamede do Coronado | PORTUGAL |
| BIAL - Portela & Ca, SA, A | | | | | | | |
| Av. da Siderurgia Nacional | | | | | | | |
| 4745-457 S. Mamede do Coronado | | | | | | | |
| PORTUGAL | | | | | | | |
| 21.4.2009 | Zebinix | Eslicarbazepine acetate | BIAL - Portela & Ca, SA, A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado PORTUGAL | BIAL - Portela & Ca, SA, A | Av. da Siderurgia Nacional | 4745-457 S. Mamede do Coronado | PORTUGAL |
| BIAL - Portela & Ca, SA, A | | | | | | | |
| Av. da Siderurgia Nacional | | | | | | | |
| 4745-457 S. Mamede do Coronado | | | | | | | |
| PORTUGAL | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| ------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 27.4.2009 | Sovrima | Santhera Pharmaceuticals (Deutschland) GmbH Wallbrunnstr. 24 79539 Lörrach DEUTSCHLAND | Santhera Pharmaceuticals (Deutschland) GmbH | Wallbrunnstr. 24 |
| Santhera Pharmaceuticals (Deutschland) GmbH | | | | |
| Wallbrunnstr. 24 | | | | |
| 79539 Lörrach | | | | |
| DEUTSCHLAND | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| ----------------------------------------------- | ------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------- | ----------------------------------------------- |
| 2.4.2009 | Xarelto | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 2.4.2009 | Altargo | Glaxo Group Limited Glaxo Wellcome House Berkely Avenue Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Limited Glaxo Wellcome House | Berkely Avenue Greenford |
| Glaxo Group Limited Glaxo Wellcome House | | | | |
| Berkely Avenue Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 2.4.2009 | Neupro | Schwarz Pharma Ltd Shannon Industrial Estate Co. Clare IRELAND | Schwarz Pharma Ltd | Shannon Industrial Estate |
| Schwarz Pharma Ltd | | | | |
| Shannon Industrial Estate | | | | |
| Co. Clare | | | | |
| IRELAND | | | | |
| 2.4.2009 | Abraxane | Abraxis BioScience Limited Hatfield AL10 9NA UNITED KINGDOM | Abraxis BioScience Limited | Hatfield |
| Abraxis BioScience Limited | | | | |
| Hatfield | | | | |
| AL10 9NA | | | | |
| UNITED KINGDOM | | | | |
| 2.4.2009 | Combivir | Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford Road Greenford |
| Glaxo Group Ltd | | | | |
| Greenford Road Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 3.4.2009 | Optimark | Covidien Deutschland GmbH Gewerbepark 1 93333 Neustadt/Donau DEUTSCHLAND | Covidien Deutschland GmbH | Gewerbepark 1 |
| Covidien Deutschland GmbH | | | | |
| Gewerbepark 1 | | | | |
| 93333 Neustadt/Donau | | | | |
| DEUTSCHLAND | | | | |
| 3.4.2009 | Intrinsa | Procter & Gamble Pharmaceuticals UK Ltd Rusham Park Technical Centre Whitehall Lane Egham Surrey TW20 9NW UNITED KINGDOM | Procter & Gamble Pharmaceuticals UK Ltd | Rusham Park Technical Centre |
| Procter & Gamble Pharmaceuticals UK Ltd | | | | |
| Rusham Park Technical Centre | | | | |
| Whitehall Lane | | | | |
| Egham Surrey | | | | |
| TW20 9NW | | | | |
| UNITED KINGDOM | | | | |
| 3.4.2009 | Livensa | Procter & Gamble Pharmaceuticals — Germany GmbH Dr Otto-Röhm-Strasse 2-4 64331 Weiterstadt DEUTSCHLAND | Procter & Gamble Pharmaceuticals — Germany GmbH | Dr Otto-Röhm-Strasse 2-4 |
| Procter & Gamble Pharmaceuticals — Germany GmbH | | | | |
| Dr Otto-Röhm-Strasse 2-4 | | | | |
| 64331 Weiterstadt | | | | |
| DEUTSCHLAND | | | | |
| 3.4.2009 | Riprazo | 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 | | | | |
| 3.4.2009 | Enviage | 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 | | | | |
| 3.4.2009 | Sprimeo | 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 | | | | |
| 3.4.2009 | Tekturna | 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 | | | | |
| 3.4.2009 | Rasilez | 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 | | | | |
| 3.4.2009 | YENTREVE | 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 | | | | |
| 3.4.2009 | DULOXETINE BOEHRINGER INGELHEIM | 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 | | | | |
| 7.4.2009 | Vectibix | 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 | | | | |
| 7.4.2009 | ADROVANCE | 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 | | | | |
| 7.4.2009 | FOSAVANCE | 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 | | | | |
| 7.4.2009 | Champix | 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 | | | | |
| 7.4.2009 | Volibris | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 7.4.2009 | Irbesartan | 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 | | | | |
| 7.4.2009 | PritorPlus | Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer HealthCare AG | 51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 7.4.2009 | KOGENATE Bayer | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 7.4.2009 | 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 | | | | |
| 7.4.2009 | 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 | | | | |
| 7.4.2009 | Helixate NexGen | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 7.4.2009 | Kinzalkomb | Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer HealthCare AG | 51368 Leverkusen |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 7.4.2009 | Nexavar | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND Bayer HealthCare AG 51368 Leverkusen DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| Bayer HealthCare AG | | | | |
| 51368 Leverkusen | | | | |
| DEUTSCHLAND | | | | |
| 7.4.2009 | Fluticasone furoate GSK | Glaxo Group Ltd Greenford Middlesex UB6 ONN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 ONN | | | | |
| UNITED KINGDOM | | | | |
| 7.4.2009 | Protopic | Astellas Pharma Europe B.V. Elisabethhof 19 2353 EW Leiderdorp NEDERLAND Astellas Pharma GmbH Neumarkter Str. 61 81673 München DEUTSCHLAND | Astellas Pharma Europe B.V. | Elisabethhof 19 |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19 | | | | |
| 2353 EW Leiderdorp | | | | |
| NEDERLAND | | | | |
| Astellas Pharma GmbH | | | | |
| Neumarkter Str. 61 | | | | |
| 81673 München | | | | |
| DEUTSCHLAND | | | | |
| 7.4.2009 | MIRCERA | 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 | | | | |
| 7.4.2009 | Integrilin | 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 | | | | |
| 7.4.2009 | Ziagen | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 7.4.2009 | Avamys | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 7.4.2009 | MicardisPlus | 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 | | | | |
| 7.4.2009 | 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 | | | | |
| 8.4.2009 | 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 | | | | |
| 8.4.2009 | PEGASYS | 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 | | | | |
| 16.4.2009 | ReFacto AF | Wyeth Europa Ltd Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Ltd | Huntercombe Lane South Taplow |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South Taplow | | | | |
| Maidenhead Berkshire | | | | |
| SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 16.4.2009 | Levemir | Novo Nordisk A/S Novo Allé 2880 Bagsvaerd DANMARK | Novo Nordisk A/S | Novo Allé |
| Novo Nordisk A/S | | | | |
| Novo Allé | | | | |
| 2880 Bagsvaerd | | | | |
| DANMARK | | | | |
| 16.4.2009 | Thelin | Encysive (UK) Limited Alder Castle House 10 Noble Street London EC2V 7QJ UNITED KINGDOM | Encysive (UK) Limited | Alder Castle House |
| Encysive (UK) Limited | | | | |
| Alder Castle House | | | | |
| 10 Noble Street | | | | |
| London | | | | |
| EC2V 7QJ | | | | |
| UNITED KINGDOM | | | | |
| 17.4.2009 | CUBICIN | 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 | | | | |
| 17.4.2009 | Mirapexin | 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 | | | | |
| 17.4.2009 | 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 | | | | |
| 17.4.2009 | Sifrol | 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 | | | | |
| 21.4.2009 | Trisenox | Cephalon Europe 5 Rue Charles Martigny 94700 Maisons Alfort Cedex FRANCE | Cephalon Europe | 5 Rue Charles Martigny |
| Cephalon Europe | | | | |
| 5 Rue Charles Martigny | | | | |
| 94700 Maisons Alfort | | | | |
| Cedex | | | | |
| FRANCE | | | | |
| 21.4.2009 | Kivexa | Glaxo Group Ltd Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd | Greenford |
| Glaxo Group Ltd | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 21.4.2009 | Prepandrix | 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 | | | | |
| 21.4.2009 | 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 | | | | |
| 21.4.2009 | 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 | | | | |
| 21.4.2009 | Angiox | The Medicines Company UK Ltd 115 L Milton Park Abingdon Oxfordshire OX14 4SA UNITED KINGDOM | The Medicines Company UK Ltd | 115 L Milton Park |
| The Medicines Company UK Ltd | | | | |
| 115 L Milton Park | | | | |
| Abingdon | | | | |
| Oxfordshire | | | | |
| OX14 4SA | | | | |
| UNITED KINGDOM | | | | |
| 21.4.2009 | 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 | | | | |
| 21.4.2009 | ISENTRESS | 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 | | | | |
| 21.4.2009 | Renagel | 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 | | | | |
| 22.4.2009 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM | Gilead Sciences International Limited | Cambridge |
| Gilead Sciences International Limited | | | | |
| Cambridge | | | | |
| CB21 6GT | | | | |
| UNITED KINGDOM | | | | |
| 22.4.2009 | Liprolog | 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 | | | | |
| 22.4.2009 | Sustiva | 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 | | | | |
| 22.4.2009 | 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 | | | | |
| 22.4.2009 | 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 | | | | |
| 22.4.2009 | Rebif | Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM | Serono Europe Limited | 56 Marsh Wall |
| Serono Europe Limited | | | | |
| 56 Marsh Wall | | | | |
| London | | | | |
| E14 9TP | | | | |
| UNITED KINGDOM | | | | |
| 22.4.2009 | Cervarix | 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 | | | | |
| 22.4.2009 | Enviage | 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 | | | | |
| 22.4.2009 | Riprazo | 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 | | | | |
| 22.4.2009 | Tekturna | 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 | | | | |
| 22.4.2009 | Rasilez | 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 | | | | |
| 22.4.2009 | Sprimeo | 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 | | | | |
| 23.4.2009 | Rebetol | Schering Plough Europe Rue de Stalle 73/Stallestraat 73 1180 Bruxelles/Brussel BELGIQUE/BELGIË | Schering Plough Europe | Rue de Stalle 73/Stallestraat 73 |
| Schering Plough Europe | | | | |
| Rue de Stalle 73/Stallestraat 73 | | | | |
| 1180 Bruxelles/Brussel | | | | |
| BELGIQUE/BELGIË | | | | |
| 23.4.2009 | Corlentor | 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 | | | | |
| 23.4.2009 | Procoralan | 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 | | | | |
| 23.4.2009 | INTELENCE | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 23.4.2009 | EVICEL | OMRIX biopharmaceuticals S.A./N.V. 200 Chaussée de Waterloo/Waterloosesteenweg 200 1640 Rhode-St-Genèse/1640 Sint-Genesius-Rode BELGIQUE/BELGIË | OMRIX biopharmaceuticals S.A./N.V. | 200 Chaussée de Waterloo/Waterloosesteenweg 200 |
| OMRIX biopharmaceuticals S.A./N.V. | | | | |
| 200 Chaussée de Waterloo/Waterloosesteenweg 200 | | | | |
| 1640 Rhode-St-Genèse/1640 Sint-Genesius-Rode | | | | |
| BELGIQUE/BELGIË | | | | |
| 24.4.2009 | KOGENATE Bayer | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 24.4.2009 | Helixate NexGen | Bayer Schering Pharma AG 13342 Berlin DEUTSCHLAND | Bayer Schering Pharma AG | 13342 Berlin |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 27.4.2009 | 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 | | | | |
| 29.4.2009 | 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 | | | | |
| 29.4.2009 | Evoltra | Genzyme Europe BV Gooimeer 10 1411 DD Naarden NEDERLAND | Genzyme Europe BV | Gooimeer 10 |
| Genzyme Europe BV | | | | |
| Gooimeer 10 | | | | |
| 1411 DD Naarden | | | | |
| NEDERLAND | | | | |
| 29.4.2009 | Rapamune | Wyeth Europa Limited Huntercombe Lane South Taplow Maidenhead Berkshire SL6 0PH UNITED KINGDOM | Wyeth Europa Limited | Huntercombe Lane |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane | | | | |
| South Taplow | | | | |
| Maidenhead | | | | |
| Berkshire | | | | |
| SL6 0PH | | | | |
| UNITED KINGDOM | | | | |
| 30.4.2009 | NovoRapid | Novo Nordisk A/S Novo Allé 2880 Bagsvaerd DANMARK | Novo Nordisk A/S Novo Allé | 2880 Bagsvaerd |
| Novo Nordisk A/S Novo Allé | | | | |
| 2880 Bagsvaerd | | | | |
| DANMARK | | | | |
| 30.4.2009 | 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 | | | | |
| 30.4.2009 | 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 | | | | |
| 30.4.2009 | Kentera | Nicobrand Limited 189 Castleroe Road Coleraine Northern Ireland BT51 3 RP UNITED KINGDOM | Nicobrand Limited | 189 Castleroe Road |
| Nicobrand Limited | | | | |
| 189 Castleroe Road | | | | |
| Coleraine | | | | |
| Northern Ireland | | | | |
| BT51 3 RP | | | | |
| UNITED KINGDOM | | | | |

—   Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --------------------- | ----------------------------- | ----------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 17.4.2009 | Raptiva | Serono Europe Limited 56 Marsh Wall London E14 9TP UNITED KINGDOM | Serono Europe Limited | 56 Marsh Wall |
| Serono Europe Limited | | | | |
| 56 Marsh Wall | | | | |
| London | | | | |
| E14 9TP | | | | |
| UNITED KINGDOM | | | | |

—   Issuing of a marketing authorisation (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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --------------------------- | ----------------------------- | ---------------------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- | ----------------------------------------------- | -------------------- |
| 16.4.2009 | Netvax | Clostridium perfringens type A toxoid | Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer NEDERLAND | Intervet International B.V. | Wim de Körverstraat 35 | 5831 AN Boxmeer | NEDERLAND |
| Intervet International B.V. | | | | | | | |
| Wim de Körverstraat 35 | | | | | | | |
| 5831 AN Boxmeer | | | | | | | |
| NEDERLAND | | | | | | | |

—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --------------------------- | ----------------------------- | ---------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 27.4.2009 | Equilis StrepE | 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 |

---

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

---