# C_2010022EN.01001801.xml

| 29.1.2010 | EN | Official Journal of the European Union | C 22/18 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 December 2009 to 31 December 2009

(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 22/04

—   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 |
| ---------------------------------- | ----------------------------- | ------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------- | ----------------------------------------------- | -------------------- |
| 3.12.2009 | Olanzapine Glenmark Europe | Olanzapine | Glenmark Generics (Europe) Limited Laxmi House 2-B Draycott Avenue Kenton Harrow Middlesex HA3 OBU UNITED KINGDOM | Glenmark Generics (Europe) Limited | Laxmi House | 2-B Draycott Avenue | Kenton |
| Glenmark Generics (Europe) Limited | | | | | | | |
| Laxmi House | | | | | | | |
| 2-B Draycott Avenue | | | | | | | |
| Kenton | | | | | | | |
| Harrow | | | | | | | |
| Middlesex | | | | | | | |
| HA3 OBU | | | | | | | |
| UNITED KINGDOM | | | | | | | |
| 3.12.2009 | Olanzapine Glenmark | Olanzapine | Glenmark Generics (Europe) Limited Laxmi House 2-B Draycott Avenue Kenton Harrow Middlesex HA3 OBU UNITED KINGDOM | Glenmark Generics (Europe) Limited | Laxmi House | 2-B Draycott Avenue | Kenton |
| Glenmark Generics (Europe) Limited | | | | | | | |
| Laxmi House | | | | | | | |
| 2-B Draycott Avenue | | | | | | | |
| Kenton | | | | | | | |
| Harrow | | | | | | | |
| Middlesex | | | | | | | |
| HA3 OBU | | | | | | | |
| UNITED KINGDOM | | | | | | | |
| 9.12.2009 | Prevenar 13 | Pneumococcalpolysaccharide conjugate vaccine (13-valent, adsorbed) | Wyeth Lederle Vaccines S.A. Rue du Bosquet 15 1348 Louvain-la-Neuve BELGIQUE | Wyeth Lederle Vaccines S.A. | Rue du Bosquet 15 | 1348 Louvain-la-Neuve | BELGIQUE |
| Wyeth Lederle Vaccines S.A. | | | | | | | |
| Rue du Bosquet 15 | | | | | | | |
| 1348 Louvain-la-Neuve | | | | | | | |
| BELGIQUE | | | | | | | |
| 10.12.2009 | Lamivudine Teva Pharma B.V | Lamivudine | 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 | | | | | | | |
| 10.12.2009 | Olazax Disperzi | Olanzapine | Glenmark Pharmaceuticals s.r.o City Tower Hvězdova 1716/2b 140 78 Praha 4 ČESKÁ REPUBLIKA | Glenmark Pharmaceuticals s.r.o | City Tower | Hvězdova 1716/2b | 140 78 Praha 4 |
| Glenmark Pharmaceuticals s.r.o | | | | | | | |
| City Tower | | | | | | | |
| Hvězdova 1716/2b | | | | | | | |
| 140 78 Praha 4 | | | | | | | |
| ČESKÁ REPUBLIKA | | | | | | | |
| 10.12.2009 | Sildenafil Actavis | Sildenafil | Actavis Group PTC ehf. Reykjavikurvegi 76-78 220 Hafnarfjordur ICELAND | Actavis Group PTC ehf. | Reykjavikurvegi 76-78 | 220 Hafnarfjordur | ICELAND |
| Actavis Group PTC ehf. | | | | | | | |
| Reykjavikurvegi 76-78 | | | | | | | |
| 220 Hafnarfjordur | | | | | | | |
| ICELAND | | | | | | | |
| 11.12.2009 | Olazax | Olanzapine | Glenmark Pharmaceuticals s.r.o. City Tower Hvězdova 1716/2b 140 78 Praha 4 ČESKÁ REPUBLIKA | Glenmark Pharmaceuticals s.r.o. | City Tower | Hvězdova 1716/2b | 140 78 Praha 4 |
| Glenmark Pharmaceuticals s.r.o. | | | | | | | |
| City Tower | | | | | | | |
| Hvězdova 1716/2b | | | | | | | |
| 140 78 Praha 4 | | | | | | | |
| ČESKÁ REPUBLIKA | | | | | | | |
| 11.12.2009 | Rivastigmine Hexal | Rivastigmine | HEXAL AG Industriestrasse 25 83607 Holzkirchen DEUTSCHLAND | HEXAL AG | Industriestrasse 25 | 83607 Holzkirchen | DEUTSCHLAND |
| HEXAL AG | | | | | | | |
| Industriestrasse 25 | | | | | | | |
| 83607 Holzkirchen | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 11.12.2009 | Rivastigmine Sandoz | Rivastigmine | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11 83607 Holzkirchen DEUTSCHLAND | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11 | 83607 Holzkirchen | DEUTSCHLAND |
| Sandoz Pharmaceuticals GmbH | | | | | | | |
| Raiffeisenstraße 11 | | | | | | | |
| 83607 Holzkirchen | | | | | | | |
| DEUTSCHLAND | | | | | | | |
| 23.12.2009 | Zenas | Amifampridine | EUSA Pharma SAS 3 allée des Séquoias 69760 Limonest FRANCE | EUSA Pharma SAS | 3 allée des Séquoias | 69760 Limonest | FRANCE |
| EUSA Pharma SAS | | | | | | | |
| 3 allée des Séquoias | | | | | | | |
| 69760 Limonest | | | | | | | |
| FRANCE | | | | | | | |
| 23.12.2009 | Sildenafil ratiopharm | Sildenafil | Ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm DEUTSCHLAND | Ratiopharm GmbH | Graf-Arco-Straße 3 | 89079 Ulm | DEUTSCHLAND |
| Ratiopharm GmbH | | | | | | | |
| Graf-Arco-Straße 3 | | | | | | | |
| 89079 Ulm | | | | | | | |
| DEUTSCHLAND | | | | | | | |

—   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 |
| ------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------- |
| 3.12.2009 | Champix | Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd. | Ramsgate Road |
| Pfizer Ltd. | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 3.12.2009 | 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 | | | | |
| 8.12.2009 | Xigiris | 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 | | | | |
| 8.12.2009 | 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 | | | | |
| 9.12.2009 | 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 | | | | |
| 9.12.2009 | 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 | | | | |
| 9.12.2009 | 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 | | | | |
| 10.12.2009 | Effentora | Cephalon Europe 5 rue Charles Martigny 94700 Maisons-Alfort FRANCE | Cephalon Europe | 5 rue Charles Martigny |
| Cephalon Europe | | | | |
| 5 rue Charles Martigny | | | | |
| 94700 Maisons-Alfort | | | | |
| FRANCE | | | | |
| 10.12.2009 | Effentora | Cephalon Europe 5 rue Charles Martigny 94700 Maisons-Alfort FRANCE | Cephalon Europe | 5 rue Charles Martigny |
| Cephalon Europe | | | | |
| 5 rue Charles Martigny | | | | |
| 94700 Maisons-Alfort | | | | |
| FRANCE | | | | |
| 10.12.2009 | Synflorix | 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 | | | | |
| 10.12.2009 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM | Gilead Sciences International Limited | Cambridge |
| Gilead Sciences International Limited | | | | |
| Cambridge | | | | |
| CB21 6GT | | | | |
| UNITED KINGDOM | | | | |
| 10.12.2009 | Fendrix | 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 | | | | |
| 10.12.2009 | 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 | | | | |
| 10.12.2009 | Revatio | Pfizer Limited Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Limited | Sandwich |
| Pfizer Limited | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 11.12.2009 | Kivexa | Glaxo Group Ltd. Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd. | Greenford |
| Glaxo Group Ltd. | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 11.12.2009 | Clopidogrel Mylan Pharma | Apotex Europe B.V. Darwingweg 20 2333 CR Leiden NEDERLAND Mylan S.A.S. 117 allée des Parcs 69800 Saint Priest FRANCE | Apotex Europe B.V. | Darwingweg 20 |
| Apotex Europe B.V. | | | | |
| Darwingweg 20 | | | | |
| 2333 CR Leiden | | | | |
| NEDERLAND | | | | |
| Mylan S.A.S. | | | | |
| 117 allée des Parcs | | | | |
| 69800 Saint Priest | | | | |
| FRANCE | | | | |
| 11.12.2009 | Rivastigmine 1A Pharma | 1A Pharma GmbH Keltenring 1+3 82041 Oberhaching DEUTSCHLAND | 1A Pharma GmbH | Keltenring 1+3 |
| 1A Pharma GmbH | | | | |
| Keltenring 1+3 | | | | |
| 82041 Oberhaching | | | | |
| DEUTSCHLAND | | | | |
| 11.12.2009 | 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 | | | | |
| 11.12.2009 | 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 | | | | |
| 14.12.2009 | Efient | 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 | | | | |
| 14.12.2009 | Exalief | 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 |
| BIAL-Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional | | | | |
| 4745-457 S. Mamede do Coronado | | | | |
| PORTUGAL | | | | |
| 14.12.2009 | Zebinix | 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 |
| BIAL-Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional | | | | |
| 4745-457 S. Mamede do Coronado | | | | |
| PORTUGAL | | | | |
| 16.12.2009 | 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 | | | | |
| 18.12.2009 | Docetaxel Winthrop | Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex FRANCE | Aventis Pharma S.A. | 20 avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron | | | | |
| 92165 Antony Cedex | | | | |
| FRANCE | | | | |
| 18.12.2009 | Emtriva | Gilead Sciences International Limited Cambridge CB21 6GT UNITED KINGDOM | Gilead Sciences International Limited | Cambridge |
| Gilead Sciences International Limited | | | | |
| Cambridge | | | | |
| CB21 6GT | | | | |
| UNITED KINGDOM | | | | |
| 18.12.2009 | Adenuric | Ipsen Pharma 65 quai Georges Gorse 92100 Boulogne-Billancourt FRANCE Menarini International Operations Luxembourg S.A. 1, avenue de la Gare 1611 Luxembourg LUXEMBOURG | Ipsen Pharma | 65 quai Georges Gorse |
| Ipsen Pharma | | | | |
| 65 quai Georges Gorse | | | | |
| 92100 Boulogne-Billancourt | | | | |
| FRANCE | | | | |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, avenue de la Gare | | | | |
| 1611 Luxembourg | | | | |
| LUXEMBOURG | | | | |
| 18.12.2009 | Aloxi | Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart Dublin 15 IRELAND | Helsinn Birex Pharmaceuticals Ltd. | Damastown |
| Helsinn Birex Pharmaceuticals Ltd. | | | | |
| Damastown | | | | |
| Mulhuddart | | | | |
| Dublin 15 | | | | |
| IRELAND | | | | |
| 16.12.2009 | Binocrit | Sandoz GmbH Biochemiestraße 10 6250 Kundl ÖSTERREICH | Sandoz GmbH | Biochemiestraße 10 |
| Sandoz GmbH | | | | |
| Biochemiestraße 10 | | | | |
| 6250 Kundl | | | | |
| ÖSTERREICH | | | | |
| 16.12.2009 | Epoetin alfa hexal | Hexal AG. Industriestraße 25 83607 Holzkirchen DEUTSCHLAND | Hexal AG. | Industriestraße 25 |
| Hexal AG. | | | | |
| Industriestraße 25 | | | | |
| 83607 Holzkirchen | | | | |
| DEUTSCHLAND | | | | |
| 16.12.2009 | Silapo | STADA Arzneimittel AG Stadastraße 2—18 61118 Bad Vilbel DEUTSCHLAND | STADA Arzneimittel AG | Stadastraße 2—18 |
| STADA Arzneimittel AG | | | | |
| Stadastraße 2—18 | | | | |
| 61118 Bad Vilbel | | | | |
| DEUTSCHLAND | | | | |
| 18.12.2009 | Litak | Lipomed GmbH Hegenheimer Straße 2 79576 Weil/Rhein DEUTSCHLAND | Lipomed GmbH | Hegenheimer Straße 2 |
| Lipomed GmbH | | | | |
| Hegenheimer Straße 2 | | | | |
| 79576 Weil/Rhein | | | | |
| DEUTSCHLAND | | | | |
| 21.12.2009 | AZARGA | 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 | | | | |
| 21.12.2009 | 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 | | | | |
| 21.12.2009 | Zyprexa Velotab | 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 | | | | |
| 21.12.2009 | 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 | | | | |
| 21.12.2009 | LYRICA | Pfizer Ltd. Ramsgate Road Sandwich Kent CT13 9NJ UNITED KINGDOM | Pfizer Ltd. | Ramsgate Road |
| Pfizer Ltd. | | | | |
| Ramsgate Road | | | | |
| Sandwich | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| UNITED KINGDOM | | | | |
| 21.12.2009 | Taxotere | Aventis Pharma S.A. 20 avenue Raymond Aron 92165 Antony Cedex FRANCE | Aventis Pharma S.A. | 20 avenue Raymond Aron |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron | | | | |
| 92165 Antony Cedex | | | | |
| FRANCE | | | | |
| 21.12.2009 | Zyprexa | 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 | | | | |
| 21.12.2009 | Revasc | Canyon Pharmaceuticals Ltd. 20-22 Bedford Row London WC1R 4JS UNITED KINGDOM | Canyon Pharmaceuticals Ltd. | 20-22 Bedford Row |
| Canyon Pharmaceuticals Ltd. | | | | |
| 20-22 Bedford Row | | | | |
| London | | | | |
| WC1R 4JS | | | | |
| UNITED KINGDOM | | | | |
| 21.12.2009 | 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 | | | | |
| 21.12.2009 | SOLIRIS | Alexion Europe S.A.S. 25 Boulevard de l'Amiral Bruix 75016 Paris FRANCE | Alexion Europe S.A.S. | 25 Boulevard de l'Amiral Bruix |
| Alexion Europe S.A.S. | | | | |
| 25 Boulevard de l'Amiral Bruix | | | | |
| 75016 Paris | | | | |
| FRANCE | | | | |
| 21.12.2009 | Vimpat | UCB Pharma SA. Allée de la Recherche 66/Researchdreef 60 1070 Bruxelles/Brussel BELGIQUE/BELGIË | UCB Pharma SA. | Allée de la Recherche 66/Researchdreef 60 |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 66/Researchdreef 60 | | | | |
| 1070 Bruxelles/Brussel | | | | |
| BELGIQUE/BELGIË | | | | |
| 21.12.2009 | ZONEGRAN | Eisai Limited European Knowledge Centre Mosquito Way Hatfield Hertfordshire AL10 9SN UNITED KINGDOM | Eisai Limited | European Knowledge Centre |
| Eisai Limited | | | | |
| European Knowledge Centre | | | | |
| Mosquito Way | | | | |
| Hatfield | | | | |
| Hertfordshire | | | | |
| AL10 9SN | | | | |
| UNITED KINGDOM | | | | |
| 21.12.2009 | ZYPADHERA | 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 | | | | |
| 21.12.2009 | Agenerase | 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 | | | | |
| 21.12.2009 | 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 | | | | |
| 21.12.2009 | 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 | | | | |
| 21.12.2009 | Tevagrastim | Teva Generics GmbH Wasastraße 50 01445 Radebeul DEUTSCHLAND | Teva Generics GmbH | Wasastraße 50 |
| Teva Generics GmbH | | | | |
| Wasastraße 50 | | | | |
| 01445 Radebeul | | | | |
| DEUTSCHLAND | | | | |
| 21.12.2009 | Avamys | Glaxo Group Ltd. Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd. | Greenford |
| Glaxo Group Ltd. | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 21.12.2009 | 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 | | | | |
| 21.12.2009 | Volibris | Glaxo Group Ltd. Greenford Middlesex UB6 0NN UNITED KINGDOM | Glaxo Group Ltd. | Greenford |
| Glaxo Group Ltd. | | | | |
| Greenford | | | | |
| Middlesex | | | | |
| UB6 0NN | | | | |
| UNITED KINGDOM | | | | |
| 22.12.2009 | CELVAPAN | Baxter AG Industriestraße 67 1221 Wien ÖSTERREICH | Baxter AG | Industriestraße 67 |
| Baxter AG | | | | |
| Industriestraße 67 | | | | |
| 1221 Wien | | | | |
| ÖSTERREICH | | | | |
| 22.12.2009 | 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 | | | | |
| 22.12.2009 | Stelara | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 22.12.2009 | 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 | | | | |
| 22.12.2009 | Replagal | 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 | | | | |
| 22.12.2009 | Evra | Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse BELGIË | Janssen-Cilag International NV | Turnhoutseweg 30 |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30 | | | | |
| 2340 Beerse | | | | |
| BELGIË | | | | |
| 22.12.2009 | Crixivan | Merck Sharp & Dohme Ltd. Hertford Road Hoddesdon Hertfordshire EN11 9BU UNITED KINGDOM | Merck Sharp & Dohme Ltd. | Hertford Road |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road | | | | |
| Hoddesdon | | | | |
| Hertfordshire | | | | |
| EN11 9BU | | | | |
| UNITED KINGDOM | | | | |
| 22.12.2009 | Onsior | Novartis Animal Health UK Ltd. Frimley Business Park Frimley/Camberley Surrey GU16 7SR UNITED KINGDOM | Novartis Animal Health UK Ltd. | Frimley Business Park |
| Novartis Animal Health UK Ltd. | | | | |
| Frimley Business Park | | | | |
| Frimley/Camberley | | | | |
| Surrey | | | | |
| GU16 7SR | | | | |
| UNITED KINGDOM | | | | |
| 22.12.2009 | RELISTOR | 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 | | | | |
| 23.12.2009 | Tractocile | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11 2300 Copenhagen S DANMARK | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11 |
| Ferring Pharmaceuticals A/S | | | | |
| Kay Fiskers Plads 11 | | | | |
| 2300 Copenhagen S | | | | |
| DANMARK | | | | |
| 23.12.2009 | Biograstim | CT Arzneimittel GmbH Lengeder Straße 42a 13407 Berlin DEUTSCHLAND | CT Arzneimittel GmbH | Lengeder Straße 42a |
| CT Arzneimittel GmbH | | | | |
| Lengeder Straße 42a | | | | |
| 13407 Berlin | | | | |
| DEUTSCHLAND | | | | |
| 23.12.2009 | Retacrit | HOSPIRA Enterprises B.V. Taurusavenue 19-21b 2132 LS Hoofddorp NEDERLAND | HOSPIRA Enterprises B.V. | Taurusavenue 19-21b |
| HOSPIRA Enterprises B.V. | | | | |
| Taurusavenue 19-21b | | | | |
| 2132 LS Hoofddorp | | | | |
| NEDERLAND | | | | |
| 23.12.2009 | 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 | | | | |
| 23.12.2009 | 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 | | | | |
| 23.12.2009 | Alisade | Glaxo Group Ltd, Greenford Middlesex UB6 ONN UNITED KINGDOM | Glaxo Group Ltd, Greenford | Middlesex |
| Glaxo Group Ltd, Greenford | | | | |
| Middlesex | | | | |
| UB6 ONN | | | | |
| UNITED KINGDOM | | | | |
| 23.12.2009 | Focetria | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina 1 Siena SI ITALIA | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina 1 |
| Novartis Vaccines and Diagnostics S.r.l. | | | | |
| Via Fiorentina 1 | | | | |
| Siena SI | | | | |
| ITALIA | | | | |

—   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 |
| ------------------------------ | ----------------------------- | --------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------- |
| 14.12.2009 | Aivlosin | ECO Animal Health Ltd. 78 Coombe Road New Malden Surrey KT3 4QS UNITED KINGDOM | ECO Animal Health Ltd. | 78 Coombe Road |
| ECO Animal Health Ltd. | | | | |
| 78 Coombe Road | | | | |
| New Malden | | | | |
| Surrey | | | | |
| KT3 4QS | | | | |
| UNITED KINGDOM | | | | |
| 18.12.2009 | Equioxx | MERIAL 29 avenue Tony Garnier 69007 Lyon FRANCE | MERIAL | 29 avenue Tony Garnier |
| MERIAL | | | | |
| 29 avenue Tony Garnier | | | | |
| 69007 Lyon | | | | |
| FRANCE | | | | |
| 21.12.2009 | Flexicam | Dechra Veterinary Products A/S Mekuvej 9 7171 Uldum DANMARK Omnipharm Ltd. The Spire Egypt Road Nottingham NG7 7GD UNITED KINGDOM | Dechra Veterinary Products A/S | Mekuvej 9 |
| Dechra Veterinary Products A/S | | | | |
| Mekuvej 9 | | | | |
| 7171 Uldum | | | | |
| DANMARK | | | | |
| Omnipharm Ltd. | | | | |
| The Spire | | | | |
| Egypt Road | | | | |
| Nottingham | | | | |
| NG7 7GD | | | | |
| UNITED KINGDOM | | | | |

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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