# C_2012190EN.01000101.xml

| 29.6.2012 | EN | Official Journal of the European Union | C 190/1 |
| --------- | -- | -------------------------------------- | ------- |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2012 to 31 May 2012

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

2012/C 190/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| ---------------------------- | ----------------------------- | ---------------------------------------- | -------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------- | ----------------------------------------------- | --------------------- |
| 7.5.2012 | Riluzole Zentiva | Riluzole | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, | F-92165 Antony Cedex, | France |
| Aventis Pharma S.A. | | | | | | | |
| 20 avenue Raymond Aron, | | | | | | | |
| F-92165 Antony Cedex, | | | | | | | |
| France | | | | | | | |
| 10.5.2012 | Pixuvri | pixantrone | CTI Life Sciences Ltd Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom | CTI Life Sciences Ltd | Biopark, Broadwater Road, | Welwyn Garden City, | Hertfordshire AL73AX, |
| CTI Life Sciences Ltd | | | | | | | |
| Biopark, Broadwater Road, | | | | | | | |
| Welwyn Garden City, | | | | | | | |
| Hertfordshire AL73AX, | | | | | | | |
| United Kingdom | | | | | | | |
| 22.5.2012 | Docetaxel Accord | Docetaxel | Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom | Accord Healthcare Limited | Sage house, 319 Pinner road, | North Harrow, | Middlesex HA1 4HF |
| Accord Healthcare Limited | | | | | | | |
| Sage house, 319 Pinner road, | | | | | | | |
| North Harrow, | | | | | | | |
| Middlesex HA1 4HF | | | | | | | |
| United Kingdom | | | | | | | |
| 22.5.2012 | Docetaxel Kabi | Docetaxel | Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom | Fresenius Kabi Oncology Plc. | Lion Court, Farnham Road, | Bordon, | Hampshire, |
| Fresenius Kabi Oncology Plc. | | | | | | | |
| Lion Court, Farnham Road, | | | | | | | |
| Bordon, | | | | | | | |
| Hampshire, | | | | | | | |
| GU35 0NF, | | | | | | | |
| United Kingdom | | | | | | | |

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------- | ------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------- |
| 7.5.2012 | Intanza | Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France | Sanofi Pasteur MSD SNC | 8, rue Jonas Salk, |
| Sanofi Pasteur MSD SNC | | | | |
| 8, rue Jonas Salk, | | | | |
| Lyon 69007, | | | | |
| France | | | | |
| 7.5.2012 | Ovitrelle | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56, Marsh Wall, |
| Merck Serono Europe Limited | | | | |
| 56, Marsh Wall, | | | | |
| London E14 9TP, | | | | |
| United Kingdom | | | | |
| 10.5.2012 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House, Highbridge Business Park, |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House, Highbridge Business Park, | | | | |
| Oxford Road, | | | | |
| Uxbridge, | | | | |
| Middlesex UB8 1HU, | | | | |
| United Kingdom | | | | |
| 10.5.2012 | 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 | | | | |
| 10.5.2012 | Ibandronic Acid Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 10.5.2012 | Irbesartan / Hydrochlorothiazide Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 10.5.2012 | Siklos | ADDMEDICA 101, rue Saint Lazare, Paris 75009, France | ADDMEDICA | 101, rue Saint Lazare, |
| ADDMEDICA | | | | |
| 101, rue Saint Lazare, | | | | |
| Paris 75009, | | | | |
| France | | | | |
| 10.5.2012 | Telmisartan Actavis | Actavis Group PTC ehf. Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegi 76 78, |
| Actavis Group PTC ehf. | | | | |
| Reykjavíkurvegi 76 78, | | | | |
| 220 Hafnarfjörður, | | | | |
| Iceland | | | | |
| 10.5.2012 | Telmisartan Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 10.5.2012 | Trobalt | 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 | | | | |
| 14.5.2012 | Brilique | AstraZeneca AB Södertälje S 151 85, Sverige | AstraZeneca AB | Södertälje S 151 85, |
| AstraZeneca AB | | | | |
| Södertälje S 151 85, | | | | |
| Sverige | | | | |
| 14.5.2012 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België | Janssen-Cilag International NV | Turnhoutseweg, 30 - |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - | | | | |
| 2340 Beerse – | | | | |
| België | | | | |
| 14.5.2012 | JEVTANA | SANOFI 174, avenue de France, F-75013 Paris, France | SANOFI | 174, avenue de France, |
| SANOFI | | | | |
| 174, avenue de France, | | | | |
| F-75013 Paris, | | | | |
| France | | | | |
| 14.5.2012 | Luveris | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56, Marsh Wall, |
| Merck Serono Europe Limited | | | | |
| 56, Marsh Wall, | | | | |
| London E14 9TP, | | | | |
| United Kingdom | | | | |
| 14.5.2012 | Possia | AstraZeneca AB Södertälje S 151 85, Sverige | AstraZeneca AB | Södertälje S 151 85, |
| AstraZeneca AB | | | | |
| Södertälje S 151 85, | | | | |
| Sverige | | | | |
| 14.5.2012 | TOBI Podhaler | 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 | | | | |
| 15.5.2012 | 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 | | | | |
| 15.5.2012 | Topotecan Hospira | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, |
| Hospira UK Limited | | | | |
| Queensway, | | | | |
| Royal Leamington Spa, | | | | |
| Warwickshire CV31 3RW, | | | | |
| United Kingdom | | | | |
| 15.5.2012 | Vizarsin | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d.d., Novo mesto | Šmarješka cesta 6, |
| KRKA, d.d., Novo mesto | | | | |
| Šmarješka cesta 6, | | | | |
| 8501 Novo mesto, | | | | |
| Slovenija | | | | |
| 22.5.2012 | Aerinaze | 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 | | | | |
| 22.5.2012 | Fampyra | Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Limited | Innovation House, |
| Biogen Idec Limited | | | | |
| Innovation House, | | | | |
| 70 Norden Road, | | | | |
| Maidenhead, | | | | |
| Berkshire SL6 4AY, | | | | |
| United Kingdom | | | | |
| 22.5.2012 | 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 | | | | |
| 22.5.2012 | HALAVEN | Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom | Eisai Europe Limited | European Knowledge Centre, |
| Eisai Europe Limited | | | | |
| European Knowledge Centre, | | | | |
| Mosquito Way, | | | | |
| Hatfield, | | | | |
| Hertsforshire AL10 9SN, | | | | |
| United Kingdom | | | | |
| 22.5.2012 | Hizentra | CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland | CSL Behring GmbH | Emil-von-Behring-Strasse 76, |
| CSL Behring GmbH | | | | |
| Emil-von-Behring-Strasse 76, | | | | |
| 35041 Marburg, | | | | |
| Deutschland | | | | |
| 22.5.2012 | IDflu | Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France | Sanofi Pasteur SA | 2, avenue Pont Pasteur, |
| Sanofi Pasteur SA | | | | |
| 2, avenue Pont Pasteur, | | | | |
| F-69007 Lyon, | | | | |
| France | | | | |
| 22.5.2012 | Pergoveris | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56, Marsh Wall, |
| Merck Serono Europe Limited | | | | |
| 56, Marsh Wall, | | | | |
| London E14 9TP, | | | | |
| United Kingdom | | | | |
| 22.5.2012 | 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 | | | | |
| 22.5.2012 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 22.5.2012 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 22.5.2012 | Votrient | 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 | | | | |
| 25.5.2012 | Benlysta | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, | | | | |
| Berkeley Avenue, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Betaferon | Bayer Pharma AG D - 13342 Berlin, Deutschland | Bayer Pharma AG | D - 13342 Berlin, |
| Bayer Pharma AG | | | | |
| D - 13342 Berlin, | | | | |
| Deutschland | | | | |
| 25.5.2012 | Busilvex | Pierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France | Pierre Fabre Médicament | 45, Place Abel Gance, |
| Pierre Fabre Médicament | | | | |
| 45, Place Abel Gance, | | | | |
| 92654 Boulogne Billancourt Cedex, | | | | |
| France | | | | |
| 25.5.2012 | Clopidogrel Teva Pharma B.V. | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 25.5.2012 | Conbriza | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | DuoCover | 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 | | | | |
| 25.5.2012 | Ecalta | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | 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 | | | | |
| 25.5.2012 | Irbesartan Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 25.5.2012 | Ixiaro | Intercell AG Campus Vienna Biocenter 3 A-1030 Wien, Österreich | Intercell AG | Campus Vienna Biocenter 3 |
| Intercell AG | | | | |
| Campus Vienna Biocenter 3 | | | | |
| A-1030 Wien, | | | | |
| Österreich | | | | |
| 25.5.2012 | Keppra | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, | | | | |
| 1070 Bruxelles, | | | | |
| Belgique/Researchdreef, 60, | | | | |
| Brussel 1070, | | | | |
| België | | | | |
| 25.5.2012 | Kinzalkomb | Bayer Pharma AG Berlin 13342, Deutschland | Bayer Pharma AG | Berlin 13342, |
| Bayer Pharma AG | | | | |
| Berlin 13342, | | | | |
| Deutschland | | | | |
| 25.5.2012 | Kinzalmono | Bayer Pharma AG Berlin 13342, Deutschland | Bayer Pharma AG | Berlin 13342, |
| Bayer Pharma AG | | | | |
| Berlin 13342, | | | | |
| Deutschland | | | | |
| 25.5.2012 | Kuvan | Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56 Marsh Wall, |
| Merck Serono Europe Limited | | | | |
| 56 Marsh Wall, | | | | |
| London E14 9TP, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Lamivudine / Zidovudine Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 25.5.2012 | Micardis | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- | | | | |
| D - 55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 25.5.2012 | MicardisPlus | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- | | | | |
| D - 55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 25.5.2012 | Neulasta | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, |
| Amgen Europe B.V. | | | | |
| Minervum 7061, | | | | |
| NL-4817 ZK Breda, | | | | |
| Nederland | | | | |
| 25.5.2012 | Nevirapine Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 25.5.2012 | Onduarp | Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Str. 173, |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Str. 173, | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 25.5.2012 | Optaflu | Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland | Novartis Vaccines and Diagnostics GmbH | Emil-von-Behring-Strasse 76, |
| Novartis Vaccines and Diagnostics GmbH | | | | |
| Emil-von-Behring-Strasse 76, | | | | |
| D-35041 Marburg, | | | | |
| Deutschland | | | | |
| 25.5.2012 | Osseor | Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France | Les Laboratoires Servier | 50, rue Carnot, |
| Les Laboratoires Servier | | | | |
| 50, rue Carnot, | | | | |
| 92284 Suresnes cedex, | | | | |
| France | | | | |
| 25.5.2012 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 25.5.2012 | Pritor | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 25.5.2012 | PritorPlus | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 25.5.2012 | Protelos | Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France | Les Laboratoires Servier | 50, rue Carnot, |
| Les Laboratoires Servier | | | | |
| 50, rue Carnot, | | | | |
| 92284 Suresnes cedex, | | | | |
| France | | | | |
| 25.5.2012 | Rasilamlo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex, RH12 5AB, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Rasilez | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Rasilez HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Rasitrio | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex, RH12 5AB, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Riprazo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Riprazo HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex, RH12 5AB, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Rivastigmine Actavis | Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland | Actavis Group PTC ehf. | ReykjavÍkurvegur 76-78, |
| Actavis Group PTC ehf. | | | | |
| ReykjavÍkurvegur 76-78, | | | | |
| Hafnarfjörður 220, | | | | |
| Iceland | | | | |
| 25.5.2012 | RoActemra | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Sprimeo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Sprimeo HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex, RH12 5AB, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Temozolomide Hospira | Hospira UK Ltd. Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Ltd. | Queensway, |
| Hospira UK Ltd. | | | | |
| Queensway, | | | | |
| Royal Leamington Spa, | | | | |
| Warwickshire CV31 3RW, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Tysabri | Elan Pharma International Ltd. Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND | Elan Pharma International Ltd. | Treasury Building, |
| Elan Pharma International Ltd. | | | | |
| Treasury Building, | | | | |
| Lower Grand Canal Street, | | | | |
| Dublin 2, | | | | |
| IRELAND | | | | |
| 25.5.2012 | Vantavo | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Victoza | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 25.5.2012 | Vistide | Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge, |
| Gilead Sciences International Limited | | | | |
| Cambridge, | | | | |
| CB21 6GT, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Volibris | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, |
| Glaxo Group Ltd | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Votrient | 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 | | | | |
| 25.5.2012 | Xolair | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 31.5.2012 | Lamivudine Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 31.5.2012 | Peyona | CHIESI FARMACEUTICI SpA Via Palermo 26/A, I-43100 Parma, ITALIA | CHIESI FARMACEUTICI SpA | Via Palermo 26/A, |
| CHIESI FARMACEUTICI SpA | | | | |
| Via Palermo 26/A, | | | | |
| I-43100 Parma, | | | | |
| ITALIA | | | | |
| 31.5.2012 | Temozolomide 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 | | | | |

—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| 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 |
| ------------------------------------------ | ----------------------------- | ------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 10.5.2012 | Valtropin | BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland | BioPartners GmbH | Kaiserpassage 11 - |
| BioPartners GmbH | | | | |
| Kaiserpassage 11 - | | | | |
| D-72764 Reutlingen, | | | | |
| Deutschland | | | | |
| 25.5.2012 | Docefrez | Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland | Sun Pharmaceuticals Industries Europe B.V. | Polarisavenue 87, |
| Sun Pharmaceuticals Industries Europe B.V. | | | | |
| Polarisavenue 87, | | | | |
| 2132 JH Hoofddorp, | | | | |
| Nederland | | | | |
| 25.5.2012 | Intrinsa | Warner Chilcott UK Ltd Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom | Warner Chilcott UK Ltd | Old Belfast Road, |
| Warner Chilcott UK Ltd | | | | |
| Old Belfast Road, | | | | |
| Millbrook, Larne, | | | | |
| County Antrim BT40 2SH, | | | | |
| United Kingdom | | | | |

—   Lift of suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| 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 |
| -------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------------- |
| 25.5.2012 | 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 | | | | |
| 25.5.2012 | Caelyx | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, | | | | |
| B-2340 Beerse, | | | | |
| België | | | | |
| 25.5.2012 | Luminity | Lantheus MI UK Limited Festival House - 39 Oxford Street - Newbury - Berkshire RG14 1JG - United Kingdom | Lantheus MI UK Limited | Festival House - |
| Lantheus MI UK Limited | | | | |
| Festival House - | | | | |
| 39 Oxford Street - | | | | |
| Newbury - | | | | |
| Berkshire RG14 1JG - | | | | |
| United Kingdom | | | | |
| 25.5.2012 | Mepact | IDM PHARMA SAS 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France | IDM PHARMA SAS | 11-15 quai De Dion Bouton, |
| IDM PHARMA SAS | | | | |
| 11-15 quai De Dion Bouton, | | | | |
| 92816 Puteaux Cedex, | | | | |
| France | | | | |
| 25.5.2012 | 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 | | | | |
| 25.5.2012 | Torisel | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent, CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 25.5.2012 | VELCADE | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, | | | | |
| B-2340 Beerse, | | | | |
| België | | | | |
| 31.5.2012 | Ceplene | EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland | EpiCept GmbH | Goethestrasse 4, |
| EpiCept GmbH | | | | |
| Goethestrasse 4, | | | | |
| D-80336 München, | | | | |
| Deutschland | | | | |

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| ----------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------- |
| 10.5.2012 | Circovac | Merial 29 Avenue Tony Garnier, 69007 Lyon, France | Merial | 29 Avenue Tony Garnier, |
| Merial | | | | |
| 29 Avenue Tony Garnier, | | | | |
| 69007 Lyon, | | | | |
| France | | | | |
| 10.5.2012 | Netvax | 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 | | | | |
| 22.5.2012 | Convenia | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 22.5.2012 | Equip WNV | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 22.5.2012 | PRILACTONE | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, |
| CEVA SANTE ANIMALE | | | | |
| 10 avenue de la Ballastière, | | | | |
| 33500 Libourne, | | | | |
| France | | | | |
| 25.5.2012 | 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 | | | | |
| 25.5.2012 | Suprelorin | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros – France | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. - |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. - | | | | |
| 06516 Carros – | | | | |
| France | | | | |

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 |
| UK - LONDON E14 4H |

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

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