# C_2011061EN.01000101.xml

| 25.2.2011 | EN | Official Journal of the European Union | C 61/1 |
| --------- | -- | -------------------------------------- | ------ |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2010 to 31 December 2010

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

2011/C 61/01

—   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 |
| ---------------------------------------- | ---------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- | ------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- | ----------------------------------------------- | -------------------- |
| 29.11.2010 | Aflunov | Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina, 1, | 53100 Siena, | Italia |
| Novartis Vaccines and Diagnostics S.r.l. | | | | | | | |
| Via Fiorentina, 1, | | | | | | | |
| 53100 Siena, | | | | | | | |
| Italia | | | | | | | |
| 29.11.2010 | Leflunomide ratiopharm | leflunomide | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, | D-89079 Ulm, | Deutschland |
| ratiopharm GmbH | | | | | | | |
| Graf-Arco-Straße 3, | | | | | | | |
| D-89079 Ulm, | | | | | | | |
| Deutschland | | | | | | | |
| 29.11.2010 | Prepandemic Influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic | Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina, 1, | 53100 Siena, | Italia |
| Novartis Vaccines and Diagnostics S.r.l. | | | | | | | |
| Via Fiorentina, 1, | | | | | | | |
| 53100 Siena, | | | | | | | |
| Italia | | | | | | | |
| 3.12.2010 | Brilique | ticagrelor | AstraZeneca AB Södertälje S 151 85, Sverige | AstraZeneca AB | Södertälje S 151 85, | Sverige | EU/1/10/655/001-006 |
| AstraZeneca AB | | | | | | | |
| Södertälje S 151 85, | | | | | | | |
| Sverige | | | | | | | |
| 3.12.2010 | Possia | ticagrelor | AstraZeneca AB Södertälje S 151 85, Sverige | AstraZeneca AB | Södertälje S 151 85, | Sverige | EU/1/10/656/001-006 |
| AstraZeneca AB | | | | | | | |
| Södertälje S 151 85, | | | | | | | |
| Sverige | | | | | | | |

—   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 |
| -------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------ | -------------------------------------------------- |
| 3.11.2010 | Actraphane | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 3.11.2010 | Adcirca | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA, Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA, | | | | |
| Houten, | | | | |
| Nederland | | | | |
| 3.11.2010 | Bridion | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, 5349 AB Oss, |
| N.V. Organon | | | | |
| Kloosterstraat 6, 5349 AB Oss, | | | | |
| Nederland | | | | |
| 3.11.2010 | Combivir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, | | | | |
| Middlesex, TW8 9GS, | | | | |
| United Kingdom | | | | |
| 3.11.2010 | Doribax | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 3.11.2010 | Effentora | Cephalon Europe 5 Rue Charles Martigny, Maisons-Alfort 94700, France | Cephalon Europe | 5 Rue Charles Martigny, |
| Cephalon Europe | | | | |
| 5 Rue Charles Martigny, | | | | |
| Maisons-Alfort 94700, | | | | |
| France | | | | |
| 3.11.2010 | Efficib | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 3.11.2010 | Enyglid | 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 | | | | |
| 3.11.2010 | Filgrastim Hexal | HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | HEXAL AG | Industriestrasse 25, |
| HEXAL AG | | | | |
| Industriestrasse 25, | | | | |
| D-83607 Holzkirchen, | | | | |
| Deutschland | | | | |
| 3.11.2010 | Janumet | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 3.11.2010 | Januvia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 3.11.2010 | Norvir | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, Vanwall Business Park, Vanwall Road, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, | | | | |
| Maidenhead, | | | | |
| Berkshire SL6 4XE, | | | | |
| United Kingdom | | | | |
| 3.11.2010 | Olanzapine Mylan | Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | Generics [UK] Limited | Station Close, Potters Bar, |
| Generics [UK] Limited | | | | |
| Station Close, Potters Bar, | | | | |
| Hertfordshire, EN6 1TL, | | | | |
| United Kingdom | | | | |
| 3.11.2010 | 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 | | | | |
| 3.11.2010 | Rasilez 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 | | | | |
| 3.11.2010 | 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 | | | | |
| 3.11.2010 | Ristaben | 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 | | | | |
| 3.11.2010 | Ristfor | 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 | | | | |
| 3.11.2010 | Rotarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| Rixensart, | | | | |
| B-1330 Belgique | | | | |
| 3.11.2010 | 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 | | | | |
| 3.11.2010 | 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 | | | | |
| 3.11.2010 | Tesavel | 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 | | | | |
| 3.11.2010 | Velmetia | 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 | | | | |
| 3.11.2010 | Xelevia | 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 | | | | |
| 3.11.2010 | Zarzio | Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich | Sandoz GmbH | Biochemiestrasse 10, |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10, | | | | |
| A-6250 Kundl, | | | | |
| Österreich | | | | |
| 5.11.2010 | 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 | | | | |
| 5.11.2010 | Diacomit | Biocodex 7 avenue Gallieni, 94250 Gentilly, France | Biocodex | 7 avenue Gallieni, |
| Biocodex | | | | |
| 7 avenue Gallieni, | | | | |
| 94250 Gentilly, | | | | |
| France | | | | |
| 5.11.2010 | Erbitux | Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland | Merck KGaA | Frankfurter Straße 250, |
| Merck KGaA | | | | |
| Frankfurter Straße 250, | | | | |
| 64271 Darmstadt, | | | | |
| Deutschland | | | | |
| 5.11.2010 | Irbesartan Winthrop | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC 174 avenue de France, F- 75013 Paris, France | SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | 174 avenue de France, |
| SANOFI PHARMA BRISTOL MYERS SQUIBB SNC | | | | |
| 174 avenue de France, | | | | |
| F- 75013 Paris, | | | | |
| France | | | | |
| 5.11.2010 | Torisel | 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 | | | | |
| 5.11.2010 | Twinrix Paediatric | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| Rixensart, | | | | |
| B-1330 Belgique | | | | |
| 12.11.2010 | Kentera | Nicobrand Limited 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP | Nicobrand Limited | 189 Castleroe Road, |
| Nicobrand Limited | | | | |
| 189 Castleroe Road, | | | | |
| Coleraine, | | | | |
| Northern Ireland BT51 3 RP | | | | |
| 12.11.2010 | Xolair | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 19.11.2010 | Qutenza | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, | | | | |
| 2353 EW Leiderdorp, | | | | |
| Nederland | | | | |
| 26.11.2010 | Ambirix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| Rixensart, | | | | |
| B-1330 Belgique | | | | |
| 26.11.2010 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, AL7 1TW, | | | | |
| United Kingdom | | | | |
| 26.11.2010 | Cancidas | 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 | | | | |
| 26.11.2010 | Circadin | RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | RAD Neurim Pharmaceuticals EEC Limited | One Forbury Square, The Forbury, |
| RAD Neurim Pharmaceuticals EEC Limited | | | | |
| One Forbury Square, The Forbury, | | | | |
| Reading, | | | | |
| Berkshire RG1 3EB, | | | | |
| United Kingdom | | | | |
| 26.11.2010 | Efficib | 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 | | | | |
| 26.11.2010 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, | | | | |
| Maidenhead, | | | | |
| Berkshire, SL6 0PH, | | | | |
| United Kingdom | | | | |
| 26.11.2010 | Iressa | AstraZeneca AB Sodertalje S 151 85, Sverige | AstraZeneca AB | Sodertalje S 151 85, |
| AstraZeneca AB | | | | |
| Sodertalje S 151 85, | | | | |
| Sverige | | | | |
| 26.11.2010 | Janumet | 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 | | | | |
| 26.11.2010 | Januvia | 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 | | | | |
| 26.11.2010 | Livensa | Warner Chilcott Deutschland Gmbh Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland | Warner Chilcott Deutschland Gmbh | Dr.-Otto-Röhm-Strasse 2-4, |
| Warner Chilcott Deutschland Gmbh | | | | |
| Dr.-Otto-Röhm-Strasse 2-4, | | | | |
| Weiterstadt 64331, | | | | |
| Deutschland | | | | |
| 26.11.2010 | Nexavar | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 26.11.2010 | Nplate | Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, |
| Amgen Europe B.V. | | | | |
| Minervum 7061, | | | | |
| 4817 ZK Breda, | | | | |
| Nederland | | | | |
| 26.11.2010 | Prevenar 13 | Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15, B-1348 Louvain-la-Neuve, Belgium | Wyeth Lederle Vaccines S.A. | Rue du Bosquet, 15, |
| Wyeth Lederle Vaccines S.A. | | | | |
| Rue du Bosquet, 15, | | | | |
| B-1348 Louvain-la-Neuve, | | | | |
| Belgium | | | | |
| 26.11.2010 | Ristaben | 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 | | | | |
| 26.11.2010 | Ristfor | 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 | | | | |
| 26.11.2010 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, AL7 1TW, | | | | |
| United Kingdom | | | | |
| 26.11.2010 | 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 | | | | |
| 26.11.2010 | Thalidomide Celgene | Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | Celgene Europe Limited | Riverside House, Riverside Walk, |
| Celgene Europe Limited | | | | |
| Riverside House, Riverside Walk, | | | | |
| Windsor SL4 1NA, | | | | |
| United Kingdom | | | | |
| 26.11.2010 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 26.11.2010 | Velmetia | 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 | | | | |
| 26.11.2010 | Xagrid | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park, Chineham, |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park, Chineham, | | | | |
| Basingstoke, | | | | |
| Hampshire RG24 8EP, | | | | |
| United Kingdom | | | | |
| 26.11.2010 | Xelevia | 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 | | | | |
| 26.11.2010 | Zeffix | 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 | | | | |
| 29.11.2010 | 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 | | | | |
| 29.11.2010 | alli | 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 | | | | |
| 29.11.2010 | Atriance | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 29.11.2010 | Cimzia | 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 | | | | |
| 29.11.2010 | 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 | | | | |
| 29.11.2010 | 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 | | | | |
| 29.11.2010 | DepoCyte | Pacira Limited 3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom | Pacira Limited | 3 Glory Park Avenue, Wooburn Green, |
| Pacira Limited | | | | |
| 3 Glory Park Avenue, Wooburn Green, | | | | |
| High Wycombe, | | | | |
| Buckinghamshire, HP10 0DF, | | | | |
| United Kingdom | | | | |
| 29.11.2010 | 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 | | | | |
| 29.11.2010 | Fertavid | SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | SP Europe | Rue de Stalle, 73, |
| SP Europe | | | | |
| Rue de Stalle, 73, | | | | |
| 1180 Bruxelles, | | | | |
| Belgique - Stallestraat, | | | | |
| 73 - 1180 Brussel, | | | | |
| België | | | | |
| 29.11.2010 | 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 | | | | |
| 29.11.2010 | Intelence | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 29.11.2010 | Intelence | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 29.11.2010 | 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 | | | | |
| 29.11.2010 | NeuroBloc | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, | | | | |
| Hatfield, | | | | |
| Hertfordshire, AL10 9SN, | | | | |
| United Kingdom | | | | |
| 29.11.2010 | PREZISTA | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 29.11.2010 | 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 | | | | |
| 29.11.2010 | Puregon | Organon N.V. Kloosterstraat 6, Postbus 20, 5340 BH Oss, Nederland | Organon N.V. | Kloosterstraat 6, Postbus 20, |
| Organon N.V. | | | | |
| Kloosterstraat 6, Postbus 20, | | | | |
| 5340 BH Oss, | | | | |
| Nederland | | | | |
| 29.11.2010 | Remicade | Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | Centocor B.V. | Einsteinweg 101, |
| Centocor B.V. | | | | |
| Einsteinweg 101, | | | | |
| 2333 CB Leiden, | | | | |
| Nederland | | | | |
| 29.11.2010 | Sebivo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 29.11.2010 | Sildenafil 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 | | | | |
| 29.11.2010 | Sutent | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT 13 0NJ, | | | | |
| United Kingdom | | | | |
| 29.11.2010 | Travatan | Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Boundary Way, |
| Alcon Laboratories (UK) Ltd. | | | | |
| Boundary Way, | | | | |
| Hemel Hempstead, | | | | |
| Herts HP2 7UD, | | | | |
| United Kingdom | | | | |
| 29.11.2010 | Trizivir | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Limited | 980 Great West Road, |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex, TW8 9GS, | | | | |
| United Kingdom | | | | |
| 29.11.2010 | Tysabri | Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland | Elan Pharma International Ltd. | Monksland, |
| Elan Pharma International Ltd. | | | | |
| Monksland, | | | | |
| Athlone, | | | | |
| County Westmeath, | | | | |
| Ireland | | | | |
| 29.11.2010 | 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 | | | | |
| 29.11.2010 | Vfend | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT 13 0NJ, | | | | |
| United Kingdom | | | | |
| 29.11.2010 | 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 | | | | |
| 3.12.2010 | Aranesp | 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 | | | | |
| 3.12.2010 | Orencia | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge UB8 1DH, | | | | |
| United Kingdom | | | | |
| 3.12.2010 | Tesavel | 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 | | | | |
| 3.12.2010 | 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 | | | | |
| 6.12.2010 | Ilaris | 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 | | | | |
| 6.12.2010 | Kiovig | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | Baxter AG | Industriestraße 67, |
| Baxter AG | | | | |
| Industriestraße 67, | | | | |
| A - 1221 Wien, | | | | |
| Österreich | | | | |
| 6.12.2010 | 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 | | | | |
| 13.12.2010 | Diacomit | Biocodex 7 avenue Gallieni, 94250 Gentilly, France | Biocodex | 7 avenue Gallieni, |
| Biocodex | | | | |
| 7 avenue Gallieni, | | | | |
| 94250 Gentilly, | | | | |
| France | | | | |
| 13.12.2010 | Flebogamma DIF | Instituto Grifols, S.A. Can Guasch, 2 - Parets del Vallès, 08150 Barcelona - Espaňa | Instituto Grifols, S.A. | Can Guasch, 2 - Parets del Vallès, |
| Instituto Grifols, S.A. | | | | |
| Can Guasch, 2 - Parets del Vallès, | | | | |
| 08150 Barcelona - Espaňa | | | | |
| 13.12.2010 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 13.12.2010 | Kaletra | Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom | Abbott Laboratories | Abbott House, Vanwall Business Park, Vanwall Road, |
| Abbott Laboratories | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, | | | | |
| SL6 4XE Maidenhead, | | | | |
| Berks, | | | | |
| United Kingdom | | | | |
| 13.12.2010 | Revlimid | Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom | Celgene Europe Limited | Riverside House, Riverside Walk, Windsor, |
| Celgene Europe Limited | | | | |
| Riverside House, Riverside Walk, Windsor, | | | | |
| Berkshire SL4 1NA, | | | | |
| United Kingdom | | | | |
| 13.12.2010 | Sifrol | 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 | | | | |
| 13.12.2010 | Vectibix | 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 | | | | |
| 13.12.2010 | 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 | | | | |
| 17.12.2010 | Revlimid | Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom | Celgene Europe Limited | Riverside House, Riverside Walk, |
| Celgene Europe Limited | | | | |
| Riverside House, Riverside Walk, | | | | |
| Windsor, | | | | |
| Berkshire SL4 1NA, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Aloxi | Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Republic of Ireland | Helsinn Birex Pharmaceuticals Ltd | Damastown, |
| Helsinn Birex Pharmaceuticals Ltd | | | | |
| Damastown, | | | | |
| Mulhuddart, Dublin 15, | | | | |
| Republic of Ireland | | | | |
| 20.12.2010 | Aranesp | 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 | | | | |
| 20.12.2010 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | Bristol-Myers Squibb and Gilead Sciences Limited | IDA Business & Technology Park, |
| Bristol-Myers Squibb and Gilead Sciences Limited | | | | |
| IDA Business & Technology Park, | | | | |
| Carrigtohill, Co. Cork, | | | | |
| Ireland | | | | |
| 20.12.2010 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, AL7 1TW, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Celsentri | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex, TW8 9GS, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Champix | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT 13 0NJ, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Conbriza | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, | | | | |
| Maidenhead, | | | | |
| Berkshire, SL6 0PH, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | DuoCover | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, | | | | |
| Uxbridge UB8 1DH, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | DuoPlavin | Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France, F-75013 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 174 Avenue de France, |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 Avenue de France, | | | | |
| F-75013 Paris, | | | | |
| France | | | | |
| 20.12.2010 | Emselex | 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 | | | | |
| 20.12.2010 | Exjade | 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 | | | | |
| 20.12.2010 | 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 | | | | |
| 20.12.2010 | Helixate NexGen | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 20.12.2010 | Javlor | Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France | Pierre Fabre Médicament | 45, place Abel Gance, |
| Pierre Fabre Médicament | | | | |
| 45, place Abel Gance, | | | | |
| F-92100 Boulogne, | | | | |
| France | | | | |
| 20.12.2010 | Kogenate Bayer | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 20.12.2010 | 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 | | | | |
| 20.12.2010 | Macugen | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT 13 0NJ, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Mirapexin | 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 | | | | |
| 20.12.2010 | Mycamine | 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 | | | | |
| 20.12.2010 | Naglazyme | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | BioMarin Europe Ltd | 164 Shaftesbury Avenue, |
| BioMarin Europe Ltd | | | | |
| 164 Shaftesbury Avenue, | | | | |
| London WC2H 8HL, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Optison | GE Healthcare AS Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norway | GE Healthcare AS | Nycoveien 1-2, P.O.Box 4220 Nydalen, |
| GE Healthcare AS | | | | |
| Nycoveien 1-2, P.O.Box 4220 Nydalen, | | | | |
| N-0401 OSLO, | | | | |
| Norway | | | | |
| 20.12.2010 | Pelzont | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | 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 | | | | |
| 20.12.2010 | 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 | | | | |
| 20.12.2010 | Stelara | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 20.12.2010 | Sutent | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT 13 0NJ, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, AL7 1TW, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | 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 | | | | |
| 20.12.2010 | 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 | | | | |
| 20.12.2010 | Thalidomide Celgene | Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | Celgene Europe Limited | Riverside House, Riverside Walk, |
| Celgene Europe Limited | | | | |
| Riverside House, Riverside Walk, | | | | |
| Windsor SL4 1NA, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Tredaptive | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Trevaclyn | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Ventavis | Bayer Schering Pharma AG Müllerstrasse 170-178, D - 13342 Berlin, Deutschland | Bayer Schering Pharma AG | Müllerstrasse 170-178, |
| Bayer Schering Pharma AG | | | | |
| Müllerstrasse 170-178, | | | | |
| D - 13342 Berlin, | | | | |
| Deutschland | | | | |
| 20.12.2010 | Vfend | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 0NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT 13 0NJ, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | 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 | | | | |
| 20.12.2010 | Zostavax | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, | | | | |
| 69007 Lyon, | | | | |
| France | | | | |
| 20.12.2010 | 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 | | | | |
| 20.12.2010 | 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 | | | | |

—   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 |
| -------------------------------- | ----------------------------- | ------------------------------------------------------------------------------- | --------------------------------------------- | --------------------- |
| 13.12.2010 | Arepanrix | 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 | | | | |

—   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 |
| ----------------------- | ----------------------------- | ----------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 3.12.2010 | Avaglim | SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | SmithKline Beecham Ltd. | 980 Great West Road, |
| SmithKline Beecham Ltd. | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex, TW8 9GS | | | | |
| United Kingdom | | | | |
| 3.12.2010 | Avandamet | SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | SmithKline Beecham Ltd. | 980 Great West Road, |
| SmithKline Beecham Ltd. | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex, TW8 9GS | | | | |
| United Kingdom | | | | |
| 3.12.2010 | Avandia | SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | SmithKline Beecham Ltd. | 980 Great West Road, |
| SmithKline Beecham Ltd. | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex, TW8 9GS | | | | |
| United Kingdom | | | | |

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
( 2 )
): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ----------------------- | ----------------------------- | ------------------------------------------------------------------------- | ----------------------------------------------------- | --------------------------------------------- | ----------------------- | ----------------------------------------------- | -------------------- |
| 5.11.2010 | BTVPUR AlSap 2-4 | Bluetongue virus serotypes 2-4 | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, | 69007 LYON, | France |
| MERIAL | | | | | | | |
| 29 avenue Tony Garnier, | | | | | | | |
| 69007 LYON, | | | | | | | |
| France | | | | | | | |
| 19.11.2010 | Meloxoral | Meloxicam | Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland | Le Vet B.V. | Wilgenweg 7, | 3421 TV Oudewater, | Nederland |
| Le Vet B.V. | | | | | | | |
| Wilgenweg 7, | | | | | | | |
| 3421 TV Oudewater, | | | | | | | |
| Nederland | | | | | | | |
| 17.12.2010 | BTVPUR AlSap 1 | Bluetongue Virus Serotype 1 antigen | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, | 69007 LYON, | France |
| MERIAL | | | | | | | |
| 29 avenue Tony Garnier, | | | | | | | |
| 69007 LYON, | | | | | | | |
| France | | | | | | | |
| 17.12.2010 | BTVPUR AlSap 1-8 | Bluetongue Virus Serotype 1 antigen - Bluetongue Virus Serotype 8 antigen | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, | 69007 LYON, | France |
| MERIAL | | | | | | | |
| 29 avenue Tony Garnier, | | | | | | | |
| 69007 LYON, | | | | | | | |
| France | | | | | | | |

—   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 |
| ----------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 3.11.2010 | Melovem | Dopharma Research B.V. Zalmweg 24, 4941 VX Raamsdonksveer, Nederland | Dopharma Research B.V. | Zalmweg 24, |
| Dopharma Research B.V. | | | | |
| Zalmweg 24, | | | | |
| 4941 VX Raamsdonksveer, | | | | |
| Nederland | | | | |
| 26.11.2010 | ProMeris | 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 | | | | |
| 26.11.2010 | 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 | | | | |
| 29.11.2010 | Circovac | Merial 29 Avenue Tony Garnier, 69007 Lyon, France | Merial | 29 Avenue Tony Garnier, |
| Merial | | | | |
| 29 Avenue Tony Garnier, | | | | |
| 69007 Lyon, | | | | |
| France | | | | |
| 3.12.2010 | Masivet | AB Science S.A. 3 avenue George V, 75008 Paris, France | AB Science S.A. | 3 avenue George V, |
| AB Science S.A. | | | | |
| 3 avenue George V, | | | | |
| 75008 Paris, | | | | |
| France | | | | |
| 13.12.2010 | Poulvac FluFend H5N3 RG | Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom | Fort Dodge Animal Health Ltd | Flanders Road, Hedge End, |
| Fort Dodge Animal Health Ltd | | | | |
| Flanders Road, Hedge End, | | | | |
| Southampton SO30 4QH, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Improvac | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 20.12.2010 | Metacam | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | 55216 Ingelheim am Rhein, |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| 55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |

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.

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

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