# C_2011250EN.01000101.xml

| 26.8.2011 | EN | Official Journal of the European Union | C 250/1 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2011 to 30 June 2011

(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 250/01

—   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 |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------------- | -------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------------------------------------------------------------------------------- | ----------------------------------------------- | ----------------------------------------------------------------- |
| 6.5.2011 | Methylthioninium chloride Proveblue | methylthioninium chloride | Provepharm S.A.S. Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille | Provepharm S.A.S. | Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille | EU/1/11/682/001 | Solution for injection |
| Provepharm S.A.S. | | | | | | | |
| Technopole de Chateau Gombert, 45 rue Frederic Joliot Curie, FR-13013 Marseille | | | | | | | |
| 18.5.2011 | Eliquis | apixaban | Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol-Myers Squibb/Pfizer EEIG | Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/691/001-005 | Film-coated tablet |
| Bristol-Myers Squibb/Pfizer EEIG | | | | | | | |
| Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | | | | |
| 18.5.2011 | Yellox | bromfenac | Croma-Pharma GmbH Industriezeile 6, A-2100 Leobendorf, Österreich | Croma-Pharma GmbH | Industriezeile 6, A-2100 Leobendorf, Österreich | EU/1/11/692/001 | Eye drops, solution |
| Croma-Pharma GmbH | | | | | | | |
| Industriezeile 6, A-2100 Leobendorf, Österreich | | | | | | | |
| 15.6.2011 | Cinryze | c1 inhibitor, human | ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België | ViroPharma SPRL-BVBA | rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688/001 | Powder and solvent for solution for injection |
| ViroPharma SPRL-BVBA | | | | | | | |
| rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België | | | | | | | |
| 16.6.2011 | Clopidogrel Teva Pharma B.V. | Clopidogrel | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/10/649/001-016 | Film-coated tablet |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | | | | |
| 16.6.2011 | Leganto | Rotigotine | Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland | Schwarz Pharma Ltd | Shannon, Industrial Estate, Co.Clare, Ireland | EU/1/11/695/001-055 | Transdermal patch |
| Schwarz Pharma Ltd | | | | | | | |
| Shannon, Industrial Estate, Co.Clare, Ireland | | | | | | | |
| 16.6.2011 | Rivastigmine Actavis | Rivastigmine | Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland | Actavis Group PTC ehf. | ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland | EU/1/11/693/001-016 | Capsule, hard |
| Actavis Group PTC ehf. | | | | | | | |
| ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland | | | | | | | |
| 17.6.2011 | BYDUREON | exenatide | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/11/696/001-002 | powder and solvent for prolonged release suspension for injection |
| Eli Lilly Nederland B.V. | | | | | | | |
| Grootslag 1-5, 3991 RA Houten, Nederland | | | | | | | |
| 17.6.2011 | NULOJIX | belatacept | 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, Uxbridge UB8 1DH, United Kingdom | EU/1/11/694/001-002 | powder for concentrate for solution for infusion |
| Bristol-Myers Squibb Pharma EEIG | | | | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | | | | |
| 23.6.2011 | Sprimeo HCT | aliskiren hemifumarate / hydrochlorothiazide | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | EU/1/11/683/001-080 | Film-coated tablet |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | | | | |

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

| 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 |
| ---------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------- |
| 17.6.2011 | Movectro | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56, Marsh Wall, London E14 9TP, United Kingdom |
| Merck Serono Europe Limited | | | | |
| 56, Marsh Wall, London E14 9TP, 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 |
| ------------------------------------------------------------------------------------------------ | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
| 2.5.2011 | Combivir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 2.5.2011 | Kepivance | Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige | Swedish Orphan Biovitrum AB (publ) | SE-112 76, Stockholm, Sverige |
| Swedish Orphan Biovitrum AB (publ) | | | | |
| SE-112 76, Stockholm, Sverige | | | | |
| 2.5.2011 | Kinzalkomb | Bayer Schering Pharma AG D-13342 Berlin, Deutschland | Bayer Schering Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 2.5.2011 | Kinzalmono | Bayer Schering Pharma AG D-13342 Berlin, Deutschland | Bayer Schering Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 2.5.2011 | Micardis | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 2.5.2011 | MicardisPlus | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 2.5.2011 | Nexavar | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 2.5.2011 | Osigraft | Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland | Howmedica International S. de R.L. | Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland |
| Howmedica International S. de R.L. | | | | |
| Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland | | | | |
| 2.5.2011 | Pritor | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 2.5.2011 | PritorPlus | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 2.5.2011 | Revatio | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 2.5.2011 | Revolade | GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | GlaxoSmithKline Trading Services Limited | 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland |
| GlaxoSmithKline Trading Services Limited | | | | |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | | | | |
| 2.5.2011 | Votrient | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 5.5.2011 | M-M-RVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, 69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, 69007 Lyon, France | | | | |
| 6.5.2011 | Foclivia | 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 | | | | |
| 6.5.2011 | Kivexa | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 6.5.2011 | Rasilez HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 6.5.2011 | ReFacto AF | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 6.5.2011 | Rotarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, Rixensart, B-1330 Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, Rixensart, B-1330 Belgique | | | | |
| 6.5.2011 | Tygacil | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 6.5.2011 | Vimpat | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | | | | |
| 6.5.2011 | Votrient | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 6.5.2011 | 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, Basingstoke, Hampshire RG24 8EP, United Kingdom |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | | | | |
| 12.5.2011 | Baraclude | 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, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 12.5.2011 | Extavia | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 12.5.2011 | Ketek | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92160 Antony, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, F-92160 Antony, France |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, F-92160 Antony, France | | | | |
| 12.5.2011 | MabCampath | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | |
| 12.5.2011 | Olanzapine Apotex | Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland | Apotex Europe B.V. | Darwingweg 20, 2333 CR Leiden, Nederland |
| Apotex Europe B.V. | | | | |
| Darwingweg 20, 2333 CR Leiden, Nederland | | | | |
| 16.5.2011 | Elonva | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, 5349 AB Oss, Nederland |
| N.V. Organon | | | | |
| Kloosterstraat 6, 5349 AB Oss, Nederland | | | | |
| 16.5.2011 | Pramipexole Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 16.5.2011 | Yondelis | Pharma Mar, S.A. Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana | Pharma Mar, S.A. | Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana |
| Pharma Mar, S.A. | | | | |
| Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana | | | | |
| 16.5.2011 | Zavesca | Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | | | | |
| 18.5.2011 | Arixtra | Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd. | Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Ltd. | | | | |
| Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 18.5.2011 | Celvapan | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | Baxter AG | Industriestraße 67, A - 1221 Wien, Österreich |
| Baxter AG | | | | |
| Industriestraße 67, A - 1221 Wien, Österreich | | | | |
| 18.5.2011 | DepoCyte | Pacira Limited 3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom | Pacira Limited | 3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom |
| Pacira Limited | | | | |
| 3 Glory Park Avenue, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0DF, United Kingdom | | | | |
| 18.5.2011 | Hepsera | Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge, CB21 6GT, United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge, CB21 6GT, United Kingdom | | | | |
| 18.5.2011 | Karvea | 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, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 18.5.2011 | Karvezide | 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, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 18.5.2011 | Pelzont | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 18.5.2011 | 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 | | | | |
| 18.5.2011 | Rotarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, Rixensart, B-1330 Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, Rixensart, B-1330 Belgique | | | | |
| 18.5.2011 | RotaTeq | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, Lyon 69007, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, Lyon 69007, France | | | | |
| 18.5.2011 | Sprimeo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 18.5.2011 | Tarceva | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 18.5.2011 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT United Kingdom | | | | |
| 23.5.2011 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France - 75013 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France - 75013 Paris, France | | | | |
| 23.5.2011 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France - 75013 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France - 75013 Paris, France | | | | |
| 23.5.2011 | Emtriva | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT United Kingdom | | | | |
| 23.5.2011 | 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 4745-457 S. Mamede do Coronado – Portugal |
| BIAL - Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal | | | | |
| 23.5.2011 | Exelon | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.5.2011 | Glivec | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.5.2011 | GONAL-f | Merck Serono Europe Ltd. 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Ltd. | 56, Marsh Wall, London E14 9TP, United Kingdom |
| Merck Serono Europe Ltd. | | | | |
| 56, Marsh Wall, London E14 9TP, United Kingdom | | | | |
| 23.5.2011 | Luveris | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56, Marsh Wall, London E14 9TP, United Kingdom |
| Merck Serono Europe Limited | | | | |
| 56, Marsh Wall, London E14 9TP, United Kingdom | | | | |
| 23.5.2011 | Prometax | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.5.2011 | Rapamune | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 23.5.2011 | Rasilez | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.5.2011 | Riprazo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.5.2011 | Sprycel | 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, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 23.5.2011 | Tasigna | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.5.2011 | Telzir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 23.5.2011 | Tredaptive | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.5.2011 | Trevaclyn | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 23.5.2011 | Tygacil | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 23.5.2011 | Tyverb | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 23.5.2011 | Vectibix | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, NL-4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, NL-4817 ZK Breda, Nederland | | | | |
| 27.5.2011 | Avonex | Biogen Idec Ltd Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Ltd | Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
| Biogen Idec Ltd | | | | |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | | | | |
| 27.5.2011 | Carbaglu | Orphan Europe SARL Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux – France | Orphan Europe SARL | Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux – France |
| Orphan Europe SARL | | | | |
| Immeuble Le Wilson - 70 Avenue du Général de Gaulle - F 92 800 Puteaux – France | | | | |
| 27.5.2011 | CellCept | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 27.5.2011 | Competact | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, London WC2B 4AE, United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | |
| 27.5.2011 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 27.5.2011 | Forsteo | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, 3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, 3991 RA Houten, Nederland | | | | |
| 27.5.2011 | Levemir | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 27.5.2011 | Lucentis | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 27.5.2011 | Mycophenolate mofetil Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 27.5.2011 | Myfenax | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 27.5.2011 | Neulasta | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, NL-4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, NL-4817 ZK Breda, Nederland | | | | |
| 27.5.2011 | Olanzapine Neopharma | Neopharma Limited 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom | Neopharma Limited | 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom |
| Neopharma Limited | | | | |
| 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom | | | | |
| 27.5.2011 | Simponi | Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland | Janssen Biologics B.V. | Einsteinweg 101, CB Leiden 2333, Nederland |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, CB Leiden 2333, Nederland | | | | |
| 27.5.2011 | Temozolomide Hospira | Hospira UK Ltd. Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Ltd. | Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
| Hospira UK Ltd. | | | | |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | | | | |
| 27.5.2011 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT United Kingdom | | | | |
| 27.5.2011 | Viracept | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 7.6.2011 | Caelyx | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 7.6.2011 | Champix | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 7.6.2011 | Fabrazyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | |
| 7.6.2011 | Irbesartan Winthrop | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, F-75013 Paris, France |
| Sanofi-Aventis | | | | |
| 174, avenue de France, F-75013 Paris, France | | | | |
| 7.6.2011 | Multaq | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, F-75013 Paris, France |
| Sanofi-Aventis | | | | |
| 174, avenue de France, F-75013 Paris, France | | | | |
| 7.6.2011 | 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, Maidenhead, Berkshire SL6 4XE, United Kingdom |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | | | | |
| 7.6.2011 | Tractocile | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, Copenhagen S 2300, Danmark | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11, Copenhagen S 2300, Danmark |
| Ferring Pharmaceuticals A/S | | | | |
| Kay Fiskers Plads 11, Copenhagen S 2300, Danmark | | | | |
| 7.6.2011 | Trizivir | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Limited | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Limited | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 14.6.2011 | Afinitor | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 14.6.2011 | 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 | | | | |
| 14.6.2011 | Ivemend | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 14.6.2011 | Olanzapine Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 14.6.2011 | Opgenra | Howmedica International S. de R. L. Raheen Business Park, Limerick, Ireland | Howmedica International S. de R. L. | Raheen Business Park, Limerick, Ireland |
| Howmedica International S. de R. L. | | | | |
| Raheen Business Park, Limerick, Ireland | | | | |
| 14.6.2011 | PecFent | Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom | Archimedes Development Ltd | Nottingham, NGT7 2TN, United Kingdom |
| Archimedes Development Ltd | | | | |
| Nottingham, NGT7 2TN, United Kingdom | | | | |
| 14.6.2011 | Ribavirin BioPartners | BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland | BioPartners GmbH | Kaiserpassage 11 - D-72764 Reutlingen, Deutschland |
| BioPartners GmbH | | | | |
| Kaiserpassage 11 - D-72764 Reutlingen, Deutschland | | | | |
| 14.6.2011 | Temodal | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 14.6.2011 | Twynsta | Boehringer Ingelheim International GmbH Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 14.6.2011 | Vidaza | Celgene Europe Ltd Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom | Celgene Europe Ltd | Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom |
| Celgene Europe Ltd | | | | |
| Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom | | | | |
| 15.6.2011 | InductOs | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 15.6.2011 | Infanrix hexa | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, Rixensart, B-1330 Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, Rixensart, B-1330 Belgique | | | | |
| 15.6.2011 | PegIntron | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 15.6.2011 | Ziagen | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 16.6.2011 | INCRELEX | Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | Ipsen Pharma | 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France |
| Ipsen Pharma | | | | |
| 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | | | | |
| 16.6.2011 | IntronA | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 16.6.2011 | Irbesartan HCT Winthrop | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, F-75013 Paris, France |
| Sanofi-Aventis | | | | |
| 174, avenue de France, F-75013 Paris, France | | | | |
| 16.6.2011 | Macugen | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 16.6.2011 | Olanzapine Mylan | Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | Generics [UK] Limited | Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
| Generics [UK] Limited | | | | |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | | | | |
| 16.6.2011 | Omnitrope | Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich | Sandoz GmbH | Biochemiestrasse 10, Kundl 6250, Österreich |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10, Kundl 6250, Österreich | | | | |
| 16.6.2011 | Ozurdex | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals (Ireland) Ltd, | Castlebar Road, Westport, Co. Mayo, Ireland |
| Allergan Pharmaceuticals (Ireland) Ltd, | | | | |
| Castlebar Road, Westport, Co. Mayo, Ireland | | | | |
| 16.6.2011 | Samsca | 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, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom | | | | |
| 16.6.2011 | Tysabri | Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland | Elan Pharma International Ltd. | Monksland, Athlone, County Westmeath, Ireland |
| Elan Pharma International Ltd. | | | | |
| Monksland, Athlone, County Westmeath, Ireland | | | | |
| 16.6.2011 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 16.6.2011 | 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 4745-457 S. Mamede do Coronado – Portugal |
| BIAL - Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal | | | | |
| 17.6.2011 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France - 75013 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France - 75013 Paris, France | | | | |
| 17.6.2011 | Champix | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 17.6.2011 | INCRELEX | Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | Ipsen Pharma | 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France |
| Ipsen Pharma | | | | |
| 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | | | | |
| 17.6.2011 | Lyrica | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 17.6.2011 | Mirapexin | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 17.6.2011 | Mircera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 17.6.2011 | Pandemrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, Rixensart, B-1330 Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, Rixensart, B-1330 Belgique | | | | |
| 17.6.2011 | Ranexa | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | Menarini International Operations Luxembourg S.A. | 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | | | | |
| 17.6.2011 | Relistor | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 17.6.2011 | Remicade | Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | Janssen Biologics B.V. | Einsteinweg 101, 2333 CB Leiden, Nederland |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, 2333 CB Leiden, Nederland | | | | |
| 17.6.2011 | Sifrol | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 17.6.2011 | Tasigna | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 17.6.2011 | Tygacil | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 17.6.2011 | Tysabri | Elan Pharma International Ltd. Monksland, Athlone, County Westmeath, Ireland | Elan Pharma International Ltd. | Monksland, Athlone, County Westmeath, Ireland |
| Elan Pharma International Ltd. | | | | |
| Monksland, Athlone, County Westmeath, Ireland | | | | |
| 17.6.2011 | Xeloda | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 17.6.2011 | Xolair | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 23.6.2011 | BeneFIX | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 23.6.2011 | Docefrez | Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland | Sun Pharmaceuticals Industries Europe B.V. | Polarisavenue 87, 2132 JH Hoofddorp, Nederland |
| Sun Pharmaceuticals Industries Europe B.V. | | | | |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland | | | | |
| 23.6.2011 | Dynastat | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 23.6.2011 | Erbitux | Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland | Merck KGaA | Frankfurter Straße 250, 64271 Darmstadt, Deutschland |
| Merck KGaA | | | | |
| Frankfurter Straße 250, 64271 Darmstadt, Deutschland | | | | |
| 23.6.2011 | Ganfort | Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road, Westport, Co. Mayo, Ireland |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road, Westport, Co. Mayo, Ireland | | | | |
| 23.6.2011 | Herceptin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 23.6.2011 | Invirase | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 23.6.2011 | Mabthera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 23.6.2011 | NovoSeven | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 23.6.2011 | Orencia | 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, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 23.6.2011 | Ovitrelle | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56, Marsh Wall, London E14 9TP, United Kingdom |
| Merck Serono Europe Limited | | | | |
| 56, Marsh Wall, London E14 9TP, United Kingdom | | | | |
| 23.6.2011 | Protopic | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | | | | |
| 23.6.2011 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 23.6.2011 | Temozolomide HEXAL | HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | HEXAL AG | Industriestrasse 25, D-83607 Holzkirchen, Deutschland |
| HEXAL AG | | | | |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland | | | | |
| 23.6.2011 | Temozolomide Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | | | | |
| 23.6.2011 | Tevagrastim | Teva GmbH Wasastraße 50, 01445 Radebeul, Deutschland | Teva GmbH | Wasastraße 50, 01445 Radebeul, Deutschland |
| Teva GmbH | | | | |
| Wasastraße 50, 01445 Radebeul, Deutschland | | | | |
| 23.6.2011 | Torisel | Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom | Wyeth Europa Ltd | Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom | | | | |
| 23.6.2011 | Twinrix Adult | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, Rixensart, B-1330 Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, Rixensart, B-1330 Belgique | | | | |
| 23.6.2011 | Viramune | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 29.6.2011 | Abraxane | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | | | | |
| 29.6.2011 | Aclasta | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 29.6.2011 | Adrovance | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 29.6.2011 | Advagraf | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | | | | |
| 29.6.2011 | Advate | Baxter AG Industriesstrasse 67, 1220 Vienna, Österreich | Baxter AG | Industriesstrasse 67, 1220 Vienna, Österreich |
| Baxter AG | | | | |
| Industriesstrasse 67, 1220 Vienna, Österreich | | | | |
| 29.6.2011 | APTIVUS | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 29.6.2011 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 29.6.2011 | Bondenza | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 29.6.2011 | Bondronat | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 29.6.2011 | Bonviva | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 29.6.2011 | Byetta | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, 3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, 3991 RA Houten, Nederland | | | | |
| 29.6.2011 | Ecalta | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 29.6.2011 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 29.6.2011 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 29.6.2011 | Fosavance | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 29.6.2011 | Ibandronic Acid Teva | 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 | | | | |
| 29.6.2011 | Instanyl | Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark | Nycomed Danmark ApS | Langebjerg 1, DK-4000 Roskilde, Danmark |
| Nycomed Danmark ApS | | | | |
| Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 29.6.2011 | IntronA | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 29.6.2011 | Karvea | 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, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 29.6.2011 | 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, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | | | | |
| 29.6.2011 | Nexavar | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 29.6.2011 | Pegasys | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 29.6.2011 | PegIntron | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 29.6.2011 | Prevenar 13 | Wyeth Lederle Vaccines S.A. Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium | Wyeth Lederle Vaccines S.A. | Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium |
| Wyeth Lederle Vaccines S.A. | | | | |
| Pleainlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgium | | | | |
| 29.6.2011 | Rasilez HCT | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 29.6.2011 | Rebetol | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 29.6.2011 | Siklos | ADDMEDICA 101, rue Saint Lazare, Paris 75009, France | ADDMEDICA | 101, rue Saint Lazare, Paris 75009, France |
| ADDMEDICA | | | | |
| 101, rue Saint Lazare, Paris 75009, France | | | | |
| 29.6.2011 | Synflorix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, 1330 Rixensart, Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, 1330 Rixensart, Belgique | | | | |
| 29.6.2011 | Telmisartan Teva | 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 | | | | |
| 29.6.2011 | Vantavo | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 29.6.2011 | Velcade | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 29.6.2011 | VPRIV | Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland | Shire Pharmaceuticals Ireland Limited | 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland |
| Shire Pharmaceuticals Ireland Limited | | | | |
| 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland | | | | |
| 29.6.2011 | Zometa | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |

—   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 |
| -------------------------------------------- | ----------------------------- | -------------------------------------------------------------- | --------------------------------------------- | -------------------------------------------- |
| 14.6.2011 | Humenza | Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France | Sanofi Pasteur SA | 2, avenue Pont Pasteur, F-69007 Lyon, France |
| Sanofi Pasteur SA | | | | |
| 2, avenue Pont Pasteur, F-69007 Lyon, France | | | | |

—   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 Décision | 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 |
| --------------------------------------------------------- | ----------------------------- | ---------------------------------------------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------------------------- | ----------------------------------------------- | ---------------------- |
| 6.5.2011 | CERTIFECT | (S)-Methoprene, Fipronil, Amitraz | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, 69007 LYON, France | EU/2/11/125/001-008 | Spot-on solution |
| MERIAL | | | | | | | |
| 29 avenue Tony Garnier, 69007 LYON, France | | | | | | | |
| 6.5.2011 | Zuprevo | Tildipirosin | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/11/124/001-008 | Solution for injection |
| Intervet International B.V. | | | | | | | |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | | | | | | | |
| 14.6.2011 | MS-H vaccine | Mycoplasma synoviae
Strain MS-H live attenuated thermosensitive | Pharmsure Ltd Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom | Pharmsure Ltd | Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom | EU/2/11/126/001 | Eye drops, suspension |
| Pharmsure Ltd | | | | | | | |
| Bewell House, Bewell St, Hereford HR4 0BA, United Kingdom | | | | | | | |

—   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 |
| -------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------- | ---------------------------------------------- | -------------------------------------------------------------- |
| 16.5.2011 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea, Co. Galway, IRELAND |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | |
| Loughrea, Co. Galway, IRELAND | | | | |
| 18.5.2011 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | ECO Animal Health Ltd | 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | | | | |
| 18.5.2011 | Previcox | Merial 29 Avenue Tony Garnier, 69007 Lyon, France | Merial | 29 Avenue Tony Garnier, 69007 Lyon, France |
| Merial | | | | |
| 29 Avenue Tony Garnier, 69007 Lyon, France | | | | |
| 18.5.2011 | ProteqFlu | Merial 29 Avenue Tony Garnier, 69007 Lyon, France | Merial | 29 Avenue Tony Garnier, 69007 Lyon, France |
| Merial | | | | |
| 29 Avenue Tony Garnier, 69007 Lyon, France | | | | |
| 18.5.2011 | ProteqFlu-Te | Merial 29 Avenue Tony Garnier, 69007 Lyon, France | Merial | 29 Avenue Tony Garnier, 69007 Lyon, France |
| Merial | | | | |
| 29 Avenue Tony Garnier, 69007 Lyon, France | | | | |
| 23.5.2011 | Suvaxyn PCV | Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom | Fort Dodge Animal Health Ltd | Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom |
| Fort Dodge Animal Health Ltd | | | | |
| Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom | | | | |
| 7.6.2011 | Fevaxyn Pentofel | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 14.6.2011 | Advocate | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | 51368 Leverkusen, Deutschland |
| Bayer Animal Health GmbH | | | | |
| 51368 Leverkusen, Deutschland | | | | |
| 14.6.2011 | Naxcel | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 15.6.2011 | Convenia | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 23.6.2011 | Metacam | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | 55216 Ingelheim am Rhein, Deutschland |
| 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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