# C_2011184EN.01000101.xml

| 24.6.2011 | EN | Official Journal of the European Union | C 184/1 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2011 to 30 April 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 184/01

—   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 |
| --------------------------------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------------------------------------------------------- | ----------------------------------------------- | -------------------------------------------------- |
| 4.3.2011 | Ifirmacombi | Irbesartan/hydrochlorothiazide | KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d. d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/673/001-024 | Film-coated tablet |
| KRKA, d. d., Novo mesto | | | | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | | | | |
| 4.3.2011 | Pumarix | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) | 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 | EU/1/10/664/001 | Suspension and emulsion for emulsion for injection |
| GlaxoSmithKline Biologicals S.A. | | | | | | | |
| rue de l'Institut 89, Rixensart, B-1330 Belgique | | | | | | | |
| 4.3.2011 | Xeplion | paliperidone | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/672/001-006 | Prolonged release suspension for injection |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | | | | |
| 10.3.2011 | Leflunomide Teva | leflunomide | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/11/675/001-010 | Film-coated tablet |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | | | | |
| 14.3.2011 | Repso | leflunomide | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/11/674/001-010 | Film-coated tablet |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | | | | |
| 14.3.2011 | Teysuno | Tegafur/gimeracil/oteracil | Taiho Pharma Europe, Limited 55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom | Taiho Pharma Europe, Limited | 55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom | EU/1/11/669/001-004 | Capsule, hard |
| Taiho Pharma Europe, Limited | | | | | | | |
| 55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom | | | | | | | |
| 17.3.2011 | GILENYA | Fingolimod | 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/1/11/677/001-004 | Capsule, hard |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | | | | |
| 17.3.2011 | HALAVEN | eribulin | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | EU/1/11/678/001-002 | Solution for injection |
| Eisai Limited | | | | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | | | | | | | |
| 17.3.2011 | JEVTANA | cabazitaxel | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, F-75013 Paris, France | EU/1/11/676/001 | Concentrate and solvent for solution for infusion |
| Sanofi-Aventis | | | | | | | |
| 174, avenue de France, F-75013 Paris, France | | | | | | | |
| 28.3.2011 | Trobalt | retigabine | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/11/681/001-013 | Film-coated tablet |
| Glaxo Group Limited | | | | | | | |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | | | | |
| 13.4.2011 | Riprazo 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/1/11/680/001-080 | Film-coated tablet |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | | | | |
| 14.4.2011 | Hizentra | human normal immunoglobulin | CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland | CSL Behring GmbH | Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland | EU/1/11/687/001-012 | Solution for injection |
| CSL Behring GmbH | | | | | | | |
| Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland | | | | | | | |
| 14.4.2011 | Pravafenix | fenofibrate / pravastatin | LABORATOIRES SMB SA 26-28 rue de la Pastorale, 1080 Brussels, Belgique - 26-28 Herdersliedstraat, 1080, Brussel, Belgïe | LABORATOIRES SMB SA | 26-28 rue de la Pastorale, 1080 Brussels, Belgique - 26-28 Herdersliedstraat, 1080, Brussel, Belgïe | EU/1/11/679/001-006 | Capsule, hard |
| LABORATOIRES SMB SA | | | | | | | |
| 26-28 rue de la Pastorale, 1080 Brussels, Belgique - 26-28 Herdersliedstraat, 1080, Brussel, Belgïe | | | | | | | |
| 14.4.2011 | Rasilamlo | aliskiren / amlodipine | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | EU/1/11/686/001-056 | Film-coated tablet |
| Novartis Europharm Ltd | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, 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 |
| ------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------ |
| 4.3.2011 | Silgard | 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 | | | | |
| 4.3.2011 | Vaniqa | Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España | Almirall, S.A. | Ronda General Mitre, 151, 08022 Barcelona, España |
| Almirall, S.A. | | | | |
| Ronda General Mitre, 151, 08022 Barcelona, España | | | | |
| 8.3.2011 | Clopidogrel DURA | Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland | Mylan dura GmbH | Wittichstraße 6, D-64295 Darmstadt, Deutschland |
| Mylan dura GmbH | | | | |
| Wittichstraße 6, D-64295 Darmstadt, Deutschland | | | | |
| 8.3.2011 | Clopidogrel Mylan | Mylan S.A.S 117 allée des Parcs, 69 800 Saint Priest, France | Mylan S.A.S | 117 allée des Parcs, 69 800 Saint Priest, France |
| Mylan S.A.S | | | | |
| 117 allée des Parcs, 69 800 Saint Priest, France | | | | |
| 8.3.2011 | 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 | | | | |
| 8.3.2011 | 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 | | | | |
| 10.3.2011 | Abraxane | Abraxis BioScience Limited Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom | Abraxis BioScience Limited | Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom |
| Abraxis BioScience Limited | | | | |
| Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom | | | | |
| 10.3.2011 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland | Medice Arzneimittel Pütter GmbH & Co KG | Kuhloweg 37, D-58638 Iserlohn, Deutschland |
| Medice Arzneimittel Pütter GmbH & Co KG | | | | |
| Kuhloweg 37, D-58638 Iserlohn, Deutschland | | | | |
| 10.3.2011 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland | Medice Arzneimittel Pütter GmbH & Co KG | Kuhloweg 37, D-58638 Iserlohn, Deutschland |
| Medice Arzneimittel Pütter GmbH & Co KG | | | | |
| Kuhloweg 37, D-58638 Iserlohn, Deutschland | | | | |
| 10.3.2011 | Clopidogrel Teva Pharma | 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 | | | | |
| 14.3.2011 | Actrapid | 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 | | | | |
| 14.3.2011 | 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 | | | | |
| 14.3.2011 | Binocrit | Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich | Sandoz GmbH | Biochemiestrasse 10, Kundl 6250, Österreich |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10, Kundl 6250, Österreich | | | | |
| 14.3.2011 | Binocrit | Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich | Sandoz GmbH | Biochemiestrasse 10, Kundl 6250, Österreich |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10, Kundl 6250, Österreich | | | | |
| 14.3.2011 | Clopidogrel Acino | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, 83714 Miesbach, Deutschland |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, 83714 Miesbach, Deutschland | | | | |
| 14.3.2011 | Clopidogrel Hexal | Acino Pharma GmbH Am Windfeld 35, Miesbach 83714, Deutschland | Acino Pharma GmbH | Am Windfeld 35, Miesbach 83714, Deutschland |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, Miesbach 83714, Deutschland | | | | |
| 14.3.2011 | Epoetin alfa 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 | | | | |
| 14.3.2011 | Epoetin alfa 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 | | | | |
| 14.3.2011 | Prometax | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 14.3.2011 | Rivastigmine 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 | | | | |
| 14.3.2011 | Visudyne | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 17.3.2011 | Actraphane | 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 | | | | |
| 17.3.2011 | Clopidogrel Sandoz | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, 83714 Miesbach, Deutschland |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, 83714 Miesbach, Deutschland | | | | |
| 17.3.2011 | Copalia HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 17.3.2011 | Dafiro HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 17.3.2011 | Exelon | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 17.3.2011 | HBVAXPRO | 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 | | | | |
| 17.3.2011 | INOmax | INO Therapeutics AB SE-181 81 Lidingö, Sverige | INO Therapeutics AB | SE-181 81 Lidingö, Sverige |
| INO Therapeutics AB | | | | |
| SE-181 81 Lidingö, Sverige | | | | |
| 17.3.2011 | Liprolog | 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 | | | | |
| 17.3.2011 | Mixtard | 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 | | | | |
| 17.3.2011 | NovoMix | 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 | | | | |
| 17.3.2011 | ProQuad | 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 | | | | |
| 17.3.2011 | Protaphane | 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 | | | | |
| 18.3.2011 | 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 | | | | |
| 18.3.2011 | 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 | | | | |
| 18.3.2011 | Humira | 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 | | | | |
| 18.3.2011 | INOmax | INO Therapeutics AB SE-181 81 Lidingö, Sverige | INO Therapeutics AB | SE-181 81 Lidingö, Sverige |
| INO Therapeutics AB | | | | |
| SE-181 81 Lidingö, Sverige | | | | |
| 18.3.2011 | 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 | | | | |
| 18.3.2011 | 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, SL6 4XE Maidenhead, Berks, United Kingdom |
| Abbott Laboratories | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom | | | | |
| 18.3.2011 | 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 | | | | |
| 18.3.2011 | 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 | | | | |
| 18.3.2011 | Menveo | 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 | | | | |
| 18.3.2011 | 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 | | | | |
| 18.3.2011 | Rasilez | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 18.3.2011 | Rasilez HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 18.3.2011 | Riprazo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 18.3.2011 | RoActemra | 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 | | | | |
| 18.3.2011 | 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 | | | | |
| 18.3.2011 | Simulect | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 18.3.2011 | 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 | | | | |
| 18.3.2011 | Xyrem | UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | UCB Pharma Ltd. | 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |
| UCB Pharma Ltd. | | | | |
| 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | | | | |
| 18.3.2011 | Zerit | 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 | | | | |
| 24.3.2011 | 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 | | | | |
| 24.3.2011 | Cayston | Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Granta Park, Abington, Cambridge CB21 6GT, United Kingdom |
| Gilead Sciences International Limited | | | | |
| Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | | | | |
| 24.3.2011 | Clopidogrel ratiopharm | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, 83714 Miesbach, Deutschland |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, 83714 Miesbach, Deutschland | | | | |
| 24.3.2011 | DuoTrav | Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |
| Alcon Laboratories (UK) Ltd. | | | | |
| Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | | | | |
| 24.3.2011 | Evoltra | Genzyme Europe BV Gooimeer 10, 1411 DD Naarden, Nederland | Genzyme Europe BV | Gooimeer 10, 1411 DD Naarden, Nederland |
| Genzyme Europe BV | | | | |
| Gooimeer 10, 1411 DD Naarden, Nederland | | | | |
| 24.3.2011 | Exforge HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 24.3.2011 | 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 | | | | |
| 24.3.2011 | Grepid | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
| Pharmathen S.A. | | | | |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | | | | |
| 24.3.2011 | HBVAXPRO | 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 | | | | |
| 24.3.2011 | Humalog | 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 | | | | |
| 24.3.2011 | Imprida HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 24.3.2011 | Insulatard | 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 | | | | |
| 24.3.2011 | Levitra | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 24.3.2011 | Myocet | Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France | Cephalon Europe | 5 Rue Charles Martigny, Maisons Alfort 94700, France |
| Cephalon Europe | | | | |
| 5 Rue Charles Martigny, Maisons Alfort 94700, France | | | | |
| 24.3.2011 | 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 | | | | |
| 24.3.2011 | 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 | | | | |
| 24.3.2011 | Reyataz | 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 | | | | |
| 24.3.2011 | Scintimun | CIS bio international Boite Postale 32 - F-91192 Gif-sur-Yvette - France | CIS bio international | Boite Postale 32 - F-91192 Gif-sur-Yvette - France |
| CIS bio international | | | | |
| Boite Postale 32 - F-91192 Gif-sur-Yvette - France | | | | |
| 24.3.2011 | Silodyx | Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland | Recordati Ireland Ltd. | Raheens East, Ringaskiddy Co. Cork, Ireland |
| Recordati Ireland Ltd. | | | | |
| Raheens East, Ringaskiddy Co. Cork, Ireland | | | | |
| 24.3.2011 | Soliris | Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France | Alexion Europe S.A.S. | 25, boulevard de l'Amiral Bruix, 75016 Paris, France |
| Alexion Europe S.A.S. | | | | |
| 25, boulevard de l'Amiral Bruix, 75016 Paris, France | | | | |
| 24.3.2011 | Sprimeo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 24.3.2011 | Toviaz | 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 | | | | |
| 24.3.2011 | Urorec | Recordati Ireland Ltd. Raheens East, Ringaskiddy Co. Cork, Ireland | Recordati Ireland Ltd. | Raheens East, Ringaskiddy Co. Cork, Ireland |
| Recordati Ireland Ltd. | | | | |
| Raheens East, Ringaskiddy Co. Cork, Ireland | | | | |
| 24.3.2011 | 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 | | | | |
| 24.3.2011 | 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 | | | | |
| 24.3.2011 | Zopya | Norpharm Regulatory Services Ltd 26 Laurence Street, Drogheda, Co. Louth, Ireland | Norpharm Regulatory Services Ltd | 26 Laurence Street, Drogheda, Co. Louth, Ireland |
| Norpharm Regulatory Services Ltd | | | | |
| 26 Laurence Street, Drogheda, Co. Louth, Ireland | | | | |
| 24.3.2011 | Zostavax | 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 | | | | |
| 28.3.2011 | Adenuric | 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 | | | | |
| 28.3.2011 | Afinitor | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 28.3.2011 | Evicel | OMRIX biopharmaceuticals S.A. / N.V. 200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België | OMRIX biopharmaceuticals S.A. / N.V. | 200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België |
| OMRIX biopharmaceuticals S.A. / N.V. | | | | |
| 200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België | | | | |
| 28.3.2011 | 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 | | | | |
| 28.3.2011 | Oprymea | KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d. d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
| KRKA, d. d., Novo mesto | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | |
| 28.3.2011 | Vizarsin | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d.d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
| KRKA, d.d., Novo mesto | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | |
| 31.3.2011 | Ilaris | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 31.3.2011 | Temozolomide 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 | | | | |
| 8.4.2011 | Copalia | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 8.4.2011 | Dafiro | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 8.4.2011 | 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 | | | | |
| 8.4.2011 | 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 | | | | |
| 8.4.2011 | NovoRapid | 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 | | | | |
| 8.4.2011 | 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 | | | | |
| 8.4.2011 | 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 | | | | |
| 12.4.2011 | Aclasta | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 12.4.2011 | 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 | | | | |
| 12.4.2011 | Firdapse | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | BioMarin Europe Ltd | 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |
| BioMarin Europe Ltd | | | | |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | | | | |
| 12.4.2011 | Kineret | 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 | | | | |
| 12.4.2011 | Nexavar | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 12.4.2011 | Sildenafil ratiopharm | 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 | | | | |
| 14.4.2011 | 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 | | | | |
| 14.4.2011 | 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 | | | | |
| 14.4.2011 | 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 | | | | |
| 14.4.2011 | Brinavess | 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 | | | | |
| 14.4.2011 | Ceplene | EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland | EpiCept GmbH | Goethestrasse 4, D-80336 München, Deutschland |
| EpiCept GmbH | | | | |
| Goethestrasse 4, D-80336 München, Deutschland | | | | |
| 14.4.2011 | Integrilin | Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom | Glaxo Group Ltd | Greenford, Middlesex, UB6 ONN, United Kingdom |
| Glaxo Group Ltd | | | | |
| Greenford, Middlesex, UB6 ONN, United Kingdom | | | | |
| 14.4.2011 | NutropinAq | 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 | | | | |
| 14.4.2011 | Preotact | 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 | | | | |
| 14.4.2011 | 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 | | | | |
| 14.4.2011 | Travatan | Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |
| Alcon Laboratories (UK) Ltd. | | | | |
| Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | | | | |
| 14.4.2011 | Zopya | Norpharm Regulatory Services Ltd 26 Laurence Street, Drogheda, Co. Louth, Ireland | Norpharm Regulatory Services Ltd | 26 Laurence Street, Drogheda, Co. Louth, Ireland |
| Norpharm Regulatory Services Ltd | | | | |
| 26 Laurence Street, Drogheda, Co. Louth, Ireland | | | | |
| 18.4.2011 | Arava | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, Deutschland |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, Deutschland | | | | |
| 18.4.2011 | DaTSCAN | GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom | GE Healthcare Limited | Little Chalfont, Bucks HP7 9NA, United Kingdom |
| GE Healthcare Limited | | | | |
| Little Chalfont, Bucks HP7 9NA, United Kingdom | | | | |
| 18.4.2011 | 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 | | | | |
| 18.4.2011 | Firazyr | Jerini AG Invalidenstr. 130, D-10115 Berlin, Deutschland | Jerini AG | Invalidenstr. 130, D-10115 Berlin, Deutschland |
| Jerini AG | | | | |
| Invalidenstr. 130, D-10115 Berlin, Deutschland | | | | |
| 18.4.2011 | Humalog | 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 | | | | |
| 18.4.2011 | 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, SL6 4XE Maidenhead, Berks, United Kingdom |
| Abbott Laboratories | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, SL6 4XE Maidenhead, Berks, United Kingdom | | | | |
| 18.4.2011 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, Deutschland |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, Deutschland | | | | |
| 18.4.2011 | Modigraf | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, 2353 EW Leiderdorp, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland | | | | |
| 18.4.2011 | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | 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 | | | | |
| 18.4.2011 | 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 | | | | |
| 18.4.2011 | Rasilez | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 18.4.2011 | Somavert | 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 | | | | |
| 18.4.2011 | 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 | | | | |
| 18.4.2011 | Thalidomide Celgene | Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | Celgene Europe Limited | Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom |
| Celgene Europe Limited | | | | |
| Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | | | | |
| 18.4.2011 | Valtropin | BioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, Deutschland | BioPartners GmbH | Kaiserpassage 11 - D-72764 Reutlingen, Deutschland |
| BioPartners GmbH | | | | |
| Kaiserpassage 11 - D-72764 Reutlingen, Deutschland | | | | |
| 18.4.2011 | Xyrem | UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | UCB Pharma Ltd. | 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |
| UCB Pharma Ltd. | | | | |
| 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | | | | |
| 20.4.2011 | 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 Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 20.4.2011 | 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 | | | | |
| 20.4.2011 | Altargo | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 20.4.2011 | Efient | 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 | | | | |
| 20.4.2011 | 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 | | | | |
| 20.4.2011 | Levitra | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 20.4.2011 | Liprolog | 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 | | | | |
| 20.4.2011 | Prepandrix | 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 | | | | |
| 20.4.2011 | 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 | | | | |
| 20.4.2011 | Revasc | Canyon Pharmaceuticals Ltd 20-22 Bedford Row - WC1R 4JS London - United Kingdom | Canyon Pharmaceuticals Ltd | 20-22 Bedford Row - WC1R 4JS London - United Kingdom |
| Canyon Pharmaceuticals Ltd | | | | |
| 20-22 Bedford Row - WC1R 4JS London - United Kingdom | | | | |
| 20.4.2011 | 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 | | | | |
| 20.4.2011 | Tolura | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d.d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
| KRKA, d.d., Novo mesto | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | |
| 20.4.2011 | 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 | | | | |
| 20.4.2011 | Vivanza | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 20.4.2011 | Zerit | 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 | | | | |

—   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 |
| ------------------------------------------------------ | ----------------------------- | --------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------ |
| 24.3.2011 | Onsenal | 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 | | | | |
| 31.3.2011 | Clopidogrel Sandoz | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, 83714 Miesbach, Deutschland |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, 83714 Miesbach, Deutschland | | | | |
| 20.4.2011 | Filgrastim ratiopharm | 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 | | | | |

—   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 |
| ------------------------------------------------------ | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------ | ----------------------------------------------- | ----------------------------------------------------- |
| 14.3.2011 | CaniLeish | Leishmania infantum Excreted Secreted Proteins (ESP) | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros - France | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/11/121/001-009 | Lyophilisate and solvent for suspension for injection |
| VIRBAC S.A. | | | | | | | |
| 1ère Avenue 2065 m L.I.D. - 06516 Carros - France | | | | | | | |
| 14.3.2011 | ZULVAC 1+8 Ovis | Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 / Inactivated Bluetongue Virus, serotype 8, strain BTV-8/BEL2006/02 | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/11/120/001-003 | Suspension for injection |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | | | | |
| 12.4.2011 | Veraflox | Pradofloxacin | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | 51368 Leverkusen, Deutschland | EU/2/10/107/001-014 | Oral suspension Tablet |
| Bayer Animal Health GmbH | | | | | | | |
| 51368 Leverkusen, Deutschland | | | | | | | |
| 14.4.2011 | BLUEVAC BTV8 | Bluetongue virus inactivated, serotype 8 | CZ Veterinaria, S.A. La Relva s/n, P.O. Box 16, Porriño 36400, ESPANA | CZ Veterinaria, S.A. | La Relva s/n, P.O. Box 16, Porriño 36400, ESPANA | EU/2/11/122/001-003 | Suspension for injection |
| CZ Veterinaria, S.A. | | | | | | | |
| La Relva s/n, P.O. Box 16, Porriño 36400, ESPANA | | | | | | | |
| 20.4.2011 | Procox | emodepside & toltrazuril | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | 51368 Leverkusen, Deutschland | EU/2/11/123/001-002 | Oral suspension |
| Bayer Animal Health GmbH | | | | | | | |
| 51368 Leverkusen, Deutschland | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ----------------------------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------------------------------------------------- |
| 10.3.2011 | Flexicam | Dechra Veterinary Products A/S Mekuvej 9, 7171 Uldum, Danmark | Dechra Veterinary Products A/S | Mekuvej 9, 7171 Uldum, Danmark |
| Dechra Veterinary Products A/S | | | | |
| Mekuvej 9, 7171 Uldum, Danmark | | | | |
| 14.3.2011 | Zulvac 8 Bovis | 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 | | | | |
| 18.3.2011 | Zubrin | Schering - Plough Limited Schering - Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom | Schering - Plough Limited | Schering - Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom |
| Schering - Plough Limited | | | | |
| Schering - Plough House, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW, United Kingdom | | | | |
| 28.3.2011 | BTVPUR AlSap 8 | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, 69007 LYON, France |
| MERIAL | | | | |
| 29 avenue Tony Garnier, 69007 LYON, France | | | | |
| 12.4.2011 | Zactran | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, 69007 LYON, France |
| MERIAL | | | | |
| 29 avenue Tony Garnier, 69007 LYON, France | | | | |
| 14.4.2011 | 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 | | | | |

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, 30.4.04, p. 1.

( 2 )  OJ L 136, 30.4.04, p. 1.

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