# C_2012056EN.01000101.xml

| 24.2.2012 | EN | Official Journal of the European Union | C 56/1 |
| --------- | -- | -------------------------------------- | ------ |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011

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

2012/C 56/01

—   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 |
| ---------------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- | --------------------------- | ------------------------------------------------ | -------------------- |
| 3.11.2011 | Plenadren | hydrocortisone | DuoCort Pharma AB Kullagatan 8-10, S-252 20 Helsingborg, Sveridge | DuoCort Pharma AB | Kullagatan 8-10, | S-252 20 Helsingborg, | Sveridge |
| DuoCort Pharma AB | | | | | | | |
| Kullagatan 8-10, | | | | | | | |
| S-252 20 Helsingborg, | | | | | | | |
| Sveridge | | | | | | | |
| 16.11.2011 | IOA | nomegestrol / estradiol | 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 | | | | | | | |
| 16.11.2011 | Vyndaqel | tafamidis | Pfizer Specialty UK Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Specialty UK Limited | Ramsgate Road, | Sandwich, | Kent |
| Pfizer Specialty UK Limited | | | | | | | |
| Ramsgate Road, | | | | | | | |
| Sandwich, | | | | | | | |
| Kent | | | | | | | |
| CT13 9NJ, | | | | | | | |
| United Kingdom | | | | | | | |
| 22.11.2011 | Rasitrio | aliskiren / amlodipine / hydrochlorothiazide | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, | Horsham, | West Sussex, |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, | | | | | | | |
| Horsham, | | | | | | | |
| West Sussex, | | | | | | | |
| RH12 5AB, | | | | | | | |
| United Kingdom | | | | | | | |
| 24.11.2011 | Desloratadine Teva | desloratadine | 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 | | | | | | | |
| 24.11.2011 | Komboglyze | saxagliptin / metformin | Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, | Uxbridge Business Park, | Sanderson Road, |
| Bristol Myers Squibb/AstraZeneca EEIG | | | | | | | |
| Bristol Myers Squibb House, | | | | | | | |
| Uxbridge Business Park, | | | | | | | |
| Sanderson Road, | | | | | | | |
| Uxbridge, | | | | | | | |
| Middlesex | | | | | | | |
| UB8 1DH, | | | | | | | |
| United Kingdom | | | | | | | |
| 24.11.2011 | Onduarp | telmisartan / amlodipine | Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Str. 173, | D-55216 Ingelheim am Rhein, | Deutschland |
| Boehringer Ingelheim International GmbH | | | | | | | |
| Binger Str. 173, | | | | | | | |
| D-55216 Ingelheim am Rhein, | | | | | | | |
| Deutschland | | | | | | | |
| 28.11.2011 | Dasselta | desloratadine | 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 | | | | | | | |
| 28.11.2011 | EDURANT | rilpivirine | 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 | | | | | | | |
| 28.11.2011 | Eviplera | emtricitabine / rilpivirine (as hydrochloride) / tenofovir disoproxil (as fumarate) | 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 | | | | | | | |
| 5.12.2011 | Dificlir | fidaxomicin | FGK Representative Service GmbH Heimeranstrasse 35, 80339 München, Deutschland | FGK Representative Service GmbH | Heimeranstrasse 35, | 80339 München, | Deutschland |
| FGK Representative Service GmbH | | | | | | | |
| Heimeranstrasse 35, | | | | | | | |
| 80339 München, | | | | | | | |
| Deutschland | | | | | | | |
| 5.12.2011 | Levetiracetam Actavis Group | levetiracetam | Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland | Actavis Group PTC ehf. | ReykjavÍkurvegur 76-78, | Hafnarfjörður 220, | Iceland |
| Actavis Group PTC ehf. | | | | | | | |
| ReykjavÍkurvegur 76-78, | | | | | | | |
| Hafnarfjörður 220, | | | | | | | |
| Iceland | | | | | | | |
| 7.12.2011 | Edarbi | azilsartan medoxomil | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | | | | |
| 61 Aldwych, | | | | | | | |
| London | | | | | | | |
| WC2B 4AE, | | | | | | | |
| United Kingdom | | | | | | | |
| 7.12.2011 | Ipreziv | azilsartan medoxomil | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | | | | |
| 61 Aldwych, | | | | | | | |
| London | | | | | | | |
| WC2B 4AE, | | | | | | | |
| United Kingdom | | | | | | | |
| 14.12.2011 | Ameluz | 5-Aminolaevulinic acid | Biofrontera Bioscience GmbH Hemmelrather Weg 201, 51377 Leverkusen, Deutschland | Biofrontera Bioscience GmbH | Hemmelrather Weg 201, | 51377 Leverkusen, | Deutschland |
| Biofrontera Bioscience GmbH | | | | | | | |
| Hemmelrather Weg 201, | | | | | | | |
| 51377 Leverkusen, | | | | | | | |
| Deutschland | | | | | | | |
| 14.12.2011 | Levetiracetam SUN | levetiracetam | Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland | Sun Pharmaceutical Industries Europe BV | Polarisavenue 87, | 2132 JH Hoofddorp, | Nederland |
| Sun Pharmaceutical Industries Europe BV | | | | | | | |
| Polarisavenue 87, | | | | | | | |
| 2132 JH Hoofddorp, | | | | | | | |
| Nederland | | | | | | | |
| 22.12.2011 | Repaglinide Accord | Repaglinide | Accord Healthcare Limited Sage house, 319 Pinner road, Harrow, HA1 4HF United Kingdom | Accord Healthcare Limited | Sage house, | 319 Pinner road, | Harrow, |
| Accord Healthcare Limited | | | | | | | |
| Sage house, | | | | | | | |
| 319 Pinner road, | | | | | | | |
| Harrow, | | | | | | | |
| HA1 4HF | | | | | | | |
| United Kingdom | | | | | | | |
| 22.12.2011 | Topotecan Eagle | topotecan | Eagle Laboratories Limited The Clock House, Station Approach, Marlow, Bucks SL7 1NT, UNITED KINGDOM | Eagle Laboratories Limited | The Clock House, | Station Approach, | Marlow, |
| Eagle Laboratories Limited | | | | | | | |
| The Clock House, | | | | | | | |
| Station Approach, | | | | | | | |
| Marlow, | | | | | | | |
| Bucks | | | | | | | |
| SL7 1NT, | | | | | | | |
| 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 |
| ----------------------------------------------------------- | ----------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------- | ---------------------------------------- |
| 3.11.2011 | Clopidogrel Krka | KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d. d., Novo mesto | Šmarješka cesta 6, |
| KRKA, d. d., Novo mesto | | | | |
| Šmarješka cesta 6, | | | | |
| 8501 Novo mesto, | | | | |
| Slovenija | | | | |
| 3.11.2011 | Clopidogrel TAD | TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland | TAD Pharma GmbH | Heinz-Lohmann-Straße 5, |
| TAD Pharma GmbH | | | | |
| Heinz-Lohmann-Straße 5, | | | | |
| 27472 Cuxhaven, | | | | |
| Deutschland | | | | |
| 3.11.2011 | Ozurdex | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals (Ireland) Ltd, | Castlebar Road, Westport, |
| Allergan Pharmaceuticals (Ireland) Ltd, | | | | |
| Castlebar Road, Westport, | | | | |
| Co. Mayo, | | | | |
| Ireland | | | | |
| 3.11.2011 | Pandemrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| B-1330 Rixensart, | | | | |
| Belgique | | | | |
| 3.11.2011 | Protaphane | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 3.11.2011 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 10.11.2011 | Actraphane | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 10.11.2011 | Actrapid | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 10.11.2011 | Arava | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, | | | | |
| Deutschland | | | | |
| 10.11.2011 | Avamys | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, |
| Glaxo Group Ltd | | | | |
| Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 10.11.2011 | Clopidogrel Mylan | Mylan S.A.S 117 allée des Parcs, 69 800 Saint Priest, France | Mylan S.A.S | 117 allée des Parcs, |
| Mylan S.A.S | | | | |
| 117 allée des Parcs, | | | | |
| 69 800 Saint Priest, | | | | |
| France | | | | |
| 10.11.2011 | Clopidogrel Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 10.11.2011 | Clopidogrel Zentiva | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, |
| Sanofi-Aventis | | | | |
| 174, avenue de France, | | | | |
| F-75013 Paris, | | | | |
| France | | | | |
| 10.11.2011 | Conbriza | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 10.11.2011 | Cyanokit | Merck Santé s.a.s. 37, rue Saint-Romain, 69379 Lyon Cedex 08, France | Merck Santé s.a.s. | 37, rue Saint-Romain, |
| Merck Santé s.a.s. | | | | |
| 37, rue Saint-Romain, | | | | |
| 69379 Lyon Cedex 08, | | | | |
| France | | | | |
| 10.11.2011 | ellaOne | Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France | Laboratoire HRA Pharma | 15, rue Béranger, |
| Laboratoire HRA Pharma | | | | |
| 15, rue Béranger, | | | | |
| 75003 Paris, | | | | |
| France | | | | |
| 10.11.2011 | Helixate NexGen | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 10.11.2011 | Javlor | Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France | Pierre Fabre Médicament | 45, place Abel Gance, |
| Pierre Fabre Médicament | | | | |
| 45, place Abel Gance, | | | | |
| F-92100 Boulogne, | | | | |
| France | | | | |
| 10.11.2011 | Kogenate Bayer | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 10.11.2011 | Levitra | Bayer Pharma AG Berlin 13342, Deutschland | Bayer Pharma AG | Berlin 13342, |
| Bayer Pharma AG | | | | |
| Berlin 13342, | | | | |
| Deutschland | | | | |
| 10.11.2011 | Silgard | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 10.11.2011 | Vectibix | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, |
| Amgen Europe B.V. | | | | |
| Minervum 7061, | | | | |
| NL-4817 ZK Breda, | | | | |
| Nederland | | | | |
| 10.11.2011 | Vfend | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 10.11.2011 | Victoza | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 10.11.2011 | 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. |
| BIAL - Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional 4745-457 S. | | | | |
| Mamede do Coronado - | | | | |
| Portugal | | | | |
| 10.11.2011 | Zevalin | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 10.11.2011 | Zoely | Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56 Marsh Wall, |
| Merck Serono Europe Limited | | | | |
| 56 Marsh Wall, | | | | |
| London | | | | |
| E14 9TP, | | | | |
| United Kingdom | | | | |
| 10.11.2011 | Zomarist | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 10.11.2011 | Zylagren | KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d. d., Novo mesto | Šmarješka cesta 6, |
| KRKA, d. d., Novo mesto | | | | |
| Šmarješka cesta 6, | | | | |
| 8501 Novo mesto, | | | | |
| Slovenija | | | | |
| 16.11.2011 | Exelon | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 16.11.2011 | Gardasil | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, | | | | |
| 69007 Lyon, | | | | |
| France | | | | |
| 16.11.2011 | Vivanza | Bayer Pharma AG Berlin 13342, Deutschland | Bayer Pharma AG | Berlin 13342, |
| Bayer Pharma AG | | | | |
| Berlin 13342, | | | | |
| Deutschland | | | | |
| 21.11.2011 | Adrovance | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 21.11.2011 | Aldurazyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, | | | | |
| NL-1411 DD Naarden, | | | | |
| Nederland | | | | |
| 21.11.2011 | Celsentri | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex, | | | | |
| TW8 9GS, | | | | |
| United Kingdom | | | | |
| 21.11.2011 | Champix | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 21.11.2011 | Copalia | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 21.11.2011 | Dafiro | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 21.11.2011 | Evoltra | Genzyme Europe BV Gooimeer 10, 1411 DD Naarden, Nederland | Genzyme Europe BV | Gooimeer 10, |
| Genzyme Europe BV | | | | |
| Gooimeer 10, | | | | |
| 1411 DD Naarden, | | | | |
| Nederland | | | | |
| 21.11.2011 | Firdapse | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | BioMarin Europe Ltd | 164 Shaftesbury Avenue, |
| BioMarin Europe Ltd | | | | |
| 164 Shaftesbury Avenue, | | | | |
| London | | | | |
| WC2H 8HL, | | | | |
| United Kingdom | | | | |
| 21.11.2011 | Inovelon | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, |
| Eisai Limited | | | | |
| European Knowledge Centre, | | | | |
| Mosquito Way, | | | | |
| Hatfield, | | | | |
| Hertfordshire, | | | | |
| AL10 9SN, | | | | |
| United Kingdom | | | | |
| 21.11.2011 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, | | | | |
| Deutschland | | | | |
| 21.11.2011 | Isentress | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 21.11.2011 | Rilonacept Regeneron | Regeneron UK Limited 40 Bank Street, London, E14 5DS United Kingdom | Regeneron UK Limited | 40 Bank Street, |
| Regeneron UK Limited | | | | |
| 40 Bank Street, | | | | |
| London, | | | | |
| E14 5DS | | | | |
| United Kingdom | | | | |
| 21.11.2011 | Tygacil | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, | | | | |
| Taplow, | | | | |
| Maidenhead, | | | | |
| Berkshire, | | | | |
| SL6 0PH, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Advagraf | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, | | | | |
| NL-2353 EW Leiderdorp, | | | | |
| Nederland | | | | |
| 22.11.2011 | Afinitor | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | Bristol-Myers Squibb and Gilead Sciences Limited | IDA Business & Technology Park, |
| Bristol-Myers Squibb and Gilead Sciences Limited | | | | |
| IDA Business & Technology Park, | | | | |
| Carrigtohill, | | | | |
| Co. Cork, | | | | |
| Ireland | | | | |
| 22.11.2011 | Dynastat | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Effentora | Cephalon Europe 5 Rue Charles Martigny, Maisons-Alfort 94700, France | Cephalon Europe | 5 Rue Charles Martigny, |
| Cephalon Europe | | | | |
| 5 Rue Charles Martigny, | | | | |
| Maisons-Alfort 94700, | | | | |
| France | | | | |
| 22.11.2011 | Exforge | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Fabrazyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, | | | | |
| NL-1411 DD Naarden, | | | | |
| Nederland | | | | |
| 22.11.2011 | Grepid | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | 6 Dervenakion, |
| Pharmathen S.A. | | | | |
| 6 Dervenakion, | | | | |
| 15351 Pallini Attiki, | | | | |
| Ελλάδα | | | | |
| 22.11.2011 | Imprida | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Invirase | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Levemir | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 22.11.2011 | Lyrica | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Myozyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, | | | | |
| NL-1411 DD Naarden, | | | | |
| Nederland | | | | |
| 22.11.2011 | Norvir | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, | | | | |
| Vanwall Business Park, | | | | |
| Vanwall Road, | | | | |
| Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Onglyza | Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, |
| Bristol Myers Squibb/AstraZeneca EEIG | | | | |
| Bristol Myers Squibb House, | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge, | | | | |
| Middlesex | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Optaflu | Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland | Novartis Vaccines and Diagnostics GmbH | Emil-von-Behring-Strasse 76, |
| Novartis Vaccines and Diagnostics GmbH | | | | |
| Emil-von-Behring-Strasse 76, | | | | |
| D-35041 Marburg, | | | | |
| Deutschland | | | | |
| 22.11.2011 | 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, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| 1330 Rixensart, | | | | |
| Belgique | | | | |
| 22.11.2011 | PecFent | Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom | Archimedes Development Ltd | Nottingham, |
| Archimedes Development Ltd | | | | |
| Nottingham, | | | | |
| NGT7 2TN, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Prepandrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| B-1330 Rixensart, | | | | |
| Belgique | | | | |
| 22.11.2011 | Rasilez | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Reyataz | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Riprazo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Riprazo HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex, | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Sprimeo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Tasigna | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Thalidomide Celgene | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, | | | | |
| Stockley Park, | | | | |
| Uxbridge | | | | |
| UB11 1DB, | | | | |
| United Kingdom | | | | |
| 22.11.2011 | Trisenox | Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, Cedex, France | Cephalon Europe | 5 Rue Charles Martigny, |
| Cephalon Europe | | | | |
| 5 Rue Charles Martigny, | | | | |
| 94700 Maisons Alfort, Cedex, | | | | |
| France | | | | |
| 22.11.2011 | Victoza | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 24.11.2011 | 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, |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, Avenue de la Gare, | | | | |
| L-1611 Luxembourg, | | | | |
| Luxembourg | | | | |
| 24.11.2011 | Atriance | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, | | | | |
| Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 24.11.2011 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 24.11.2011 | Clopidogrel HCS | HCS bvba H. Kennisstraat 53, B 2650 Edegem, Belgïe | HCS bvba | H. Kennisstraat 53, |
| HCS bvba | | | | |
| H. Kennisstraat 53, | | | | |
| B 2650 Edegem, | | | | |
| Belgïe | | | | |
| 24.11.2011 | Clopidogrel Teva Generics B.V. | Teva Generics B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Generics B.V. | Computerweg 10, |
| Teva Generics B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 24.11.2011 | Eucreas | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 24.11.2011 | Galvus | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 24.11.2011 | Icandra | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 24.11.2011 | Intelence | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België | Janssen-Cilag International NV | Turnhoutseweg, 30 - |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - | | | | |
| 2340 Beerse – | | | | |
| België | | | | |
| 24.11.2011 | Jalra | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 24.11.2011 | ReFacto AF | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 24.11.2011 | 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, |
| Alexion Europe S.A.S. | | | | |
| 25, boulevard de l'Amiral Bruix, | | | | |
| 75016 Paris, | | | | |
| France | | | | |
| 24.11.2011 | 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, |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, | | | | |
| 1070 Bruxelles, | | | | |
| Belgique/Researchdreef, 60, | | | | |
| Brussel 1070, | | | | |
| België | | | | |
| 24.11.2011 | Xiliarx | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 24.11.2011 | Zomarist | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 24.11.2011 | Zypadhera | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| NL-3991 RA Houten, | | | | |
| Nederland | | | | |
| 24.11.2011 | Zyprexa | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 24.11.2011 | Zyprexa Velotab | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 28.11.2011 | Emend | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 28.11.2011 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 28.11.2011 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 28.11.2011 | Zutectra | Biotest Pharma GmbH Landsteinerstr.5, 63303 Dreieich, Deutschland | Biotest Pharma GmbH | Landsteinerstr.5, |
| Biotest Pharma GmbH | | | | |
| Landsteinerstr.5, | | | | |
| 63303 Dreieich, | | | | |
| Deutschland | | | | |
| 28.11.2011 | Zyllt | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d.d., Novo mesto | Šmarješka cesta 6, |
| KRKA, d.d., Novo mesto | | | | |
| Šmarješka cesta 6, | | | | |
| 8501 Novo mesto, | | | | |
| Slovenija | | | | |
| 5.12.2011 | Aranesp | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, |
| Amgen Europe B.V. | | | | |
| Minervum 7061, | | | | |
| NL-4817 ZK Breda, | | | | |
| Nederland | | | | |
| 5.12.2011 | Cervarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| 1330 Rixensart, | | | | |
| Belgique | | | | |
| 5.12.2011 | Clopidogrel Acino | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| 83714 Miesbach, | | | | |
| Deutschland | | | | |
| 5.12.2011 | Clopidogrel Hexal | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| 83714 Miesbach, | | | | |
| Deutschland | | | | |
| 5.12.2011 | Controloc Control | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Nycomed GmbH | Byk-Gulden-Str. 2, |
| Nycomed GmbH | | | | |
| Byk-Gulden-Str. 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 5.12.2011 | Pantozol Control | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Nycomed GmbH | Byk-Gulden-Str. 2, |
| Nycomed GmbH | | | | |
| Byk-Gulden-Str. 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 5.12.2011 | Somac Control | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Nycomed GmbH | Byk-Gulden-Str. 2, |
| Nycomed GmbH | | | | |
| Byk-Gulden-Str. 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 5.12.2011 | Xenical | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 7.12.2011 | Clopidogrel Teva Pharma | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| 3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 7.12.2011 | Pantecta Control | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Nycomed GmbH | Byk-Gulden-Str. 2, |
| Nycomed GmbH | | | | |
| Byk-Gulden-Str. 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 7.12.2011 | Pantoloc Control | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Nycomed GmbH | Byk-Gulden-Str. 2, |
| Nycomed GmbH | | | | |
| Byk-Gulden-Str. 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 7.12.2011 | Prometax | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 7.12.2011 | Torisel | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 8.12.2011 | Ceplene | EpiCept GmbH Goethestrasse 4, D-80336 München, Deutschland | EpiCept GmbH | Goethestrasse 4, |
| EpiCept GmbH | | | | |
| Goethestrasse 4, | | | | |
| D-80336 München, | | | | |
| Deutschland | | | | |
| 9.12.2011 | Rasilamlo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex, | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 9.12.2011 | Xarelto | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 9.12.2011 | Zeffix | Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd. | Greenford Road, |
| Glaxo Group Ltd. | | | | |
| Greenford Road, | | | | |
| Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Clopidogrel ratiopharm | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| 83714 Miesbach, | | | | |
| Deutschland | | | | |
| 14.12.2011 | Emselex | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | GILENYA | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Glivec | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Insulatard | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 14.12.2011 | Lucentis | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Mabthera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Pegasys | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Simulect | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Vfend | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge |
| Gilead Sciences International Limited | | | | |
| Cambridge | | | | |
| CB21 6GT | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Volibris | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, |
| Glaxo Group Ltd | | | | |
| Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Advate | Baxter AG Industriesstrasse 67, 1221 Vienna, Österreich | Baxter AG | Industriesstrasse 67, |
| Baxter AG | | | | |
| Industriesstrasse 67, | | | | |
| 1221 Vienna, | | | | |
| Österreich | | | | |
| 19.12.2011 | APTIVUS | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- | | | | |
| D - 55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 19.12.2011 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Clopidogrel Acino Pharma GmbH | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| 83714 Miesbach, | | | | |
| Deutschland | | | | |
| 19.12.2011 | Emend | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Exjade | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Fendrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| B-1330 Rixensart, | | | | |
| Belgique | | | | |
| 19.12.2011 | Gardasil | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, | | | | |
| 69007 Lyon, | | | | |
| France | | | | |
| 19.12.2011 | Herceptin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Humira | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, | | | | |
| Vanwall Business Park, | | | | |
| Vanwall Road, | | | | |
| Maidenhead, Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Kentera | Nicobrand Limited 189 Castleroe Road, Coleraine, BT51 3 RP Northern Ireland | Nicobrand Limited | 189 Castleroe Road, |
| Nicobrand Limited | | | | |
| 189 Castleroe Road, | | | | |
| Coleraine, | | | | |
| BT51 3 RP | | | | |
| Northern Ireland | | | | |
| 19.12.2011 | Levemir | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 19.12.2011 | Noxafil | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Pandemic influenza vaccine H5N1 BAXTER | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | Baxter AG | Industriestraße 67, |
| Baxter AG | | | | |
| Industriestraße 67, | | | | |
| A - 1221 Wien, | | | | |
| Österreich | | | | |
| 19.12.2011 | Pandemrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| B-1330 Rixensart, | | | | |
| Belgique | | | | |
| 19.12.2011 | Silgard | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Somavert | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Synagis | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, | | | | |
| Vanwall Business Park, | | | | |
| Vanwall Road, | | | | |
| Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Tasigna | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Tesavel | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Tracleer | Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | BSI Building 13th Floor, |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor, | | | | |
| 389 Chiswick High Road, | | | | |
| London | | | | |
| W4 4AL, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Actos | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Actos | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Ambirix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| B-1330 Rixensart, | | | | |
| Belgique | | | | |
| 22.12.2011 | Arzerra | Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Glaxo Wellcome House, |
| Glaxo Group Ltd | | | | |
| Glaxo Wellcome House, | | | | |
| Berkeley Avenue, | | | | |
| Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Glubrava | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Glubrava | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Glustin | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Glustin | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Invanz | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Ivemend | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, | | | | |
| Hodderson, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Januvia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Multaq | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, |
| Sanofi-Aventis | | | | |
| 174, avenue de France, | | | | |
| F-75013 Paris, | | | | |
| France | | | | |
| 22.12.2011 | Multaq | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, |
| Sanofi-Aventis | | | | |
| 174, avenue de France, | | | | |
| F-75013 Paris, | | | | |
| France | | | | |
| 22.12.2011 | Nevanac | Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Boundary Way, |
| Alcon Laboratories (UK) Ltd. | | | | |
| Boundary Way, | | | | |
| Hemel Hempstead, | | | | |
| Herts | | | | |
| HP2 7UD, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Norvir | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, | | | | |
| Vanwall Business Park, | | | | |
| Vanwall Road, | | | | |
| Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Onglyza | Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, |
| Bristol Myers Squibb/AstraZeneca EEIG | | | | |
| Bristol Myers Squibb House, | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge, | | | | |
| Middlesex | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Ozurdex | Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road, |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road, | | | | |
| Westport, | | | | |
| Co. Mayo, | | | | |
| Ireland | | | | |
| 22.12.2011 | 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, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| 1330 Rixensart, | | | | |
| Belgique | | | | |
| 22.12.2011 | Prepandrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| B-1330 Rixensart, | | | | |
| Belgique | | | | |
| 22.12.2011 | Renagel | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, | | | | |
| NL-1411 DD Naarden, | | | | |
| Nederland | | | | |
| 22.12.2011 | Renvela | Genzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, | | | | |
| 1411 DD Naarden, | | | | |
| Nederland | | | | |
| 22.12.2011 | Ristaben | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Tandemact | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd. | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Tandemact | 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, |
| Takeda Global Research and Development Centre (Europe) Ltd. | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Vidaza | Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | Celgene Europe Ltd | 1 Longwalk Road, |
| Celgene Europe Ltd | | | | |
| 1 Longwalk Road, | | | | |
| Stockley Park, | | | | |
| Uxbridge, | | | | |
| UB11 1DB, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Xelevia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, | | | | |
| Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 22.12.2011 | Zavesca | Actelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | BSI Building 13th Floor, |
| Actelion Registration Ltd | | | | |
| BSI Building 13th Floor, | | | | |
| 389 Chiswick High Road, | | | | |
| London | | | | |
| W4 4AL, | | | | |
| 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 |
| ------------------------ | ----------------------------- | ----------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 28.11.2011 | Xigris | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------- |
| 24.11.2011 | Busilvex | Pierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France | Pierre Fabre Médicament | 45, Place Abel Gance, |
| Pierre Fabre Médicament | | | | |
| 45, Place Abel Gance, | | | | |
| 92654 Boulogne Billancourt Cedex, | | | | |
| France | | | | |
| 24.11.2011 | Caelyx | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, | | | | |
| B-2340 Beerse, | | | | |
| België | | | | |
| 24.11.2011 | VELCADE | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, | | | | |
| B-2340 Beerse, | | | | |
| België | | | | |
| 24.11.2011 | Vidaza | Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | Celgene Europe Ltd | 1 Longwalk Road, |
| Celgene Europe Ltd | | | | |
| 1 Longwalk Road, | | | | |
| Stockley Park, | | | | |
| Uxbridge, | | | | |
| UB11 1DB, | | | | |
| United Kingdom | | | | |
| 7.12.2011 | Ecalta | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 7.12.2011 | Luminity | Lantheus MI UK Limited Festival House – 39 Oxford Street – Newbury – Berkshire RG14 1JG – United Kingdom | Lantheus MI UK Limited | Festival House – |
| Lantheus MI UK Limited | | | | |
| Festival House – | | | | |
| 39 Oxford Street – | | | | |
| Newbury – | | | | |
| Berkshire | | | | |
| RG14 1JG – | | | | |
| United Kingdom | | | | |
| 12.12.2011 | Vistide | Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge, |
| Gilead Sciences International Limited | | | | |
| Cambridge, | | | | |
| CB21 6GT, | | | | |
| United Kingdom | | | | |

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

| Date of the 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 |
| ---------------------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------ | ---------------------------------------------- | ----------------------- | ------------------------------------------------ | -------------------- |
| 9.12.2011 | Inflacam | Meloxicam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea, | Co. Galway, | IRELAND |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | | | | |
| Loughrea, | | | | | | | |
| Co. Galway, | | | | | | | |
| IRELAND | | | | | | | |
| 9.12.2011 | Panacur AquaSol | Fenbendazole | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, | 5831 AN Boxmeer, | Nederland |
| Intervet International B.V. | | | | | | | |
| Wim de Körverstraat 35, | | | | | | | |
| 5831 AN Boxmeer, | | | | | | | |
| Nederland | | | | | | | |
| 14.12.2011 | TruScient | Dibotermin alfa | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, | Sandwich, | Kent |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, | | | | | | | |
| Sandwich, | | | | | | | |
| Kent | | | | | | | |
| CT13 9NJ, | | | | | | | |
| 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 |
| ----------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------- |
| 10.11.2011 | ProMeris | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| United Kingdom | | | | |
| 10.11.2011 | ProMeris Duo | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 10.11.2011 | Zulvac 8 Bovis | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 10.11.2011 | Zulvac 8 Ovis | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 16.11.2011 | Prac-Tic | Novartis Sanidad Animal S.L. Calle de la Marina, 206, E - Barcelona 08013, ESPANA | Novartis Sanidad Animal S.L. | Calle de la Marina, 206, |
| Novartis Sanidad Animal S.L. | | | | |
| Calle de la Marina, 206, | | | | |
| E - Barcelona 08013, | | | | |
| ESPANA | | | | |
| 24.11.2011 | Coxevac | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, |
| CEVA SANTE ANIMALE | | | | |
| 10 avenue de la Ballastière, | | | | |
| 33500 Libourne, | | | | |
| France | | | | |
| 24.11.2011 | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | 55216 Ingelheim am Rhein, |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| 55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 28.11.2011 | Melosus | CP-Pharma Handelsgesellschaft mbH Ostlandring 13, D-31303 Burgdorf, Deutschland | CP-Pharma Handelsgesellschaft mbH | Ostlandring 13, |
| CP-Pharma Handelsgesellschaft mbH | | | | |
| Ostlandring 13, | | | | |
| D-31303 Burgdorf, | | | | |
| Deutschland | | | | |
| 5.12.2011 | Porcilis Porcoli | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, | | | | |
| 5831 AN Boxmeer, | | | | |
| Nederland | | | | |
| 9.12.2011 | Masivet | AB Science S.A. 3 avenue George V, 75008 Paris, France | AB Science S.A. | 3 avenue George V, |
| AB Science S.A. | | | | |
| 3 avenue George V, | | | | |
| 75008 Paris, | | | | |
| France | | | | |
| 9.12.2011 | Zulvac 1 Ovis | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Trocoxil | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ | | | | |
| United Kingdom | | | | |
| 14.12.2011 | Zulvac 1 Bovis | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 19.12.2011 | Meloxidyl | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, |
| CEVA SANTE ANIMALE | | | | |
| 10 avenue de la Ballastière, | | | | |
| 33500 Libourne, | | | | |
| France | | | | |
| 19.12.2011 | Ypozane | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. – 06516 Carros – France | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. – |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. – | | | | |
| 06516 Carros – | | | | |
| France | | | | |

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| ----------------------------- |
| 7, Westferry Circus, |
| Canary Wharf |
| UK - LONDON E14 4H |

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

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

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