# C_2011316EN.01000101.xml

| 28.10.2011 | EN | Official Journal of the European Union | C 316/1 |
| ---------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2011 to 31 August 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 316/01

—   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 |
| ---------------------------------------------------------------------------------- | ----------------------------------- | ---------------------------------------- | --------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------------------ |
| 13.7.2011 | Benlysta | belimumab | Glaxo Group Limited Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/11/700/001-002 | powder for concentrate for solution for infusion |
| Glaxo Group Limited | | | | | | | |
| Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | | | | |
| 13.7.2011 | Temozolomide Sun | temozolomide | Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland | Sun Pharmaceuticals Industries Europe B.V. | Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/697/001-012 | Capsule, hard |
| Sun Pharmaceuticals Industries Europe B.V. | | | | | | | |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland | | | | | | | |
| 13.7.2011 | Xgeva | denosumab | Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, 4817 ZK Breda, Nederland | EU/1/11/703/001-002 | Solution for injection |
| Amgen Europe B.V. | | | | | | | |
| Minervum 7061, 4817 ZK Breda, Nederland | | | | | | | |
| 13.7.2011 | Yervoy | ipilimumab | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698/001-002 | Concentrate for solution for infusion |
| Bristol-Myers Squibb Pharma EEIG | | | | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | | | | |
| 18.7.2011 | Victrelis | boceprevir | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704/001 | Capsule, hard |
| Merck Sharp & Dohme Limited | | | | | | | |
| Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | | | | | | | |
| 20.7.2011 | Fampyra | fampridine | Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Limited | Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/11/699/001-002 | Prolonged-release tablet |
| Biogen Idec Limited | | | | | | | |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | | | | | | | |
| 20.7.2011 | TOBI Podhaler | Tobramycin | 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/1/10/652/001-003 | Inhalation powder, hard capsule |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | | | | |
| 26.7.2011 | Ibandronic acid Sandoz | Ibandronic acid | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | EU/1/11/685/001-005 | Film-coated tablet |
| Sandoz Pharmaceuticals GmbH | | | | | | | |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | | | | | | | |
| 27.7.2011 | Zoely | nomegestrol/estradiol | Merck Serono Europe Limited 56 Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56 Marsh Wall, London E14 9TP, United Kingdom | EU/1/11/690/001-002 | Film-coated tablet |
| Merck Serono Europe Limited | | | | | | | |
| 56 Marsh Wall, London E14 9TP, United Kingdom | | | | | | | |
| 18.8.2011 | Entacapone Orion | entacapone | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/708/001-004 | Film-coated tablet |
| Orion Corporation | | | | | | | |
| Orionintie 1, FI-02200 Espoo, Suomi | | | | | | | |
| 24.8.2011 | Levodopa/Carbidopa/Entacapone Orion | Levodopa, carbidopa, entacapone | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/706/001-033 | Film-coated tablet |
| Orion Corporation | | | | | | | |
| Orionintie 1, FI-02200 Espoo, Suomi | | | | | | | |
| 24.8.2011 | Trajenta | linagliptin | 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 | EU/1/11/707/001-011 | Film-coated tablet |
| Boehringer Ingelheim International GmbH | | | | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | | | | |
| 26.8.2011 | Levetiracetam ratiopharm | levetiracetam | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/702/001-031 | Film-coated tablet
Oral solution |
| ratiopharm GmbH | | | | | | | |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | | | | | | | |
| 26.8.2011 | Levetiracetam Teva | levetiracetam | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/11/701/001-028 | Film-coated tablet |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | | | | |

—   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 |
| ------------------------------------------------------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------ | ------------------------------------------------------------------------------------------------------- |
| 5.7.2011 | Irbesartan Winthrop | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, F-75013 Paris, France |
| Sanofi-Aventis | | | | |
| 174, avenue de France, F-75013 Paris, France | | | | |
| 5.7.2011 | Relistor | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 7.7.2011 | 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 | | | | |
| 7.7.2011 | Ammonaps | Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige | Swedish Orphan Biovitrum International AB | SE-112 76 Stockholm, Sverige |
| Swedish Orphan Biovitrum International AB | | | | |
| SE-112 76 Stockholm, Sverige | | | | |
| 7.7.2011 | Hirobriz Breezhaler | 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 | | | | |
| 7.7.2011 | 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 | | | | |
| 7.7.2011 | Removab | Fresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, Deutschland | Fresenius Biotech GmbH | Am Haag 6-7, D-82166 Graefelfing, Deutschland |
| Fresenius Biotech GmbH | | | | |
| Am Haag 6-7, D-82166 Graefelfing, Deutschland | | | | |
| 11.7.2011 | 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 | | | | |
| 11.7.2011 | Onbrez Breezhaler | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 11.7.2011 | 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, D-35041 Marburg, Deutschland |
| Novartis Vaccines and Diagnostics GmbH | | | | |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland | | | | |
| 13.7.2011 | 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 | | | | |
| 13.7.2011 | Stocrin | 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 | | | | |
| 13.7.2011 | Sustiva | 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 | | | | |
| 13.7.2011 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 13.7.2011 | 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 | | | | |
| 18.7.2011 | Crixivan | 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 | | | | |
| 18.7.2011 | Intrinsa | Warner Chilcott UK Ltd Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom | Warner Chilcott UK Ltd | Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom |
| Warner Chilcott UK Ltd | | | | |
| Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom | | | | |
| 18.7.2011 | Livensa | Warner Chilcott Deutschland Gmbh Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland | Warner Chilcott Deutschland Gmbh | Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland |
| Warner Chilcott Deutschland Gmbh | | | | |
| Dr.-Otto-Röhm-Strasse 2-4, Weiterstadt 64331, Deutschland | | | | |
| 18.7.2011 | Multaq | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, F-75013 Paris, France |
| Sanofi-Aventis | | | | |
| 174, avenue de France, F-75013 Paris, France | | | | |
| 18.7.2011 | ReFacto AF | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 18.7.2011 | Savene | SpePharm Holding BV Kingsfordweg 151, GR Amsterdam 1043, Nederland | SpePharm Holding BV | Kingsfordweg 151, GR Amsterdam 1043, Nederland |
| SpePharm Holding BV | | | | |
| Kingsfordweg 151, GR Amsterdam 1043, Nederland | | | | |
| 20.7.2011 | Atriance | 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 | | | | |
| 20.7.2011 | Betaferon | Bayer Schering Pharma AG Müllerstrasse 170-178, D - 13342 Berlin, Deutschland | Bayer Schering Pharma AG | Müllerstrasse 170-178, D - 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| Müllerstrasse 170-178, D - 13342 Berlin, Deutschland | | | | |
| 20.7.2011 | Esbriet | InterMune UK Ltd 4th Floor, One Victoria Street, Bristol, BS1 6AA, United Kingdom | InterMune UK Ltd | 4th Floor, One Victoria Street, Bristol, BS1 6AA, United Kingdom |
| InterMune UK Ltd | | | | |
| 4th Floor, One Victoria Street, Bristol, BS1 6AA, United Kingdom | | | | |
| 20.7.2011 | Intelence | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 20.7.2011 | Ratiograstim | 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 | | | | |
| 20.7.2011 | Rivastigmine 1 A Pharma | 1 A Pharma GmbH Keltenring 1+3, Oberhaching 82041, Deutschland | 1 A Pharma GmbH | Keltenring 1+3, Oberhaching 82041, Deutschland |
| 1 A Pharma GmbH | | | | |
| Keltenring 1+3, Oberhaching 82041, Deutschland | | | | |
| 20.7.2011 | Rivastigmine Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | | | | |
| 20.7.2011 | 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 | | | | |
| 20.7.2011 | Zalasta | 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 | | | | |
| 26.7.2011 | Avaglim | SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | SmithKline Beecham Ltd. | 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom |
| SmithKline Beecham Ltd. | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | | | | |
| 26.7.2011 | 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 | | | | |
| 26.7.2011 | Busilvex | Pierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France | Pierre Fabre Médicament | 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France |
| Pierre Fabre Médicament | | | | |
| 45, Place Abel Gance, 92654 Boulogne Billancourt Cedex, France | | | | |
| 26.7.2011 | Cymbalta | 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 | | | | |
| 26.7.2011 | 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 | | | | |
| 26.7.2011 | Infanrix hexa | GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l’Institut 89, Rixensart, B-1330 Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l’Institut 89, Rixensart, B-1330 Belgique | | | | |
| 26.7.2011 | Kuvan | 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 | | | | |
| 26.7.2011 | 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 | | | | |
| 26.7.2011 | 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 | | | | |
| 26.7.2011 | Retacrit | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
| Hospira UK Limited | | | | |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | | | | |
| 26.7.2011 | Stelara | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 26.7.2011 | Xeristar | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, 3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, 3991 RA Houten, Nederland | | | | |
| 27.7.2011 | 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 | | | | |
| 27.7.2011 | Beromun | 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 | | | | |
| 27.7.2011 | 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 | | | | |
| 27.7.2011 | 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 | | | | |
| 27.7.2011 | Copalia | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 27.7.2011 | Dafiro | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 27.7.2011 | Ecalta | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 27.7.2011 | 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 | | | | |
| 27.7.2011 | Eporatio | 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 | | | | |
| 27.7.2011 | Exforge | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 27.7.2011 | Exjade | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 27.7.2011 | Faslodex | AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom | AstraZeneca UK Limited | Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom |
| AstraZeneca UK Limited | | | | |
| Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom | | | | |
| 27.7.2011 | 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 | | | | |
| 27.7.2011 | Gardasil | 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 | | | | |
| 27.7.2011 | Imprida | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 27.7.2011 | 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 | | | | |
| 27.7.2011 | Kiovig | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | Baxter AG | Industriestraße 67, A - 1221 Wien, Österreich |
| Baxter AG | | | | |
| Industriestraße 67, A - 1221 Wien, Österreich | | | | |
| 27.7.2011 | 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 | | | | |
| 27.7.2011 | Nevanac | 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 | | | | |
| 27.7.2011 | PhotoBarr | Axcan Pharma International BV Engelenkampstraat 72, 6131 JJ Sittard, Nederland | Axcan Pharma International BV | Engelenkampstraat 72, 6131 JJ Sittard, Nederland |
| Axcan Pharma International BV | | | | |
| Engelenkampstraat 72, 6131 JJ Sittard, Nederland | | | | |
| 27.7.2011 | PREZISTA | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 27.7.2011 | Rapamune | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 27.7.2011 | Relistor | TMC Pharma Services Ltd. Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom | TMC Pharma Services Ltd. | Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom |
| TMC Pharma Services Ltd. | | | | |
| Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire, RG27 8AS, United Kingdom | | | | |
| 27.7.2011 | 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 | | | | |
| 27.7.2011 | Sycrest | 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 | | | | |
| 27.7.2011 | Thymanax | Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland | Servier (Ireland) Industries Limited | Gorey Road, Arklow, Co. Wicklow, Ireland |
| Servier (Ireland) Industries Limited | | | | |
| Gorey Road, Arklow, Co. Wicklow, Ireland | | | | |
| 27.7.2011 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT United Kingdom | | | | |
| 27.7.2011 | Valdoxan | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | Les Laboratoires Servier | 22, rue Garnier, 92200 Neuilly-sur-Seine, France |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France | | | | |
| 27.7.2011 | 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 | | | | |
| 27.7.2011 | Yentreve | 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 | | | | |
| 1.8.2011 | alli | 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 | | | | |
| 1.8.2011 | Doribax | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 1.8.2011 | Gardasil | 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 | | | | |
| 1.8.2011 | Iressa | AstraZeneca AB Sodertalje S 151 85, Sverige | AstraZeneca AB | Sodertalje S 151 85, Sverige |
| AstraZeneca AB | | | | |
| Sodertalje S 151 85, Sverige | | | | |
| 1.8.2011 | Nexavar | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 1.8.2011 | Pradaxa | 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 | | | | |
| 1.8.2011 | Rivastigmine Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | |
| 1.8.2011 | 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 | | | | |
| 5.8.2011 | ATryn | GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom | GTC Biotherapeutics UK Limited | 10 Norwich Street, London EC4A 1BD, United Kingdom |
| GTC Biotherapeutics UK Limited | | | | |
| 10 Norwich Street, London EC4A 1BD, United Kingdom | | | | |
| 5.8.2011 | Biograstim | CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland | CT Arzneimittel GmbH | Lengeder Straße 42a, D-13407 Berlin, Deutschland |
| CT Arzneimittel GmbH | | | | |
| Lengeder Straße 42a, D-13407 Berlin, Deutschland | | | | |
| 5.8.2011 | Biopoin | CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland | CT Arzneimittel GmbH | Lengeder Straße 42a, D-13407 Berlin, Deutschland |
| CT Arzneimittel GmbH | | | | |
| Lengeder Straße 42a, D-13407 Berlin, Deutschland | | | | |
| 5.8.2011 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 5.8.2011 | Focetria | 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 | | | | |
| 5.8.2011 | Hepsera | Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge, CB21 6GT, United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge, CB21 6GT, United Kingdom | | | | |
| 5.8.2011 | Hycamtin | SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | SmithKline Beecham Ltd. | 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom |
| SmithKline Beecham Ltd. | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | | | | |
| 5.8.2011 | InductOs | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 5.8.2011 | Silapo | STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland | STADA Arzneimittel AG | Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland |
| STADA Arzneimittel AG | | | | |
| Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland | | | | |
| 5.8.2011 | Synflorix | GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l’Institut 89, 1330 Rixensart, Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l’Institut 89, 1330 Rixensart, Belgique | | | | |
| 5.8.2011 | 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 | | | | |
| 10.8.2011 | 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 | | | | |
| 10.8.2011 | Cholestagel | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | |
| 10.8.2011 | Filgrastim 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 | | | | |
| 10.8.2011 | Lantus | 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 | | | | |
| 10.8.2011 | Optisulin | 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 | | | | |
| 10.8.2011 | Oslif Breezhaler | 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 | | | | |
| 10.8.2011 | Vidaza | Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | Celgene Europe Ltd | 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom |
| Celgene Europe Ltd | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | | | | |
| 10.8.2011 | Zarzio | Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich | Sandoz GmbH | Biochemiestrasse 10, A-6250 Kundl, Österreich |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10, A-6250 Kundl, Österreich | | | | |
| 18.8.2011 | Ariclaim | 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 | | | | |
| 18.8.2011 | Karvezide | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 18.8.2011 | Osseor | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | Les Laboratoires Servier | 22, rue Garnier, 92200 Neuilly-sur-Seine, France |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France | | | | |
| 18.8.2011 | 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 | | | | |
| 18.8.2011 | Protelos | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | Les Laboratoires Servier | 22, rue Garnier, 92200 Neuilly-sur-Seine, France |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France | | | | |
| 18.8.2011 | Sutent | 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 | | | | |
| 18.8.2011 | Volibris | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Ltd | | | | |
| Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 19.8.2011 | 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, Carrigtohill, Co. Cork, Ireland |
| Bristol-Myers Squibb and Gilead Sciences Limited | | | | |
| IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | | | | |
| 24.8.2011 | Afinitor | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 24.8.2011 | Efficib | 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 | | | | |
| 24.8.2011 | Enbrel | 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 | | | | |
| 24.8.2011 | Intelence | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | Janssen-Cilag International NV | Turnhoutseweg, 30 - 2340 Beerse - België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - 2340 Beerse - België | | | | |
| 24.8.2011 | IntronA | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 24.8.2011 | Janumet | 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 | | | | |
| 24.8.2011 | Januvia | 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 | | | | |
| 24.8.2011 | Kentera | Nicobrand Limited 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP | Nicobrand Limited | 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP |
| Nicobrand Limited | | | | |
| 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP | | | | |
| 24.8.2011 | Lantus | 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 | | | | |
| 24.8.2011 | Mepact | IDM PHARMA SAS 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France | IDM PHARMA SAS | 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France |
| IDM PHARMA SAS | | | | |
| 11-15 quai De Dion Bouton, 92816 Puteaux Cedex, France | | | | |
| 24.8.2011 | Micardis | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 24.8.2011 | 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 | | | | |
| 24.8.2011 | Multaq | Sanofi-Aventis 174, avenue de France, F-75013 Paris, France | Sanofi-Aventis | 174, avenue de France, F-75013 Paris, France |
| Sanofi-Aventis | | | | |
| 174, avenue de France, F-75013 Paris, France | | | | |
| 24.8.2011 | Mycamine | 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 | | | | |
| 24.8.2011 | Neupro | Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland | Schwarz Pharma Ltd | Shannon, Industrial Estate, Co.Clare, Ireland |
| Schwarz Pharma Ltd | | | | |
| Shannon, Industrial Estate, Co.Clare, Ireland | | | | |
| 24.8.2011 | Nplate | Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, 4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, 4817 ZK Breda, Nederland | | | | |
| 24.8.2011 | Optisulin | 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 | | | | |
| 24.8.2011 | Osigraft | Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland | Howmedica International S. de R.L. | Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland |
| Howmedica International S. de R.L. | | | | |
| Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland | | | | |
| 24.8.2011 | PegIntron | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 24.8.2011 | Pelzont | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 24.8.2011 | 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 | | | | |
| 24.8.2011 | 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 | | | | |
| 24.8.2011 | Ristaben | 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 | | | | |
| 24.8.2011 | Ristfor | 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 | | | | |
| 24.8.2011 | Stalevo | Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FIN-02200 Espoo, Suomi |
| Orion Corporation | | | | |
| Orionintie 1, FIN-02200 Espoo, Suomi | | | | |
| 24.8.2011 | Starlix | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 24.8.2011 | 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 | | | | |
| 24.8.2011 | Tesavel | 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 | | | | |
| 24.8.2011 | Thyrogen | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | |
| 24.8.2011 | Tredaptive | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 24.8.2011 | Trevaclyn | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 24.8.2011 | Tygacil | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | | | | |
| 24.8.2011 | VELCADE | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 24.8.2011 | Velmetia | 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 | | | | |
| 24.8.2011 | Vfend | 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 | | | | |
| 24.8.2011 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 24.8.2011 | Yttriga | Eckert & Ziegler Nuclitec GmbH Gieselweg 1, Braunschweig 38110, Deutschland | Eckert & Ziegler Nuclitec GmbH | Gieselweg 1, Braunschweig 38110, Deutschland |
| Eckert & Ziegler Nuclitec GmbH | | | | |
| Gieselweg 1, Braunschweig 38110, Deutschland | | | | |
| 24.8.2011 | Zevalin | Bayer Schering Pharma AG D-13342 Berlin, Deutschland | Bayer Schering Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 24.8.2011 | Zometa | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 26.8.2011 | Alisade | 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 | | | | |
| 26.8.2011 | Avamys | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Ltd | | | | |
| Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 26.8.2011 | Cervarix | 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 | | | | |
| 26.8.2011 | Corlentor | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | Les Laboratoires Servier | 22, rue Garnier, 92200 Neuilly-sur-Seine, France |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France | | | | |
| 26.8.2011 | Fertavid | SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | SP Europe | Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België |
| SP Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | | | | |
| 26.8.2011 | 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 | | | | |
| 26.8.2011 | Insulin Human 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 | | | | |
| 26.8.2011 | Procoralan | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | Les Laboratoires Servier | 22, rue Garnier, 92200 Neuilly-sur-Seine, France |
| Les Laboratoires Servier | | | | |
| 22, rue Garnier, 92200 Neuilly-sur-Seine, France | | | | |
| 26.8.2011 | Prolia | 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 | | | | |
| 26.8.2011 | Sebivo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 26.8.2011 | Tepadina | ADIENNE S.r.l. via Broseta, 64/B, 24128 Bergamo, Italia | ADIENNE S.r.l. | via Broseta, 64/B, 24128 Bergamo, Italia |
| ADIENNE S.r.l. | | | | |
| via Broseta, 64/B, 24128 Bergamo, Italia | | | | |
| 26.8.2011 | Topotecan 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 | | | | |

—   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 |
| ------------------------------------------------------ | ----------------------------- | --------------------------------------------------------------------------- | --------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------ | ----------------------------------------------- | ------------------------ |
| 5.8.2011 | Proteq West Nile | West Nile recombinant canarypox virus (vCP2017 virus) | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, 69007 LYON, France | EU/2/11/129/001-004 | Suspension for injection |
| MERIAL | | | | | | | |
| 29 avenue Tony Garnier, 69007 LYON, France | | | | | | | |
| 5.8.2011 | Zulvac 1 Bovis | Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP ≥ 1 | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/11/130/001-003 | Suspension for injection |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | | | | |
| 5.8.2011 | Zulvac 1 Ovis | Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP ≥ 1 | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/11/131/001-006 | Suspension for injection |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | | | | |
| 18.8.2011 | Emdocam | Meloxicam | Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe | Emdoka bvba | J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe | EU/2/11/128/001-003 | Solution for injection |
| Emdoka bvba | | | | | | | |
| J. Lijsenstraat 16, B-2321 Hoogstraten, Belgïe | | | | | | | |

—   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 |
| -------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------------------------------------- |
| 7.7.2011 | Leucofeligen FeLV/RCP | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros Cedex France | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. - 06516 Carros Cedex France |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. - 06516 Carros Cedex France | | | | |
| 7.7.2011 | Palladia | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 7.7.2011 | ProMeris Duo | 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 | | | | |
| 11.7.2011 | Trocoxil | 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 | | | | |
| 13.7.2011 | Loxicom | Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | Norbrook Laboratories Limited | Station Works, Newry, Co. Down, BT35 6JP, United Kindgom |
| Norbrook Laboratories Limited | | | | |
| Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | | | | |
| 20.7.2011 | Posatex | 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 | | | | |
| 27.7.2011 | Poulvac FluFend H5N3 RG | 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 | | | | |
| 27.7.2011 | ProMeris | 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 | | | | |
| 27.7.2011 | Slentrol | 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 | | | | |
| 5.8.2011 | Cerenia | 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 | | | | |
| 5.8.2011 | Virbagen Omega | 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 |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. - 06516 Carros - France | | | | |
| 19.8.2011 | Nobilis Influenza H5N2 | 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 | | | | |
| 19.8.2011 | Zolvix | Novartis Healthcare A/S Lyngbyvej 172, DK-2100 Copenhagen, Danmark | Novartis Healthcare A/S | Lyngbyvej 172, DK-2100 Copenhagen, Danmark |
| Novartis Healthcare A/S | | | | |
| Lyngbyvej 172, DK-2100 Copenhagen, Danmark | | | | |
| 24.8.2011 | Suvaxyn Aujeszky 783 +O/W | Fort Dodge Animal Health Holland C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland | Fort Dodge Animal Health Holland | C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland |
| Fort Dodge Animal Health Holland | | | | |
| C.J. van Houtenlaan 36, 1381 CP Weesp, Nederland | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------- | ----------------------------- | ------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------- |
| 10.8.2011 | Yarvitan | Janssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse, België | Janssen Pharmaceutica N.V. | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen Pharmaceutica N.V. | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |

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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