# C_2010359EN.01000101.xml

| 31.12.2010 | EN | Official Journal of the European Union | C 359/1 |
| ---------- | -- | -------------------------------------- | ------- |

---

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

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

2010/C 359/01

—   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 |
| --------------------------------------- | ------------------------------ | ---------------------------------------- | ------------------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------- | ----------------------------------------------- | -------------------- |
| 1.9.2010 | Brinavess | vernakalant hydrochloride | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, | Hodderson, | Hertfordshire |
| Merck Sharp & Dohme Limited | | | | | | | |
| Hertford Road, | | | | | | | |
| Hodderson, | | | | | | | |
| Hertfordshire | | | | | | | |
| EN11 9BU, | | | | | | | |
| United Kingdom | | | | | | | |
| 1.9.2010 | Sycrest | Asenapine | 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 | | | | | | | |
| 6.9.2010 | Rapiscan | regadenoson | 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 | | | | | | | |
| 17.9.2010 | Ibandronic Acid Teva | Ibandronic acid | 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 | | | | | | | |
| 30.9.2010 | Telmisartan Actavis | telmisartan | Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegi 76-78, | 220 Hafnarfjörður, | Iceland |
| Actavis Group PTC ehf. | | | | | | | |
| Reykjavíkurvegi 76-78, | | | | | | | |
| 220 Hafnarfjörður, | | | | | | | |
| Iceland | | | | | | | |
| 7.10.2010 | Myclausen | mycophenolate mofetil | Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, 14167 Berlin, Deutschland | Herbert J. Passauer GmbH & Co. KG | Stubenrauchstrasse 33, | 14167 Berlin, | Deutschland |
| Herbert J. Passauer GmbH & Co. KG | | | | | | | |
| Stubenrauchstrasse 33, | | | | | | | |
| 14167 Berlin, | | | | | | | |
| Deutschland | | | | | | | |
| 7.10.2010 | Twynsta | telmisartan/amlodipine | 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 | | | | | | | |
| 28.10.2010 | Clopidogrel HCS | Clopidogrel | HCS bvba H. Kennisstraat 53, B 2650 Edegem, Belgïe | HCS bvba | H. Kennisstraat 53, | B 2650 Edegem, | Belgïe |
| HCS bvba | | | | | | | |
| H. Kennisstraat 53, | | | | | | | |
| B 2650 Edegem, | | | | | | | |
| Belgïe | | | | | | | |
| 28.10.2010 | Clopidogrel Teva Generics B.V. | Clopidogrel | Teva Generics B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Generics B.V. | Computerweg 10, | 3542 DR Utrecht, | Nederland |
| Teva Generics B.V. | | | | | | | |
| Computerweg 10, | | | | | | | |
| 3542 DR Utrecht, | | | | | | | |
| Nederland | | | | | | | |
| 28.10.2010 | Ruconest | Conestat alfa | Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland | Pharming Group N.V. | Darwinweg 24, | NL-2333 CR Leiden, | Nederland |
| Pharming Group N.V. | | | | | | | |
| Darwinweg 24, | | | | | | | |
| NL-2333 CR Leiden, | | | | | | | |
| Nederland | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ------------------------------ | ----------------------------- | ---------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 16.9.2010 | Zeftera | 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 | | | | |

—   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 |
| ------------------------------------------------------------------------------ | ----------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------------------------ |
| 1.9.2010 | Altargo | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, | | | | |
| Berkeley Avenue, | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 1.9.2010 | 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 | | | | |
| 1.9.2010 | Keppra | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, | | | | |
| 1070 Bruxelles, | | | | |
| Belgique/Researchdreef, 60, | | | | |
| Brussel 1070, | | | | |
| België | | | | |
| 1.9.2010 | Levitra | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 1.9.2010 | Prevenar 13 | Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-la-Neuve, Belgique | Wyeth Lederle Vaccines S.A. | Rue du Bosquet, 15 |
| Wyeth Lederle Vaccines S.A. | | | | |
| Rue du Bosquet, 15 | | | | |
| B-1348 Louvain-la-Neuve, | | | | |
| Belgique | | | | |
| 1.9.2010 | Regranex | 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 | | | | |
| 1.9.2010 | Relistor | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, | | | | |
| Maidenhead, | | | | |
| Berkshire, SL6 0PH, | | | | |
| United Kingdom | | | | |
| 1.9.2010 | Vfend | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 1.9.2010 | 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 | | | | |
| 6.9.2010 | Abraxane | Abraxis BioScience Limited Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United Kingdom | Abraxis BioScience Limited | Rosanne House, Parkway, |
| Abraxis BioScience Limited | | | | |
| Rosanne House, Parkway, | | | | |
| Welwyn Garden City, | | | | |
| Herts, AL8 6HG, | | | | |
| United Kingdom | | | | |
| 6.9.2010 | Apidra | 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 | | | | |
| 6.9.2010 | Cialis | 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 | | | | |
| 6.9.2010 | Clopidogrel Winthrop | 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 | | | | |
| 6.9.2010 | Cymbalta | 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 | | | | |
| 6.9.2010 | 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 | | | | |
| 6.9.2010 | Emadine | Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Pentagon Park, Boundary Way, |
| Alcon Laboratories (UK) Ltd. | | | | |
| Pentagon Park, Boundary Way, | | | | |
| Hemel Hempstead, | | | | |
| Herts HP2 7UD, | | | | |
| United Kingdom | | | | |
| 6.9.2010 | Insuman | 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 | | | | |
| 6.9.2010 | Menveo | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina, 1, |
| Novartis Vaccines and Diagnostics S.r.l. | | | | |
| Via Fiorentina, 1, | | | | |
| 53100 Siena, | | | | |
| Italia | | | | |
| 6.9.2010 | M-M-RVAXPRO | 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 | | | | |
| 6.9.2010 | 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, Uxbridge Business Park, |
| Bristol Myers Squibb/AstraZeneca EEIG | | | | |
| Bristol Myers Squibb House, Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge, | | | | |
| Middlesex UB8 1DH, | | | | |
| United Kingdom | | | | |
| 6.9.2010 | Oslif Breezhaler | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex, RH12 5AB, | | | | |
| United Kingdom | | | | |
| 6.9.2010 | ProQuad | 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 | | | | |
| 6.9.2010 | Relistor | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Limited | Huntercombe Lane South, Taplow, |
| Wyeth Europa Limited | | | | |
| Huntercombe Lane South, Taplow, | | | | |
| Maidenhead, | | | | |
| Berkshire, SL6 0PH, | | | | |
| United Kingdom | | | | |
| 6.9.2010 | 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 | | | | |
| 6.9.2010 | Thyrogen | 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 | | | | |
| 6.9.2010 | Vimpat | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, 1070 Bruxelles, |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, 1070 Bruxelles, | | | | |
| Belgique/Researchdreef, 60, | | | | |
| Brussel 1070, | | | | |
| België | | | | |
| 6.9.2010 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT | | | | |
| United Kingdom | | | | |
| 6.9.2010 | Xeristar | 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 | | | | |
| 6.9.2010 | Xolair | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 6.9.2010 | Zerit | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge UB8 1DH, | | | | |
| United Kingdom | | | | |
| 6.9.2010 | Zyprexa | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 6.9.2010 | Zyprexa Velotab | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 10.9.2010 | Pandemrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| Rixensart, | | | | |
| B-1330 Belgique | | | | |
| 10.9.2010 | Siklos | ADDMEDICA 101, rue Saint Lazare, Paris 75009, FRANCE | ADDMEDICA | 101, rue Saint Lazare, |
| ADDMEDICA | | | | |
| 101, rue Saint Lazare, | | | | |
| Paris 75009, | | | | |
| FRANCE | | | | |
| 16.9.2010 | Alimta | 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 | | | | |
| 16.9.2010 | 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 | | | | |
| 17.9.2010 | Xyrem | UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | UCB Pharma Ltd. | 208 Bath Road, Slough, |
| UCB Pharma Ltd. | | | | |
| 208 Bath Road, Slough, | | | | |
| Berkshire SL1 3WE, | | | | |
| United Kingdom | | | | |
| 23.9.2010 | Kepivance | Biovitrum AB (publ) SE-112 76 Stockholm, Sverige | Biovitrum AB (publ) | SE-112 76 Stockholm, |
| Biovitrum AB (publ) | | | | |
| SE-112 76 Stockholm, | | | | |
| Sverige | | | | |
| 23.9.2010 | 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 | | | | |
| 23.9.2010 | Revatio | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Sandwich, |
| Pfizer Limited | | | | |
| Sandwich, | | | | |
| Kent, CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 27.9.2010 | Caelyx | 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, |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, | | | | |
| België | | | | |
| 27.9.2010 | Panretin | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, | | | | |
| Hatfield, | | | | |
| Hertfordshire, | | | | |
| AL10 9SN, United Kingdom | | | | |
| 30.9.2010 | Clopidogrel Apotex | Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland | Apotex Europe B.V. | Darwingweg 20, |
| Apotex Europe B.V. | | | | |
| Darwingweg 20, | | | | |
| 2333 CR Leiden, | | | | |
| Nederland | | | | |
| 30.9.2010 | Mepact | IDM PHARMA SAS 11-15 Quai De Dion Bouton, 92816 Puteaux Cedex, France | IDM PHARMA SAS | 11-15 Quai De Dion Bouton, |
| IDM PHARMA SAS | | | | |
| 11-15 Quai De Dion Bouton, | | | | |
| 92816 Puteaux Cedex, | | | | |
| France | | | | |
| 30.9.2010 | Noxafil | SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | SP Europe | Rue de Stalle, 73, 1180 Bruxelles, |
| SP Europe | | | | |
| Rue de Stalle, 73, 1180 Bruxelles, | | | | |
| Belgique - Stallestraat, 73 - 1180 Brussel, | | | | |
| België | | | | |
| 30.9.2010 | Rotarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| Rixensart, | | | | |
| B-1330 Belgique | | | | |
| 30.9.2010 | Sprycel | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge UB8 1DH, | | | | |
| United Kingdom | | | | |
| 30.9.2010 | Thalidomide Celgene | Celgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | Celgene Europe Limited | Riverside House, |
| Celgene Europe Limited | | | | |
| Riverside House, | | | | |
| Riverside Walk, | | | | |
| Windsor SL4 1NA, | | | | |
| United Kingdom | | | | |
| 5.10.2010 | 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 | | | | |
| 5.10.2010 | Mircera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 5.10.2010 | Revlimid | Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom | Celgene Europe Limited | Riverside House, Riverside Walk, |
| Celgene Europe Limited | | | | |
| Riverside House, Riverside Walk, | | | | |
| Windsor, | | | | |
| Berkshire SL4 1NA, | | | | |
| United Kingdom | | | | |
| 7.10.2010 | 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 | | | | |
| 7.10.2010 | DuoTrav | Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Pentagon Park, Boundary Way, |
| Alcon Laboratories (UK) Ltd. | | | | |
| Pentagon Park, Boundary Way, | | | | |
| Hemel Hempstead, | | | | |
| Herts HP2 7UD, | | | | |
| United Kingdom | | | | |
| 7.10.2010 | 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 | | | | |
| 11.10.2010 | Retacrit | HOSPIRA Enterprises B.V. Randstad 22-11, 1316 BN, Almere, Nederland | HOSPIRA Enterprises B.V. | Randstad 22-11, |
| HOSPIRA Enterprises B.V. | | | | |
| Randstad 22-11, | | | | |
| 1316 BN, Almere, | | | | |
| Nederland | | | | |
| 14.10.2010 | Alisade | Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom | Glaxo Group Ltd | Greenford, |
| Glaxo Group Ltd | | | | |
| Greenford, | | | | |
| Middlesex, UB6 ONN, | | | | |
| United Kingdom | | | | |
| 14.10.2010 | Avamys | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, |
| Glaxo Group Ltd | | | | |
| Greenford, | | | | |
| Middlesex UB6 0NN, | | | | |
| United Kingdom | | | | |
| 14.10.2010 | Biograstim | CT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, Deutschland | CT Arzneimittel GmbH | Lengeder Straße 42a, |
| CT Arzneimittel GmbH | | | | |
| Lengeder Straße 42a, | | | | |
| D-13407 Berlin, | | | | |
| Deutschland | | | | |
| 14.10.2010 | Firmagon | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, Copenhagen S 2300, Danmark | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11, |
| Ferring Pharmaceuticals A/S | | | | |
| Kay Fiskers Plads 11, | | | | |
| Copenhagen S 2300, | | | | |
| Danmark | | | | |
| 14.10.2010 | 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 | | | | |
| 14.10.2010 | Ratiograstim | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, |
| ratiopharm GmbH | | | | |
| Graf-Arco-Straße 3, | | | | |
| D-89079 Ulm, | | | | |
| Deutschland | | | | |
| 14.10.2010 | Vidaza | Celgene Europe Ltd Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom | Celgene Europe Ltd | Riverside House, Riverside Walk, |
| Celgene Europe Ltd | | | | |
| Riverside House, Riverside Walk, | | | | |
| Windsor, SL4 1NA, | | | | |
| United Kingdom | | | | |
| 14.10.2010 | Xarelto | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 15.10.2010 | Riprazo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 15.10.2010 | Silapo | STADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland | STADA Arzneimittel AG | Stadastrasse 2-18, |
| STADA Arzneimittel AG | | | | |
| Stadastrasse 2-18, | | | | |
| 61118 Bad Vilbel, | | | | |
| Deutschland | | | | |
| 15.10.2010 | Sprimeo | 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 | | | | |
| 25.10.2010 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100, |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100, | | | | |
| D-60318 Frankfurt/Main - Deutschland | | | | |
| 25.10.2010 | Azilect | Teva Pharma GmbH Kandelstrasse 10, Kirchzarten 79199, Deutschland | Teva Pharma GmbH | Kandelstrasse 10, |
| Teva Pharma GmbH | | | | |
| Kandelstrasse 10, | | | | |
| Kirchzarten 79199, | | | | |
| Deutschland | | | | |
| 25.10.2010 | Baraclude | 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 | | | | |
| 25.10.2010 | Cerezyme | 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 | | | | |
| 25.10.2010 | 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 | | | | |
| 25.10.2010 | Ebixa | H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark | H. Lundbeck A/S | Ottiliavej 9, |
| H. Lundbeck A/S | | | | |
| Ottiliavej 9, | | | | |
| DK-2500 Valby, | | | | |
| Danmark | | | | |
| 25.10.2010 | Epivir | 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 | | | | |
| 25.10.2010 | Faslodex | AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom | AstraZeneca UK Limited | Alderley Park, |
| AstraZeneca UK Limited | | | | |
| Alderley Park, | | | | |
| Macclesfield, | | | | |
| Cheshire, SK10 4TG | | | | |
| United Kingdom | | | | |
| 25.10.2010 | Forsteo | 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 | | | | |
| 25.10.2010 | 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 | | | | |
| 25.10.2010 | Irbesartan/Hydrochlorothiazide 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 | | | | |
| 25.10.2010 | Karvea | 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 | | | | |
| 25.10.2010 | Mabthera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, | | | | |
| Shire Park, | | | | |
| Welwyn Garden City, AL7 1TW, | | | | |
| United Kingdom | | | | |
| 25.10.2010 | Mirapexin | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- | | | | |
| D - 55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 25.10.2010 | M-M-RVAXPRO | 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 | | | | |
| 25.10.2010 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 25.10.2010 | ProQuad | 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 | | | | |
| 25.10.2010 | Puregon | Organon N.V. Kloosterstraat 6, Postbus 20, 5340 BH Oss, Nederland | Organon N.V. | Kloosterstraat 6, Postbus 20, |
| Organon N.V. | | | | |
| Kloosterstraat 6, Postbus 20, | | | | |
| 5340 BH Oss, | | | | |
| Nederland | | | | |
| 25.10.2010 | Revlimid | Celgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom | Celgene Europe Limited | Riverside House, Riverside Walk, |
| Celgene Europe Limited | | | | |
| Riverside House, Riverside Walk, | | | | |
| Windsor, | | | | |
| Berkshire SL4 1NA, | | | | |
| United Kingdom | | | | |
| 25.10.2010 | Sifrol | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, | | | | |
| D-55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 25.10.2010 | Simponi | Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | Centocor B.V. | Einsteinweg 101, |
| Centocor B.V. | | | | |
| Einsteinweg 101, | | | | |
| 2333 CB Leiden, | | | | |
| Nederland | | | | |
| 25.10.2010 | Sprimeo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex RH12 5AB, | | | | |
| United Kingdom | | | | |
| 25.10.2010 | Sprycel | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, | | | | |
| Uxbridge UB8 1DH, | | | | |
| United Kingdom | | | | |
| 25.10.2010 | Toviaz | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 25.10.2010 | Vantavo | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, Hoddesdon, |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, Hoddesdon, | | | | |
| Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 25.10.2010 | Vasovist | TMC Pharma Services Ltd. Finchampstead, Berks, RG40 4LJ, UK | TMC Pharma Services Ltd. | Finchampstead, |
| TMC Pharma Services Ltd. | | | | |
| Finchampstead, | | | | |
| Berks, RG40 4LJ, | | | | |
| UK | | | | |
| 25.10.2010 | 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 | | | | |
| 25.10.2010 | Zonegran | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, | | | | |
| Hatfield, | | | | |
| Hertfordshire, AL10 9SN, | | | | |
| United Kingdom | | | | |
| 25.10.2010 | Zostavax | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, | | | | |
| 69007 Lyon, | | | | |
| France | | | | |
| 28.10.2010 | Ambirix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| Rixensart, | | | | |
| B-1330 Belgique | | | | |
| 28.10.2010 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France - |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France - | | | | |
| 75013 Paris, | | | | |
| France | | | | |
| 28.10.2010 | Fertavid | SP Europe Rue de Stalle, 73 B-1180 Bruxelles, Belgique | SP Europe | Rue de Stalle, 73 |
| SP Europe | | | | |
| Rue de Stalle, 73 | | | | |
| B-1180 Bruxelles, | | | | |
| Belgique | | | | |
| 28.10.2010 | Hycamtin | SmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United Kingdom | SmithKline Beecham Ltd. | 980 Great West Road, |
| SmithKline Beecham Ltd. | | | | |
| 980 Great West Road, | | | | |
| Brentford, | | | | |
| Middlesex, TW8 9GS | | | | |
| United Kingdom | | | | |
| 28.10.2010 | Mimpara | 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 | | | | |
| 28.10.2010 | NovoSeven | 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 | | | | |
| 28.10.2010 | Olanzapine Neopharma | Neopharma Limited 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom | Neopharma Limited | 57 High Street, Odiham, |
| Neopharma Limited | | | | |
| 57 High Street, Odiham, | | | | |
| Hampshire RG29 1LF, | | | | |
| United Kingdom | | | | |
| 28.10.2010 | Olanzapine Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, | | | | |
| DR Utrecht 3542, | | | | |
| Nederland | | | | |
| 28.10.2010 | PegIntron | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, | | | | |
| 1180 Bruxelles, | | | | |
| Belgique - Stallestraat, 73 - | | | | |
| 1180 Brussel, | | | | |
| België | | | | |
| 28.10.2010 | Travatan | Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Boundary Way, |
| Alcon Laboratories (UK) Ltd. | | | | |
| Boundary Way, | | | | |
| Hemel Hempstead, | | | | |
| Herts HP2 7UD, | | | | |
| United Kingdom | | | | |
| 28.10.2010 | ViraferonPeg | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | Schering Plough Europe | Rue de Stalle, 73, |
| Schering Plough Europe | | | | |
| Rue de Stalle, 73, | | | | |
| 1180 Bruxelles, | | | | |
| Belgique - Stallestraat, 73 - | | | | |
| 1180 Brussel, | | | | |
| België | | | | |
| 29.10.2010 | Mycamine | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, | | | | |
| 2353 EW Leiderdorp, | | | | |
| Nederland | | | | |

—   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 |
| ------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 6.9.2010 | ImmunoGam | Cangene Europe Limited Parkshot House, 5 Kew Road, Richmond, Surrey TW9 2PR, United Kingdom | Cangene Europe Limited | Parkshot House, |
| Cangene Europe Limited | | | | |
| Parkshot House, | | | | |
| 5 Kew Road, | | | | |
| Richmond, | | | | |
| Surrey TW9 2PR, | | | | |
| United Kingdom | | | | |
| 27.9.2010 | Enviage | 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 | | | | |
| 28.10.2010 | NeoSpect | CIS bio international Boite Postale 32 - F-91192 Gif-sur-Yvette – France | CIS bio international | Boite Postale 32 - |
| CIS bio international | | | | |
| Boite Postale 32 - | | | | |
| F-91192 Gif-sur-Yvette – France | | | | |

—   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 |
| -------------------- | ----------------------------- | ------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 16.9.2010 | Clopidogrel 1A Pharma | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| 83714 Miesbach, | | | | |
| Deutschland | | | | |
| 16.9.2010 | 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 | | | | |
| 16.9.2010 | Clopidogrel Acino Pharma | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| 83714 Miesbach, | | | | |
| Deutschland | | | | |
| 16.9.2010 | 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 | | | | |
| 16.9.2010 | Clopidogrel Hexal | Acino Pharma GmbH Am Windfeld 35, Miesbach 83714, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| Miesbach 83714, | | | | |
| Deutschland | | | | |
| 16.9.2010 | 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 | | | | |
| 16.9.2010 | Clopidogrel ratiopharm 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 | | | | |
| 16.9.2010 | Clopidogrel Sandoz | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| 83714 Miesbach, | | | | |
| Deutschland | | | | |

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ---------------------------- | ----------------------------- | ----------------------------------------------------- | -------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------- | ----------------------------------------------- | -------------------- |
| 6.9.2010 | Bovilis BTV8 | Inactivated Bluetongue virus | Intervet International B.V. Wim de Körverstraat 35, NL - 5831 Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, | NL - 5831 Boxmeer, | Nederland |
| Intervet International B.V. | | | | | | | |
| Wim de Körverstraat 35, | | | | | | | |
| NL - 5831 Boxmeer, | | | | | | | |
| Nederland | | | | | | | |
| 16.9.2010 | Rhiniseng | inactivated vaccine against atrophic rhinitis in pigs | Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170- Amer (Girona), España | Laboratorios Hipra, S.A. | Avda. La Selva, 135, | 17170- Amer (Girona), | España |
| Laboratorios Hipra, S.A. | | | | | | | |
| Avda. La Selva, 135, | | | | | | | |
| 17170- Amer (Girona), | | | | | | | |
| España | | | | | | | |
| 30.9.2010 | Coxevac | Inactivated Coxiella burnetii vaccine | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, | 33500 Libourne, | France |
| CEVA SANTE ANIMALE | | | | | | | |
| 10 avenue de la Ballastière, | | | | | | | |
| 33500 Libourne, | | | | | | | |
| France | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ----------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 1.9.2010 | Acticam | Ecuphar NV Legeweg 157-I, B-8020 Oostkamp, Belgïe | Ecuphar NV | Legeweg 157-I, |
| Ecuphar NV | | | | |
| Legeweg 157-I, | | | | |
| B-8020 Oostkamp, | | | | |
| Belgïe | | | | |
| 17.9.2010 | Porcilis AR-T DF | 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 | | | | |
| 23.9.2010 | Porcilis AR-T DF | 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 | | | | |
| 30.9.2010 | Poulvac FluFend H5N3 RG | Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom | Fort Dodge Animal Health Ltd | Flanders Road, Hedge End, |
| Fort Dodge Animal Health Ltd | | | | |
| Flanders Road, Hedge End, | | | | |
| Southampton SO30 4QH, | | | | |
| United Kingdom | | | | |
| 30.9.2010 | 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 | | | | |
| 5.10.2010 | Nobilis Influenza H5N2 | 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 | | | | |
| 11.10.2010 | Equioxx | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, |
| MERIAL | | | | |
| 29 avenue Tony Garnier, | | | | |
| 69007 LYON, | | | | |
| France | | | | |
| 14.10.2010 | Cerenia | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 14.10.2010 | Improvac | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 14.10.2010 | Novem | 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 | | | | |
| 14.10.2010 | Posatex | 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 | | | | |
| 14.10.2010 | Quadrisol | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 28.10.2010 | Trocoxil | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, | | | | |
| Kent CT13 9NJ | | | | |
| United Kingdom | | | | |
| 28.10.2010 | Zactran | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, |
| MERIAL | | | | |
| 29 avenue Tony Garnier, | | | | |
| 69007 LYON, | | | | |
| France | | | | |

—   Suspension of a marketing authorization (Article 45 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 |
| ------------------------------ | ----------------------------- | ------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 27.9.2010 | Flexicam | Dechra Veterinary Products A/S Mekuvej 9, 7171 Uldum, Danmark | Dechra Veterinary Products A/S | Mekuvej 9, |
| Dechra Veterinary Products A/S | | | | |
| Mekuvej 9, | | | | |
| 7171 Uldum, | | | | |
| Danmark | | | | |

—   Lift of suspension of a marketing authorization (Article 45 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 |
| --------------------------- | ----------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------- | ----------------------- |
| 1.9.2010 | Porcilis Pesti | 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 | | | | |

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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