# C_2011383EN.01000101.xml

| 30.12.2011 | EN | Official Journal of the European Union | C 383/1 |
| ---------- | -- | -------------------------------------- | ------- |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 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 383/01

—   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 |
| ----------------------------------------------- | ----------------------------- | --------------------------------------------- | -------------------------------------------------------------------------------------------------------- | ----------------------------------------------- | ----------------------------------------------- | ----------------------------------------------- | -------------------- |
| 2.9.2011 | Vibativ | telavancin | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, | NL-2353 EW Leiderdorp, | Nederland |
| Astellas Pharma Europe B.V. | | | | | | | |
| Elisabethhof 19, | | | | | | | |
| NL-2353 EW Leiderdorp, | | | | | | | |
| Nederland | | | | | | | |
| 2.9.2011 | Votubia | Everolimus | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, | West Sussex, | RH12 5AB, |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, | | | | | | | |
| West Sussex, | | | | | | | |
| RH12 5AB, | | | | | | | |
| United Kingdom | | | | | | | |
| 5.9.2011 | Zytiga | abiraterone | 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 | | | | | | | |
| 16.9.2011 | Dexdor | dexmedetomidine | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, | FI-02200 Espoo, | Suomi |
| Orion Corporation | | | | | | | |
| Orionintie 1, | | | | | | | |
| FI-02200 Espoo, | | | | | | | |
| Suomi | | | | | | | |
| 19.9.2011 | Incivo | telaprevir | 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 | | | | | | | |
| 30.9.2011 | Pramipexole Accord | pramipexole | Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom | Accord Healthcare Limited | 5th Floor Charles House, 108/110 Finchley road, | London | NW3 5JJ, |
| Accord Healthcare Limited | | | | | | | |
| 5th Floor Charles House, 108/110 Finchley road, | | | | | | | |
| London | | | | | | | |
| NW3 5JJ, | | | | | | | |
| United Kingdom | | | | | | | |
| 3.10.2011 | Levetiracetam Accord | levetiracetam | Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom | Accord Healthcare Limited | 5th Floor Charles House, 108/110 Finchley road, | London | NW3 5JJ, |
| Accord Healthcare Limited | | | | | | | |
| 5th Floor Charles House, 108/110 Finchley road, | | | | | | | |
| London | | | | | | | |
| NW3 5JJ, | | | | | | | |
| United Kingdom | | | | | | | |
| 3.10.2011 | Levetiracetam Actavis | levetiracetam | Actavis Group PTC ehf. Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland | Actavis Group PTC ehf. | Reykjavikurvegur 76-78, | 220 Hafnarfjordur, | Iceland |
| Actavis Group PTC ehf. | | | | | | | |
| Reykjavikurvegur 76-78, | | | | | | | |
| 220 Hafnarfjordur, | | | | | | | |
| Iceland | | | | | | | |
| 3.10.2011 | Matever | levetiracetam | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | 6 Dervenakion, | 15351 Pallini Attiki, | Ελλάδα |
| Pharmathen S.A. | | | | | | | |
| 6 Dervenakion, | | | | | | | |
| 15351 Pallini Attiki, | | | | | | | |
| Ελλάδα | | | | | | | |
| 3.10.2011 | Telmisartan Teva Pharma | telmisartan | 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 | | | | | | | |
| 27.10.2011 | Eurartesim | dihydroartemisinin/piperaquine tetraphosphate | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Viale Shakespeare 47, 00144 Rome, Italia | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A | Viale Shakespeare 47, | 00144 Rome, | Italia |
| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A | | | | | | | |
| Viale Shakespeare 47, | | | | | | | |
| 00144 Rome, | | | | | | | |
| Italia | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| -------------------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- | -------------------------------------------------------------- |
| 2.9.2011 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France - |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France - | | | | |
| 75013 Paris, | | | | |
| France | | | | |
| 2.9.2011 | Lucentis | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 2.9.2011 | Torisel | Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom | Wyeth Europa Ltd | Huntercombe Lane South, Taplow, Maidenhead, |
| Wyeth Europa Ltd | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 0PH, | | | | |
| United Kingdom | | | | |
| 5.9.2011 | Advagraf | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, | | | | |
| NL-2353 EW Leiderdorp, | | | | |
| Nederland | | | | |
| 5.9.2011 | Aflunov | 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 | | | | |
| 5.9.2011 | 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 | | | | |
| 5.9.2011 | Cayston | Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Granta Park, Abington, |
| Gilead Sciences International Limited | | | | |
| Granta Park, Abington, | | | | |
| Cambridge | | | | |
| CB21 6GT, | | | | |
| United Kingdom | | | | |
| 5.9.2011 | 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 | | | | |
| 5.9.2011 | 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 | | | | |
| 5.9.2011 | Removab | Fresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, Deutschland | Fresenius Biotech GmbH | Am Haag 6-7, |
| Fresenius Biotech GmbH | | | | |
| Am Haag 6-7, | | | | |
| D-82166 Graefelfing, | | | | |
| Deutschland | | | | |
| 5.9.2011 | Simponi | Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland | Janssen Biologics B.V. | Einsteinweg 101, |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, | | | | |
| CB Leiden 2333, | | | | |
| Nederland | | | | |
| 5.9.2011 | Viracept | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 7.9.2011 | CANCIDAS | 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 | | | | |
| 7.9.2011 | Circadin | RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | RAD Neurim Pharmaceuticals EEC Limited | One Forbury Square, The Forbury, Reading, |
| RAD Neurim Pharmaceuticals EEC Limited | | | | |
| One Forbury Square, The Forbury, Reading, | | | | |
| Berkshire | | | | |
| RG1 3EB, | | | | |
| United Kingdom | | | | |
| 7.9.2011 | Irbesartan HCT 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 | | | | |
| 13.9.2011 | Ammonaps | Swedish Orphan Biovitrum International AB SE-11276 Stockholm, Sverige | Swedish Orphan Biovitrum International AB | SE-11276 Stockholm, |
| Swedish Orphan Biovitrum International AB | | | | |
| SE-11276 Stockholm, | | | | |
| Sverige | | | | |
| 13.9.2011 | Luminity | Lantheus MI UK Limited Festival House - 39 Oxford Street - Newbury - Berkshire RG14 1JG - United Kingdom | Lantheus MI UK Limited | Festival House - 39 Oxford Street - Newbury - |
| Lantheus MI UK Limited | | | | |
| Festival House - 39 Oxford Street - Newbury - | | | | |
| Berkshire | | | | |
| RG14 1JG - | | | | |
| United Kingdom | | | | |
| 13.9.2011 | Raloxifene 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 | | | | |
| 13.9.2011 | Synagis | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 13.9.2011 | Xelevia | 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 | | | | |
| 13.9.2011 | Zypadhera | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| NL-3991 RA Houten, | | | | |
| Nederland | | | | |
| 16.9.2011 | Aerius | 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 | | | | |
| 16.9.2011 | Angiox | The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom | The Medicines Company UK Ltd | 115 L Milton Park, Abingdon, |
| The Medicines Company UK Ltd | | | | |
| 115 L Milton Park, Abingdon, | | | | |
| Oxfordshire, | | | | |
| OX14 4SA, | | | | |
| United Kingdom | | | | |
| 16.9.2011 | Azomyr | 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 | | | | |
| 16.9.2011 | Azopt | Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Pentagon Park, Boundary Way, Hemel Hempstead, |
| Alcon Laboratories (UK) Ltd. | | | | |
| Pentagon Park, Boundary Way, Hemel Hempstead, | | | | |
| Herts | | | | |
| HP2 7UD, | | | | |
| United Kingdom | | | | |
| 16.9.2011 | Ilaris | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 16.9.2011 | Myclausen | Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, 14167 Berlin, Deutschland | Herbert J. Passauer GmbH & Co. KG | Stubenrauchstrasse 33, |
| Herbert J. Passauer GmbH & Co. KG | | | | |
| Stubenrauchstrasse 33, | | | | |
| 14167 Berlin, | | | | |
| Deutschland | | | | |
| 16.9.2011 | Neoclarityn | 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 | | | | |
| 16.9.2011 | NeuroBloc | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, Hatfield, |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, | | | | |
| Hertfordshire, | | | | |
| AL10 9SN, | | | | |
| United Kingdom | | | | |
| 16.9.2011 | 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 | | | | |
| 16.9.2011 | Resolor | Shire-Movetis NV Veedjik 58 (1004), B-2300 Turnhout, Belgium | Shire-Movetis NV | Veedjik 58 (1004), |
| Shire-Movetis NV | | | | |
| Veedjik 58 (1004), | | | | |
| B-2300 Turnhout, | | | | |
| Belgium | | | | |
| 16.9.2011 | Suboxone | RB Pharmaceuticals Limited 103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom | RB Pharmaceuticals Limited | 103-105 Bath Road, Slough, |
| RB Pharmaceuticals Limited | | | | |
| 103-105 Bath Road, Slough, | | | | |
| Berkshire, | | | | |
| SL1 3UH, | | | | |
| United Kingdom | | | | |
| 16.9.2011 | Viramune | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173- |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- | | | | |
| D - 55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 19.9.2011 | Byetta | 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 | | | | |
| 19.9.2011 | Docetaxel Winthrop | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, | | | | |
| F-92165 Antony Cedex, | | | | |
| France | | | | |
| 19.9.2011 | Ifirmasta | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d.d., Novo mesto | Šmarješka cesta 6, |
| KRKA, d.d., Novo mesto | | | | |
| Šmarješka cesta 6, | | | | |
| 8501 Novo mesto, | | | | |
| Slovenija | | | | |
| 19.9.2011 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg – Deutschland | medac Gesellschaft für klinische Spezialpräparate mbH | Fehlandtstrasse 3, |
| medac Gesellschaft für klinische Spezialpräparate mbH | | | | |
| Fehlandtstrasse 3, | | | | |
| D-20354 Hamburg – | | | | |
| Deutschland | | | | |
| 19.9.2011 | Zonegran | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, Hatfield, |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, | | | | |
| Hertfordshire, | | | | |
| AL10 9SN, | | | | |
| United Kingdom | | | | |
| 22.9.2011 | Clopidogrel DURA | Mylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, Deutschland | Mylan dura GmbH | Wittichstraße 6, |
| Mylan dura GmbH | | | | |
| Wittichstraße 6, | | | | |
| D-64295 Darmstadt, | | | | |
| Deutschland | | | | |
| 22.9.2011 | Ixiaro | Intercell AG Campus Vienna Biocenter 3 A-1030 Wien, Österreich | Intercell AG | Campus Vienna Biocenter 3 |
| Intercell AG | | | | |
| Campus Vienna Biocenter 3 | | | | |
| A-1030 Wien, | | | | |
| Österreich | | | | |
| 22.9.2011 | Leflunomide ratiopharm | 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 | | | | |
| 22.9.2011 | Pergoveris | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | Merck Serono Europe Limited | 56, Marsh Wall, |
| Merck Serono Europe Limited | | | | |
| 56, Marsh Wall, | | | | |
| London | | | | |
| E14 9TP, | | | | |
| United Kingdom | | | | |
| 22.9.2011 | RoActemra | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 22.9.2011 | Taxotere | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, | | | | |
| F-92165 Antony Cedex, | | | | |
| France | | | | |
| 30.9.2011 | Aerinaze | SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | SP Europe | Rue de Stalle, 73, |
| SP Europe | | | | |
| Rue de Stalle, 73, | | | | |
| 1180 Bruxelles, | | | | |
| Belgique - | | | | |
| Stallestraat, 73 - | | | | |
| 1180 Brussel, | | | | |
| België | | | | |
| 3.10.2011 | Elaprase | Shire Human Genetic Therapies AB Svärdvägen 11D, 18233 Danderyd, Sverige | Shire Human Genetic Therapies AB | Svärdvägen 11D, |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D, | | | | |
| 18233 Danderyd, | | | | |
| Sverige | | | | |
| 3.10.2011 | Lysodren | Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France | Laboratoire HRA Pharma | 15, rue Béranger, |
| Laboratoire HRA Pharma | | | | |
| 15, rue Béranger, | | | | |
| 75003 Paris, | | | | |
| France | | | | |
| 3.10.2011 | Sprycel | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, | | | | |
| Uxbridge | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 3.10.2011 | Xagrid | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park, Chineham, Basingstoke, |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park, Chineham, Basingstoke, | | | | |
| Hampshire | | | | |
| RG24 8EP, | | | | |
| United Kingdom | | | | |
| 6.10.2011 | NeoRecormon | 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 | | | | |
| 6.10.2011 | Noxafil | SP Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | SP Europe | Rue de Stalle, 73, |
| SP Europe | | | | |
| Rue de Stalle, 73, | | | | |
| 1180 Bruxelles, | | | | |
| Belgique - | | | | |
| Stallestraat, 73 - | | | | |
| 1180 Brussel, | | | | |
| België | | | | |
| 6.10.2011 | Sildenafil Actavis | Actavis Group PTC ehf. Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland | Actavis Group PTC ehf. | Reykjavikurvegur 76-78, |
| Actavis Group PTC ehf. | | | | |
| Reykjavikurvegur 76-78, | | | | |
| 220 Hafnarfjordur, | | | | |
| Iceland | | | | |
| 6.10.2011 | 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, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, | | | | |
| Uxbridge | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 6.10.2011 | Topotecan Hospira | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, Royal Leamington Spa, |
| Hospira UK Limited | | | | |
| Queensway, Royal Leamington Spa, | | | | |
| Warwickshire | | | | |
| CV31 3RW, | | | | |
| United Kingdom | | | | |
| 12.10.2011 | Celsentri | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, | | | | |
| Middlesex, | | | | |
| TW8 9GS, | | | | |
| United Kingdom | | | | |
| 12.10.2011 | Galvus | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 12.10.2011 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België | Janssen-Cilag International NV | Turnhoutseweg, 30 - |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - | | | | |
| 2340 Beerse – | | | | |
| België | | | | |
| 12.10.2011 | Jalra | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 12.10.2011 | Rilonacept Regeneron | Regeneron UK Limited 40 Bank Street, London, E14 5DS United Kingdom | Regeneron UK Limited | 40 Bank Street, |
| Regeneron UK Limited | | | | |
| 40 Bank Street, | | | | |
| London, | | | | |
| E14 5DS | | | | |
| United Kingdom | | | | |
| 12.10.2011 | Stelara | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België | Janssen-Cilag International NV | Turnhoutseweg, 30 - |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 - | | | | |
| 2340 Beerse – | | | | |
| België | | | | |
| 12.10.2011 | Teysuno | Taiho Pharma Europe, Limited 55 Colmore Row, Birmingham, West Midlands, B3 2AS, United Kingdom | Taiho Pharma Europe, Limited | 55 Colmore Row, Birmingham, |
| Taiho Pharma Europe, Limited | | | | |
| 55 Colmore Row, Birmingham, | | | | |
| West Midlands, | | | | |
| B3 2AS, | | | | |
| United Kingdom | | | | |
| 12.10.2011 | Xeplion | 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 | | | | |
| 12.10.2011 | Xiliarx | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 17.10.2011 | Docetaxel 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 | | | | |
| 20.10.2011 | Arixtra | Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd. | Greenford Road, Greenford, |
| Glaxo Group Ltd. | | | | |
| Greenford Road, Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 20.10.2011 | 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, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, | | | | |
| Uxbridge | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 20.10.2011 | Mircera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, | | | | |
| Welwyn Garden City, | | | | |
| AL7 1TW, | | | | |
| United Kingdom | | | | |
| 20.10.2011 | Naglazyme | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | BioMarin Europe Ltd | 164 Shaftesbury Avenue, |
| BioMarin Europe Ltd | | | | |
| 164 Shaftesbury Avenue, | | | | |
| London | | | | |
| WC2H 8HL, | | | | |
| United Kingdom | | | | |
| 20.10.2011 | Zypadhera | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| NL-3991 RA Houten, | | | | |
| Nederland | | | | |
| 20.10.2011 | Zyprexa | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 20.10.2011 | Zyprexa Velotab | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 24.10.2011 | 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 | | | | |
| 24.10.2011 | Avonex | Biogen Idec Ltd Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Ltd | Innovation House, |
| Biogen Idec Ltd | | | | |
| Innovation House, | | | | |
| 70 Norden Road, Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4AY, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 174 avenue de France - |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 174 avenue de France - | | | | |
| 75013 Paris, | | | | |
| France | | | | |
| 24.10.2011 | Daxas | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Nycomed GmbH | Byk-Gulden-Str. 2, |
| Nycomed GmbH | | | | |
| Byk-Gulden-Str. 2, | | | | |
| D-78467 Konstanz, | | | | |
| Deutschland | | | | |
| 24.10.2011 | Docetaxel Winthrop | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, | | | | |
| F-92165 Antony Cedex, | | | | |
| France | | | | |
| 24.10.2011 | 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 | | | | |
| 24.10.2011 | Efient | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, | | | | |
| 3991 RA Houten, | | | | |
| Nederland | | | | |
| 24.10.2011 | Emend | 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 | | | | |
| 24.10.2011 | Erbitux | Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland | Merck KGaA | Frankfurter Straße 250, |
| Merck KGaA | | | | |
| Frankfurter Straße 250, | | | | |
| 64271 Darmstadt, | | | | |
| Deutschland | | | | |
| 24.10.2011 | Humira | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, Vanwall Business Park, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, | | | | |
| Vanwall Road, Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | Icandra | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | IntronA | 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 | | | | |
| 24.10.2011 | Irbesartan HCT 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 | | | | |
| 24.10.2011 | Keppra | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/ Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, | | | | |
| 1070 Bruxelles, | | | | |
| Belgique/ | | | | |
| Researchdreef, 60, | | | | |
| Brussel 1070, | | | | |
| België | | | | |
| 24.10.2011 | Kivexa | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, | | | | |
| Middlesex, | | | | |
| TW8 9GS, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | Levemir | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 24.10.2011 | Lyrica | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 139NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 139NJ, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | Nexavar | Bayer Pharma AG Berlin 13342, Deutschland | Bayer Pharma AG | Berlin 13342, |
| Bayer Pharma AG | | | | |
| Berlin 13342, | | | | |
| Deutschland | | | | |
| 24.10.2011 | Onglyza | Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, |
| Bristol Myers Squibb/AstraZeneca EEIG | | | | |
| Bristol Myers Squibb House, | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, Uxbridge, | | | | |
| Middlesex | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | Prevenar 13 | Wyeth-Lederle Vaccines S.A. Pleinlaan 17 Boulevard de la Plaine, 1050 Brussels - Bruxelles, Belgïe-Belgique | Wyeth-Lederle Vaccines S.A. | Pleinlaan 17 Boulevard de la Plaine, |
| Wyeth-Lederle Vaccines S.A. | | | | |
| Pleinlaan 17 Boulevard de la Plaine, | | | | |
| 1050 Brussels - Bruxelles, | | | | |
| Belgïe-Belgique | | | | |
| 24.10.2011 | Revatio | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Sandwich, |
| Pfizer Limited | | | | |
| Sandwich, | | | | |
| Kent, | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | 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 | | | | |
| 24.10.2011 | Starlix | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | Sycrest | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, |
| N.V. Organon | | | | |
| Kloosterstraat 6, | | | | |
| 5349 AB Oss, | | | | |
| Nederland | | | | |
| 24.10.2011 | Toviaz | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | Votrient | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 24.10.2011 | Ziagen | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, | | | | |
| Middlesex, | | | | |
| TW8 9GS, | | | | |
| United Kingdom | | | | |
| 27.10.2011 | Advagraf | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, | | | | |
| NL-2353 EW Leiderdorp, | | | | |
| Nederland | | | | |
| 27.10.2011 | 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 | | | | |
| 27.10.2011 | Ceprotin | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | Baxter AG | Industriestraße 67, |
| Baxter AG | | | | |
| Industriestraße 67, | | | | |
| A - 1221 Wien, | | | | |
| Österreich | | | | |
| 27.10.2011 | Eucreas | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 27.10.2011 | Exalief | BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado – Portugal | BIAL - Portela & Ca, SA | A Av. da Siderurgia Nacional |
| BIAL - Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional | | | | |
| 4745-457 S. Mamede do Coronado – | | | | |
| Portugal | | | | |
| 27.10.2011 | Galvus | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 27.10.2011 | Jalra | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 27.10.2011 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, | | | | |
| Deutschland | | | | |
| 27.10.2011 | Mixtard | 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 | | | | |
| 27.10.2011 | Rapiscan | Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, UK | Rapidscan Pharma Solutions EU Ltd. | Regent's Place, 338 Euston Road, |
| Rapidscan Pharma Solutions EU Ltd. | | | | |
| Regent's Place, 338 Euston Road, | | | | |
| London | | | | |
| NW1 3BT, | | | | |
| UK | | | | |
| 27.10.2011 | Rasilamlo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex, | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 27.10.2011 | Riprazo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 27.10.2011 | Riprazo HCT | 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 | | | | |
| 27.10.2011 | Sprimeo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 27.10.2011 | Sprimeo HCT | 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 | | | | |
| 27.10.2011 | Taxotere | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, | | | | |
| F-92165 Antony Cedex, | | | | |
| France | | | | |
| 27.10.2011 | Tygacil | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | Wyeth Europa Ltd. | Huntercombe Lane South, Taplow, Maidenhead, |
| Wyeth Europa Ltd. | | | | |
| Huntercombe Lane South, Taplow, Maidenhead, | | | | |
| Berkshire, | | | | |
| SL6 0PH, | | | | |
| United Kingdom | | | | |
| 27.10.2011 | Xiliarx | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| -------------------------------------- | -------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------------------- |
| 3.10.2011 | Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | GlaxoSmithKline Biologicals S.A. Rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | Rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| Rue de l'Institut 89, | | | | |
| 1330 Rixensart, | | | | |
| Belgique | | | | |
| 17.10.2011 | Ablavar | 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, |
| TMC Pharma Services Ltd. | | | | |
| Lodge Farm Barn, Elvetham Park Estate, | | | | |
| Fleet Road, Hartley Wintney, | | | | |
| Hampshire, | | | | |
| RG27 8AS, | | | | |
| United Kingdom | | | | |

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

| Date of the Décision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ----------------------------- | ----------------------------- | ----------------------------------------- | ------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------- | ----------------------------------------------- | -------------------- |
| 7.9.2011 | Nobivac Myxo-RHD | Live myxoma vectored RHD virus strain 009 | 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 | | | | | | | |
| 13.9.2011 | Recocam | Meloxicam | CF Pharma Limited Unit 622, Northern Extension, Waterford, Ireland | CF Pharma Limited | Unit 622, Northern Extension, | Waterford, | Ireland |
| CF Pharma Limited | | | | | | | |
| Unit 622, Northern Extension, | | | | | | | |
| Waterford, | | | | | | | |
| Ireland | | | | | | | |
| 6.10.2011 | Recuvyra | Fentanyl | Nexcyon Pharmaceuticals Ltd. Bank Barn, How Mill, Brampton, Cumbria CA8 9JY, UNITED KINGDOM | Nexcyon Pharmaceuticals Ltd. | Bank Barn, How Mill, | Brampton, | Cumbria |
| Nexcyon Pharmaceuticals Ltd. | | | | | | | |
| Bank Barn, How Mill, | | | | | | | |
| Brampton, | | | | | | | |
| Cumbria | | | | | | | |
| CA8 9JY, | | | | | | | |
| UNITED KINGDOM | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ----------------------------- | ----------------------------- | -------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------- |
| 5.9.2011 | Improvac | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, |
| Pfizer Limited | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 13.9.2011 | Cortavance | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros – France | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. - |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. - | | | | |
| 06516 Carros – | | | | |
| France | | | | |
| 16.9.2011 | Loxicom | Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | Norbrook Laboratories Limited | Station Works, Newry, |
| Norbrook Laboratories Limited | | | | |
| Station Works, Newry, | | | | |
| Co. Down, | | | | |
| BT35 6JP, | | | | |
| United Kindgom | | | | |
| 16.9.2011 | 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 | | | | |
| 19.9.2011 | ZULVAC 1+8 Ovis | 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 | | | | |
| 20.10.2011 | Suprelorin | VIRBAC S.A. 1ère Avenue 2065 m L.I.D. - 06516 Carros – France | VIRBAC S.A. | 1ère Avenue 2065 m L.I.D. - |
| VIRBAC S.A. | | | | |
| 1ère Avenue 2065 m L.I.D. - | | | | |
| 06516 Carros – | | | | |
| France | | | | |
| 24.10.2011 | Meloxoral | Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland | Le Vet B.V. | Wilgenweg 7, |
| Le Vet B.V. | | | | |
| Wilgenweg 7, | | | | |
| 3421 TV | | | | |
| Oudewater, | | | | |
| 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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