# C_2012094EN.01000101.xml

| 30.3.2012 | EN | Official Journal of the European Union | C 94/1 |
| --------- | -- | -------------------------------------- | ------ |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2012 to 29 February 2012

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

2012/C 94/01

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ----------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------------------------- | ----------------------------------------------- | -------------------- |
| 13.2.2012 | Colobreathe | Colistimethate sodium | Forest Laboratories UK Ltd Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom | Forest Laboratories UK Ltd | Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, | Kent | DA2 6SL, |
| Forest Laboratories UK Ltd | | | | | | | |
| Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, | | | | | | | |
| Kent | | | | | | | |
| DA2 6SL, | | | | | | | |
| United Kingdom | | | | | | | |
| 17.2.2012 | Caprelsa | vandetanib | AstraZeneca AB Building 411A, Floor 4, S-151 85 Sodertalje, Sverige | AstraZeneca AB | Building 411A, Floor 4, | S-151 85 Sodertalje, | Sverige |
| AstraZeneca AB | | | | | | | |
| Building 411A, Floor 4, | | | | | | | |
| S-151 85 Sodertalje, | | | | | | | |
| Sverige | | | | | | | |
| 17.2.2012 | Vepacel | Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated) | Baxter Innovations GmbH Industriestrasse 67, A – 1221 Vienna, Österreich | Baxter Innovations GmbH | Industriestrasse 67, | A – 1221 Vienna, | Österreich |
| Baxter Innovations GmbH | | | | | | | |
| Industriestrasse 67, | | | | | | | |
| A – 1221 Vienna, | | | | | | | |
| Österreich | | | | | | | |
| 17.2.2012 | Zelboraf | vemurafenib | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, | Welwyn Garden City, | AL7 1TW, |
| Roche Registration Limited | | | | | | | |
| 6 Falcon Way, Shire Park, | | | | | | | |
| Welwyn Garden City, | | | | | | | |
| AL7 1TW, | | | | | | | |
| United Kingdom | | | | | | | |
| 23.2.2012 | Esmya | ulipristal | PregLem France SAS. 32, route de l’Eglise, 74140 Massongy, France | PregLem France SAS. | 32, route de l’Eglise, | 74140 Massongy, | France |
| PregLem France SAS. | | | | | | | |
| 32, route de l’Eglise, | | | | | | | |
| 74140 Massongy, | | | | | | | |
| France | | | | | | | |

—   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 |
| ------------------------------- | ----------------------------- | ---------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------- |
| 9.2.2012 | Sumatriptan Galpharm | Galpharm Healthcare Ltd. Dodworth Business ParkDodworth, Barnsley S75 3SP United Kingdom | Galpharm Healthcare Ltd. | Dodworth Business ParkDodworth, |
| Galpharm Healthcare Ltd. | | | | |
| Dodworth Business ParkDodworth, | | | | |
| Barnsley | | | | |
| S75 3SP | | | | |
| United Kingdom | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ----------------------------------------------------- | ------------------------------------ | ---------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- | -------------------------------------------------- |
| 6.2.2012 | Aclasta | 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 | | | | |
| 6.2.2012 | 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 | | | | |
| 6.2.2012 | 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 | | | | |
| 6.2.2012 | Avastin | 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 | | | | |
| 6.2.2012 | Corlentor | Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes, Cedex, France | Les Laboratoires Servier | 50 rue Carnot, |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, | | | | |
| 92284 Suresnes, Cedex, | | | | |
| France | | | | |
| 6.2.2012 | Dificlir | FGK Representative Service GmbH Heimeranstrasse 35, 80339 München, Deutschland | FGK Representative Service GmbH | Heimeranstrasse 35, |
| FGK Representative Service GmbH | | | | |
| Heimeranstrasse 35, | | | | |
| 80339 München, | | | | |
| Deutschland | | | | |
| 6.2.2012 | Erbitux | Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland | Merck KGaA | Frankfurter Straße 250, |
| Merck KGaA | | | | |
| Frankfurter Straße 250, | | | | |
| 64271 Darmstadt, | | | | |
| Deutschland | | | | |
| 6.2.2012 | Intanza | 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 | | | | |
| 6.2.2012 | Olanzapine 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 | | | | |
| 6.2.2012 | Optimark | Covidien Deutschland GmbH Gewerbepark 1, 93333 Neustadt/Donau, Deutschland | Covidien Deutschland GmbH | Gewerbepark 1, |
| Covidien Deutschland GmbH | | | | |
| Gewerbepark 1, | | | | |
| 93333 Neustadt/Donau, | | | | |
| Deutschland | | | | |
| 6.2.2012 | Orencia | 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 | | | | |
| 6.2.2012 | Prialt | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, Hatfield, |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, | | | | |
| Herts, | | | | |
| AL10 9SN, | | | | |
| United Kingdom | | | | |
| 6.2.2012 | Rapamune | 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 | | | | |
| 6.2.2012 | Remicade | Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | Janssen Biologics B.V. | Einsteinweg 101, |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, | | | | |
| 2333 CB Leiden, | | | | |
| Nederland | | | | |
| 6.2.2012 | 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 | | | | |
| 6.2.2012 | Simponi | Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | Janssen Biologics B.V. | Einsteinweg 101, |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, | | | | |
| 2333 CB Leiden, | | | | |
| Nederland | | | | |
| 6.2.2012 | Sonata | Meda AB Pipers väg 2A, 170 09 Solna, Sverige | Meda AB | Pipers väg 2A, |
| Meda AB | | | | |
| Pipers väg 2A, | | | | |
| 170 09 Solna, | | | | |
| Sverige | | | | |
| 6.2.2012 | 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 | | | | |
| 6.2.2012 | Tevagrastim | Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland | Teva GmbH | Graf-Arco-Straße 3, |
| Teva GmbH | | | | |
| Graf-Arco-Straße 3, | | | | |
| 89079 Ulm, | | | | |
| Deutschland | | | | |
| 6.2.2012 | Votubia | 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 | | | | |
| 6.2.2012 | Yellox | Croma-Pharma GmbH Industriezeile 6, A-2100 Leobendorf, Österreich | Croma-Pharma GmbH | Industriezeile 6, |
| Croma-Pharma GmbH | | | | |
| Industriezeile 6, | | | | |
| A-2100 Leobendorf, | | | | |
| Österreich | | | | |
| 9.2.2012 | Aerius | 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 | | | | |
| 9.2.2012 | Arzerra | Glaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Glaxo Wellcome House, Berkeley Avenue, Greenford, |
| Glaxo Group Ltd | | | | |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 9.2.2012 | Azomyr | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, | | | | |
| Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 9.2.2012 | Olazax Disperzi | Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | Glenmark Pharmaceuticals s.r.o. | City Tower, Hvězdova 1716/2b, |
| Glenmark Pharmaceuticals s.r.o. | | | | |
| City Tower, Hvězdova 1716/2b, | | | | |
| 140 78 Praha 4, | | | | |
| Česká republika | | | | |
| 9.2.2012 | 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 | | | | |
| 9.2.2012 | Prepandemic Influenza | 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 | | | | |
| 9.2.2012 | Prepandemic Influenza | 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 | | | | |
| 9.2.2012 | Procoralan | Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France | Les Laboratoires Servier | 50, rue Carnot, |
| Les Laboratoires Servier | | | | |
| 50, rue Carnot, | | | | |
| 92284 Suresnes cedex, | | | | |
| France | | | | |
| 9.2.2012 | Rivastigmine HEXAL | HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | HEXAL AG | Industriestrasse 25, |
| HEXAL AG | | | | |
| Industriestrasse 25, | | | | |
| D-83607 Holzkirchen, | | | | |
| Deutschland | | | | |
| 13.2.2012 | 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 | | | | |
| 13.2.2012 | Cystadane | Orphan Europe S.a.r.l. Immeuble Le Wilson, 70 Avenue du Général de Gaulle, 92800 Puteaux, France | Orphan Europe S.a.r.l. | Immeuble Le Wilson, |
| Orphan Europe S.a.r.l. | | | | |
| Immeuble Le Wilson, | | | | |
| 70 Avenue du Général de Gaulle, | | | | |
| 92800 Puteaux, | | | | |
| France | | | | |
| 17.2.2012 | Aerinaze | 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 | | | | |
| 17.2.2012 | Elonva | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, |
| N.V. Organon | | | | |
| Kloosterstraat 6, | | | | |
| 5349 AB Oss, | | | | |
| Nederland | | | | |
| 17.2.2012 | Fablyn | 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 | | | | |
| 17.2.2012 | Faslodex | AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom | AstraZeneca UK Limited | Alderley Park, Macclesfield, |
| AstraZeneca UK Limited | | | | |
| Alderley Park, Macclesfield, | | | | |
| Cheshire, | | | | |
| SK10 4TG | | | | |
| United Kingdom | | | | |
| 17.2.2012 | Gliolan | 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 | | | | |
| 17.2.2012 | Herceptin | 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 | | | | |
| 17.2.2012 | Isentress | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, | | | | |
| Hoddesdon, Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 17.2.2012 | Myocet | Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, France | Cephalon Europe | 5 Rue Charles Martigny, |
| Cephalon Europe | | | | |
| 5 Rue Charles Martigny, | | | | |
| 94700 Maisons Alfort, | | | | |
| France | | | | |
| 17.2.2012 | Neoclarityn | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd. | Hertford Road, |
| Merck Sharp & Dohme Ltd. | | | | |
| Hertford Road, | | | | |
| Hoddesdon, Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| EU/1/00/161/001-013 | | | | |
| EU/1/00/161/022-067 | | | | |
| 17.2.2012 | Olanzapine 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 | | | | |
| 17.2.2012 | Olazax | Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | Glenmark Pharmaceuticals s.r.o. | City Tower, Hvězdova 1716/2b, |
| Glenmark Pharmaceuticals s.r.o. | | | | |
| City Tower, Hvězdova 1716/2b, | | | | |
| 140 78 Praha 4, | | | | |
| Česká republika | | | | |
| 17.2.2012 | Replagal | Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige | Shire Human Genetic Therapies AB | Svärdvägen 11D, |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D, | | | | |
| 182 33 Danderyd, | | | | |
| Sverige | | | | |
| 17.2.2012 | Rivastigmine 1 A Pharma | 1 A Pharma GmbH Keltenring 1+3, 82041 Oberhaching, Deutschland | 1 A Pharma GmbH | Keltenring 1+3, |
| 1 A Pharma GmbH | | | | |
| Keltenring 1+3, | | | | |
| 82041 Oberhaching, | | | | |
| Deutschland | | | | |
| 17.2.2012 | Rivastigmine Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, | | | | |
| 83607 Holzkirchen, | | | | |
| Deutschland | | | | |
| 17.2.2012 | Tractocile | Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark | Ferring Pharmaceuticals A/S | Kay Fiskers Plads 11, |
| Ferring Pharmaceuticals A/S | | | | |
| Kay Fiskers Plads 11, | | | | |
| 2300 Copenhagen S, | | | | |
| Danmark | | | | |
| 17.2.2012 | Vectibix | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, |
| Amgen Europe B.V. | | | | |
| Minervum 7061, | | | | |
| NL-4817 ZK Breda, | | | | |
| Nederland | | | | |
| 21.2.2012 | Aloxi | Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Republic of Ireland | Helsinn Birex Pharmaceuticals Ltd | Damastown, Mulhuddart, |
| Helsinn Birex Pharmaceuticals Ltd | | | | |
| Damastown, Mulhuddart, | | | | |
| Dublin 15, | | | | |
| Republic of Ireland | | | | |
| 21.2.2012 | 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 | | | | |
| 21.2.2012 | Cholestagel | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, | | | | |
| NL-1411 DD Naarden, | | | | |
| Nederland | | | | |
| 21.2.2012 | Cubicin | 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 | | | | |
| 21.2.2012 | Evra | Janssen-Cilag International NV Turnhoutseweg, 30 – 2340 Beerse – België | Janssen-Cilag International NV | Turnhoutseweg, 30 – |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 – | | | | |
| 2340 Beerse – | | | | |
| België | | | | |
| 21.2.2012 | Fertavid | 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 | | | | |
| 21.2.2012 | Glivec | 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 | | | | |
| 21.2.2012 | Kaletra | Abbott Laboratories Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berks, SL6 4XE United Kingdom | Abbott Laboratories | Abbott House, Vanwall Business Park, |
| Abbott Laboratories | | | | |
| Abbott House, Vanwall Business Park, | | | | |
| Vanwall Road, Maidenhead, | | | | |
| Berks, | | | | |
| SL6 4XE | | | | |
| United Kingdom | | | | |
| 21.2.2012 | Levitra | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 21.2.2012 | 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 | | | | |
| 21.2.2012 | PREZISTA | Janssen-Cilag International NV Turnhoutseweg, 30 – 2340 Beerse – België | Janssen-Cilag International NV | Turnhoutseweg, 30 – |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 – | | | | |
| 2340 Beerse – | | | | |
| België | | | | |
| 21.2.2012 | 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 | | | | |
| 21.2.2012 | Remicade | Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | Janssen Biologics B.V. | Einsteinweg 101, |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, | | | | |
| 2333 CB Leiden, | | | | |
| Nederland | | | | |
| 21.2.2012 | RotaTeq | 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 | | | | |
| 21.2.2012 | 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 | | | | |
| 21.2.2012 | 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 | | | | |
| 21.2.2012 | 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 | | | | |
| 21.2.2012 | Victoza | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 21.2.2012 | Vimpat | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/ Researchdreef, 60, 1070 Brussel, België | UCB Pharma SA. | Allée de la Recherche 60, |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, | | | | |
| 1070 Bruxelles, | | | | |
| Belgique/ | | | | |
| Researchdreef, 60, | | | | |
| 1070 Brussel, | | | | |
| België | | | | |
| 21.2.2012 | Visudyne | 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 | | | | |
| 21.2.2012 | Vivanza | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 21.2.2012 | 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 | | | | |
| 23.2.2012 | Clopidogrel Qualimed | Qualimed 117, Allée des Parcs, 69 800 Saint Priest, France | Qualimed | 117, Allée des Parcs, |
| Qualimed | | | | |
| 117, Allée des Parcs, | | | | |
| 69 800 Saint Priest, | | | | |
| France | | | | |
| 23.2.2012 | Januvia | 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 | | | | |
| 23.2.2012 | Resolor | Shire-Movetis NV Veedjik 58, B-2300 Turnhout, België | Shire-Movetis NV | Veedjik 58, |
| Shire-Movetis NV | | | | |
| Veedjik 58, | | | | |
| B-2300 Turnhout, | | | | |
| België | | | | |
| 27.2.2012 | Bridion | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, |
| N.V. Organon | | | | |
| Kloosterstraat 6, | | | | |
| 5349 AB Oss, | | | | |
| Nederland | | | | |
| 27.2.2012 | Evicel | Omrix Biopharmaceuticals N.V. Leonardo Da Vinci Laan 15, B-1831 Diegem, België | Omrix Biopharmaceuticals N.V. | Leonardo Da Vinci Laan 15, |
| Omrix Biopharmaceuticals N.V. | | | | |
| Leonardo Da Vinci Laan 15, | | | | |
| B-1831 Diegem, | | | | |
| België | | | | |
| 27.2.2012 | Instanyl | Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark | Nycomed Danmark ApS | Langebjerg 1, |
| Nycomed Danmark ApS | | | | |
| Langebjerg 1, | | | | |
| DK-4000 Roskilde, | | | | |
| Danmark | | | | |
| 27.2.2012 | Irbesartan HCT Zentiva (Ex-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 | | | | |
| 27.2.2012 | Olanzapine Glenmark | Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | Glenmark Generics (Europe) Limited | Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, |
| Glenmark Generics (Europe) Limited | | | | |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, | | | | |
| Middlesex | | | | |
| HA3 OBU, | | | | |
| United Kingdom | | | | |
| 27.2.2012 | Olanzapine Glenmark Europe | Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | Glenmark Generics (Europe) Limited | Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, |
| Glenmark Generics (Europe) Limited | | | | |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, | | | | |
| Middlesex | | | | |
| HA3 OBU, | | | | |
| United Kingdom | | | | |
| 27.2.2012 | Prolia | 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 | | | | |
| 27.2.2012 | Twynsta | 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 | | | | |

—   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 |
| -------------------- | ----------------------------- | ------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 9.2.2012 | 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 | | | | |
| 9.2.2012 | Clopidogrel Hexal | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| 83714 Miesbach, | | | | |
| Deutschland | | | | |
| 13.2.2012 | 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 | | | | |

—   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 |
| -------------------------------------------------------------- | ----------------------------- | ---------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------------------------------------------- | ----------------------------------------------- | -------------------- |
| 23.2.2012 | RevitaCAM | Meloxicam | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM | Abbott Laboratories Limited | Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, | Berkshire | SL6 4XE, |
| Abbott Laboratories Limited | | | | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, | | | | | | | |
| Berkshire | | | | | | | |
| SL6 4XE, | | | | | | | |
| 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 |
| ---------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------ | --------------------------------------------- | ---------------------------- |
| 17.2.2012 | Purevax Rabies | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, |
| MERIAL | | | | |
| 29 avenue Tony Garnier, | | | | |
| 69007 LYON, | | | | |
| France | | | | |
| 21.2.2012 | Dicural | 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 | | | | |
| 27.2.2012 | Reconcile | Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | Eli Lilly and Company Ltd | Priestley Road, Basingstoke, |
| Eli Lilly and Company Ltd | | | | |
| Priestley Road, Basingstoke, | | | | |
| Hampshire, | | | | |
| RG24 9NL, | | | | |
| United Kingdom | | | | |

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

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

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

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

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