# C_2012124EN.01000101.xml

| 27.4.2012 | EN | Official Journal of the European Union | C 124/1 |
| --------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2012 to 31 March 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 124/01

—   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 |
| ----------------------------------------------- | -------------------------------- | ---------------------------------------- | -------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------- | ----------------------------------------------- | -------------------- |
| 9.3.2012 | Mercaptopurine Nova Laboratories | Mercaptopurine | Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom | Nova Laboratories Limited | Martin House, Gloucester Crescent, | Wigston Leicester, | LE18 4YL, |
| Nova Laboratories Limited | | | | | | | |
| Martin House, Gloucester Crescent, | | | | | | | |
| Wigston Leicester, | | | | | | | |
| LE18 4YL, | | | | | | | |
| United Kingdom | | | | | | | |
| 9.3.2012 | Sepioglin | pioglitazone | Vaia S.A. 1, 28 Octovriou str., Ag. Varvara 123 51, Athens, Ελλάδα | Vaia S.A. | 1, 28 Octovriou str., | Ag. Varvara | 123 51, Athens, |
| Vaia S.A. | | | | | | | |
| 1, 28 Octovriou str., | | | | | | | |
| Ag. Varvara | | | | | | | |
| 123 51, Athens, | | | | | | | |
| Ελλάδα | | | | | | | |
| 15.3.2012 | Pioglitazone Actavis | pioglitazone | 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 | | | | | | | |
| 15.3.2012 | Pioglitazone Actavis Group | pioglitazone | 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 | | | | | | | |
| 21.3.2012 | Paglitaz | pioglitazone | KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d. d., Novo mesto | Šmarješka cesta 6, | 8501 Novo mesto, | Slovenija |
| KRKA, d. d., Novo mesto | | | | | | | |
| Šmarješka cesta 6, | | | | | | | |
| 8501 Novo mesto, | | | | | | | |
| Slovenija | | | | | | | |
| 21.3.2012 | Pioglitazone Accord | pioglitazone | 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, | United Kingdom |
| Accord Healthcare Limited | | | | | | | |
| 5th Floor Charles House, 108/110 Finchley road, | | | | | | | |
| London NW3 5JJ, | | | | | | | |
| United Kingdom | | | | | | | |
| 26.3.2012 | Pioglitazone Teva | pioglitazone | 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 | | | | | | | |
| 26.3.2012 | Pioglitazone Teva Pharma | pioglitazone | 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 | | | | | | | |

—   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 |
| ---------------------------------------------------------- | -------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- | ---------------------------------------------------- |
| 2.3.2012 | ATryn | GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom | GTC Biotherapeutics UK Limited | 10 Norwich Street, |
| GTC Biotherapeutics UK Limited | | | | |
| 10 Norwich Street, | | | | |
| London | | | | |
| EC4A 1BD, | | | | |
| United Kingdom | | | | |
| 2.3.2012 | Daliresp | 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 | | | | |
| 2.3.2012 | Esbriet | InterMune UK Ltd Euston Tower, Floor 32, 286 Euston Road, London, NW1 3DP, United Kingdom | InterMune UK Ltd | Euston Tower, Floor 32, 286 Euston Road, |
| InterMune UK Ltd | | | | |
| Euston Tower, Floor 32, 286 Euston Road, | | | | |
| London, | | | | |
| NW1 3DP, | | | | |
| United Kingdom | | | | |
| 2.3.2012 | Fampyra | Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Limited | Innovation House, 70 Norden Road, Maidenhead, |
| Biogen Idec Limited | | | | |
| Innovation House, 70 Norden Road, Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4AY, | | | | |
| United Kingdom | | | | |
| 2.3.2012 | Invirase | 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 | | | | |
| 2.3.2012 | Leflunomide 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 | | | | |
| 2.3.2012 | Libertek | 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 | | | | |
| 2.3.2012 | NutropinAq | Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | Ipsen Pharma | 65, quai Georges Gorse, |
| Ipsen Pharma | | | | |
| 65, quai Georges Gorse, | | | | |
| 92100 Boulogne-Billancourt, | | | | |
| France | | | | |
| 2.3.2012 | Ruconest | Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland | Pharming Group N.V. | Darwinweg 24, |
| Pharming Group N.V. | | | | |
| Darwinweg 24, | | | | |
| NL-2333 CR Leiden, | | | | |
| Nederland | | | | |
| 2.3.2012 | Tandemact | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, | | | | |
| London | | | | |
| WC2B 4AE, | | | | |
| United Kingdom | | | | |
| 2.3.2012 | Valtropin | BioPartners GmbH Kaiserpassage 11 – D-72764 Reutlingen, Deutschland | BioPartners GmbH | Kaiserpassage 11 – |
| BioPartners GmbH | | | | |
| Kaiserpassage 11 – | | | | |
| D-72764 Reutlingen, | | | | |
| Deutschland | | | | |
| 6.3.2012 | 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 | | | | |
| 6.3.2012 | Repso | 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 | | | | |
| 6.3.2012 | Rivastigmine 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 | | | | |
| 6.3.2012 | Topotecan 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 | | | | |
| 8.3.2012 | 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 | | | | |
| 8.3.2012 | Firazyr | Shire Orphan Therapies GmbH Friedrichstrasse 149, D-10117 Berlin, Deutschland | Shire Orphan Therapies GmbH | Friedrichstrasse 149, |
| Shire Orphan Therapies GmbH | | | | |
| Friedrichstrasse 149, | | | | |
| D-10117 Berlin, | | | | |
| Deutschland | | | | |
| 8.3.2012 | Pritor | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 8.3.2012 | PritorPlus | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 9.3.2012 | Samsca | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House, Highbridge Business Park, Oxford Road, |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House, Highbridge Business Park, Oxford Road, | | | | |
| Uxbridge, Middlesex | | | | |
| UB8 1HU, | | | | |
| United Kingdom | | | | |
| 15.3.2012 | Avamys | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, Middlesex |
| Glaxo Group Ltd | | | | |
| Greenford, Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 15.3.2012 | Carbaglu | Orphan Europe Immeuble Le Wilson, 70 Avenue du General de Gaulle, 92800 Puteaux, France | Orphan Europe | Immeuble Le Wilson, |
| Orphan Europe | | | | |
| Immeuble Le Wilson, | | | | |
| 70 Avenue du General de Gaulle, | | | | |
| 92800 Puteaux, | | | | |
| France | | | | |
| 15.3.2012 | 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 | | | | |
| 15.3.2012 | 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 | | | | |
| 15.3.2012 | 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 | | | | |
| 15.3.2012 | Ventavis | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 15.3.2012 | Vizarsin | 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 | | | | |
| 19.3.2012 | Afinitor | 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 | | | | |
| 19.3.2012 | Arava | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | Sanofi-Aventis Deutschland GmbH | D-65926 Frankfurt am Main, |
| Sanofi-Aventis Deutschland GmbH | | | | |
| D-65926 Frankfurt am Main, | | | | |
| Deutschland | | | | |
| 19.3.2012 | 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 | | | | |
| 19.3.2012 | Benlysta | Glaxo Group Limited Glaxo Wellcome House, Berkely Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, Berkely Avenue, Greenford, |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, Berkely Avenue, Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 19.3.2012 | 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 | | | | |
| 19.3.2012 | Fasturtec | 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 | | | | |
| 19.3.2012 | Helixate NexGen | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 19.3.2012 | IDflu | Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France | Sanofi Pasteur SA | 2, avenue Pont Pasteur, |
| Sanofi Pasteur SA | | | | |
| 2, avenue Pont Pasteur, | | | | |
| F-69007 Lyon, | | | | |
| France | | | | |
| 19.3.2012 | Incivo | 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 | | | | |
| 19.3.2012 | 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 | | | | |
| 19.3.2012 | Intelence | Janssen-Cilag International NV Turnhoutseweg, 30 – 2340 Beerse – België | Janssen-Cilag International NV | Turnhoutseweg, 30 – |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, 30 – | | | | |
| 2340 Beerse – | | | | |
| België | | | | |
| 19.3.2012 | 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 | | | | |
| 19.3.2012 | Kogenate Bayer | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 19.3.2012 | 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 | | | | |
| 19.3.2012 | Levitra | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, |
| Bayer Pharma AG | | | | |
| 13342 Berlin, | | | | |
| Deutschland | | | | |
| 19.3.2012 | Norvir | 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, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, | | | | |
| Maidenhead, Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 19.3.2012 | PegIntron | Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België | Schering Plough Europe | Clos du Lynx 5, |
| Schering Plough Europe | | | | |
| Clos du Lynx 5, | | | | |
| 1200 Bruxelles, | | | | |
| Belgique – | | | | |
| Lynx Binnenhof 5, | | | | |
| 1200 Brussel, | | | | |
| België | | | | |
| 19.3.2012 | Prevenar 13 | Wyeth-Lederle Vaccines S.A. Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - 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 Brussel - Bruxelles, | | | | |
| Belgïe-Belgique | | | | |
| 19.3.2012 | Privigen | CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland | CSL Behring GmbH | Emil-von-Behring-Strasse 76, |
| CSL Behring GmbH | | | | |
| Emil-von-Behring-Strasse 76, | | | | |
| 35041 Marburg, | | | | |
| Deutschland | | | | |
| 19.3.2012 | 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 | | | | |
| 19.3.2012 | Ranexa | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | Menarini International Operations Luxembourg S.A. | 1, Avenue de la Gare, |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, Avenue de la Gare, | | | | |
| L-1611 Luxembourg, | | | | |
| Luxembourg | | | | |
| 19.3.2012 | Refludan | Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | Celgene Europe Ltd | 1 Longwalk Road, Stockley Park, |
| Celgene Europe Ltd | | | | |
| 1 Longwalk Road, Stockley Park, | | | | |
| Uxbridge, | | | | |
| UB11 1DB, | | | | |
| United Kingdom | | | | |
| 19.3.2012 | 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 | | | | |
| 19.3.2012 | Resolor | Shire-Movetis NV Veedjik 58, B-2300 Turnhout, België | Shire-Movetis NV | Veedjik 58, |
| Shire-Movetis NV | | | | |
| Veedjik 58, | | | | |
| B-2300 Turnhout, | | | | |
| België | | | | |
| 19.3.2012 | Tasmar | Meda AB Pipers väg 2A, 170 09 Solna, Sverige | Meda AB | Pipers väg 2A, |
| Meda AB | | | | |
| Pipers väg 2A, | | | | |
| 170 09 Solna, | | | | |
| Sverige | | | | |
| 19.3.2012 | 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 | | | | |
| 19.3.2012 | Votrient | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, | | | | |
| Greenford, Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 21.3.2012 | Atriance | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, | | | | |
| Greenford, Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 21.3.2012 | Champix | 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 | | | | |
| 21.3.2012 | Clopidogrel Krka d.d. | 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 | | | | |
| 21.3.2012 | Foclivia | 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 | | | | |
| 21.3.2012 | Integrilin | Glaxo Group Ltd Greenford, Middlesex, UB6 ONN, United Kingdom | Glaxo Group Ltd | Greenford, Middlesex, |
| Glaxo Group Ltd | | | | |
| Greenford, Middlesex, | | | | |
| UB6 ONN, | | | | |
| United Kingdom | | | | |
| 21.3.2012 | 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 | | | | |
| 21.3.2012 | Revatio | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Sandwich, |
| Pfizer Limited | | | | |
| Sandwich, | | | | |
| Kent, | | | | |
| CT13 9NJ, | | | | |
| United Kingdom | | | | |
| 21.3.2012 | Thymanax | Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland | Servier (Ireland) Industries Limited | Gorey Road, Arklow, Co. Wicklow, |
| Servier (Ireland) Industries Limited | | | | |
| Gorey Road, Arklow, Co. Wicklow, | | | | |
| Ireland | | | | |
| 21.3.2012 | VELCADE | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, | | | | |
| B-2340 Beerse, | | | | |
| België | | | | |
| 21.3.2012 | Victrelis | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, | | | | |
| Hodderson, Hertfordshire | | | | |
| EN11 9BU, | | | | |
| United Kingdom | | | | |
| 21.3.2012 | Volibris | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, |
| Glaxo Group Ltd | | | | |
| Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 21.3.2012 | Xgeva | Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, |
| Amgen Europe B.V. | | | | |
| Minervum 7061, | | | | |
| 4817 ZK Breda, | | | | |
| Nederland | | | | |
| 21.3.2012 | 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 | | | | |
| 26.3.2012 | Azilect | Teva Pharma GmbH Graf-Arco-Str. 3, 89079 Ulm, Deutschland | Teva Pharma GmbH | Graf-Arco-Str. 3, |
| Teva Pharma GmbH | | | | |
| Graf-Arco-Str. 3, | | | | |
| 89079 Ulm, | | | | |
| Deutschland | | | | |
| 26.3.2012 | Eurartesim | 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, |
| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A | | | | |
| Viale Shakespeare 47, | | | | |
| 00144 Rome, | | | | |
| Italia | | | | |
| 26.3.2012 | Neupro | Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland | Schwarz Pharma Ltd | Shannon, Industrial Estate, |
| Schwarz Pharma Ltd | | | | |
| Shannon, Industrial Estate, | | | | |
| Co.Clare, | | | | |
| Ireland | | | | |
| 26.3.2012 | Nimvastid | 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 | | | | |
| 26.3.2012 | Pandemic influenza vaccine H5N1 BAXTER | Baxter AG Industriestraße 67, A – 1221 Wien, Österreich | Baxter AG | Industriestraße 67, |
| Baxter AG | | | | |
| Industriestraße 67, | | | | |
| A – 1221 Wien, | | | | |
| Österreich | | | | |
| 26.3.2012 | PegIntron | Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België | Schering Plough Europe | Clos du Lynx 5, |
| Schering Plough Europe | | | | |
| Clos du Lynx 5, | | | | |
| 1200 Bruxelles, | | | | |
| Belgique – | | | | |
| Lynx Binnenhof 5, | | | | |
| 1200 Brussel, | | | | |
| België | | | | |
| 26.3.2012 | Plenadren | DuoCort Pharma AB Kullagatan 8-10, S-252 20 Helsingborg, Sverige | DuoCort Pharma AB | Kullagatan 8-10, |
| DuoCort Pharma AB | | | | |
| Kullagatan 8-10, | | | | |
| S-252 20 Helsingborg, | | | | |
| Sverige | | | | |
| 26.3.2012 | Valdoxan | 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 | | | | |
| 26.3.2012 | ViraferonPeg | Schering Plough Europe Clos du Lynx 5, 1200 Bruxelles, Belgique – Lynx Binnenhof 5, 1200 Brussel, België | Schering Plough Europe | Clos du Lynx 5, |
| Schering Plough Europe | | | | |
| Clos du Lynx 5, | | | | |
| 1200 Bruxelles, | | | | |
| Belgique – | | | | |
| Lynx Binnenhof 5, | | | | |
| 1200 Brussel, | | | | |
| België | | | | |
| 26.3.2012 | VPRIV | Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland | Shire Pharmaceuticals Ireland Limited | 5 Riverside Walk, Citywest Business Campus, |
| Shire Pharmaceuticals Ireland Limited | | | | |
| 5 Riverside Walk, Citywest Business Campus, | | | | |
| Dublin 24, | | | | |
| Ireland | | | | |

—   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 |
| -------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------ | --------------------------------------------- | -------------------------- |
| 15.3.2012 | Livensa | Warner Chilcott Deutschland Gmbh Dr.-Otto-Röhm-Strasse 2-4, 64331 Weiterstadt, Deutschland | Warner Chilcott Deutschland Gmbh | Dr.-Otto-Röhm-Strasse 2-4, |
| Warner Chilcott Deutschland Gmbh | | | | |
| Dr.-Otto-Röhm-Strasse 2-4, | | | | |
| 64331 Weiterstadt, | | | | |
| Deutschland | | | | |

—   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 |
| -------------------- | ----------------------------- | ------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 2.3.2012 | Omnitrope | Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich | Sandoz GmbH | Biochemiestrasse 10, |
| Sandoz GmbH | | | | |
| Biochemiestrasse 10, | | | | |
| 6250 Kundl, | | | | |
| Österreich | | | | |

—   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 |
| ------------------------ | ----------------------------- | ---------------------------------------- | -------------------------------------------------------------------- | --------------------------------------------- | ------------------------ | ----------------------------------------------- | -------------------- |
| 8.3.2012 | Zulvac 1+8 Bovis | — | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, | Kent | CT13 9NJ |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, Sandwich, | | | | | | | |
| Kent | | | | | | | |
| CT13 9NJ | | | | | | | |
| United Kingdom | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ------------------------------ | ----------------------------- | ------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------- |
| 2.3.2012 | Easotic | 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 | | | | |
| 2.3.2012 | 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 | | | | |
| 9.3.2012 | Purevax Rabies | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, |
| MERIAL | | | | |
| 29 avenue Tony Garnier, | | | | |
| 69007 LYON, | | | | |
| France | | | | |
| 15.3.2012 | BTVPUR AlSap 8 | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, |
| MERIAL | | | | |
| 29 avenue Tony Garnier, | | | | |
| 69007 LYON, | | | | |
| France | | | | |
| 15.3.2012 | Masivet | AB Science S.A. 3 avenue George V, 75008 Paris, France | AB Science S.A. | 3 avenue George V, |
| AB Science S.A. | | | | |
| 3 avenue George V, | | | | |
| 75008 Paris, | | | | |
| France | | | | |
| 15.3.2012 | Recuvyra | Nexcyon Pharmaceuticals Ltd. Bank Barn, How Mill, Brampton, Cumbria CA8 9JY, United Kingdom | Nexcyon Pharmaceuticals Ltd. | Bank Barn, How Mill, |
| Nexcyon Pharmaceuticals Ltd. | | | | |
| Bank Barn, How Mill, | | | | |
| Brampton, Cumbria | | | | |
| CA8 9JY, | | | | |
| United Kingdom | | | | |
| 26.3.2012 | Aivlosin | ECO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United Kingdom | ECO Animal Health Ltd | 78 Coombe Road New Malden |
| ECO Animal Health Ltd | | | | |
| 78 Coombe Road New Malden | | | | |
| Surrey | | | | |
| KT3 4QS | | | | |
| United Kingdom | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------- | ----------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------- | ----------------------- |
| 19.3.2012 | Gonazon | 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 | | | | |
| 19.3.2012 | Zubrin | 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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