# C_2012078EN.01000101.xml

| 16.3.2012 | EN | Official Journal of the European Union | C 78/1 |
| --------- | -- | -------------------------------------- | ------ |

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 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 78/01

—   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 |
| ----------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------- | --------------------------------------------- | ----------------------- | ----------------------------------------------- | -------------------- |
| 9.1.2012 | Efavirenz Teva | efavirenz | Teva Pharma BV Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma BV | Computerweg 10, | 3542 DR Utrecht, | Nederland |
| Teva Pharma BV | | | | | | | |
| Computerweg 10, | | | | | | | |
| 3542 DR Utrecht, | | | | | | | |
| Nederland | | | | | | | |
| 13.1.2012 | Desloratadine Actavis | desloratadine | Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland | Actavis Group PTC ehf. | ReykjavÍkurvegur 76-78, | Hafnarfjörður 220, | Iceland |
| Actavis Group PTC ehf. | | | | | | | |
| ReykjavÍkurvegur 76-78, | | | | | | | |
| Hafnarfjörður 220, | | | | | | | |
| Iceland | | | | | | | |
| 13.1.2012 | Desloratadine ratiopharm | desloratadine | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, | D-89079 Ulm, | Deutschland |
| ratiopharm GmbH | | | | | | | |
| Graf-Arco-Straße 3, | | | | | | | |
| D-89079 Ulm, | | | | | | | |
| Deutschland | | | | | | | |
| 31.1.2012 | Docetaxel Mylan | Docetaxel | Mylan S.A.S 117 allée des Parcs, 69 800 Saint Priest, France | Mylan S.A.S | 117 allée des Parcs, | 69 800 Saint Priest, | France |
| Mylan S.A.S | | | | | | | |
| 117 allée des Parcs, | | | | | | | |
| 69 800 Saint Priest, | | | | | | | |
| 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 |
| -------------------- | ----------------------------- | ------------------------------------------------------------------------------- | --------------------------------------------- | -------------------- |
| 20.1.2012 | Luveniq | Lux Biosciences GmbH MlawGroup, Maximilianstr. 31, D-80539 Munich, Deutschland. | Lux Biosciences GmbH | MlawGroup, |
| Lux Biosciences GmbH | | | | |
| MlawGroup, | | | | |
| Maximilianstr. 31, | | | | |
| D-80539 Munich, | | | | |
| Deutschland. | | | | |

—   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 |
| -------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------- | -------------------------------------------------------------- |
| 9.1.2012 | Inovelon | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, |
| Eisai Limited | | | | |
| European Knowledge Centre, | | | | |
| Mosquito Way, Hatfield, | | | | |
| Hertfordshire, | | | | |
| AL10 9SN, | | | | |
| United Kingdom | | | | |
| 9.1.2012 | Leganto | UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland | UCB Manufacturing Ireland Ltd. | Shannon Industrial Estate, |
| UCB Manufacturing Ireland Ltd. | | | | |
| Shannon Industrial Estate, | | | | |
| Co, Clare, | | | | |
| Ireland | | | | |
| 9.1.2012 | Pumarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| B-1330 Rixensart, | | | | |
| Belgique | | | | |
| 9.1.2012 | Revlimid | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, | | | | |
| Stockley Park, Uxbridge, | | | | |
| Middlesex, | | | | |
| UB11 1BD, | | | | |
| United Kingdom | | | | |
| 9.1.2012 | Sutent | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 13.1.2012 | Diacomit | Biocodex 7 avenue Gallieni, 94250 Gentilly, France | Biocodex | 7 avenue Gallieni, |
| Biocodex | | | | |
| 7 avenue Gallieni, | | | | |
| 94250 Gentilly, | | | | |
| France | | | | |
| 13.1.2012 | Erbitux | Merck KGaA Frankfurter Straße 250, 64271 Darmstadt, Deutschland | Merck KGaA | Frankfurter Straße 250, |
| Merck KGaA | | | | |
| Frankfurter Straße 250, | | | | |
| 64271 Darmstadt, | | | | |
| Deutschland | | | | |
| 13.1.2012 | Ilaris | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, | | | | |
| Horsham, West Sussex, | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 13.1.2012 | NovoSeven | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, |
| Novo Nordisk A/S | | | | |
| Novo Allé, | | | | |
| DK-2880 Bagsvaerd, | | | | |
| Danmark | | | | |
| 13.1.2012 | Olanzapine Mylan | Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | Generics [UK] Limited | Station Close, Potters Bar, |
| Generics [UK] Limited | | | | |
| Station Close, Potters Bar, | | | | |
| Hertfordshire, | | | | |
| EN6 1TL, | | | | |
| United Kingdom | | | | |
| 13.1.2012 | Revlimid | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, | | | | |
| Stockley Park, Uxbridge, | | | | |
| Middlesex, | | | | |
| UB11 1BD, | | | | |
| United Kingdom | | | | |
| 13.1.2012 | Stelara | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse – België | Janssen-Cilag International NV | Turnhoutseweg, |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg, | | | | |
| 30 - 2340 Beerse – | | | | |
| België | | | | |
| 13.1.2012 | Temodal | 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 | | | | |
| 13.1.2012 | Twinrix Adult | GlaxoSmithKline Biologicals S.A rue de l'Institut 89, B-1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A | | | | |
| rue de l'Institut 89, | | | | |
| B-1330 Rixensart, | | | | |
| Belgique | | | | |
| 13.1.2012 | Twinrix Paediatric | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, B-1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, | | | | |
| B-1330 Rixensart, | | | | |
| Belgique | | | | |
| 20.1.2012 | Champix | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 20.1.2012 | ChondroCelect | TiGenix NV Romeinse straat 12/2, B-3001 LEUVEN, België | TiGenix NV | Romeinse straat 12/2, |
| TiGenix NV | | | | |
| Romeinse straat 12/2, | | | | |
| B-3001 LEUVEN, | | | | |
| België | | | | |
| 20.1.2012 | 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 | | | | |
| 20.1.2012 | Clopidogrel ratiopharm GmbH | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, | | | | |
| 83714 Miesbach, | | | | |
| Deutschland | | | | |
| 20.1.2012 | 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 | | | | |
| 20.1.2012 | 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, Vanwall Road, Maidenhead, |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, | | | | |
| Berkshire | | | | |
| SL6 4XE, | | | | |
| United Kingdom | | | | |
| 20.1.2012 | Irbesartan Zentiva | 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 | | | | |
| 20.1.2012 | Rebif | 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 | | | | |
| 20.1.2012 | Sprycel | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, | | | | |
| Sanderson Road, | | | | |
| Uxbridge | | | | |
| UB8 1DH, | | | | |
| United Kingdom | | | | |
| 20.1.2012 | 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 | | | | |
| 20.1.2012 | 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 | | | | |
| 20.1.2012 | 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 | | | | |
| 24.1.2012 | Adenuric | 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 | | | | |
| 24.1.2012 | Celvapan | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | Baxter AG | Industriestraße 67, |
| Baxter AG | | | | |
| Industriestraße 67, | | | | |
| A - 1221 Wien, | | | | |
| Österreich | | | | |
| 24.1.2012 | Cerezyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, | | | | |
| NL-1411 DD Naarden, | | | | |
| Nederland | | | | |
| 24.1.2012 | Dynastat | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, |
| Pfizer Ltd | | | | |
| Ramsgate Road, | | | | |
| Sandwich, | | | | |
| Kent | | | | |
| CT 13 9NJ, | | | | |
| United Kingdom | | | | |
| 30.1.2012 | alli | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, | | | | |
| Berkeley Avenue, Greenford, | | | | |
| Middlesex | | | | |
| UB6 0NN, | | | | |
| United Kingdom | | | | |
| 30.1.2012 | Galvus | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 30.1.2012 | 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 | | | | |
| 30.1.2012 | 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 | | | | |
| 30.1.2012 | Leflunomide medac | 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 | | | | |
| 30.1.2012 | 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 | | | | |
| 30.1.2012 | Resolor | Shire-Movetis NV Veedjik 58, B-2300 Turnhout, België | Shire-Movetis NV | Veedjik 58, |
| Shire-Movetis NV | | | | |
| Veedjik 58, | | | | |
| B-2300 Turnhout, | | | | |
| België | | | | |
| 30.1.2012 | Simulect | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 30.1.2012 | Xiliarx | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, | | | | |
| Horsham, | | | | |
| West Sussex | | | | |
| RH12 5AB, | | | | |
| United Kingdom | | | | |
| 31.1.2012 | 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 | | | | |
| 31.1.2012 | InductOs | Medtronic Biopharma BV Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland | Medtronic Biopharma BV | Earl Bakkenstraat 10, |
| Medtronic Biopharma BV | | | | |
| Earl Bakkenstraat 10, | | | | |
| 6422 PJ Heerlen, | | | | |
| Nederland | | | | |
| 31.1.2012 | Synflorix | 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 | | | | |
| 31.1.2012 | Temodal | 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 | | | | |
| 31.1.2012 | Teysuno | Nordic Group BV Siriusdreef 22, 2132 WT Hoofddorp, Nederland | Nordic Group BV | Siriusdreef 22, |
| Nordic Group BV | | | | |
| Siriusdreef 22, | | | | |
| 2132 WT Hoofddorp, | | | | |
| Nederland | | | | |
| 31.1.2012 | Tyverb | 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 | | | | |
| 31.1.2012 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | Gilead Sciences International Limited | Cambridge |
| Gilead Sciences International Limited | | | | |
| Cambridge | | | | |
| CB21 6GT | | | | |
| United Kingdom | | | | |
| 31.1.2012 | 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 | | | | |
| 31.1.2012 | Xyrem | UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | UCB Pharma Ltd. | 208 Bath Road, Slough, |
| UCB Pharma Ltd. | | | | |
| 208 Bath Road, Slough, | | | | |
| Berkshire | | | | |
| SL1 3WE, | | | | |
| United Kingdom | | | | |
| 31.1.2012 | Yondelis | Pharma Mar, S.A. Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), Espana | Pharma Mar, S.A. | Avda. de los Reyes 1, |
| Pharma Mar, S.A. | | | | |
| Avda. de los Reyes 1, | | | | |
| Polígono Industrial La Mina, | | | | |
| 28770 Colmenar Viejo | | | | |
| (Madrid), | | | | |
| Espana | | | | |

—   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 |
| --------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------- | ----------------------- | ----------------------------------------------- | -------------------- |
| 9.1.2012 | Activyl Tick Plus | Indoxacarb + permethrin | 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 | | | | | | | |

—   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 |
| ---------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------ | ---------------------------------------------- | ------------------------- |
| 9.1.2012 | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170- Amer (Girona), España | Laboratorios Hipra, S.A. | Avda. La Selva, 135, |
| Laboratorios Hipra, S.A. | | | | |
| Avda. La Selva, 135, | | | | |
| 17170- Amer (Girona), | | | | |
| España | | | | |
| 20.1.2012 | Posatex | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, | | | | |
| 5831 AN Boxmeer, | | | | |
| Nederland | | | | |
| 24.1.2012 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, IRELAND | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea, |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | |
| Loughrea, | | | | |
| Co. Galway, | | | | |
| IRELAND | | | | |
| 31.1.2012 | Metacam | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | 55216 Ingelheim am Rhein, |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| 55216 Ingelheim am Rhein, | | | | |
| Deutschland | | | | |
| 31.1.2012 | Procox | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | 51368 Leverkusen, |
| Bayer Animal Health GmbH | | | | |
| 51368 Leverkusen, | | | | |
| Deutschland | | | | |
| 31.1.2012 | Suvaxyn Aujeszky 783 +O/W | 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 | | | | |
| 31.1.2012 | 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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