# C_2012401EN.01000101.xml

| 28.12.2012 | EN | Official Journal of the European Union | C 401/1 |
| ---------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 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 401/01

—   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 |
| --------------------------------------------------------------------------- | ------------------------------ | ------------------------------------------------------------------------------------------------------ | ----------------------------------------------------- | --------------------------------------------------------------------------- |
| 29.10.2012 | Clopidogrel Teva Generics B.V. | Teva Generics B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Generics B.V. | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Generics B.V. | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | |
| 29.10.2012 | Desloratadine Teva | 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 | | | | |
| 29.10.2012 | Docetaxel Accord | Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom | Accord Healthcare Limited | Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom |
| Accord Healthcare Limited | | | | |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom | | | | |
| 29.10.2012 | Docetaxel Kabi | Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom | Fresenius Kabi Oncology Plc. | Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom |
| Fresenius Kabi Oncology Plc. | | | | |
| Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom | | | | |
| 29.10.2012 | Esmya | Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország | Gedeon Richter Plc. | Gyömrői út 19-21., 1103 Budapest, Magyarország |
| Gedeon Richter Plc. | | | | |
| Gyömrői út 19-21., 1103 Budapest, Magyarország | | | | |
| 29.10.2012 | Galvus | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 29.10.2012 | Jalra | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 29.10.2012 | JEVTANA | Sanofi-aventis groupe 54, rue de la Boétie, F-75008 France | Sanofi-aventis groupe | 54, rue de la Boétie, F-75008 France |
| Sanofi-aventis groupe | | | | |
| 54, rue de la Boétie, F-75008 France | | | | |
| 29.10.2012 | Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | medac Gesellschaft für klinische Spezialpräparate mbH | Fehlandtstrasse 3, D-20354 Hamburg - Deutschland |
| medac Gesellschaft für klinische Spezialpräparate mbH | | | | |
| Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | | | | |
| 29.10.2012 | Tarceva | 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, United Kingdom |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 29.10.2012 | Xgeva | Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, 4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, 4817 ZK Breda, Nederland | | | | |
| 29.10.2012 | Xiliarx | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 29.10.2012 | Zoely | Theramex S.r.l. Via Messina 38, 20154 Milano, Italia | Theramex S.r.l. | Via Messina 38, 20154 Milano, Italia |
| Theramex S.r.l. | | | | |
| Via Messina 38, 20154 Milano, Italia | | | | |
| 31.10.2012 | Clopidogrel Teva Pharma B.V. | 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 | | | | |
| 31.10.2012 | Ibandronic acid Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | | | | |
| 31.10.2012 | Lamivudine/Zidovudine Teva | 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 | | | | |
| 31.10.2012 | Levetiracetam SUN | Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland | Sun Pharmaceutical Industries Europe BV | Polarisavenue 87, 2132 JH Hoofddorp, Nederland |
| Sun Pharmaceutical Industries Europe BV | | | | |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland | | | | |
| 31.10.2012 | Levetiracetam Teva | 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 | | | | |
| 31.10.2012 | PecFent | Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom | Archimedes Development Ltd | Nottingham, NGT7 2TN, United Kingdom |
| Archimedes Development Ltd | | | | |
| Nottingham, NGT7 2TN, United Kingdom | | | | |
| 31.10.2012 | Rivastigmine Actavis | 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 | | | | |

—   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 |
| ------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------ | --------------------------------------------- | ------------------------------------------------------- |
| 29.10.2012 | Naxcel | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 29.10.2012 | Zuprevo | 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 | | | | |

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

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