# C_2013053EN.01000301.xml

| 22.2.2013 | EN | Official Journal of the European Union | C 53/3 |
| --------- | -- | -------------------------------------- | ------ |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2013 to 31 January 2013

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

2013/C 53/03

—   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 |
| ------------------------------------------------------------------- | ----------------------------- | --------------------------------------------------------- | ------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------- |
| 8.1.2013 | Imatinib Teva | imatinib | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/12/808 | Capsule, hard
Film-coated tablet |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | | | | |
| 8.1.2013 | Krystexxa | pegloticase | Savient Pharma Ireland Limited Mespil House, Sussex Road, Dublin 4, Ireland | Savient Pharma Ireland Limited | Mespil House, Sussex Road, Dublin 4, Ireland | EU/1/12/810 | Concentrate for solution for infusion |
| Savient Pharma Ireland Limited | | | | | | | |
| Mespil House, Sussex Road, Dublin 4, Ireland | | | | | | | |
| 14.1.2013 | Amyvid | Florbetapir (18F) | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/12/805 | Solution for injection |
| Eli Lilly Nederland B.V. | | | | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | | | | |
| 14.1.2013 | Bexsero | Meningococcal group B Vaccine (rDNA, component, adsorbed) | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | Novartis Vaccines and Diagnostics S.r.l. | Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | Suspension for injection |
| Novartis Vaccines and Diagnostics S.r.l. | | | | | | | |
| Via Fiorentina, 1, 53100 Siena, Italia | | | | | | | |
| 21.1.2013 | BindRen | colestilan | Mitsubishi Pharma Europe Ltd. Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom | Mitsubishi Pharma Europe Ltd. | Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom | EU/1/12/804 | Film-coated tablet
Granules |
| Mitsubishi Pharma Europe Ltd. | | | | | | | |
| Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom | | | | | | | |
| 21.1.2013 | Ryzodeg | Insulin degludec/insulin aspart | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/806 | Solution for injection |
| Novo Nordisk A/S | | | | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | | | | |
| 21.1.2013 | Tresiba | Insulin degludec | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/807 | Solution for injection |
| Novo Nordisk A/S | | | | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | | | | |

—   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 |
| ------------------------------------------------------------------------------------------------ | ----------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- | ------------------------------------------------------------------------------------------------ |
| 14.1.2013 | Abraxane | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | | | | |
| 14.1.2013 | Entacapone Orion | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FI-02200 Espoo, Suomi |
| Orion Corporation | | | | |
| Orionintie 1, FI-02200 Espoo, Suomi | | | | |
| 14.1.2013 | Exelon | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 14.1.2013 | Ilaris | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 14.1.2013 | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FI-02200 Espoo, Suomi |
| Orion Corporation | | | | |
| Orionintie 1, FI-02200 Espoo, Suomi | | | | |
| 14.1.2013 | Myocet | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 14.1.2013 | Neupro | UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland | UCB Manufacturing Ireland Ltd. | Shannon Industrial Estate, Co, Clare, Ireland |
| UCB Manufacturing Ireland Ltd. | | | | |
| Shannon Industrial Estate, Co, Clare, Ireland | | | | |
| 14.1.2013 | Prepandrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, 1330 Rixensart, Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, 1330 Rixensart, Belgique | | | | |
| 14.1.2013 | PREZISTA | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 14.1.2013 | Stalevo | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FI-02200 Espoo, Suomi |
| Orion Corporation | | | | |
| Orionintie 1, FI-02200 Espoo, Suomi | | | | |
| 14.1.2013 | 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, London WC2B 4AE, United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | |
| 14.1.2013 | Vectibix | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, NL-4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, NL-4817 ZK Breda, Nederland | | | | |
| 14.1.2013 | Volibris | Glaxo Group Ltd Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Ltd | Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Ltd | | | | |
| Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 14.1.2013 | Xagrid | Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | Shire Pharmaceutical Contracts Ltd | Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom |
| Shire Pharmaceutical Contracts Ltd | | | | |
| Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | | | | |
| 14.1.2013 | Zebinix | BIAL - Portela & Ca, SA A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | BIAL - Portela & Ca, SA | A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal |
| BIAL - Portela & Ca, SA | | | | |
| A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | | | | |
| 17.1.2013 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 17.1.2013 | Revlimid | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | | | | |
| 21.1.2013 | Cialis | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 21.1.2013 | Levitra | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 21.1.2013 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 21.1.2013 | Rasilamlo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 21.1.2013 | Rasitrio | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 21.1.2013 | Vivanza | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 24.1.2013 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom | | | | |
| 24.1.2013 | Adcirca | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 24.1.2013 | Comtess | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FI-02200 Espoo, Suomi |
| Orion Corporation | | | | |
| Orionintie 1, FI-02200 Espoo, Suomi | | | | |
| 24.1.2013 | Ilaris | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 24.1.2013 | Rasilez | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 28.1.2013 | Olazax Disperzi | Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika | Glenmark Pharmaceuticals s.r.o. | City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika |
| Glenmark Pharmaceuticals s.r.o. | | | | |
| City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika | | | | |
| 28.1.2013 | Rasilez HCT | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 28.1.2013 | Trisenox | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |

—   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 |
| --------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------ | --------------------------------------------- | --------------------------------------------------------------- |
| 24.1.2013 | Riprazo | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |

—   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 |
| ---------------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------- |
| 17.1.2013 | Pelzont | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 17.1.2013 | Tredaptive | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 17.1.2013 | Trevaclyn | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |

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

| Date of the Décision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| -------------------------------------------------------------------------------------------------- | ----------------------------- | ---------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | -------------------------------------------------------------------------------------------------- | ----------------------------------------------- | -------------------------------------- |
| 28.1.2013 | Kexxtone | Monensin sodium | Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | Eli Lilly and Company Limited | Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/12/145 | Continuous release intraruminal device |
| Eli Lilly and Company Limited | | | | | | | |
| Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, 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 |
| ----------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------- |
| 14.1.2013 | Advocate | Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | D-51368 Leverkusen, Deutschland |
| Bayer Animal Health GmbH | | | | |
| D-51368 Leverkusen, Deutschland | | | | |
| 14.1.2013 | BLUEVAC BTV8 | CZ Veterinaria, S.A. La Relva s/n, P.O. Box 16, E-36400 Porriño, España | CZ Veterinaria, S.A. | La Relva s/n, P.O. Box 16, E-36400 Porriño, España |
| CZ Veterinaria, S.A. | | | | |
| La Relva s/n, P.O. Box 16, E-36400 Porriño, España | | | | |
| 14.1.2013 | Bovilis BTV8 | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | | | | |
| 14.1.2013 | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim Vetmedica GmbH | | | | |
| D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 21.1.2013 | Panacur AquaSol | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | | | | |
| 24.1.2013 | Purevax RCP | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |
| 28.1.2013 | Purevax RC | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |
| 28.1.2013 | Purevax RCPCh | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |

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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