# C_2013093EN.01000101.xml

| 28.3.2013 | EN | Official Journal of the European Union | C 93/1 |
| --------- | -- | -------------------------------------- | ------ |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2013 to 28 February 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 93/01

—   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 |
| ---------------------------------------------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------- |
| 1.2.2013 | Lyxumia | lixisenatide | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France | EU/1/12/811 | Solution for injection |
| Sanofi-Aventis groupe | | | | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | | | | |
| 1.2.2013 | ZALTRAP | aflibercept | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France | EU/1/12/814 | Concentrate for solution for infusion |
| Sanofi-Aventis groupe | | | | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | | | | |
| 20.2.2013 | Adasuve | loxapine | Alexza UK Ltd. 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom | Alexza UK Ltd. | 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom | EU/1/13/823 | Inhalation powder, pre-dispensed |
| Alexza UK Ltd. | | | | | | | |
| 10 Station Road, Henley-on-Thames, Oxfordshire RG9 1AY, United Kingdom | | | | | | | |
| 25.2.2013 | Selincro | nalmefene | H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark | H. Lundbeck A/S | Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/12/815 | Film-coated tablet |
| H. Lundbeck A/S | | | | | | | |
| Ottiliavej 9, DK-2500 Valby, Danmark | | | | | | | |

—   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 |
| ---------------------------------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------------------- |
| 12.2.2013 | Istodax | 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 | | | | |
| 20.2.2013 | Acrescent | H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark | H. Lundbeck A/S | Ottiliavej 9, DK-2500 Valby, Danmark |
| H. Lundbeck A/S | | | | |
| Ottiliavej 9, DK-2500 Valby, Danmark | | | | |
| 20.2.2013 | Balaxur | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100-104, D-60318 Frankfurt am Main, Deutschland | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100-104, D-60318 Frankfurt am Main, Deutschland |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100-104, D-60318 Frankfurt am Main, 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 |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
| 1.2.2013 | Ixiaro | Intercell AG Campus Vienna Biocenter 3, A-1030 Wien, Österreich | Intercell AG | Campus Vienna Biocenter 3, A-1030 Wien, Österreich |
| Intercell AG | | | | |
| Campus Vienna Biocenter 3, A-1030 Wien, Österreich | | | | |
| 8.2.2013 | Aflunov | 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 |
| Novartis Vaccines and Diagnostics S.r.l. | | | | |
| Via Fiorentina, 1, 53100 Siena, Italia | | | | |
| 8.2.2013 | Vibativ | Theravance UK Limited 90 Fetter Lane London EC4A 1EQ United Kingdom | Theravance UK Limited | 90 Fetter Lane London EC4A 1EQ United Kingdom |
| Theravance UK Limited | | | | |
| 90 Fetter Lane London EC4A 1EQ United Kingdom | | | | |
| 12.2.2013 | 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 | | | | |
| 13.2.2013 | 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 | | | | |
| 13.2.2013 | Evicel | Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België | Omrix Biopharmaceuticals N.V. | Leonardo Da Vincilaan 15, B-1831 Diegem, België |
| Omrix Biopharmaceuticals N.V. | | | | |
| Leonardo Da Vincilaan 15, B-1831 Diegem, België | | | | |
| 13.2.2013 | Forsteo | 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 | | | | |
| 13.2.2013 | Zostavax | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk, F-69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk, F-69007 Lyon, France | | | | |
| 18.2.2013 | Advagraf | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | Astellas Pharma Europe B.V. | Sylviusweg 62, NL-2333 BE Leiden, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland | | | | |
| 18.2.2013 | Aldurazyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland |
| Genzyme Europe B.V. | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | |
| 18.2.2013 | BeneFIX | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 18.2.2013 | Caprelsa | AstraZeneca AB Building 411A, Floor 4, SE-151 85 Södertälje, Sverige | AstraZeneca AB | Building 411A, Floor 4, SE-151 85 Södertälje, Sverige |
| AstraZeneca AB | | | | |
| Building 411A, Floor 4, SE-151 85 Södertälje, Sverige | | | | |
| 18.2.2013 | 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 | | | | |
| 18.2.2013 | Karvea | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 18.2.2013 | Karvezide | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 18.2.2013 | Komboglyze | Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol-Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |
| Bristol-Myers Squibb/AstraZeneca EEIG | | | | |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | |
| 18.2.2013 | Modigraf | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | Astellas Pharma Europe B.V. | Sylviusweg 62, NL-2333 BE Leiden, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland | | | | |
| 18.2.2013 | Onglyza | Bristol-Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol-Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |
| Bristol-Myers Squibb/AstraZeneca EEIG | | | | |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | |
| 18.2.2013 | ProQuad | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk, F-69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk, F-69007 Lyon, France | | | | |
| 18.2.2013 | 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 | | | | |
| 18.2.2013 | 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 | | | | |
| 18.2.2013 | 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 | | | | |
| 20.2.2013 | Arzerra | Glaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 20.2.2013 | Effentora | 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 | | | | |
| 20.2.2013 | M-M-RVAXPRO | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk, F-69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk, F-69007 Lyon, France | | | | |
| 25.2.2013 | Humira | AbbVie Ltd Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd | Maidenhead, SL6 4XE, United Kingdom |
| AbbVie Ltd | | | | |
| Maidenhead, SL6 4XE, United Kingdom | | | | |
| 25.2.2013 | Isentress | 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 | | | | |
| 25.2.2013 | Lumigan | Allergan Pharmaceuticals Ireland, (514125) Castlebar Road, Westport, County Mayo, Ireland | Allergan Pharmaceuticals Ireland, (514125) | Castlebar Road, Westport, County Mayo, Ireland |
| Allergan Pharmaceuticals Ireland, (514125) | | | | |
| Castlebar Road, Westport, County Mayo, Ireland | | | | |
| 25.2.2013 | 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 | | | | |
| 28.2.2013 | DuoCover | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |

—   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 |
| --------------------------------------- | ----------------------------- | ---------------------------------------- | --------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------- | ----------------------------------------------- | -------------------- |
| 13.2.2013 | Semintra | Telmisartan | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/146 | Oral solution |
| Boehringer Ingelheim Vetmedica GmbH | | | | | | | |
| D-55216 Ingelheim am Rhein, Deutschland | | | | | | | |
| 25.2.2013 | Pexion | Imepitoin | Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/147 | Tablet |
| Boehringer Ingelheim Vetmedica GmbH | | | | | | | |
| D-55216 Ingelheim am Rhein, Deutschland | | | | | | | |

—   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 |
| -------------------------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------- | ---------------------------------------------- | -------------------------------------------------------------------------- |
| 1.2.2013 | Profender | Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | D-51368 Leverkusen, Deutschland |
| Bayer Animal Health GmbH | | | | |
| D-51368 Leverkusen, Deutschland | | | | |
| 8.2.2013 | Recocam | Cross Vetpharm Group, Ltd Broomhill Road, Tallaght Dublin 24, Ireland | Cross Vetpharm Group, Ltd | Broomhill Road, Tallaght Dublin 24, Ireland |
| Cross Vetpharm Group, Ltd | | | | |
| Broomhill Road, Tallaght Dublin 24, Ireland | | | | |
| 12.2.2013 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea, Co. Galway, Ireland |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | |
| Loughrea, Co. Galway, Ireland | | | | |
| 13.2.2013 | Onsior | Novartis Animal Health UK Ltd Frimley Business Park, Frimley/Camberley, Surrey, GU16 7SR, United Kingdom | Novartis Animal Health UK Ltd | Frimley Business Park, Frimley/Camberley, Surrey, GU16 7SR, United Kingdom |
| Novartis Animal Health UK Ltd | | | | |
| Frimley Business Park, Frimley/Camberley, Surrey, GU16 7SR, United Kingdom | | | | |
| 13.2.2013 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland | Chanelle Pharmaceuticals Manufacturing Limited | Loughrea, Co. Galway, Ireland |
| Chanelle Pharmaceuticals Manufacturing Limited | | | | |
| Loughrea, Co. Galway, Ireland | | | | |
| 20.2.2013 | Zulvac 1 Bovis | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 20.2.2013 | Zulvac 1 Ovis | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | | | | |
| 25.2.2013 | BTVPUR AlSap 2-4 | 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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