# C_2013282EN.01000101.xml

| 27.9.2013 | EN | Official Journal of the European Union | C 282/1 |
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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2013 to 31 August 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 282/01

—   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 |
| ---------------------------------------------------------------------------- | ----------------------------- | --------------------------------------------------------- | ----------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------------------- | ----------------------------------------------- | ----------------------------------------------------------------- |
| 5.8.2013 | Pomalidomide Celgene | Pomalidomide | 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 | EU/1/13/850 | Capsule, hard |
| Celgene Europe Limited | | | | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | | | | | | | |
| 5.8.2013 | Somatropin Biopartners | somatropin | BioPartners GmbH Kaiserpassage 11, D-72764 Reutlingen, Deutschland | BioPartners GmbH | Kaiserpassage 11, D-72764 Reutlingen, Deutschland | EU/1/13/849 | Powder and solvent for prolonged-release suspension for injection |
| BioPartners GmbH | | | | | | | |
| Kaiserpassage 11, D-72764 Reutlingen, Deutschland | | | | | | | |
| 12.8.2013 | Voncento | human coagulation factor VIII/human von Willebrand factor | CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/13/857 | Powder and solvent for solution for injection/infusion | B02BD06 | 14.8.2013 |
| 26.8.2013 | AUBAGIO | Teriflunomide | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France | EU/1/13/838 | Film-coated tablet |
| Sanofi-Aventis groupe | | | | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | | | | |
| 26.8.2013 | Cholib | fenofibrate/simvastatin | Abbott Healthcare Products Ltd
Mansbridge Road, West End Southampton, SO18 3JD, United Kingdom | EU/1/13/866 | Film-coated tablet | C10BA04 | 28.8.2013 |
| 26.8.2013 | Nexium Control | esomeprazole | AstraZeneca AB SE-151 85 Södertälje, Sverige | AstraZeneca AB | SE-151 85 Södertälje, Sverige | EU/1/13/860 | Gastro-resistant tablet |
| AstraZeneca AB | | | | | | | |
| SE-151 85 Södertälje, Sverige | | | | | | | |
| 26.8.2013 | Stivarga | regorafenib | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland | EU/1/13/858 | Film-coated tablet |
| Bayer Pharma AG | | | | | | | |
| D-13342 Berlin, Deutschland | | | | | | | |
| 26.8.2013 | Tafinlar | DABRAFENIB | GlaxoSmithKline Trading Services Limited 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | GlaxoSmithKline Trading Services Limited | 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | EU/1/13/865 | Capsule, hard |
| GlaxoSmithKline Trading Services Limited | | | | | | | |
| 6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland | | | | | | | |

—   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 |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------ | ---------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
| 5.8.2013 | Icandra | 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 | | | | |
| 5.8.2013 | Marixino | Consilient Health Ltd. Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland | Consilient Health Ltd. | Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland |
| Consilient Health Ltd. | | | | |
| Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland | | | | |
| 5.8.2013 | 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 | | | | |
| 5.8.2013 | Xarelto | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 5.8.2013 | Zomarist | 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 | | | | |
| 12.8.2013 | Circadin | RAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | RAD Neurim Pharmaceuticals EEC Limited | One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom |
| RAD Neurim Pharmaceuticals EEC Limited | | | | |
| One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | | | | |
| 12.8.2013 | Pixuvri | CTI Life Sciences Ltd Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom | CTI Life Sciences Ltd | Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom |
| CTI Life Sciences Ltd | | | | |
| Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom | | | | |
| 12.8.2013 | Signifor | 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 | | | | |
| 12.8.2013 | Twynsta | 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 | | | | |
| 12.8.2013 | Zavesca | Actelion Registration Ltd Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom |
| Actelion Registration Ltd | | | | |
| Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom | | | | |
| 14.8.2013 | Conbriza | 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 | | | | |
| 14.8.2013 | FLUENZ | MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | MedImmune, LLC | Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland |
| MedImmune, LLC | | | | |
| Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | | | | |
| 14.8.2013 | IOA | Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland | Organon N.V. | Kloosterstraat 6, NL-5349 AB Oss, Nederland |
| Organon N.V. | | | | |
| Kloosterstraat 6, NL-5349 AB Oss, Nederland | | | | |
| 26.8.2013 | ADCETRIS | 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 | | | | |
| 26.8.2013 | Azarga | Alcon Laboratories (UK) Ltd. Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | Alcon Laboratories (UK) Ltd. | Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |
| Alcon Laboratories (UK) Ltd. | | | | |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | | | | |
| 26.8.2013 | Ceplene | Meda AB Box 906, SE-170 09 Solna, Sverige | Meda AB | Box 906, SE-170 09 Solna, Sverige |
| Meda AB | | | | |
| Box 906, SE-170 09 Solna, Sverige | | | | |
| 26.8.2013 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol-Myers Squibb/Pfizer EEIG | Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |
| Bristol-Myers Squibb/Pfizer EEIG | | | | |
| Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | |
| 26.8.2013 | Eylea | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 26.8.2013 | Herceptin | 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 | | | | |
| 26.8.2013 | Hirobriz Breezhaler | 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 | | | | |
| 26.8.2013 | Ifirmasta | 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 | | | | |
| 26.8.2013 | 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 | | | | |
| 26.8.2013 | Inlyta | 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 | | | | |
| 26.8.2013 | Invega | 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 | | | | |
| 26.8.2013 | Keppra | UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | UCB Pharma S.A. | Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
| UCB Pharma S.A. | | | | |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | | | | |
| 26.8.2013 | Onbrez Breezhaler | 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 | | | | |
| 26.8.2013 | Oslif Breezhaler | 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 | | | | |
| 26.8.2013 | Pramipexole Teva | 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 | | | | |
| 26.8.2013 | 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 | | | | |
| 26.8.2013 | Tysabri | Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Limited | Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
| Biogen Idec Limited | | | | |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | | | | |
| 26.8.2013 | Ventavis | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 26.8.2013 | XALKORI | 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 | | | | |
| 26.8.2013 | Zypadhera | 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 | | | | |

—   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 |
| --------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------- |
| 5.8.2013 | Econor | Novartis Animal Health Austria GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich | Novartis Animal Health Austria GmbH | Biochemiestrasse 10, A-6250 Kundl, Österreich |
| Novartis Animal Health Austria GmbH | | | | |
| Biochemiestrasse 10, A-6250 Kundl, Österreich | | | | |
| 12.8.2013 | Trocoxil | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 14.8.2013 | Cerenia | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |

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.

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