Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2013 to 30 November 2013 (published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2013-12-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013380EN.01000101.xml










28.12.2013   


EN


Official Journal of the European Union


C 380/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2013 to 30 November 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 380/01
—   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




11.11.2013


Levodopa-Carbidopa-Entacapone Sandoz


levodopa / carbidopa / entacapone







Orion Corporation




Orionintie 1,




FI-02200 Espoo,




Suomi






EU/1/13/859


Film-coated tablet


N04BA03


13.11.2013




13.11.2013


NovoEight


turoctocog alfa







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/13/888


Powder and solvent for solution for injection


B02BD02


15.11.2013




13.11.2013


Relvar Elllipta


fluticasone furoate/vilanterol trifenatate







Glaxo Group Ltd




980 Great West Road,




Brentford, Middlesex,




TW8 9GS,




United Kingdom






EU/1/13/886


Inhalation powder, pre-dispensed


R03AK10


14.11.2013




13.11.2013


Vitekta


elvitegravir







Gilead Sciences International Limited




Cambridge




CB21 6GT,




United Kingdom






EU/1/13/883


Film-coated tablet


J05AX11


14.11.2013




13.11.2013


Xofigo


Radium Ra 223 dichloride







Bayer Pharma AG




D-13342 Berlin,




Deutschland






EU/1/13/873


Solution for injection


V10XX03


14.11.2013




15.11.2013


ABILIFY MAINTENA


Aripiprazole







Otsuka Pharmaceutical Europe Ltd.




Gallions Wexham Springs,




Framewood Road,




Wexham, Slough,




Berkshire SL3 6PJ,




United Kingdom






EU/1/13/882


Powder and solvent for prolonged-release suspension for injection


N05AX12


19.11.2013




15.11.2013


Invokana


canagliflozin







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/13/884


Film-coated tablet


A10BX11


19.11.2013




15.11.2013


Kadcyla


Trastuzumab emtansine







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/13/885


Powder for concentrate for solution for infusion


L01XC14


19.11.2013




15.11.2013


Lidocaine/Prilocaine Plethora


lidocaine / prilocaine







Plethora Solutions Limited




Hampden House,




Monument Business Park,




Chalgrove, OX44 7RW




United Kingdom






EU/1/13/881


Cutaneous spray, solution


N01BB20


19.11.2013




20.11.2013


Intelence


etravirine







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/08/468


Tablet


J05AG04


22.11.2013







—   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




8.11.2013


Xeljanz







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/13/874


12.11.2013







—   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




11.11.2013


Edarbi







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London WC2B 4AE,




United Kingdom






EU/1/11/734


12.11.2013




11.11.2013


Ipreziv







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych,




London WC2B 4AE,




United Kingdom






EU/1/11/735


12.11.2013




11.11.2013


Oprymea







Krka, d. d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/08/469


13.11.2013




11.11.2013


Rapamune







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/01/171


13.11.2013




13.11.2013


Actos







Takeda Pharma A/S




Langebjerg 1,




DK-4000 Roskilde,




Danmark






EU/1/00/150


15.11.2013




13.11.2013


Competact







Takeda Pharma A/S




PO Box 88,




Langebjerg 1,




DK-4000 Roskilde,




Danmark






EU/1/06/354


14.11.2013




13.11.2013


Efient







Eli Lilly Nederland B.V.




Grootslag 1-5,




NL-3991 RA Houten,




Nederland






EU/1/08/503


15.11.2013




13.11.2013


Enbrel







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/99/126


15.11.2013




13.11.2013


Filgrastim Hexal







Hexal AG




Industriestrasse 25,




D-83607 Holzkirchen,




Deutschland






EU/1/08/496


15.11.2013




13.11.2013


Firmagon







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11,




DK-2300 København S,




Danmark






EU/1/08/504


15.11.2013




13.11.2013


Firmagon







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11,




DK-2300 København S,




Danmark






EU/1/08/504


15.11.2013




13.11.2013


Fycompa







Eisai Europe Limited




European Knowledge Centre,




Mosquito Way,




Hatfield,




Herts AL10 9SN,




United Kingdom






EU/1/12/776


15.11.2013




13.11.2013


Glubrava







Takeda Pharma A/S




Langebjerg 1,




DK-4000 Roskilde,




Danmark






EU/1/07/421


15.11.2013




13.11.2013


Glustin







Takeda Pharma A/S




Langebjerg 1,




DK-4000 Roskilde,




Danmark






EU/1/00/151


15.11.2013




13.11.2013


Invirase







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/96/026


15.11.2013




13.11.2013


Jakavi







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/12/773


15.11.2013




13.11.2013


Kuvan







Merck Serono Europe Limited




56, Marsh Wall,




London E14 9TP,




United Kingdom






EU/1/08/481


15.11.2013




13.11.2013


Ranexa







Menarini International Operations Luxembourg S.A.




1 avenue de la Gare,




L-1611 Luxembourg,




Grand-Duché de Luxembourg






EU/1/08/462


22.11.2013




13.11.2013


Rasilez HCT







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/08/491


15.11.2013




13.11.2013


ReFacto AF







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/99/103


15.11.2013




13.11.2013


Revlimid







Celgene Europe Limited




1 Longwalk Road,




Stockley Park,




Uxbridge,




Middlesex UB11 1DB,




United Kingdom






EU/1/07/391


15.11.2013




13.11.2013


Silodyx







Recordati Ireland Ltd.




Raheens East,




Ringaskiddy Co. Cork,




Ireland






EU/1/09/607


15.11.2013




13.11.2013


Tandemact







Takeda Pharma A/S




Langebjerg 1,




DK-4000 Roskilde,




Danmark






EU/1/06/366


15.11.2013




13.11.2013


Thymanax







Servier (Ireland) Industries Limited




Gorey Road,




Arklow,




Co. Wicklow,




Ireland






EU/1/08/498


15.11.2013




13.11.2013


Thymanax







Servier (Ireland) Industries Limited




Gorey Road,




Arklow,




Co. Wicklow,




Ireland






EU/1/08/498


15.11.2013




13.11.2013


Urorec







Recordati Ireland Ltd.




Raheens East,




Ringaskiddy Co. Cork,




Ireland






EU/1/09/608


15.11.2013




13.11.2013


Valdoxan







Les Laboratoires Servier




50 rue Carnot,




F-92284 Suresnes CEDEX,




France






EU/1/08/499


15.11.2013




13.11.2013


Valdoxan







Les Laboratoires Servier




50 rue Carnot,




F-92284 Suresnes CEDEX,




France






EU/1/08/499


15.11.2013




13.11.2013


Vidaza







Celgene Europe Limited




Riverside House,




Riverside Walk,




Windsor,




Berkshire SL4 1NA,




United Kingdom






EU/1/08/488


15.11.2013




13.11.2013


Zarzio







Sandoz GmbH




Biochemiestrasse 10,




A-6250 Kundl,




Österreich






EU/1/08/495


15.11.2013




15.11.2013


Alimta







Eli Lilly Nederland B.V.




Grootslag 1-5,




NL-3991 RA Houten,




Nederland






EU/1/04/290


19.11.2013




15.11.2013


Azilect







Teva Pharma GmbH




Graf-Arco-Straße 3,




D-89079 Ulm,




Deutschland






EU/1/04/304


19.11.2013




15.11.2013


Bretaris Genuair







Almirall, S.A.




Ronda General Mitre, 151,




E-08022 Barcelona,




España






EU/1/12/781


18.11.2013




15.11.2013


Ecansya







Krka, d. d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/12/763


19.11.2013




15.11.2013


Eklira Genuair







Almirall, S.A.




Ronda General Mitre, 151,




E-08022 Barcelona,




España






EU/1/12/778


18.11.2013




15.11.2013


Eliquis







Bristol-Myers Squibb/Pfizer EEIG




Bristol-Myers Squibb House,




Uxbridge Business Park,




Sanderson Road,




Uxbridge,




Middlesex UB8 1DH,




United Kingdom






EU/1/11/691


18.11.2013




15.11.2013


Kineret







Swedish Orphan Biovitrum AB (publ)




SE-112 76,




Stockholm,




Sverige






EU/1/02/203


19.11.2013




15.11.2013


Multaq







Sanofi-Aventis groupe




54 rue La Boétie,




F-75008 Paris,




France






EU/1/09/591


19.11.2013




15.11.2013


Neulasta







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/02/227


19.11.2013




15.11.2013


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/06/380


19.11.2013




15.11.2013


Rapiscan







Rapidscan Pharma Solutions EU Ltd.




Regent's Place,




338 Euston Road,




London NW1 3BT,




United Kingdom






EU/1/10/643


19.11.2013




15.11.2013


Sutent







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/06/347


19.11.2013




15.11.2013


Tygacil







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/06/336


19.11.2013




15.11.2013


Votubia







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/11/710


19.11.2013




20.11.2013


Angiox







The Medicines Company UK Ltd




115 L Milton Park,




Abingdon,




Oxfordshire OX14 4SA,




United Kingdom






EU/1/04/289


22.11.2013




20.11.2013


Beromun







Boehringer Ingelheim International GmbH




Binger Straße 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/99/097


22.11.2013




20.11.2013


Evicel







Omrix Biopharmaceuticals N.V.




Leonardo Da Vincilaan 15,




B-1831 Diegem,




België






EU/1/08/473


22.11.2013




20.11.2013


Fasturtec







Sanofi-Aventis groupe




54 rue La Boétie,




F-75008 Paris,




France






EU/1/00/170


22.11.2013




20.11.2013


HALAVEN







Eisai Europe Limited




European Knowledge Centre,




Mosquito Way,




Hatfield,




Herts AL10 9SN,




United Kingdom






EU/1/11/678


25.11.2013




20.11.2013


Hycamtin







SmithKline Beecham Ltd.




980 Great West Road,




Brentford,




Middlesex TW8 9GS,




United Kingdom






EU/1/96/027


22.11.2013




20.11.2013


Kalydeco







Vertex Pharmaceuticals (U.K.) Limited




Cardinal Point,




Park Road,




Rickmansworth,




Herts WD3 1RE,




United Kingdom






EU/1/12/782


22.11.2013




20.11.2013


Mabthera







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/98/067


25.11.2013




20.11.2013


Opgenra







Olympus Biotech International Limited




Raheen Business Park,




Limerick,




Ireland






EU/1/08/489


25.11.2013




20.11.2013


Plenadren







ViroPharma SPRL-BVBA




rue Montoyer 47,




1000 Bruxelles,




Belgique / Montoyerstraat 47,




1000 Brussel,




België






EU/1/11/715


21.11.2013




20.11.2013


Prevenar 13







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/09/590


22.11.2013




20.11.2013


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/05/330


22.11.2013




20.11.2013


Telzir







ViiV Healthcare UK Limited




980 Great West Road,




Brentford,




Middlesex TW8 9GS,




United Kingdom






EU/1/04/282


22.11.2013




20.11.2013


Torisel







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/07/424


22.11.2013




20.11.2013


Zoledronic acid Teva Pharma







Teva Pharma B.V.




Computerweg 10,




NL-3542 DR Utrecht,




Nederland






EU/1/12/772


22.11.2013




25.11.2013


Cimzia







UCB Pharma S.A.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/Researchdreef 60,




1070 Brussel,




België






EU/1/09/544


27.11.2013




25.11.2013


Elaprase







Shire Human Genetic Therapies AB




Svärdvägen 11D,




SE-182 33 Danderyd,




Sverige






EU/1/06/365


27.11.2013




25.11.2013


GILENYA







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/11/677


27.11.2013




25.11.2013


Pandemic influenza vaccine H5N1 BAXTER







Baxter AG




Industriestraße 67,




A-1221 Wien,




Österreich






EU/1/09/571


27.11.2013




25.11.2013


Reyataz







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge UB8 1DH,




United Kingdom






EU/1/03/267


27.11.2013




25.11.2013


Synflorix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/09/508


27.11.2013




25.11.2013


Vepacel







Baxter Innovations GmbH




Industriestraße 67,




A-1221 Wien,




Österreich






EU/1/12/752


27.11.2013




28.11.2013


Jalra







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/08/485


29.11.2013




28.11.2013


Xiliarx







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/08/486


29.11.2013




29.11.2013


Arixtra







Glaxo Group Ltd




980 Great West Road,




Brentford, Middlesex,




TW8 9GS,




United Kingdom






EU/1/02/206


2.12.2013




29.11.2013


Busilvex







Pierre Fabre Médicament




45 place Abel Gance,




F-92654 Boulogne-Billancourt CEDEX,




France






EU/1/03/254


3.12.2013




29.11.2013


Eviplera







Gilead Sciences International Limited




Cambridge CB21 6GT,




United Kingdom






EU/1/11/737


4.12.2013




29.11.2013


Preotact







NPS Pharma Holdings Limited




Grand Canal House,




1 Grand Canal Street Upper,




Dublin 4,




Ireland






EU/1/06/339


3.12.2013




29.11.2013


Prevenar







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/00/167


3.12.2013




29.11.2013


Xeloda







Roche Registration Limited




6 Falcon Way,




Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/00/163


3.12.2013







—   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




8.11.2013


Onsior







Novartis Animal Health UK Ltd




Frimley Business Park,




Frimley/Camberley,




Surrey,




GU16 7SR,




United Kingdom






EU/2/08/089


13.11.2013




8.11.2013


Zulvac 1+8 Bovis







Zoetis Belgium S.A.




Rue Laid Burniat 1,




1348 Louvain-La-Neuve,




Belgique






EU/2/12/139


13.11.2013




11.11.2013


Easotic







VIRBAC S.A.




1ère Avenue - 2065 m - L.I.D.,




F-06516 Carros CEDEX,




France






EU/2/08/085


13.11.2013




13.11.2013


Comfortis







Eli Lilly and Company Ltd




Priestley Road,




Basingstoke,




Hampshire RG24 9NL,




United Kingdom






EU/2/10/115


15.11.2013




20.11.2013


CERTIFECT







Merial




29 avenue Tony Garnier,




F-69007 Lyon,




France






EU/2/11/125


22.11.2013




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






(1)  OJ L 136, 30.4.2004, p. 1.