Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2013-06-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2013184EN.01000101.xml










28.6.2013   


EN


Official Journal of the European Union


C 184/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 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 184/01
—   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




16.5.2013


HyQvia


human normal immunoglobulin







Baxter Innovations GmbH




Industriestraße 67, A-1221 Wien, Österreich






EU/1/13/840


Solution for infusion


J06BA


22.5.2013




16.5.2013


Voriconazole Accord


voriconazole







Accord Healthcare Limited




Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom






EU/1/13/835


Film-coated tablet


J02AC03


22.5.2013




24.5.2013


Stribild


elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (as fumarate)







Gilead Sciences International Limited




Cambridge CB21 6GT, United Kingdom






EU/1/13/830


Film-coated tablet


J05AR09


27.5.2013







—   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




14.5.2013


Qsiva







VIVUS BV




Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland






—


16.5.2013




29.5.2013


Kynamro







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






—


31.5.2013




31.5.2013


Raxone







Santhera Pharmaceuticals (Deutschland) GmbH




Wallbrunnstrasse 24, D-79539 Lörrach, Deutschland






—


4.6.2013







—   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




3.5.2013


Nevanac







Alcon Laboratories (UK) Ltd.




Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom






EU/1/07/433


7.5.2013




3.5.2013


Votrient







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/10/628


7.5.2013




6.5.2013


Vibativ







Theravance UK Limited




90 Fetter Lane, London EC4A 1EQ, United Kingdom






EU/1/11/705


8.5.2013




14.5.2013


Hepsera







Gilead Sciences International Limited




Cambridge CB21 6GT, United Kingdom






EU/1/03/251


16.5.2013




14.5.2013


Olanzapine Cipla







Cipla (EU) Limited




Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom






EU/1/07/426


16.5.2013




16.5.2013


Ozurdex







Allergan Pharmaceuticals Ireland, (514125)




Castlebar Road, Westport, County Mayo, Ireland






EU/1/10/638


22.5.2013




16.5.2013


Xagrid







Shire Pharmaceutical Contracts Ltd




Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom






EU/1/04/295


22.5.2013




22.5.2013


Adcirca







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/08/476


24.5.2013




22.5.2013


Aloxi







Helsinn Birex Pharmaceuticals Ltd




Damastown, Mulhuddart, Dublin 15, Ireland






EU/1/04/306


27.5.2013




22.5.2013


Leganto







UCB Manufacturing Ireland Ltd.




Shannon Industrial Estate, Co, Clare, Ireland






EU/1/11/695


27.5.2013




22.5.2013


Olanzapine Mylan







Generics [UK] Limited




Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom






EU/1/08/475


24.5.2013




22.5.2013


Xarelto







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/08/472


24.5.2013




23.5.2013


Trizivir







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/00/156


28.5.2013




27.5.2013


Afinitor







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/09/538


29.5.2013




27.5.2013


Avastin







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/04/300


29.5.2013




27.5.2013


Combivir







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/98/058


29.5.2013




27.5.2013


DuoCover







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/10/623


29.5.2013




27.5.2013


Incivo







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/720


29.5.2013




27.5.2013


Ixiaro







Intercell Austria AG




Campus Vienna Biocenter 3, A-1030 Wien, Österreich






EU/1/08/501


29.5.2013




27.5.2013


Kivexa







ViiV Healthcare UK Limited




980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/04/298


29.5.2013




27.5.2013


Neupro







UCB Manufacturing Ireland Ltd.




Shannon Industrial Estate, Co, Clare, Ireland






EU/1/05/331


29.5.2013




27.5.2013


PANTECTA Control







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/09/518


29.5.2013




27.5.2013


PANTOLOC Control







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/09/519


29.5.2013




27.5.2013


Relistor







TMC Pharma Services Ltd.




Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom






EU/1/08/463


29.5.2013




27.5.2013


Samsca







Otsuka Pharmaceutical Europe Ltd




Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom.






EU/1/09/539


29.5.2013




27.5.2013


Zometa







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom






EU/1/01/176


29.5.2013




27.5.2013


Zypadhera







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/08/479


29.5.2013




27.5.2013


Zyprexa







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/96/022


29.5.2013




27.5.2013


Zyprexa Velotab







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/99/125


29.5.2013




29.5.2013


Pritor







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/98/089


31.5.2013




29.5.2013


PritorPlus







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/02/215


31.5.2013




30.5.2013


Clopidogrel Zentiva







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/08/465


3.6.2013




30.5.2013


CONTROLOC Control







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/09/515


3.6.2013




30.5.2013


DuoPlavin







Sanofi Pharma Bristol-Myers Squibb SNC




54 rue La Boétie, F-75008 Paris, France






EU/1/10/619


3.6.2013




30.5.2013


Epivir







ViiV Healthcare UK Limited




980 Great West Road,




Brentford, Middlesex TW8 9GS, United Kingdom






EU/1/96/015


3.6.2013




30.5.2013


Iscover







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/98/070


3.6.2013




30.5.2013


Kinzalkomb







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/02/214


3.6.2013




30.5.2013


Kinzalmono







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/98/091


3.6.2013




30.5.2013


Micardis







Boehringer Ingelheim International GmbH




Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/98/090


3.6.2013




30.5.2013


MicardisPlus







Boehringer Ingelheim International GmbH




Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/02/213


3.6.2013




30.5.2013


PANTOZOL Control







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/09/517


3.6.2013




30.5.2013


PegIntron







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/00/131


3.6.2013




30.5.2013


Plavix







Sanofi Pharma Bristol-Myers Squibb SNC




54 rue La Boétie, F-75008 Paris, France






EU/1/98/069


3.6.2013




30.5.2013


RoActemra







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom






EU/1/08/492


3.6.2013




30.5.2013


SOMAC Control







Takeda GmbH




Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland






EU/1/09/516


3.6.2013




30.5.2013


ViraferonPeg







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom






EU/1/00/132


3.6.2013




31.5.2013


Imatinib Teva







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/12/808


4.6.2013







—   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 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




3.5.2013


Oncept IL-2


Feline interleukin-2 recombinant canarypox virus (vCP1338)







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/13/150


Lyophilisate and solvent for suspension for injection


QL03AX


7.5.2013







—   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




6.5.2013


BTVPUR AlSap 1







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/10/112


13.5.2013




6.5.2013


BTVPUR AlSap 1-8







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/10/113


13.5.2013




14.5.2013


Cerenia







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/06/062


16.5.2013




14.5.2013


Posatex







Intervet International B.V.




Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland






EU/2/08/081


16.5.2013




16.5.2013


Convenia







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/06/059


22.5.2013




16.5.2013


Suvaxyn PCV







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/09/099


22.5.2013




16.5.2013


Zulvac 1 Ovis







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/11/131


22.5.2013




16.5.2013


Zulvac 8 Ovis







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/09/104


22.5.2013




22.5.2013


Draxxin







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/03/041


24.5.2013




22.5.2013


Improvac







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/09/095


25.5.2013




22.5.2013


Pirsue







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/00/027


24.5.2013




22.5.2013


Poulvac E. coli







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/12/140


24.5.2013




22.5.2013


Quadrisol







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/97/005


24.5.2013




22.5.2013


Stronghold







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/99/014


24.5.2013




22.5.2013


Zulvac 1+8 Bovis







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/12/139


24.5.2013




22.5.2013


Zulvac 1 Bovis







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/11/130


24.5.2013




22.5.2013


Zulvac 8 Bovis







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/09/105


24.5.2013




23.5.2013


Naxcel







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/05/053


27.5.2013




23.5.2013


TruScient







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/11/136


27.5.2013




27.5.2013


Equip WNV







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/08/086


29.5.2013




27.5.2013


Fevaxyn Pentofel







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/96/002


29.5.2013




27.5.2013


Palladia







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/09/100


29.5.2013




27.5.2013


Slentrol







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/07/071


29.5.2013




27.5.2013


Zulvac 1+8 Ovis







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/11/120


29.5.2013




30.5.2013


Trocoxil







Zoetis Belgium S.A.




Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique






EU/2/08/084


3.6.2013







—   Withdrawal of a marketing authorization (Article 38 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




22.5.2013


Nobivac Piro


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/04/046


24.5.2013




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.

(2)  OJ L 136, 30.4.2004, p. 1.