Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2013-10-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013311EN.01000101.xml










25.10.2013   


EN


Official Journal of the European Union


C 311/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

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

2013/C 311/01
—   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




6.9.2013


Procysbi


mercaptamine (cysteamine bitartrate)







Raptor Pharmaceuticals Europe BV




Naritaweg 165, NL-1043 BW Amsterdam, Nederland






EU/1/13/861


Gastro-resistant capsule, hard


A16AA04


10.9.2013




6.9.2013


Provenge


Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T)







Dendreon UK Limited




41 Chalton Street, London NW1 1JD, United Kingdom






EU/1/13/867


Dispersion for infusion


L03AX17


10.9.2013




10.9.2013


Inflectra


Infliximab







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom






EU/1/13/854


powder for concentrate for solution for infusion


L04AB02


12.9.2013




10.9.2013


Remsima


Infliximab







Celltrion Healthcare Hungary Kft.




Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország






EU/1/13/853


powder for concentrate for solution for infusion


L04AB02


12.9.2013




12.9.2013


Lemtrada


Alemtuzumab







Genzyme Therapeutics Ltd




4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom






EU/1/13/869


Concentrate for solution for infusion


Pending


16.9.2013




12.9.2013


Orphacol


Cholic acid







Laboratoires CTRS (Cell Therapies Research & Services)




69 rue d’Aguesseau, F-92100 Boulogne-Billancourt, France






EU/1/13/870


Capsule, hard


A05AA03


16.9.2013




19.9.2013


Incresync


alogliptin / pioglitazone







Takeda Pharma A/S




PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/13/842


Film-coated tablet


A10BD09


23.9.2013




19.9.2013


Tybost


cobicistat







Gilead Sciences International Limited




Cambridge CB21 6GT, United Kingdom






EU/1/13/872


Film-coated tablet


V03AX03


23.9.2013




19.9.2013


Ultibro Breezhaler


indacaterol/glycopyrronium bromide







Novartis Europharm Limited




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






EU/1/13/862


Inhalation powder, hard capsule


R03AL04


23.9.2013




19.9.2013


Vipdomet


alogliptin / metformin







Takeda Pharma A/S




PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/13/843


Film-coated tablet


A10BD13


23.9.2013




19.9.2013


Vipidia


alogliptin







Takeda Pharma A/S




PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/13/844


Film-coated tablet


A10BH04


23.9.2013




19.9.2013


Xoterna Breezhaler


indacaterol/glycopyrronium bromide







Novartis Europharm Limited




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






EU/1/13/863


Inhalation powder, hard capsule


R03AL04


23.9.2013




25.9.2013


EVARREST


Human fibrinogen/Human thrombin







Omrix Biopharmaceuticals N.V.




Leonardo Da Vincilaan 15, B-1831 Diegem, België






EU/1/13/868


Sealant matrix


B02BC30


27.9.2013




25.9.2013


Giotrif


afatinib







Boehringer Ingelheim International GmbH




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






EU/1/13/879


Film-coated tablet


L01XE13


27.9.2013




25.9.2013


Imatinib Medac


Imatinib







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstr. 6, D-22880 Wedel, Deutschland






EU/1/13/876


Capsule, hard


L01XE01


27.9.2013




27.9.2013


Ovaleap


Follitropin alfa







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/13/871


Solution for injection


G03GA05


1.10.2013







—   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




6.9.2013


Labazenit







LABORATOIRES SMB SA




26-28 rue de la Pastorale / 26-28 Herdersliedstraat, 1080 Brussel/Bruxelles, Belgique/België






—


10.9.2013







—   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




3.9.2013


Neulasta







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/02/227


5.9.2013




3.9.2013


Simponi







Janssen Biologics B.V.




Einsteinweg 101, NL-2333 CB Leiden, Nederland






EU/1/09/546


5.9.2013




3.9.2013


Vibativ







Clinigen Healthcare Limited




Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom






EU/1/11/705


5.9.2013




3.9.2013


Victrelis







Merck Sharp & Dohme Limited




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






EU/1/11/704


5.9.2013




3.9.2013


Xeplion







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/672


5.9.2013




5.9.2013


Mepact







Takeda France SAS




Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France






EU/1/08/502


9.9.2013




9.9.2013


IDflu







Sanofi Pasteur SA




2 avenue Pont Pasteur, F-69007 Lyon, France






EU/1/08/507


10.9.2013




9.9.2013


Intanza







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk, F-69007 Lyon, France






EU/1/08/505


10.9.2013




12.9.2013


Cystagon







Orphan Europe S.A.R.L.




Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France






EU/1/97/039


16.9.2013




12.9.2013


Puregon







Merck Sharp & Dohme Limited




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






EU/1/96/008


16.9.2013




19.9.2013


Elaprase







Shire Human Genetic Therapies AB




Svärdvägen 11D, SE-182 33 Danderyd, Sverige






EU/1/06/365


23.9.2013




19.9.2013


Elonva







Merck Sharp & Dohme Limited




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






EU/1/09/609


23.9.2013




19.9.2013


Insuman







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/97/030


23.9.2013




19.9.2013


NexoBrid







MediWound Germany GmbH




Eisenstr. 5, D-65428 Ruesselsheim, Deutschland






EU/1/12/803


23.9.2013




19.9.2013


Orgalutran







Merck Sharp & Dohme Limited




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






EU/1/00/130


23.9.2013




19.9.2013


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/06/380


23.9.2013




19.9.2013


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/06/380


23.9.2013




19.9.2013


Revolade







GlaxoSmithKline Trading Services Limited




6900 Cork Airport Business Park, Kinsale Road, Cork, Ireland






EU/1/10/612


23.9.2013




19.9.2013


Savene







Norgine B.V.




Hogehilweg 7, 1101 CA Amsterdam ZO, Nederland






EU/1/06/350


23.9.2013




19.9.2013


Simponi







Janssen Biologics B.V.




Einsteinweg 101, NL-2333 CB Leiden, Nederland






EU/1/09/546


23.9.2013




19.9.2013


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/08/494


23.9.2013




24.9.2013


Intanza







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk, F-69007 Lyon, France






EU/1/08/505


26.9.2013




24.9.2013


TOBI Podhaler







Novartis Europharm Limited




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






EU/1/10/652


26.9.2013




25.9.2013


IDflu







Sanofi Pasteur SA




2 avenue Pont Pasteur, F-69007 Lyon, France






EU/1/08/507


27.9.2013




25.9.2013


Multaq







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/09/591


27.9.2013




25.9.2013


Resolor







Shire Pharmaceuticals Ireland Limited




5 River Walk, Citywest Business Campus, Dublin 24, Ireland






EU/1/09/581


27.9.2013




25.9.2013


RoActemra







Roche Registration Limited




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






EU/1/08/492


30.9.2013







—   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




3.9.2013


Rasitrio







Novartis Europharm Limited




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






EU/1/11/730


5.9.2013








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




12.9.2013


Apoquel


Oclacitinib maleate







Zoetis Belgium S.A.




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






EU/2/13/154


Film-coated tablet


QD11AH90


16.9.2013




19.9.2013


Trifexis


Spinosad / Milbemycin oxime







Eli Lilly and Company Ltd




Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom






EU/2/13/155


Chewable tablet


QP54AB51


23.9.2013







—   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




12.9.2013


Equip WNV







Zoetis Belgium S.A.




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






EU/2/08/086


16.9.2013




13.9.2013


Zulvac 8 Bovis







Zoetis Belgium S.A.




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






EU/2/09/105


17.9.2013




13.9.2013


Zulvac 8 Ovis







Zoetis Belgium S.A.




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






EU/2/09/104


17.9.2013




24.9.2013


Masivet







AB Science S.A.




3 avenue George V, F-75008 Paris, France






EU/2/08/087


26.9.2013




25.9.2013


Melovem


Dopharma Research B.V.
Zalmweg 24, NL-4941 VX Raamsdonksveer, Nederland


EU/2/09/098


27.9.2013







—   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




19.9.2013


Netvax







Intervet International B.V.




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






EU/2/09/093


23.9.2013




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.