EN Official Journal of the European Union C 154/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2016 to 31 March 2016

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

(2016/C 154/01)

— Issuing of a marketing authorisation (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 authorisation Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 16.3.2016 Coagadex human coagulation factor X Bio Products Laboratory Ltd Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom EU/1/16/1087 Powder and solvent for solution for injection B02BD13 18.3.2016 16.3.2016 Neofordex dexamethasone Laboratoires CTRS 63 rue de l’Est, F-92100 Boulogne-Billancourt, France EU/1/15/1053 Tablet H02AB02 18.3.2016 22.3.2016 Amlodipine/Valsartan Mylan amlodipine/valsartan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/16/1092 Film-coated tablet C09DB01 29.3.2016 31.3.2016 Wakix Pitolisant hydrochloride Bioprojet Pharma 9 rue Rameau, F-75002 Paris, France EU/1/15/1068 Film-coated tablet N07XX11 4.4.2016 31.3.2016 Zonisamide Mylan zonisamide Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/16/1093 Capsule, hard N03AX15 4.4.2016

— Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 2.3.2016 Copalia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/372 4.3.2016 2.3.2016 Dafiro Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/371 4.3.2016 2.3.2016 DuoPlavin Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/10/619 7.3.2016 2.3.2016 Efavirenz Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/742 4.3.2016 2.3.2016 Exforge HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/569 4.3.2016 2.3.2016 Faslodex AstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United Kingdom EU/1/03/269 4.3.2016 2.3.2016 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780 7.3.2016 2.3.2016 Menveo GSK Vaccines S.r.l. Via Fiorentina, 1, IT-53100 Siena, Italia EU/1/10/614 4.3.2016 2.3.2016 Mozobil Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/09/537 4.3.2016 2.3.2016 Xydalba Durata Therapeutics International B.V. Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland EU/1/14/986 4.3.2016 7.3.2016 Avamys Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/434 9.3.2016 7.3.2016 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/12/792 9.3.2016 7.3.2016 Signifor Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/753 9.3.2016 7.3.2016 Triumeq ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/14/940 9.3.2016 10.3.2016 Celsentri ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/07/418 14.3.2016 10.3.2016 Onglyza AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/09/545 14.3.2016 11.3.2016 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, D-80636 München, Deutschland EU/1/13/875 16.3.2016 11.3.2016 Savene Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom EU/1/06/350 16.3.2016 11.3.2016 Topotecan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/552 16.3.2016 16.3.2016 Cuprymina SPARKLE S.r.l. Località Cavallino, 62010 Montecosaro (MC), Italia EU/1/12/784 21.3.2016 22.3.2016 Copalia HCT Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/575 29.3.2016 22.3.2016 Exforge Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/370 29.3.2016 22.3.2016 Exjade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/356 29.3.2016 22.3.2016 Iclusig ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 29.3.2016 22.3.2016 Kepivance Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/05/314 29.3.2016 22.3.2016 Laventair Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/899 29.3.2016 22.3.2016 Mekinist Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/14/931 29.3.2016 22.3.2016 Pixuvri CTI Life Sciences Ltd Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom EU/1/12/764 29.3.2016 22.3.2016 Trajenta Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/11/707 29.3.2016 22.3.2016 Zykadia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/999 29.3.2016 23.3.2016 Elocta Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/15/1046 30.3.2016 30.3.2016 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland EU/1/07/412 1.4.2016 30.3.2016 Anoro Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/898 1.4.2016 30.3.2016 Evra Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/02/223 1.4.2016 30.3.2016 TachoSil Takeda Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich EU/1/04/277 1.4.2016 30.3.2016 Vidaza Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/08/488 1.4.2016 31.3.2016 Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/12/809 4.4.2016 31.3.2016 Binocrit Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/07/410 4.4.2016 31.3.2016 Caelyx Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/96/011 4.4.2016 31.3.2016 Capecitabine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/761 4.4.2016 31.3.2016 Ecansya Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/12/763 4.4.2016 31.3.2016 Epoetin alfa Hexal Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/07/411 4.4.2016 31.3.2016 Eviplera Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/11/737 4.4.2016 31.3.2016 Giotrif Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/13/879 4.4.2016 31.3.2016 Lynparza AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/959 4.4.2016 31.3.2016 Revatio Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/05/318 4.4.2016 31.3.2016 Ruconest Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland EU/1/10/641 4.4.2016 31.3.2016 Vargatef Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/954 4.4.2016

— Withdrawal of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 2.3.2016 Nuedexta Jenson Pharmaceutical Services Ltd Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom EU/1/13/833 4.3.2016

— Suspension of a marketing authorisation (Article 20 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 authorisation Number of the entry in the Community Register Date of notification 23.3.2016 Zydelig Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/938 30.3.2016

— Modification of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 8.3.2016 Palladia Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/100 10.3.2016 15.3.2016 BLUEVAC BTV8 CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño, España EU/2/11/122 17.3.2016 15.3.2016 Versican Plus DHPPi Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/169 17.3.2016 15.3.2016 Versican Plus DHPPi/L4 Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/164 17.3.2016 15.3.2016 Versican Plus DHPPi/L4R Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/163 17.3.2016

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

European Medicines Agency 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

(1) OJ L 136, 30.4.2004, p. 1.