EN Official Journal of the European Union C 28/1

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

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

(2017/C 028/01)

* * *

— 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 5.12.2016 Venclyxto venetoclax AbbVie Ltd Vanwall Road, Maidenhead, SL6 4UB, United Kingdom EU/1/16/1138 Film-coated tablet L01X 7.12.2016 8.12.2016 Emtricitabine/Tenofovir disoproxil Krka emtricitabine/tenofovir disoproxil Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/16/1151 Film-coated tablet J05AR03 12.12.2016 8.12.2016 SomaKit TOC edotreotide Advanced Accelerator Applications 20 rue Diesel, F-1630 Saint-Genis-Pouilly, France EU/1/16/1141 Powder for solution for injection V09IX09 12.12.2016 8.12.2016 Tenofovir disoproxil Mylan Tenofovir disoproxil MYLAN S.A.S 117 Allée des Parcs, 69800 Saint-Priest, France EU/1/16/1129 Film-coated tablet J05AF07 12.12.2016 12.12.2016 OCALIVA obeticholic acid Intercept Pharma Ltd 2 Pancras Square, London N1C 4AG, United Kingdom EU/1/16/1139 Film-coated tablet A05AA04 15.12.2016 12.12.2016 Rekovelle follitropin delta Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, DK-2300 Copenhagen S, Danmark EU/1/16/1150 G03GA10 14.12.2016 16.12.2016 Emtricitabine/Tenofovir disoproxil Mylan emtricitabine/tenofovir disoproxil Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/16/1133 Film-coated tablet J05AR03 20.12.2016

— 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 2.12.2016 Aclasta Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/05/308 6.12.2016 5.12.2016 Pioglitazone Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/722 7.12.2016 5.12.2016 Spedra Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/13/841 7.12.2016 5.12.2016 Truberzi Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland EU/1/16/1126 7.12.2016 8.12.2016 Actraphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/229 12.12.2016 8.12.2016 Actrapid Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/230 12.12.2016 8.12.2016 Adenuric Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/447 12.12.2016 8.12.2016 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 12.12.2016 8.12.2016 CONTROLOC Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/515 12.12.2016 8.12.2016 Cystadane Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/06/379 12.12.2016 8.12.2016 DuoPlavin Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France EU/1/10/619 12.12.2016 8.12.2016 Eperzan GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/13/908 14.12.2016 8.12.2016 GILENYA Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/677 12.12.2016 8.12.2016 Holoclar Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/987 12.12.2016 8.12.2016 Icandra Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/484 12.12.2016 8.12.2016 Lamivudine/Zidovudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/663 12.12.2016 8.12.2016 Mimpara Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/04/292 5.12.2016 8.12.2016 Otezla Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/14/981 12.12.2016 8.12.2016 PANTOZOL Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/517 12.12.2016 8.12.2016 SOMAC Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/516 12.12.2016 8.12.2016 Voriconazole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/835 12.12.2016 8.12.2016 Zebinix Bial — Portela & Ca, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal EU/1/09/514 12.12.2016 8.12.2016 Zoledronic acid Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/12/759 12.12.2016 9.12.2016 Ecansya Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/12/763 12.12.2016 12.12.2016 Accofil Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/14/946 14.12.2016 12.12.2016 Aldara Meda AB Pipers väg 2A, SE-170 73 Solna, Sverige EU/1/98/080 14.12.2016 12.12.2016 Aripiprazole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1045 14.12.2016 12.12.2016 Colobreathe Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/747 14.12.2016 12.12.2016 Cometriq Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/13/890 14.12.2016 12.12.2016 Competact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/354 14.12.2016 12.12.2016 Crixivan Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/96/024 14.12.2016 12.12.2016 Docetaxel Kabi Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom EU/1/12/770 15.12.2016 12.12.2016 Ebymect AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/15/1051 14.12.2016 12.12.2016 Efficib Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457 14.12.2016 12.12.2016 Eucreas Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/425 14.12.2016 12.12.2016 Flebogamma DIF Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa EU/1/07/404 14.12.2016 12.12.2016 Glubrava Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/07/421 14.12.2016 12.12.2016 Humira AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/03/256 14.12.2016 12.12.2016 Inflectra Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/13/854 14.12.2016 12.12.2016 Janumet Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455 14.12.2016 12.12.2016 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/12/780 14.12.2016 12.12.2016 Komboglyze AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/731 14.12.2016 12.12.2016 Kyprolis Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1060 14.12.2016 12.12.2016 Lynparza AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/959 14.12.2016 12.12.2016 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 14.12.2016 12.12.2016 Nimenrix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/767 14.12.2016 12.12.2016 NovoMix Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/00/142 14.12.2016 12.12.2016 Optaflu Seqirus GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland EU/1/07/394 14.12.2016 12.12.2016 Orbactiv The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom EU/1/15/989 14.12.2016 12.12.2016 Pregabalin Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1027 14.12.2016 12.12.2016 Ristfor Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620 14.12.2016 12.12.2016 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 14.12.2016 12.12.2016 TAGRISSO AstraZeneca AB Gärtunavägen, SE-151 85 Södertälje, Sverige EU/1/16/1086 14.12.2016 12.12.2016 Trulicity Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/956 14.12.2016 12.12.2016 Velmetia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456 14.12.2016 12.12.2016 Vimpat UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/08/470 14.12.2016 12.12.2016 Vipdomet Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/13/843 14.12.2016 12.12.2016 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/918 14.12.2016 12.12.2016 Xigduo AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/13/900 14.12.2016 12.12.2016 Xtandi Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland EU/1/13/846 14.12.2016 12.12.2016 Zomarist Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/483 14.12.2016 13.12.2016 GONAL-f Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/95/001 16.12.2016 16.12.2016 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430 21.12.2016 16.12.2016 Caprelsa Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/11/749 20.12.2016 16.12.2016 Kentera Nicobrand Limited 189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom EU/1/03/270 20.12.2016 16.12.2016 Levemir Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/04/278 20.12.2016 16.12.2016 Mixtard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/231 20.12.2016 16.12.2016 Pemetrexed Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1034 20.12.2016 16.12.2016 Pramipexole Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/490 20.12.2016 16.12.2016 RotaTeq Sanofi Pasteur MSD SAS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/348 20.12.2016 16.12.2016 Sebivo Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/388 20.12.2016 19.12.2016 Entyvio Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/923 21.12.2016 19.12.2016 Pemetrexed Sandoz Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/15/1037 21.12.2016 19.12.2016 Tractocile Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, DK-2300 Copenhagen S, Danmark EU/1/99/124 21.12.2016 19.12.2016 Visudyne Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/00/140 21.12.2016 23.12.2016 Duloxetine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/15/1010 5.1.2017 23.12.2016 Fareston Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/96/004 4.1.2017 23.12.2016 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026 4.1.2017 23.12.2016 Mepact Takeda France SAS Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France EU/1/08/502 4.1.2017 23.12.2016 Orkambi Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/15/1059 4.1.2017 23.12.2016 Raplixa Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland EU/1/14/985 4.1.2017 23.12.2016 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/901 4.1.2017

— 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 16.12.2016 Budesonide/Formoterol Teva Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/948 20.12.2016 16.12.2016 Budesonide/Formoterol Teva Pharma B.V. Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/950 20.12.2016

— Issuing 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 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 13.12.2016 Cepedex dexmedetomidine CP Pharma Handelsgesellschaft mbH Ostlandring 13, D-31303 Burgdorf, Deutschland EU/2/16/200 Solution for injection QN05CM18 15.12.2016 13.12.2016 Halagon halofuginone Emdoka bvba J. Lijsenstraat 16, B-2321 Hoogstraten, België EU/2/16/201 Oral solution QP51AX08 15.12.2016

— 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 13.12.2016 Parvoduk Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/14/162 15.12.2016 13.12.2016 Zulvac 1 + 8 Bovis Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/139 15.12.2016 14.12.2016 Activyl Tick Plus Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/11/137 16.12.2016 14.12.2016 Porcilis PCV M Hyo Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/14/175 16.12.2016 14.12.2016 Versican Plus DHPPi Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/169 16.12.2016 14.12.2016 Versican Plus DHPPi/L4 Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/164 16.12.2016 14.12.2016 Versican Plus DHPPi/L4R Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/163 16.12.2016

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.