EN Official Journal of the European Union C 399/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 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 399/01)

— 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 9.9.2016 CABOMETYX cabozantinib Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/16/1136 Film-coated tablet L01XE26 13.9.2016 15.9.2016 Inhixa enoxaparin sodium Techdow Europe AB Banérgatan 36, 75237 Uppsala, Sverige EU/1/16/1132 Solution for injection B01AB05 19.9.2016 15.9.2016 Mysildecard sildenafil Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/16/1134 Film-coated tablet G04BE03 19.9.2016 15.9.2016 Sialanar glycopyrronium bromide Proveca Limited Daresbury Innovation Centre, Keckwick Lane, Daresbury, Halton, Cheshire, WA4 4FS, United Kingdom EU/1/16/1135 Oral solution A03AB02 19.9.2016 15.9.2016 Tenofovir disoproxil Zentiva tenofovir disoproxil Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1127 Film-coated tablet J05AF07 19.9.2016 15.9.2016 Thorinane enoxaparin sodium Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/16/1131 Solution for injection B01AB05 19.9.2016 19.9.2016 Truberzi eluxadoline Aptalis Pharma SAS 5/6 Place de l’Iris — La Défense 5 92400 Courbevoie France EU/1/16/1126 Film-coated tablet Pending 21.9.2016

— 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 2.9.2016 Enzepi Allergan Pharmaceuticals International Limited, Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland EU/1/16/1113 6.9.2016 2.9.2016 Extavia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/454 6.9.2016 2.9.2016 Kengrexal Chiesi Farmaceutici S.P.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/15/994 6.9.2016 2.9.2016 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/979 6.9.2016 5.9.2016 Nimvastid Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/525 7.9.2016 8.9.2016 Betaferon Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/95/003 12.9.2016 8.9.2016 Budesonide/Formoterol Teva Pharma B.V. Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/950 12.9.2016 8.9.2016 Caprelsa Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/11/749 12.9.2016 8.9.2016 DUAVIVE Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/14/960 12.9.2016 8.9.2016 Insulatard Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/233 12.9.2016 8.9.2016 Levetiracetam Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland EU/1/11/713 12.9.2016 8.9.2016 Lucentis Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/374 12.9.2016 8.9.2016 Panretin Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/00/149 12.9.2016 8.9.2016 Plegridy Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/14/934 12.9.2016 8.9.2016 Protaphane Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/02/234 12.9.2016 9.9.2016 Ameluz Biofrontera Bioscience GmbH Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland EU/1/11/740 13.9.2016 9.9.2016 Efavirenz Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/742 13.9.2016 9.9.2016 Elaprase Shire Human Genetic Therapies AB Vasagatan 7, 111 20 Stockholm, Sverige EU/1/06/365 13.9.2016 9.9.2016 Eurartesim Sigma-Tau Industrie Farmaceutiche Riunite S.p.A Viale Shakespeare 47, 00144 Roma, Italia EU/1/11/716 13.9.2016 9.9.2016 Laventair Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/899 16.9.2016 9.9.2016 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 13.9.2016 9.9.2016 Tandemact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/366 13.9.2016 9.9.2016 Tracleer Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/02/220 13.9.2016 9.9.2016 Velphoro Vifor Fresenius Medical Care Renal Pharma France 7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France EU/1/14/943 15.9.2016 9.9.2016 Xolair Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/05/319 13.9.2016 15.9.2016 Arava Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/99/118 19.9.2016 15.9.2016 Arixtra Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland EU/1/02/206 19.9.2016 15.9.2016 Evoltra Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/334 19.9.2016 15.9.2016 Fosavance Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/310 19.9.2016 15.9.2016 Ganfort Allergan Pharmaceuticals Ireland, (514125) Castlebar Road, Westport, County Mayo, Ireland EU/1/06/340 19.9.2016 15.9.2016 Ibandronic Acid Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/10/642 19.9.2016 15.9.2016 Intelence Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/468 19.9.2016 15.9.2016 PANTECTA Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/518 19.9.2016 15.9.2016 Trulicity Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/956 19.9.2016 15.9.2016 Zydelig Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/938 19.9.2016 16.9.2016 Lamivudine Teva Pharma B.V. Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/596 20.9.2016 19.9.2016 Adrovance Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/364 21.9.2016 19.9.2016 Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/126 21.9.2016 19.9.2016 Fycompa Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/12/776 21.9.2016 19.9.2016 Repaglinide Accord Accord Healthcare Limited Sage House, 319 Pinner Road, Harrow, HA1 4HF, United Kingdom EU/1/11/743 21.9.2016 19.9.2016 Soliris Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/07/393 21.9.2016 19.9.2016 Sovaldi Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/894 21.9.2016 19.9.2016 Vantavo Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/572 21.9.2016 19.9.2016 Zydelig Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/938 21.9.2016 22.9.2016 Anoro Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/898 26.9.2016 22.9.2016 Blincyto Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/15/1047 26.9.2016 22.9.2016 EVARREST Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België EU/1/13/868 26.9.2016 22.9.2016 Instanyl Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/09/531 26.9.2016 22.9.2016 Leflunomide ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/10/654 26.9.2016 22.9.2016 Pregabalin Sandoz GmbH Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/15/1012 26.9.2016 22.9.2016 Saxenda Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/15/992 26.9.2016 22.9.2016 Stayveer Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland EU/1/13/832 26.9.2016 22.9.2016 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529 26.9.2016 22.9.2016 Zelboraf Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/12/751 26.9.2016 26.9.2016 Colobreathe Forest Laboratories UK Ltd. Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom EU/1/11/747 28.9.2016 26.9.2016 Tivicay ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/13/892 28.9.2016 30.9.2016 Cometriq Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/13/890 4.10.2016 30.9.2016 Moventig Kyowa Kirin Limited Galabank Business Park, Galashiels, TD1 1QH, United Kingdom EU/1/14/962 4.10.2016 30.9.2016 Vantobra PARI Pharma GmbH Moosstrasse 3, D-82319 Starnberg, Deutschland EU/1/14/932 4.10.2016

— 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 19.9.2016 PANTECTA Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/518 21.9.2016

— 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 22.9.2016 ERAVAC rabbit haemorrhagic disease vaccine (inactivated) Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170 Amer (Girona), España EU/2/16/199 Emulsion for injection QI08AA 26.9.2016

— 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 19.9.2016 Reconcile Nexcyon Pharmaceuticals Ltd First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom EU/2/08/080 29.9.2016 28.9.2016 Coliprotec F4 Prevtec Microbia GmbH Geyerspergerstr 27, 80689 München, Deutschland EU/2/14/180 30.9.2016

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.