EN Official Journal of the European Union C 490/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2016 to 30 November 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 490/01)

— 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 9.11.2016 Emtricitabine/Tenofovir disoproxil Zentiva emtricitabine/tenofovir disoproxil Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1148 Film-coated tablet J05AR03 11.11.2016 9.11.2016 IBRANCE palbociclib Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/16/1147 Capsule, hard L01XE33 11.11.2016 9.11.2016 Lartruvo olaratumab Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/16/1143 Concentrate for solution for infusion L01XC27 11.11.2016 11.11.2016 Glyxambi empagliflozin/linagliptin Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/16/1146 Film-coated tablet A10BD19 15.11.2016 11.11.2016 Ivabradine JensonR ivabradine JensonR+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 UD, United Kingdom EU/1/16/1145 Film-coated tablet C01EB17 15.11.2016 11.11.2016 Ivabradine Zentiva ivabradine Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1144 Film-coated tablet C01EB17 15.11.2016 11.11.2016 Parsabiv etelcalcetide Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/16/1142 Solution for injection H05BX04 15.11.2016 11.11.2016 XALKORI crizotinib Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 Capsule, hard L01XE16 15.11.2016 14.11.2016 Erivedge vismodegib Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/848 Capsule, hard L01XX43 16.11.2016 14.11.2016 Granpidam sildenafil Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/16/1137 Film-coated tablet G04BE03 16.11.2016 21.11.2016 Ninlaro ixazomib Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/16/1094 Capsule, hard L01XX50 23.11.2016

— 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 3.11.2016 Daliresp AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/668 7.11.2016 3.11.2016 Emtriva Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/03/261 7.11.2016 3.11.2016 Intanza Sanofi Pasteur Europe 2 Avenue Pont Pasteur, 69007 Lyon, France EU/1/08/505 7.11.2016 3.11.2016 Libertek AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/666 7.11.2016 3.11.2016 Vibativ Theravance Biopharma Ireland Limited Fitzwilliam Hall, Fitzwilliam Place, Dublin 2, Ireland EU/1/11/705 7.11.2016 9.11.2016 Iclusig Incyte Biosciences UK Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom EU/1/13/839 11.11.2016 9.11.2016 Lyrica Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/04/279 11.11.2016 9.11.2016 Sutent Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/347 11.11.2016 9.11.2016 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/714 14.11.2016 11.11.2016 Abraxane Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom EU/1/07/428 15.11.2016 11.11.2016 Desloratadine Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/11/745 15.11.2016 11.11.2016 Erivedge Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/13/848 15.11.2016 11.11.2016 Foscan biolitec Pharma Ltd. Otto-Schott-Str. 15, 07745 Jena, Deutschland EU/1/01/197 15.11.2016 11.11.2016 Glidipion Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/12/756 15.11.2016 11.11.2016 Hexyon Sanofi Pasteur Europe 2 Avenue Pont Pasteur, 69007 Lyon, France EU/1/13/829 15.11.2016 11.11.2016 Incruse Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/922 15.11.2016 11.11.2016 Keppra UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/00/146 15.11.2016 11.11.2016 Lojuxta Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom EU/1/13/851 15.11.2016 11.11.2016 Lucentis Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/374 15.11.2016 11.11.2016 Mirvaso Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France EU/1/13/904 15.11.2016 11.11.2016 Neuraceq Piramal Imaging Limited Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom EU/1/13/906 15.11.2016 11.11.2016 Picato Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark EU/1/12/796 15.11.2016 11.11.2016 Pioglitazone Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/12/755 15.11.2016 11.11.2016 Pregabalin Pfizer Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/14/916 15.11.2016 11.11.2016 Stelara Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/494 15.11.2016 11.11.2016 Strensiq Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France EU/1/15/1015 15.11.2016 11.11.2016 Taxespira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/15/1017 15.11.2016 11.11.2016 Teysuno Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland EU/1/11/669 15.11.2016 11.11.2016 Translarna PTC Therapeutics International Limited 77 Sir John Rogerson’s Quay, Dublin 2, Ireland EU/1/13/902 15.11.2016 14.11.2016 Bretaris Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/781 16.11.2016 14.11.2016 Clopidogrel ratiopharm Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/975 16.11.2016 14.11.2016 Duloxetine Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1028 16.11.2016 14.11.2016 Edarbi Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/11/734 16.11.2016 14.11.2016 Eklira Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/12/778 16.11.2016 14.11.2016 Esmya Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország EU/1/12/750 16.11.2016 14.11.2016 Giotrif Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/13/879 16.11.2016 14.11.2016 Iasibon Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/10/659 16.11.2016 14.11.2016 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436 16.11.2016 14.11.2016 Levetiracetam SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/11/741 16.11.2016 14.11.2016 Lucentis Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/374 16.11.2016 14.11.2016 Numient Impax Laboratories Ireland Limited, 56 Fitzwilliam Square, Dublin 2, Ireland EU/1/15/1044 16.11.2016 14.11.2016 Pioglitazone Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/12/755 17.11.2016 14.11.2016 Pioglitazone Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/757 16.11.2016 14.11.2016 Praluent Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/15/1031 16.11.2016 14.11.2016 Ribavirin Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/509 16.11.2016 14.11.2016 Ribavirin Teva Pharma BV Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/527 16.11.2016 14.11.2016 Topotecan Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/10/633 16.11.2016 14.11.2016 Trisenox Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/02/204 16.11.2016 14.11.2016 Triumeq ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/14/940 16.11.2016 18.11.2016 Daxas AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/10/636 22.11.2016 18.11.2016 Jakavi Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/773 22.11.2016 18.11.2016 Pioglitazone Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/758 22.11.2016 18.11.2016 Procysbi Raptor Pharmaceuticals Europe BV Naritaweg 165, NL-1043 BW Amsterdam, Nederland EU/1/13/861 22.12.2016 18.11.2016 Selincro H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark EU/1/12/815 22.11.2016 18.11.2016 Signifor Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/753 22.11.2016 18.11.2016 Thymanax Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland EU/1/08/498 22.11.2016 18.11.2016 Valdoxan Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes Cedex, France EU/1/08/499 22.11.2016 18.11.2016 Xaluprine Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom EU/1/11/727 22.11.2016 21.11.2016 Ameluz Biofrontera Bioscience GmbH Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland EU/1/11/740 23.11.2016 21.11.2016 Bemfola Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország EU/1/13/909 23.11.2016 21.11.2016 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 23.11.2016 21.11.2016 Elonva Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/609 23.11.2016 21.11.2016 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 23.11.2016 29.11.2016 Ammonaps Swedish Orphan Biovitrum International AB SE-112 76 Stockholm, Sverige EU/1/99/120 1.12.2016 29.11.2016 PANTOLOC Control Takeda GmbH, (HRB 701016) Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland EU/1/09/519 1.12.2016

— 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 3.11.2016 Vitekta Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/13/883 7.11.2016 21.11.2016 Celvapan Nanotherapeutics Bohumil, s.r.o. Bohumil 138, 28163 Jevany, Česká republika EU/1/08/506 23.11.2016

— 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 3.11.2016 Fungitraxx Avimedical B.V. Abbinkdijk 1, 7255 LX Hengelo (Gld), Nederland EU/2/13/160 7.11.2016 9.11.2016 Draxxin Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/03/041 14.11.2016 9.11.2016 Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/11/134 11.11.2016 9.11.2016 Semintra Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/146 11.11.2016 11.11.2016 Sileo Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/2/15/181 15.11.2016 29.11.2016 BROADLINE Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/157 1.12.2016

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.