EN Official Journal of the European Union C 245/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2017 to 30 June 2017

(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 245/01)

— 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 2.6.2017 Elmiron pentosan polysulfate sodium bene-Arzneimittel GmbH Herterichstr. 1-3, 81479 München, Deutschland EU/1/17/1189 Capsule, hard G04BX15 7.6.2017 2.6.2017 Refixia nonacog beta pegol Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/17/1193 Powder and solvent for solution for injection B02BD04 7.6.2017 15.6.2017 Febuxostat Mylan febuxostat Mylan S.A.S. 117 Allée des Parcs, 69800 Saint-Priest, France EU/1/17/1194 Film-coated tablet M04AA03 19.6.2017 15.6.2017 Rixathon rituximab Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/17/1185 Concentrate for solution for infusion L01XC02 19.6.2017 15.6.2017 Riximyo rituximab Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/17/1184 Concentrate for solution for infusion L01XC02 19.6.2017 23.6.2017 Erelzi etanercept Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/17/1195 Solution for injection L04AB01 27.6.2017 23.6.2017 Kevzara sarilumab Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/17/1196 Solution for injection L04AC14 27.6.2017 23.6.2017 Skilarence dimethyl fumarate Almirall, S.A. Ronda General Mitre, 151, E-08022 Barcelona, España EU/1/17/1201 Gastro-resistant tablet Pending 27.6.2017 23.6.2017 Ucedane carglumic acid Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/17/1202 Dispersible tablet A16AA05 27.6.2017 29.6.2017 Besponsa inotuzumab ozogamicin Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/17/1200 Powder for concentrate for solution for infusion L01XC26 3.7.2017

— 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 2.6.2017 Avastin Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/04/300 7.6.2017 2.6.2017 Caspofungin Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1081 7.6.2017 2.6.2017 Cerezyme Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/97/053 7.6.2017 2.6.2017 Emtricitabine/Tenofovir disoproxil Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/16/1133 7.6.2017 2.6.2017 INCRELEX Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/07/402 7.6.2017 2.6.2017 Norvir AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/96/016 7.6.2017 2.6.2017 Nplate Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/08/497 7.6.2017 2.6.2017 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 7.6.2017 2.6.2017 PecFent Archimedes Development Ltd Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom EU/1/10/644 7.6.2017 2.6.2017 Pregabalin Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/15/997 8.6.2017 2.6.2017 Pregabalin Mylan Pharma Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/15/998 8.6.2017 2.6.2017 Somavert Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/02/240 7.6.2017 8.6.2017 ellaOne Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/09/522 12.6.2017 12.6.2017 Biopoin Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/565 14.6.2017 12.6.2017 Stivarga Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/13/858 14.6.2017 15.6.2017 AUBAGIO Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/13/838 19.6.2017 15.6.2017 Clopidogrel Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/09/559 19.6.2017 15.6.2017 Eporatio ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland EU/1/09/573 19.6.2017 15.6.2017 Nexium Control Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/13/860 19.6.2017 15.6.2017 Zometa Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/01/176 19.6.2017 16.6.2017 Atriance Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/403 20.6.2017 16.6.2017 Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/802 20.6.2017 16.6.2017 Clopidogrel ratiopharm GmbH Archie Samuel s.r.o. Slunná 16, CZ-61700 Brno, Česká republika EU/1/09/541 20.6.2017 16.6.2017 Cubicin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/328 20.6.2017 16.6.2017 INCRELEX Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France EU/1/07/402 20.6.2017 16.6.2017 Intuniv Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/15/1040 20.6.2017 16.6.2017 KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 20.6.2017 16.6.2017 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/13/901 21.6.2017 16.6.2017 Sivextro Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/991 20.6.2017 16.6.2017 Translarna PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland EU/1/13/902 20.6.2017 16.6.2017 Trizivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/00/156 20.6.2017 16.6.2017 Trulicity Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/956 20.6.2017 16.6.2017 Xagrid Shire Pharmaceutical Contracts Ltd Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom EU/1/04/295 20.6.2017 16.6.2017 Xgeva Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/11/703 20.6.2017 16.6.2017 Yondelis Pharma Mar S.A. Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España EU/1/07/417 20.6.2017 16.6.2017 Zoledronic acid Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/12/800 20.6.2017 16.6.2017 Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/779 20.6.2017 23.6.2017 ALPROLIX Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sverige EU/1/16/1098 28.6.2017 23.6.2017 Clopidogrel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/540 27.6.2017 23.6.2017 Emselex Merus Labs Luxco S.à R.L. 26-28, rue Edward Steichen, L-2540 Luxembourg EU/1/04/294 27.6.2017 23.6.2017 Evra Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/02/223 27.6.2017 23.6.2017 Farydak Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/1023 27.6.2017 23.6.2017 Flixabi Samsung Bioepis UK Limited 3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom EU/1/16/1106 27.6.2017 23.6.2017 Izba Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/905 27.6.2017 23.6.2017 KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 27.6.2017 23.6.2017 Mysimba Orexigen Therapeutics Ireland Limited 2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland EU/1/14/988 27.6.2017 23.6.2017 Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/16/1089 28.6.2017 23.6.2017 Prolia Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/10/618 27.6.2017 23.6.2017 Rapamune Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/01/171 27.6.2017 23.6.2017 Revestive Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/12/787 27.6.2017 23.6.2017 Sebivo Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/388 27.6.2017 23.6.2017 Sevelamer carbonate Zentiva Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/14/952 27.6.2017 23.6.2017 Tadalafil Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/14/961 27.6.2017 23.6.2017 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 27.6.2017 23.6.2017 Zykadia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/999 27.6.2017 26.6.2017 Grastofil Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland EU/1/13/877 28.6.2017 26.6.2017 Komboglyze AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/731 28.6.2017 26.6.2017 Macugen PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika EU/1/05/325 28.6.2017 26.6.2017 Noxafil Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/320 28.6.2017 26.6.2017 Onglyza AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/09/545 28.6.2017 26.6.2017 Pregabalin Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1027 28.6.2017 26.6.2017 Renvela Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/09/521 28.6.2017 26.6.2017 Triumeq ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/14/940 28.6.2017 26.6.2017 Voriconazole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/835 28.6.2017 29.6.2017 alli Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/401 3.7.2017 29.6.2017 Clopidogrel HCS HCS bvba H. Kennisstraat 53, B-2650 Edegem, België EU/1/10/651 4.7.2017 29.6.2017 Clopidogrel ratiopharm Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/14/975 3.7.2017 29.6.2017 Ibandronic acid Sandoz Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/11/685 3.7.2017 29.6.2017 IKERVIS Santen Oy Niittyhaankatu 20, FI-33720 Tampere, Suomi EU/1/15/990 3.7.2017 29.6.2017 Uptravi Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/15/1083 3.7.2017 29.6.2017 Vizamyl GE Healthcare Ltd Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom EU/1/14/941 3.7.2017 29.6.2017 Xyrem UCB Pharma Ltd 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom EU/1/05/312 3.7.2017

— 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 2.6.2017 Removab Neovii Biotech GmbH Am Haag 6-7, 82166 Graefelfing, Deutschland EU/1/09/512 7.6.2017 15.6.2017 Clopidogrel Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/561 19.6.2017 23.6.2017 Zontivity Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/14/976 27.6.2017

— 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 19.6.2017 Prevomax maropitant Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland EU/2/17/211 Solution for injection QA04AD90 21.6.2017 27.6.2017 CLYNAV Salmon pancreas disease vaccine (recombinant DNA plasmid) Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/16/197 Solution for injection QI10AX 29.6.2017

— 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 6.6.2017 Advocate Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/03/039 8.6.2017 7.6.2017 Econor Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM EU/2/98/010 9.6.2017 8.6.2017 Cardalis CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/12/142 12.6.2017 13.6.2017 BROADLINE Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/13/157 15.6.2017 13.6.2017 Circovac Ceva-Phylaxia Zrt. 1107 Budapest, Szállás u. 5., MAGYARORSZÁG EU/2/07/075 15.6.2017 13.6.2017 Clomicalm Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/98/007 15.6.2017 13.6.2017 Veraflox Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/10/107 16.6.2017 29.6.2017 EQUIOXX CEVA SANTE ANIMALE 10 avenue de la Ballastière, F-33500 Libourne, France EU/2/08/083 3.7.2017

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.