EN Official Journal of the European Union C 229/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2018 to 31 May 2018

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

(2018/C 229/01)

— 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 16.5.2018 Juluca dolutegravir/rilpivirine ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/18/1282 Film-coated tablet J05AR21 18.5.2018 16.5.2018 KANJINTI trastuzumab Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/18/1281 Powder for concentrate for solution for infusion L01XC03 18.5.2018 16.5.2018 Prasugrel Mylan prasugrel Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1273 Film-coated tablet B01AC22 18.5.2018 18.5.2018 Zessly infliximab Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/18/1280 Powder for concentrate and diluent for solution for infusion L04AB02 23.5.2018 22.5.2018 Pemetrexed Krka pemetrexed KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/18/1283 Powder for concentrate for solution for infusion L01BA04 24.5.2018 24.5.2018 AMGLIDIA glibenclamide AMMTeK 15 rue Béranger, 75003 Paris, France EU/1/18/1279 Oral suspension A10BB01 28.5.2018 24.5.2018 Rubraca rucaparib Clovis Oncology UK Limited Sheraton House, Castle Park, Castle Hill, Cambridge CB3 0AX, United Kingdom EU/1/17/1250 Film-coated tablet L01XX55 29.5.2018

— 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 8.5.2018 Afinitor Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/538 15.5.2018 8.5.2018 Aflunov Seqirus S.r.l. Via Fiorentina 1, Siena, Italia EU/1/10/658 15.5.2018 8.5.2018 Alofisel Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/17/1261 16.5.2018 8.5.2018 Busulfan Fresenius Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/14/951 16.5.2018 8.5.2018 CABOMETYX Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/16/1136 15.5.2018 8.5.2018 Docetaxel Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/12/770 16.5.2018 8.5.2018 Effentora Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/441 15.5.2018 8.5.2018 Elonva Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/09/609 16.5.2018 8.5.2018 Flixabi Samsung Bioepis UK Limited 5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom EU/1/16/1106 15.5.2018 8.5.2018 Inflectra Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom EU/1/13/854 16.5.2018 8.5.2018 Instanyl Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/09/531 15.5.2018 8.5.2018 Invanz Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/02/216 15.5.2018 8.5.2018 Izba Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/905 15.5.2018 8.5.2018 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 15.5.2018 8.5.2018 LIFMIOR Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/16/1165 15.5.2018 8.5.2018 Lonquex UAB ‘Sicor Biotech’ Molėtų pl. 5, 08409 Vilnius, Lietuva EU/1/13/856 15.5.2018 8.5.2018 Lynparza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/959 15.5.2018 8.5.2018 Odomzo Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/15/1030 15.5.2018 8.5.2018 Orphacol Laboratoires CTRS 63 rue de l’Est, 92100 Boulogne-Billancourt, France EU/1/13/870 15.5.2018 8.5.2018 Oslif Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/586 15.5.2018 8.5.2018 PecFent Kyowa Kirin Services Ltd Galabank Business Park, Galashiels, TD1 1QH, United Kingdom EU/1/10/644 15.5.2018 8.5.2018 Pemetrexed Fresenius Kabi Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom EU/1/16/1115 15.5.2018 8.5.2018 Pemetrexed Hospira Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead SL6 6RJ, United Kingdom EU/1/15/1057 15.5.2018 8.5.2018 Pramipexole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/728 15.5.2018 8.5.2018 Prometax Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/092 15.5.2018 8.5.2018 Rekovelle Ferring Pharmaceuticals A/S Kay Fiskers Plads 11, 2300 Copenhagen S, Danmark EU/1/16/1150 15.5.2018 8.5.2018 Repatha Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1016 15.5.2018 8.5.2018 Riluzole Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/12/768 15.5.2018 8.5.2018 Starlix Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/174 15.5.2018 8.5.2018 Synagis AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/99/117 15.5.2018 8.5.2018 Tafinlar Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/865 15.5.2018 8.5.2018 Tivicay ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/13/892 16.5.2018 8.5.2018 Travatan Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/199 15.5.2018 8.5.2018 Ulunar Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/917 15.5.2018 8.5.2018 Votrient Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/628 15.5.2018 8.5.2018 Zerbaxa Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1032 15.5.2018 16.5.2018 Giotrif Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/13/879 18.5.2018 16.5.2018 Januvia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/383 18.5.2018 16.5.2018 Nordimet Nordic Group B.V. Siriusdreef 22, 2132 WT Hoofddorp, Nederland EU/1/16/1124 18.5.2018 16.5.2018 Odefsey Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1112 18.5.2018 16.5.2018 Ovaleap Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/13/871 18.5.2018 22.5.2018 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 24.5.2018 22.5.2018 Efficib Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/457 24.5.2018 22.5.2018 Jakavi Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/773 25.5.2018 22.5.2018 Janumet Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/455 24.5.2018 22.5.2018 Jylamvo Therakind Ltd 314 Regents Park Road, London N3 2JX, United Kingdom EU/1/17/1172 24.5.2018 22.5.2018 Osseor Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/04/287 24.5.2018 22.5.2018 Pedea Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/04/284 24.5.2018 22.5.2018 Protelos Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/04/288 24.5.2018 22.5.2018 Ristaben Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/621 24.5.2018 22.5.2018 Ristfor Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/10/620 24.5.2018 22.5.2018 Stivarga Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/858 24.5.2018 22.5.2018 Stribild Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/830 24.5.2018 22.5.2018 Tesavel Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/435 24.5.2018 22.5.2018 Tybost Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/872 24.5.2018 22.5.2018 Tyverb Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/440 24.5.2018 22.5.2018 Ultibro Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/862 24.5.2018 22.5.2018 Velmetia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/08/456 24.5.2018 22.5.2018 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 24.5.2018 22.5.2018 Xelevia Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/382 24.5.2018 22.5.2018 Xoterna Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/863 24.5.2018 23.5.2018 Kaletra AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/01/172 25.5.2018 24.5.2018 Atazanavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1091 28.5.2018 24.5.2018 Cayston Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/09/543 28.5.2018 24.5.2018 Darunavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1140 28.5.2018 24.5.2018 Emend Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/03/262 29.5.2018 24.5.2018 Norvir AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/96/016 29.5.2018 24.5.2018 Procysbi Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/13/861 28.5.2018 24.5.2018 Vipdomet Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/13/843 28.5.2018 24.5.2018 Vipidia Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/13/844 28.5.2018 25.5.2018 Armisarte Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/15/1063 28.5.2018 25.5.2018 Incresync Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/13/842 28.5.2018 28.5.2018 Atosiban SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/13/852 30.5.2018 28.5.2018 AUBAGIO Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/13/838 30.5.2018 28.5.2018 Bortezomib Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1019 30.5.2018 28.5.2018 Descovy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1099 30.5.2018 28.5.2018 Epclusa Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1116 30.5.2018 28.5.2018 Eviplera Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/11/737 30.5.2018 28.5.2018 Hepsera Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/03/251 30.5.2018 28.5.2018 Ledaga Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/16/1171 30.5.2018 28.5.2018 Lixiana Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/15/993 30.5.2018 28.5.2018 Plavix Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France EU/1/98/069 30.5.2018 28.5.2018 Senshio Shionogi Limited 33 Kingsway, London WC2B 6UF, United Kingdom EU/1/14/978 30.5.2018 28.5.2018 Tecfidera Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/13/837 30.5.2018 28.5.2018 Temodal Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/98/096 30.5.2018 28.5.2018 Vemlidy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1154 30.5.2018 28.5.2018 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/918 30.5.2018 31.5.2018 Alecensa Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/16/1169 4.6.2018 31.5.2018 Champix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/360 4.6.2018 31.5.2018 Chenodeoxycholic acid Leadiant Leadiant GmbH Liebherrstraße 22, 80538 München, Deutschland EU/1/16/1110 4.6.2018 31.5.2018 DuoTrav Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/338 5.6.2018 31.5.2018 Eliquis Bristol-Myers Squibb/Pfizer EEIG Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom EU/1/11/691 4.6.2018 31.5.2018 Exviera AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/983 4.6.2018 31.5.2018 Perjeta Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/813 4.6.2018 31.5.2018 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363 4.6.2018 31.5.2018 Tadalafil Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/17/1177 4.6.2018 31.5.2018 Twynsta Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/10/648 4.6.2018 31.5.2018 Venclyxto AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/16/1138 4.6.2018 31.5.2018 Votubia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/11/710 4.6.2018 31.5.2018 Yervoy Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/11/698 4.6.2018

— 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 8.5.2018 Imatinib Teva B.V. Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/17/1243 15.5.2018

— 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 8.5.2018 Bravecto Plus fluralaner/moxidectin Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/18/224 Spot-on solution QP54AB52 16.5.2018

— 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 8.5.2018 Fevaxyn Pentofel Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/96/002 15.5.2018 8.5.2018 Semintra Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/12/146 16.5.2018 8.5.2018 Suvaxyn Aujeszky 783 + O/W Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/98/009 16.5.2018 25.5.2018 GALLIPRANT Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/17/221 29.5.2018 25.5.2018 Osurnia Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/14/170 29.5.2018 25.5.2018 Profender Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/05/054 29.5.2018 25.5.2018 Sevohale Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/16/196 30.5.2018

— Withdrawal of a marketing authorization (Article 38 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 8.5.2018 BTVPUR AlSap 1 Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/10/112 16.5.2018 8.5.2018 BTVPUR AlSap 8 Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/09/094 16.5.2018 25.5.2018 Meloxivet Eli Lilly and Company Limited Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom EU/2/07/077 29.5.2018

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.