EN Official Journal of the European Union C 150/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2018 to 31 March 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 150/01)

— 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 21.3.2018 Shingrix herpes zoster vaccine (recombinant, adjuvanted) GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/18/1272 Powder and suspension for suspension for injection J07BK03 23.3.2018 21.3.2018 Steglatro ertugliflozin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/18/1267 Film-coated tablet A10BK04 23.3.2018 22.3.2018 Lokelma sodium zirconium cyclosilicate AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1173 Powder for oral suspension V03AE10 26.3.2018 23.3.2018 Alofisel Darvadstrocel TiGenix S.A.U. C/Marconi 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, España EU/1/17/1261 Suspension for injection L04 27.3.2018 23.3.2018 Lamzede velmanase alfa Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/17/1258 Powder for solution for infusion A16AB 27.3.2018 23.3.2018 Segluromet ertugliflozin / metformin hydrochloride Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/18/1265 Film-coated tablet A10BD23 27.3.2018 23.3.2018 Semglee Insulin glargine Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1270 Solution for injection in pre-filled pen A10AE04 27.3.2018 23.3.2018 Steglujan ertugliflozin / sitagliptin Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/18/1266 Film-coated tablet A10BD24 27.3.2018

— 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 1.3.2018 Ameluz Biofrontera Bioscience GmbH Hemmelrather Weg 201, 51377 Leverkusen, Deutschland EU/1/11/740 5.3.2018 1.3.2018 BiResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/921 5.3.2018 1.3.2018 Galvus Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/414 5.3.2018 1.3.2018 GONAL-f Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/95/001 5.3.2018 1.3.2018 IDELVION CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/16/1095 5.3.2018 1.3.2018 Insulatard Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/233 5.3.2018 1.3.2018 Jalra Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/485 5.3.2018 1.3.2018 Mixtard Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/231 5.3.2018 1.3.2018 Neparvis Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/16/1103 5.3.2018 1.3.2018 Protaphane Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/234 5.3.2018 1.3.2018 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/11/672 5.3.2018 1.3.2018 Xiliarx Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/486 5.3.2018 5.3.2018 Adenuric Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/447 7.3.2018 5.3.2018 CellCept Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/005 7.3.2018 5.3.2018 Epivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/96/015 7.3.2018 5.3.2018 Hizentra CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/11/687 7.3.2018 5.3.2018 Myclausen Passauer Pharma GmbH Eiderstedter Weg 3, 14129 Berlin, Deutschland EU/1/10/647 8.3.2018 5.3.2018 Mycophenolate mofetil Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/439 7.3.2018 5.3.2018 Myfenax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/07/438 7.3.2018 5.3.2018 Relvar Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/13/886 7.3.2018 5.3.2018 Sirturo Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/13/901 7.3.2018 5.3.2018 Terrosa Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/16/1159 7.3.2018 5.3.2018 Viekirax AbbVie Ltd Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom EU/1/14/982 7.3.2018 5.3.2018 Zydelig Gilead Sciences International Limited Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom EU/1/14/938 7.3.2018 7.3.2018 Aclasta Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/05/308 9.3.2018 7.3.2018 Adempas Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/907 9.3.2018 7.3.2018 Kisplyx Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/16/1128 9.3.2018 7.3.2018 Levetiracetam Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/11/713 9.3.2018 7.3.2018 Litak Lipomed GmbH Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland EU/1/04/275 9.3.2018 7.3.2018 Lonsurf Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes CEDEX, France EU/1/16/1096 9.3.2018 7.3.2018 Pregabalin Pfizer Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/14/916 9.3.2018 7.3.2018 PritorPlus Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/02/215 9.3.2018 7.3.2018 Raplixa Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland EU/1/14/985 9.3.2018 7.3.2018 Revinty Ellipta Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/14/929 9.3.2018 7.3.2018 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 9.3.2018 12.3.2018 CellCept Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/005 14.3.2018 12.3.2018 DuoResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/920 14.3.2018 12.3.2018 Latuda Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A. Viale Amelia 70, 00181 Roma, Italia EU/1/14/913 14.3.2018 12.3.2018 MicardisPlus Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/02/213 14.3.2018 12.3.2018 Neuraceq Piramal Imaging Limited Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom EU/1/13/906 14.3.2018 12.3.2018 Oprymea Krka d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/469 15.3.2018 12.3.2018 Trajenta Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/11/707 14.3.2018 15.3.2018 Alecensa Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/16/1169 19.3.2018 15.3.2018 Erivedge Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/848 19.3.2018 15.3.2018 Humira AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/03/256 19.3.2018 15.3.2018 NeoRecormon Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/97/031 19.3.2018 15.3.2018 Pegasys Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/02/221 19.3.2018 15.3.2018 Vaxelis MCM Vaccine B.V. Robert Boyleweg 4, 2333 CG Leiden, Nederland EU/1/15/1079 19.3.2018 16.3.2018 Aripiprazole Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1029 20.3.2018 16.3.2018 Avastin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/04/300 20.3.2018 16.3.2018 Cetrotide Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/99/100 22.3.2018 16.3.2018 Cotellic Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/15/1048 20.3.2018 16.3.2018 Glyxambi Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/16/1146 20.3.2018 16.3.2018 Herceptin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/145 20.3.2018 16.3.2018 IDflu Sanofi Pasteur SA 2 avenue Pont Pasteur, 69007 Lyon, France EU/1/08/507 20.3.2018 16.3.2018 Integrilin Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/99/109 20.3.2018 16.3.2018 Jentadueto Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/12/780 20.3.2018 16.3.2018 Kadcyla Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/885 20.3.2018 16.3.2018 Kinzalkomb Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/02/214 20.3.2018 16.3.2018 Mabthera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/98/067 21.3.2018 16.3.2018 Mircera Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/07/400 20.3.2018 16.3.2018 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 21.3.2018 16.3.2018 Vaniqa Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/01/173 20.3.2018 16.3.2018 Xeloda Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/163 20.3.2018 16.3.2018 Zomarist Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/08/483 20.3.2018 19.3.2018 Xofigo Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/873 21.3.2018 20.3.2018 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026 22.3.2018 21.3.2018 Aripiprazole Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1009 23.3.2018 21.3.2018 Faslodex AstraZeneca AB 151 85 Södertälje, Sverige EU/1/03/269 23.3.2018 21.3.2018 OCALIVA Intercept Pharma Ltd 2 Pancras Square, London N1C 4AG, United Kingdom EU/1/16/1139 23.3.2018 21.3.2018 PHEBURANE Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/13/822 23.3.2018 21.3.2018 Pixuvri CTI Life Sciences Ltd Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom EU/1/12/764 23.3.2018 21.3.2018 Vibativ Theravance Biopharma Ireland Limited Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland EU/1/11/705 23.3.2018 23.3.2018 Atripla Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland EU/1/07/430 27.3.2018 23.3.2018 Blincyto Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1047 27.3.2018 23.3.2018 Feraccru Shield TX (UK) Limited Gateshead Quays, NE8 3DF, United Kingdom EU/1/15/1075 27.3.2018 23.3.2018 Invirase Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/96/026 27.3.2018 23.3.2018 Isentress Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/436 27.3.2018 23.3.2018 KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 27.3.2018 23.3.2018 Nuwiq Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/14/936 27.3.2018 23.3.2018 Ocrevus Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1231 27.3.2018 23.3.2018 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 27.3.2018 23.3.2018 Perjeta Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/813 27.3.2018 23.3.2018 Pixuvri CTI Life Sciences Ltd Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom EU/1/12/764 27.3.2018 23.3.2018 Torisel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/07/424 27.3.2018 23.3.2018 Translarna PTC Therapeutics International Limited 5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland EU/1/13/902 27.3.2018 27.3.2018 EndolucinBeta ITG Isotope Technologies Garching GmbH Lichtenbergstraße 1, 85748 Garching, Deutschland EU/1/16/1105 29.3.2018 27.3.2018 Ganfort Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/06/340 29.3.2018 27.3.2018 Xgeva Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/11/703 29.3.2018

— 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 5.3.2018 OLYSIO Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/924 7.3.2018 19.3.2018 IDflu Sanofi Pasteur SA 2 avenue Pont Pasteur, 69007 Lyon, France EU/1/08/507 21.3.2018 23.3.2018 Vibativ Theravance Biopharma Ireland Limited Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland EU/1/11/705 27.3.2018 27.3.2018 Raplixa Mallinckrodt Pharmaceuticals Ireland Limited College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland EU/1/14/985 29.3.2018 27.3.2018 Zinbryta Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/16/1107 29.3.2018

— Suspension of a marketing authorization (Article 20 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 8.3.2018 Zinbryta Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/16/1107 12.3.2018

— 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 19.3.2018 Bravecto Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/13/158 21.3.2018 19.3.2018 Metacam Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/97/004 21.3.2018 19.3.2018 Porcilis PCV ID Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/15/187 21.3.2018 20.3.2018 ECOPORC SHIGA IDT Biologika GmbH Am Pharmapark, 06861 Dessau-Rosslau, Deutschland EU/2/13/149 22.3.2018 20.3.2018 Oncept IL-2 Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/13/150 22.3.2018 20.3.2018 Panacur AquaSol Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/11/135 22.3.2018 22.3.2018 Draxxin Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/03/041 26.3.2018 22.3.2018 ERAVAC Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/16/199 26.3.2018 22.3.2018 Palladia Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/100 26.3.2018 22.3.2018 Suvaxyn CSF Marker Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/179 26.3.2018 22.3.2018 Suvaxyn PCV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/099 26.3.2018 27.3.2018 Versican Plus DHPPi Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/169 29.3.2018 27.3.2018 Versican Plus DHPPi/L4 Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/164 29.3.2018 27.3.2018 Versican Plus DHPPi/L4R Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/163 29.3.2018 27.3.2018 Zulvac 1+8 Bovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/139 29.3.2018 27.3.2018 Zulvac 1+8 Ovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/120 29.3.2018 27.3.2018 Zulvac SBV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/178 29.3.2018

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.