EN Official Journal of the European Union C 312/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016

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

(2016/C 312/01)

— 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 authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 1.7.2016 Zinbryta daclizumab Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/16/1107 Solution for injection L04AC01 5.7.2016 6.7.2016 EndolucinBeta Lutetium (177 Lu) chloride ITG Isotope Technologies Garching GmbH Lichtenbergstr. 1, D-85748 Garching, Deutschland EU/1/16/1105 Radiopharmaceutical precursor, solution Pending 8.7.2016 6.7.2016 Epclusa sofosbuvir/velpatasvir Gilead Sciences International Ltd Cambridge, CB21 6GT, United Kingdom EU/1/16/1116 Film-coated tablet Pending 8.7.2016 15.7.2016 Qtern saxagliptin/dapagliflozin AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/16/1108 Film-coated tablet A10BD21 19.7.2016 22.7.2016 Bortezomib Hospira bortezomib Hospira UK Limited Horizon, Honey Lane, Hurley, SL6 6RJ, United Kingdom EU/1/16/1114 Powder for solution for infusion L01XX32 26.7.2016 22.7.2016 Bortezomib SUN bortezomib Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/16/1102 Powder for solution for injection L01XX32 26.7.2016 22.7.2016 Pemetrexed Fresenius Kabi pemetrexed Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom EU/1/16/1115 Powder for concentrate for solution for infusion L01BA04 26.7.2016 22.7.2016 Zepatier elbasvir/grazoprevir Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/16/1119 Film-coated tablet J05A 26.7.2016

— 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 4.7.2016 BiResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/921 6.7.2016 4.7.2016 Clopidogrel Apotex Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland EU/1/09/568 6.7.2016 4.7.2016 Duloxetine Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/14/972 6.7.2016 4.7.2016 DuoResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/920 6.7.2016 6.7.2016 Arzerra Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/625 8.7.2016 6.7.2016 Budesonide/Formoterol Teva Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/948 8.7.2016 6.7.2016 Mircera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/07/400 8.7.2016 6.7.2016 Nivestim Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom EU/1/10/631 8.7.2016 6.7.2016 Olanzapine Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/08/475 12.7.2016 6.7.2016 Oprymea Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/469 8.7.2016 6.7.2016 Rapilysin Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland EU/1/96/018 8.7.2016 6.7.2016 Vylaer Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/949 8.7.2016 6.7.2016 Xarelto Bayer Pharma AG D-13342 Berlin, Deutschland EU/1/08/472 8.7.2016 8.7.2016 Otezla Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/14/981 12.7.2016 8.7.2016 Revlimid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/07/391 12.7.2016 14.7.2016 Ariclaim Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/283 18.7.2016 14.7.2016 Votrient Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/10/628 18.7.2016 15.7.2016 ATryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom EU/1/06/355 19.7.2016 15.7.2016 Exjade Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/06/356 19.7.2016 15.7.2016 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/930 19.7.2016 15.7.2016 Komboglyze AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/11/731 19.7.2016 15.7.2016 Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/10/637 19.7.2016 15.7.2016 Levetiracetam Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/701 19.7.2016 15.7.2016 Luminity Lantheus MI UK Limited Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom EU/1/06/361 19.7.2016 15.7.2016 NeoRecormon Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/97/031 19.7.2016 15.7.2016 Noxafil Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/320 19.7.2016 15.7.2016 Opsumit Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/13/893 19.7.2016 15.7.2016 Pramipexole Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/728 19.7.2016 15.7.2016 Remicade Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland EU/1/99/116 19.7.2016 15.7.2016 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363 19.7.2016 15.7.2016 Stelara Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/08/494 19.7.2016 15.7.2016 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 19.7.2016 15.7.2016 Temozolomide HEXAL Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland EU/1/10/616 19.7.2016 15.7.2016 Temozolomide Sandoz Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich EU/1/10/617 19.7.2016 15.7.2016 Thalidomide Celgene Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/08/443 19.7.2016 15.7.2016 Thyrogen Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/99/122 19.7.2016 15.7.2016 Zoledronic acid Teva Pharma Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/772 19.7.2016 22.7.2016 Byetta AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/06/362 26.7.2016 22.7.2016 Cialis Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/02/237 26.7.2016 22.7.2016 Conbriza Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/511 26.7.2016 22.7.2016 Cymbalta Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/296 26.7.2016 22.7.2016 EDURANT Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/736 26.7.2016 22.7.2016 Eviplera Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/11/737 26.7.2016 22.7.2016 Granupas Lucane Pharma 172 rue de Charonne, 75011 Paris, France EU/1/13/896 26.7.2016 22.7.2016 Harvoni Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/958 26.7.2016 22.7.2016 Levetiracetam Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/11/712 26.7.2016 22.7.2016 Noxafil Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/05/320 26.7.2016 22.7.2016 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland EU/1/14/979 26.7.2016 22.7.2016 Rebif Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom EU/1/98/063 27.7.2016 22.7.2016 Ryzodeg Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/12/806 26.7.2016 22.7.2016 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/09/605 26.7.2016 22.7.2016 Vizamyl GE Healthcare Ltd Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom EU/1/14/941 26.7.2016 22.7.2016 Vyndaqel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/11/717 26.7.2016 22.7.2016 Xeristar Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/297 26.7.2016 29.7.2016 Cervarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/07/419 2.8.2016 29.7.2016 Firdapse BioMarin Europe Ltd 10 Bloomsbury Way, London WC1A 2SL, United Kingdom EU/1/09/601 2.8.2016 29.7.2016 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 2.8.2016 29.7.2016 Jakavi Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/773 2.8.2016 29.7.2016 KEYTRUDA Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/15/1024 2.8.2016 29.7.2016 Nevanac Alcon Laboratories (UK) Ltd Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom EU/1/07/433 2.8.2016 29.7.2016 ReFacto AF Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/99/103 3.8.2016 29.7.2016 Revatio Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/05/318 3.8.2016 29.7.2016 Ribavirin Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/10/634 4.8.2016 29.7.2016 RoActemra Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/08/492 2.8.2016 29.7.2016 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 4.8.2016

— 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 29.7.2016 ChondroCelect TiGenix NV Romeinse straat 12/2, B-3001 Leuven, België EU/1/09/563 2.8.2016

— 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 4.7.2016 Suvaxyn CSF Marker Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/179 6.7.2016 8.7.2016 Oxyglobin OPK Biotech Netherlands BV Teleportboulevard 140, NL-1043 EJ Amsterdam, Nederland EU/2/99/015 12.7.2016 19.7.2016 ERYSENG Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/14/166 21.7.2016 25.7.2016 Eurican Herpes 205 Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/01/029 27.7.2016 25.7.2016 Osurnia Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM EU/2/14/170 27.7.2016 25.7.2016 Porcilis ColiClos Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/12/141 27.7.2016 25.7.2016 Prac-Tic Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM EU/2/06/066 27.7.2016 25.7.2016 STARTVAC Laboratorios Hipra, S.A. Avda. La Selva, 135, E-17170- Amer (Girona), España EU/2/08/092 27.7.2016 29.7.2016 Ingelvac CircoFLEX Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/07/079 2.8.2016

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.