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 2016 to 31 May 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 229/01)

— 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 11.5.2016 Empliciti elotuzumab Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/16/1088 Powder for concentrate for solution for infusion L01XC23 13.5.2016 11.5.2016 IDELVION albutrepenonacog alfa CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland EU/1/16/1095 Powder and solvent for solution for injection B02BD04 13.5.2016 12.5.2016 ALPROLIX eftrenonacog alfa Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/16/1098 Powder and solvent for solution for injection B02BD04 13.5.2016 12.5.2016 Uptravi selexipag Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/15/1083 Film-coated tablet B01AC27 19.5.2016 20.5.2016 Darzalex daratumumab Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/16/1101 Concentrate for solution for infusion L01XC24 24.5.2016 20.5.2016 Pandemic influenza vaccine H5N1 MedImmune Pandemic influenza vaccine (H5N1) (live attenuated, nasal) MedImmune, LLC Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland EU/1/16/1089 Nasal spray, suspension J07BB03 24.5.2016 26.5.2016 Galafold migalastat Amicus Therapeutics UK Ltd Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom EU/1/15/1082 Capsule, hard Pending 31.5.2016 26.5.2016 Neparvis sacubitril/valsartan Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/16/1103 Film-coated tablet C09DX04 30.5.2016 26.5.2016 Palonosetron Accord palonosetron Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/16/1104 Solution for injection A04AA05 31.5.2016

— 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 2.5.2016 Bortezomib Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/15/1019 4.5.2016 2.5.2016 Combivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/98/058 4.5.2016 2.5.2016 Ebilfumin Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland EU/1/14/915 4.5.2016 2.5.2016 ellaOne Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France EU/1/09/522 4.5.2016 2.5.2016 HALAVEN Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom EU/1/11/678 4.5.2016 2.5.2016 Harvoni Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom EU/1/14/958 4.5.2016 2.5.2016 Ixiaro Valneva Austria GmbH Campus Vienna Biocenter 3, A-1030 Wien, Österreich EU/1/08/501 4.5.2016 2.5.2016 Lyxumia Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France EU/1/12/811 4.5.2016 2.5.2016 Norvir AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/96/016 4.5.2016 2.5.2016 Quadramet CIS bio international Boite Postale 32, F-91192 Gif-sur-Yvette, France EU/1/97/057 4.5.2016 2.5.2016 Synflorix GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique EU/1/09/508 4.5.2016 2.5.2016 Tafinlar Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/13/865 4.5.2016 11.5.2016 Desloratadine Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland EU/1/11/745 13.5.2016 11.5.2016 Humalog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/007 13.5.2016 11.5.2016 Humira AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/03/256 13.5.2016 11.5.2016 Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/13/876 13.5.2016 11.5.2016 Inlyta Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/777 13.5.2016 11.5.2016 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 13.5.2016 11.5.2016 Plenadren ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/715 13.5.2016 11.5.2016 Zerit Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/96/009 13.5.2016 12.5.2016 Brimica Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/963 16.5.2016 12.5.2016 Clopidogrel Mylan Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France EU/1/09/559 17.5.2016 12.5.2016 Desloratadine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/732 17.5.2016 12.5.2016 Docetaxel Winthrop Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/07/384 17.5.2016 12.5.2016 Enurev Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/789 16.5.2016 12.5.2016 Glybera uniQure biopharma B.V. Meibergdreef 61, NL-1105 BA Amsterdam, Nederland EU/1/12/791 17.5.2016 12.5.2016 Integrilin Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/99/109 16.5.2016 12.5.2016 NovoEight Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/13/888 17.5.2016 12.5.2016 Seebri Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/788 16.5.2016 12.5.2016 Tepadina ADIENNE S.r.l. Via Galileo Galilei 19, 20867 Caponago (MB), Italia EU/1/10/622 16.5.2016 12.5.2016 Tovanor Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/12/790 16.5.2016 13.5.2016 Hexacima Sanofi Pasteur SA 2 avenue Pont Pasteur, F-69007 Lyon, France EU/1/13/828 24.5.2016 17.5.2016 Capecitabine SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland EU/1/13/831 19.5.2016 17.5.2016 Champix Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/360 19.5.2016 17.5.2016 Epivir ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom EU/1/96/015 19.5.2016 17.5.2016 Imatinib Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/12/808 19.5.2016 17.5.2016 Wilzin Orphan Europe S.A.R.L. Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France EU/1/04/286 19.5.2016 20.5.2016 Ceprotin Baxter AG Industriestrasse 67, A-1221 Wien, Österreich EU/1/01/190 24.5.2016 20.5.2016 Clopidogrel Krka d.d. Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/562 24.5.2016 20.5.2016 Gazyvaro Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/14/937 24.5.2016 20.5.2016 Hexyon Sanofi Pasteur MSD SNC 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/13/829 24.5.2016 26.5.2016 Actos Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/00/150 30.5.2016 26.5.2016 Afinitor Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/538 30.5.2016 26.5.2016 Buccolam Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/709 30.5.2016 26.5.2016 Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr. 6, D-22880 Wedel, Deutschland EU/1/12/802 30.5.2016 26.5.2016 Cayston Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom EU/1/09/543 31.5.2016 26.5.2016 Cinryze Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/688 30.5.2016 26.5.2016 Clopidogrel/Acetylsalicylic acid Teva Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/942 30.5.2016 26.5.2016 Clopidogrel HCS HCS bvba H. Kennisstraat 53, B-2650 Edegem, België EU/1/10/651 30.5.2016 26.5.2016 Clopidogrel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/540 30.5.2016 26.5.2016 Competact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/354 30.5.2016 26.5.2016 Conbriza Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/09/511 31.5.2016 26.5.2016 Constella Allergan Pharmaceuticals International Ltd. Clonshaugh Business and Technology Park Coolock Dublin D17 E400, Ireland EU/1/12/801 30.5.2016 26.5.2016 DepoCyte Pacira Limited Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom EU/1/01/187 28.5.2016 26.5.2016 Dexdor Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/718 30.5.2016 26.5.2016 Duaklir Genuair AstraZeneca AB SE-151 85 Södertälje, Sverige EU/1/14/964 30.5.2016 26.5.2016 Ferriprox Apotex Europe B.V. Darwinweg 20, NL-2333 CR Leiden, Nederland EU/1/99/108 30.5.2016 26.5.2016 Firazyr Shire Orphan Therapies GmbH Friedrichstraße 149, D-10117 Berlin, Deutschland EU/1/08/461 30.5.2016 26.5.2016 Glubrava Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/07/421 30.5.2016 26.5.2016 Glustin Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/00/151 30.5.2016 26.5.2016 HyQvia Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich EU/1/13/840 30.5.2016 26.5.2016 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/945 30.5.2016 26.5.2016 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 31.5.2016 26.5.2016 Levodopa/Carbidopa/Entacapone Orion Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi EU/1/11/706 30.5.2016 26.5.2016 Liprolog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/01/195 30.5.2016 26.5.2016 Mabthera Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom EU/1/98/067 31.5.2016 26.5.2016 Neulasta Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland EU/1/02/227 30.5.2016 26.5.2016 Nexium Control Pfizer Consumer Healthcare Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom EU/1/13/860 31.5.2016 26.5.2016 Rixubis Baxalta Innovations GmbH Industriestrasse 67, A-1221 Wien, Österreich EU/1/14/970 30.5.2016 26.5.2016 Strimvelis GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/16/1097 30.5.2016 26.5.2016 Tandemact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/366 30.5.2016 26.5.2016 Taxotere Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony CEDEX, France EU/1/95/002 30.5.2016 26.5.2016 Trevicta Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/14/971 30.5.2016 26.5.2016 Vibativ Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom EU/1/11/705 28.5.2016 26.5.2016 Victoza Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark EU/1/09/529 30.5.2016 26.5.2016 XALKORI Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/12/793 31.5.2016 26.5.2016 Ytracis CIS bio international Boite Postale 32, F-91192 Gif-sur-Yvette, France EU/1/03/250 30.5.2016 26.5.2016 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België EU/1/11/714 30.5.2016

— 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 3.5.2016 Suvaxyn PCV Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/099 20.5.2016 17.5.2016 Apoquel Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/13/154 19.5.2016 17.5.2016 Bravecto Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland EU/2/13/158 19.5.2016 17.5.2016 MS-H vaccine Pharmsure International Ltd Unit 28, Moorlands Trading Estate, Moor Lane, Metheringham Lincolnshire, LN4 3HX, United Kingdom EU/2/11/126 19.5.2016 17.5.2016 Proteq West Nile Merial 29 avenue Tony Garnier, F-69007 Lyon, France EU/2/11/129 19.5.2016 26.5.2016 Aivlosin ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom EU/2/04/044 31.5.2016

— Withdrawal of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 26.5.2016 RevitaCAM Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/138 30.5.2016

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.