Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2018 to 31 August 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 349/01)

— 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 23.8.2018 Duzallo allopurinol/lesinurad Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland EU/1/18/1300 Film-coated tablet M04AA51 27.8.2018 23.8.2018 Kymriah tisagenlecleucel Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1297 Dispersion for infusion Pending 27.8.2018 23.8.2018 Mepsevii vestronidase alfa Ultragenyx Germany GmbH Friedrichstraße 191, 10117 Berlin, Deutschland EU/1/18/1301 Concentrate for solution for infusion A16AB18 27.8.2018 23.8.2018 Vyxeos daunorubicin/cytarabine Jazz Pharmaceuticals Ireland Ltd 5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland EU/1/18/1308 Powder for concentrate for solution for infusion L01XY01 27.8.2018 23.8.2018 Yescarta axicabtagene ciloleucel Kite Pharma EU B.V. Science Park 408, 1098 XH Amsterdam, Nederland EU/1/18/1299 Dispersion for infusion L01X 27.8.2018 27.8.2018 Onpattro patisiran Alnylam Netherlands B.V. Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland EU/1/18/1320 Concentrate for solution for infusion Pending 29.8.2018 27.8.2018 Ulipristal Acetate Gedeon Richter Ulipristal Acetate Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/18/1309 Tablet G03XB02 29.8.2018 31.8.2018 Cablivi caplacizumab Ablynx N.V. Technologiepark 21, 9052 Zwijnaarde, België EU/1/18/1305 Powder and solvent for solution for injection B01AX07 4.9.2018 31.8.2018 Nerlynx neratinib Puma Biotechnology, Ltd 11th Floor, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom EU/1/18/1311 Film-coated tablet L01XE45 4.9.2018 31.8.2018 VEYVONDI vonicog alfa Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/18/1298 Powder and solvent for solution for injection B02BD10 4.9.2018

— 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 2.8.2018 Avonex Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/97/033 6.8.2018 2.8.2018 Bosulif Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/13/818 6.8.2018 2.8.2018 Cetrotide Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/99/100 6.8.2018 2.8.2018 Conbriza Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/09/511 6.8.2018 2.8.2018 Dexdor Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/1/11/718 6.8.2018 2.8.2018 DUAVIVE Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/14/960 6.8.2018 2.8.2018 Fampyra Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/11/699 6.8.2018 2.8.2018 Insulin lispro Sanofi Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1203 6.8.2018 2.8.2018 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 6.8.2018 2.8.2018 Kyntheum Leo Pharma A/S Industriparken 55, 2750 Ballerup, Danmark EU/1/16/1155 6.8.2018 2.8.2018 Onglyza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/09/545 6.8.2018 2.8.2018 Otezla Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/14/981 6.8.2018 2.8.2018 Rapamune Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/01/171 6.8.2018 2.8.2018 ReFacto AF Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/99/103 6.8.2018 2.8.2018 Siklos Addmedica 37 rue de Caumartin, 75009 Paris, France EU/1/07/397 6.8.2018 2.8.2018 Temomedac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/09/605 6.8.2018 2.8.2018 Tepadina ADIENNE S.r.l. Via Galileo Galilei 19, 20867 Caponago (MB), Italia EU/1/10/622 6.8.2018 2.8.2018 Tysabri Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/06/346 6.8.2018 2.8.2018 Zoledronic acid Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/834 6.8.2018 3.8.2018 Accofil Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/14/946 7.8.2018 3.8.2018 Brimica Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/963 7.8.2018 3.8.2018 Crixivan Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/96/024 7.8.2018 3.8.2018 Duaklir Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/964 7.8.2018 3.8.2018 Duloxetine Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1010 7.8.2018 3.8.2018 Inlyta Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/777 7.8.2018 3.8.2018 Inovelon Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/06/378 7.8.2018 3.8.2018 Memantine Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/880 7.8.2018 3.8.2018 Numient Amneal Pharma Europe Ltd 70 Sir John Rogerson’s Quay, Dublin 2, Ireland EU/1/15/1044 7.8.2018 3.8.2018 Ribavirin Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/10/634 7.8.2018 3.8.2018 Tadalafil Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/14/961 7.8.2018 3.8.2018 Vyndaqel Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/11/717 7.8.2018 6.8.2018 GONAL-f Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/95/001 8.8.2018 8.8.2018 Bortezomib Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/16/1114 10.8.2018 8.8.2018 Brinavess Correvio 15 rue du Bicentenaire, 92800 Puteaux, France EU/1/10/645 10.8.2018 8.8.2018 CANCIDAS Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/01/196 10.8.2018 8.8.2018 Cubicin Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/05/328 10.8.2018 8.8.2018 Januvia Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/383 10.8.2018 8.8.2018 Lymphoseek Norgine B.V. Hogehilweg 7, 1101 CA Amsterdam, Nederland EU/1/14/955 10.8.2018 8.8.2018 Sivextro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/991 10.8.2018 8.8.2018 Tesavel Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/435 10.8.2018 8.8.2018 Thalidomide Celgene Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/08/443 10.8.2018 8.8.2018 Torisel Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/07/424 10.8.2018 13.8.2018 Ivabradine Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/16/1144 15.8.2018 13.8.2018 Komboglyze AstraZeneca AB 151 85 Södertälje, Sverige EU/1/11/731 15.8.2018 13.8.2018 Orbactiv Rempex London Ltd 115L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom EU/1/15/989 15.8.2018 13.8.2018 Xyrem UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/05/312 15.8.2018 20.8.2018 Cholib Mylan IRE Healthcare Ltd Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/13/866 22.8.2018 20.8.2018 Lenvima Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/15/1002 22.8.2018 20.8.2018 Luveris Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/00/155 22.8.2018 20.8.2018 Pergoveris Merck Europe B.V. Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland EU/1/07/396 22.8.2018 20.8.2018 Xelevia Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/382 22.8.2018 23.8.2018 Abilify Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland EU/1/04/276 28.8.2018 23.8.2018 Aranesp Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/01/185 27.8.2018 23.8.2018 Arixtra Aspen Pharma Trading Limited 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland EU/1/02/206 27.8.2018 23.8.2018 Beromun BELPHARMA s.a. 2, Rue Albert 1er, L-1117, Luxembourg, Luxembourg EU/1/99/097 27.8.2018 23.8.2018 Biktarvy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/18/1289 27.8.2018 23.8.2018 Blincyto Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1047 27.8.2018 23.8.2018 CABOMETYX Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/16/1136 27.8.2018 23.8.2018 Entyvio Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/923 27.8.2018 23.8.2018 Evicel Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, 1831 Diegem, België EU/1/08/473 27.8.2018 23.8.2018 Firazyr Shire Pharmaceuticals Ireland Limited Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland EU/1/08/461 27.8.2018 23.8.2018 IMBRUVICA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/945 27.8.2018 23.8.2018 Intelence Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/468 27.8.2018 23.8.2018 Kalydeco Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/12/782 28.8.2018 23.8.2018 Lemtrada Sanofi Belgium Leonardo Da Vincilaan 19, B-1831 Diegem, België EU/1/13/869 28.8.2018 23.8.2018 LIFMIOR Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/16/1165 28.8.2018 23.8.2018 Nivestim Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/10/631 27.8.2018 23.8.2018 Opsumit Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom EU/1/13/893 27.8.2018 23.8.2018 Orkambi Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom EU/1/15/1059 28.8.2018 23.8.2018 Parsabiv Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/16/1142 27.8.2018 23.8.2018 Pixuvri CTI Life Sciences Ltd Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom EU/1/12/764 28.8.2018 23.8.2018 Ristaben Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/10/621 28.8.2018 23.8.2018 RoActemra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/08/492 27.8.2018 23.8.2018 Somavert Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/02/240 27.8.2018 23.8.2018 Sovaldi Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/894 27.8.2018 23.8.2018 Steglujan Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1266 27.8.2018 23.8.2018 Strimvelis Orchard Therapeutics (Netherlands) B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland EU/1/16/1097 27.8.2018 23.8.2018 Temodal Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/98/096 28.8.2018 23.8.2018 Venclyxto AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/16/1138 27.8.2018 23.8.2018 Xagrid Shire Pharmaceuticals Ireland Limited Block 2-3 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Ireland EU/1/04/295 25.8.2018 23.8.2018 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 27.8.2018 27.8.2018 ABILIFY MAINTENA Otsuka Pharmaceutical Europe Ltd Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom EU/1/13/882 29.8.2018 27.8.2018 BYDUREON AstraZeneca AB 151 85 Södertälje, Sverige EU/1/11/696 29.8.2018 27.8.2018 Cinryze Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/688 29.8.2018 27.8.2018 Coagadex Bio Products Laboratory Ltd Dagger Lane, Elstree, Hertfordshire WD6 3BX, United Kingdom EU/1/16/1087 29.8.2018 27.8.2018 Cometriq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/13/890 29.8.2018 27.8.2018 Filgrastim Hexal Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland EU/1/08/496 29.8.2018 27.8.2018 Fulvestrant Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1253 29.8.2018 27.8.2018 Lojuxta Amryt Pharmaceuticals DAC 90 Harcourt Street, Dublin 2, Ireland EU/1/13/851 29.8.2018 27.8.2018 Mekinist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/931 29.8.2018 27.8.2018 Nucala GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/15/1043 29.8.2018 27.8.2018 Rasilez HCT Noden Pharma DAC D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland EU/1/08/491 29.8.2018 27.8.2018 Tafinlar Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/865 29.8.2018 27.8.2018 Varuby TESARO U.K. Limited 55 Baker Street, London W1U 7EU, United Kingdom EU/1/17/1180 29.8.2018 27.8.2018 Victoza Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/09/529 29.8.2018 27.8.2018 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/918 29.8.2018 27.8.2018 Xarelto Bayer AG D-51368 Leverkusen, Deutschland EU/1/08/472 29.8.2018 27.8.2018 Zarzio Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/08/495 29.8.2018 28.8.2018 Fluenz Tetra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/13/887 30.8.2018 28.8.2018 Steglatro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1267 30.8.2018 31.8.2018 Abseamed Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, 58638 Iserlohn, Deutschland EU/1/07/412 4.9.2018 31.8.2018 Bavencio Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/17/1214 4.9.2018 31.8.2018 Binocrit Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/07/410 4.9.2018 31.8.2018 Darzalex Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/16/1101 4.9.2018 31.8.2018 Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/17/1263 4.9.2018 31.8.2018 Epoetin alfa Hexal Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland EU/1/07/411 4.9.2018 31.8.2018 Spinraza Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/17/1188 4.9.2018 31.8.2018 TAGRISSO AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1086 4.9.2018 31.8.2018 Viekirax AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/14/982 4.9.2018 31.8.2018 XALKORI Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/793 4.9.2018

— Withdrawal of a marketing authorisation (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 authorisation Number of the entry in the Community Register Date of notification 3.8.2018 Intanza Sanofi Pasteur Europe 2 avenue Pont Pasteur, 69007 Lyon, France EU/1/08/505 7.8.2018

— Issuing 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 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 27.8.2018 Cortacare Hydrocortisone aceponate Ecuphar NV Legeweg 157-i, 8020 Oostkamp, België EU/2/18/230 Cutaneous spray, solution QD07AC16 29.8.2018

— 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 3.8.2018 Cerenia Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/06/062 7.8.2018 3.8.2018 LETIFEND Laboratorios LETI, S.L.unipersonal C/Del Sol 5, Polígono Industrial Norte, Tres Cantos, 28760 Madrid, España EU/2/16/195 7.8.2018 3.8.2018 Novem Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/042 7.8.2018 3.8.2018 Onsior Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/08/089 7.8.2018 9.8.2018 Leucofeligen FeLV/RCP Virbac 1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France EU/2/09/097 14.8.2018 9.8.2018 Nobivac LeuFel Virbac 1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France EU/2/17/217 14.8.2018 20.8.2018 BTVPUR Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/10/113 22.8.2018 20.8.2018 CLYNAV Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/16/197 22.8.2018 20.8.2018 Leucogen Virbac 1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France EU/2/09/096 22.8.2018 27.8.2018 Prac-Tic Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/06/066 29.8.2018 27.8.2018 Vectra 3D Ceva Santé Animale 10 avenue de la Ballastière, 33500 Libourne, France EU/2/13/156 29.8.2018

— 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 20.8.2018 Gripovac 3 Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/09/102 22.8.2018

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.