EN Official Journal of the European Union C 188/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2018 to 30 April 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 188/01)

— 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 13.4.2018 Alpivab peramivir BioCryst UK Ltd c/o Morgan Lewis & Bockius, Condor House, 5-10 St. Paul’s Churchyard, London EC4M 8AL, United Kingdom EU/1/18/1269 Concentrate for solution for infusion J05AH03 17.4.2018 19.4.2018 Mylotarg gemtuzumab ozogamicin Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/18/1277 Powder for concentrate for solution for infusion L01XC05 23.4.2018 23.4.2018 Riarify beclometasone/formoterol/glycopyrronium bromide Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/18/1275 Pressurised inhalation, solution R03AL 26.4.2018 26.4.2018 Trydonis beclometasone/formoterol/glycopyrronium bromide Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/18/1274 Pressurised inhalation, solution R03AL 2.5.2018

— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

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 6.4.2018 EnCyzix Renable Pharma Limited 20-22 Bedford Row, London WC1R 4JS, United Kingdom — 23.4.2018

— 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 4.4.2018 Bondronat Atnahs Pharma UK Limited Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom EU/1/96/012 6.4.2018 4.4.2018 Bonviva Atnahs Pharma UK Limited Sovereign House Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom EU/1/03/265 6.4.2018 4.4.2018 Esbriet Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/11/667 6.4.2018 4.4.2018 Kinzalmono Bayer AG D-51368 Leverkusen, Deutschland EU/1/98/091 6.4.2018 4.4.2018 Lacosamide Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/17/1230 6.4.2018 4.4.2018 Lumark IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland EU/1/15/1013 6.4.2018 4.4.2018 Marixino KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/820 6.4.2018 4.4.2018 Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1089 6.4.2018 4.4.2018 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 6.4.2018 6.4.2018 Fuzeon Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/03/252 10.4.2018 6.4.2018 Gazyvaro Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/14/937 10.4.2018 6.4.2018 Herceptin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/145 10.4.2018 6.4.2018 Kineret Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/02/203 10.4.2018 6.4.2018 Revolade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/612 10.4.2018 6.4.2018 RoActemra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/08/492 10.4.2018 6.4.2018 Tamiflu Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/02/222 10.4.2018 6.4.2018 Tarceva Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/05/311 10.4.2018 6.4.2018 Zelboraf Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/12/751 10.4.2018 12.4.2018 Actraphane Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/02/229 16.4.2018 12.4.2018 Actrapid Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/02/230 16.4.2018 12.4.2018 Azopt Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/00/129 16.4.2018 12.4.2018 Extavia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/454 16.4.2018 12.4.2018 Farydak Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/1023 16.4.2018 12.4.2018 Ferriprox Apotex Europe B.V. Darwinweg 20, 2333 CR Leiden, Nederland EU/1/99/108 16.4.2018 12.4.2018 Fiasp Novo Nordisk A/S Novo Allé, 2880 Bagsværd, Danmark EU/1/16/1160 16.4.2018 12.4.2018 Forxiga AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/795 16.4.2018 12.4.2018 Galafold Amicus Therapeutics UK Ltd Phoenix House, Oxford Road, Tatling End, Gerrards Cross, Buckinghamshire SL9 7AP, United Kingdom EU/1/15/1082 16.4.2018 12.4.2018 Icandra Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/484 16.4.2018 12.4.2018 Kinzalkomb Bayer AG D-51368 Leverkusen, Deutschland EU/1/02/214 16.4.2018 12.4.2018 Kisqali Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1221 16.4.2018 12.4.2018 Lumigan Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland EU/1/02/205 16.4.2018 12.4.2018 Mekinist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/931 16.4.2018 12.4.2018 Neparvis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/16/1103 16.4.2018 12.4.2018 Pemetrexed Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1034 16.4.2018 12.4.2018 Ravicti Horizon Pharma Ireland Limited Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland EU/1/15/1062 16.4.2018 12.4.2018 RoActemra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/08/492 16.4.2018 12.4.2018 Sebivo Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/388 16.4.2018 12.4.2018 Sialanar Proveca Limited Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom EU/1/16/1135 17.4.2018 12.4.2018 Signifor Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/12/753 16.4.2018 12.4.2018 Simulect Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/084 16.4.2018 12.4.2018 Sylvant Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/928 16.4.2018 12.4.2018 Tadalafil Mylan Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom EU/1/14/961 16.4.2018 12.4.2018 Vidaza Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/08/488 16.4.2018 12.4.2018 Zomarist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/483 16.4.2018 13.4.2018 Bretaris Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/781 17.4.2018 13.4.2018 Eklira Genuair AstraZeneca AB 151 85 Södertälje, Sverige EU/1/12/778 17.4.2018 13.4.2018 Memantine ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/13/836 17.4.2018 13.4.2018 Pritor Bayer AG D-51368 Leverkusen, Deutschland EU/1/98/089 17.4.2018 13.4.2018 PritorPlus Bayer AG D-51368 Leverkusen, Deutschland EU/1/02/215 17.4.2018 13.4.2018 Sialanar Proveca Limited Neo, Charlotte Street, Manchester, M1 4ET, United Kingdom EU/1/16/1135 17.4.2018 13.4.2018 Travatan Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/01/199 17.4.2018 19.4.2018 Aclasta Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/05/308 23.4.2018 19.4.2018 Azarga Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/482 23.4.2018 19.4.2018 Blincyto Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1047 23.4.2018 19.4.2018 Comtan Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/98/081 23.4.2018 19.4.2018 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland EU/1/13/875 23.4.2018 19.4.2018 Descovy Gilead Sciences International Limited Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom EU/1/16/1099 23.4.2018 19.4.2018 Exjade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/356 23.4.2018 19.4.2018 Imatinib Accord Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom EU/1/13/845 23.4.2018 19.4.2018 Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/13/876 23.4.2018 19.4.2018 Kyprolis Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1060 23.4.2018 19.4.2018 Movymia STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/16/1161 23.4.2018 19.4.2018 Natpar Shire Pharmaceuticals Ireland Limited 5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/15/1078 23.4.2018 19.4.2018 Opatanol Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/02/217 23.4.2018 19.4.2018 Peyona Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/09/528 23.4.2018 19.4.2018 Repatha Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1016 23.4.2018 19.4.2018 Simbrinza Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/933 23.4.2018 19.4.2018 Stribild Gilead Sciences International Limited Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom EU/1/13/830 23.4.2018 19.4.2018 Suliqua Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/16/1157 23.4.2018 19.4.2018 Sutent Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/06/347 23.4.2018 19.4.2018 Volibris Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/08/451 23.4.2018 19.4.2018 Xadago Zambon S.p.A. Via Lillo del Duca 10, 20 091 Bresso (MI), Italia EU/1/14/984 23.4.2018 19.4.2018 Yargesa JensonR+ Limited Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom EU/1/17/1176 23.4.2018 23.4.2018 Aerinaze Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/07/399 25.4.2018 23.4.2018 Bosulif Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom EU/1/13/818 25.4.2018 23.4.2018 Daxas AstraZeneca AB 151 85 Södertälje, Sverige EU/1/10/636 25.4.2018 23.4.2018 Desloratadine Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/11/745 25.4.2018 23.4.2018 Duloxetine Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1028 25.4.2018 23.4.2018 Emadine Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/98/095 25.4.2018 23.4.2018 Entresto Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/1058 25.4.2018 23.4.2018 Eucreas Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/07/425 25.4.2018 23.4.2018 Exelon Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/98/066 25.4.2018 23.4.2018 Fycompa Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/12/776 25.4.2018 23.4.2018 GILENYA Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/11/677 25.4.2018 23.4.2018 Humira AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/03/256 25.4.2018 23.4.2018 Hycamtin Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/96/027 25.4.2018 23.4.2018 Imnovid Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom EU/1/13/850 25.4.2018 23.4.2018 Imvanex Bavarian Nordic A/S Hejreskovvej 10a, 3490 Kvistgaard, Danmark EU/1/13/855 25.4.2018 23.4.2018 Lojuxta Aegerion Pharmaceuticals Limited Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom EU/1/13/851 25.4.2018 23.4.2018 NeuroBloc Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom EU/1/00/166 25.4.2018 23.4.2018 Nevanac Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/433 25.4.2018 23.4.2018 Onbrez Breezhaler Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/09/593 25.4.2018 23.4.2018 Opdivo Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/15/1014 25.4.2018 23.4.2018 Pregabalin Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1021 25.4.2018 23.4.2018 Spedra Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/13/841 25.4.2018 23.4.2018 TOBI Podhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/652 25.4.2018 23.4.2018 Viread Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom EU/1/01/200 25.4.2018 23.4.2018 Zydelig Gilead Sciences International Limited Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom EU/1/14/938 25.4.2018 23.4.2018 Zykadia Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom EU/1/15/999 25.4.2018 26.4.2018 Aloxi Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland EU/1/04/306 30.4.2018 26.4.2018 Avonex Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom EU/1/97/033 30.4.2018 26.4.2018 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 30.4.2018 26.4.2018 Elonva Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/09/609 30.4.2018 26.4.2018 Firazyr Shire Orphan Therapies GmbH Friedrichstraße 149, 10117 Berlin, Deutschland EU/1/08/461 30.4.2018 26.4.2018 Galvus Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/414 30.4.2018 26.4.2018 Jalra Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/485 30.4.2018 26.4.2018 Lucentis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/374 30.4.2018 26.4.2018 Maviret AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom EU/1/17/1213 30.4.2018 26.4.2018 Tasigna Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/422 30.4.2018 26.4.2018 Truxima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/16/1167 2.5.2018 26.4.2018 Voncento CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/13/857 30.4.2018 26.4.2018 Xiliarx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/08/486 30.4.2018 26.4.2018 Xolair Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/05/319 30.4.2018 26.4.2018 Zometa Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/176 30.4.2018 30.4.2018 Avamys Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/434 3.5.2018 30.4.2018 Clopidogrel Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/08/465 3.5.2018 30.4.2018 Entresto Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/1058 3.5.2018 30.4.2018 Hemlibra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/18/1271 3.5.2018 30.4.2018 Perjeta Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/13/813 3.5.2018 30.4.2018 Pramipexole Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/08/490 3.5.2018 30.4.2018 Remsima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/13/853 3.5.2018 30.4.2018 Rydapt Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1218 3.5.2018

— 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 13.4.2018 Clevor Ropinirole Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/2/17/222 Eye drops, solution QN04BC04 17.4.2018

— 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 4.4.2018 Convenia Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/06/059 6.4.2018 4.4.2018 Stronghold Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/99/014 6.4.2018 4.4.2018 Zulvac 1 Bovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/130 6.4.2018 4.4.2018 Zulvac 1 Ovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/131 6.4.2018 4.4.2018 Zulvac 8 Bovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/105 6.4.2018 6.4.2018 Apoquel Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/13/154 10.4.2018 6.4.2018 Stronghold Plus Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/16/204 10.4.2018 11.4.2018 Zulvac 8 Ovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/104 13.4.2018 13.4.2018 Equip WNV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/08/086 17.4.2018 13.4.2018 ProZinc Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/2/13/152 17.4.2018 16.4.2018 BTVPUR Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/10/113 18.4.2018 16.4.2018 Equilis West Nile Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/13/151 18.4.2018 20.4.2018 Meloxidolor Le Vet Beheer B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/13/148 24.4.2018 26.4.2018 Naxcel Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/05/053 30.4.2018 26.4.2018 Onsior Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom EU/2/08/089 30.4.2018

— 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 26.4.2018 CERTIFECT Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/11/125 30.4.2018

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.