Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2019 to 30 April 2019

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

(2019/C 180/01)

— 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 2.4.2019 Idacio adalimumab Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/19/1356 Solution for injection L04AB04 4.4.2019 2.4.2019 Kromeya adalimumab Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/19/1357 Solution for injection L04AB04 4.4.2019 2.4.2019 Vizimpro dacomitinib Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/19/1354 Film-coated tablet L01XE47 4.4.2019 26.4.2019 Dectova zanamivir GlaxoSmithKline Trading Services Limited Currabinny, Carrigaline, County Cork, Ireland EU/1/18/1349 Solution for infusion J05AH01 30.4.2019 26.4.2019 Ondexxya andexanet alfa Portola Netherlands B.V. Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands EU/1/18/1345 Powder for solution for infusion V03AB38 30.4.2019 26.4.2019 Skyrizi risankizumab AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/19/1361 Solution for injection L04AC 30.4.2019 26.4.2019 Zynquista sotagliflozin Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/19/1363 Film-coated tablet A10BK06 30.4.2019

— 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 2.4.2019 Afinitor Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/538 4.4.2019 2.4.2019 Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/12/809 4.4.2019 2.4.2019 Capecitabine Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/762 4.4.2019 2.4.2019 Clopidogrel BGR Laboratoires BIOGARAN 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France EU/1/09/558 4.4.2019 2.4.2019 Copalia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/372 4.4.2019 2.4.2019 Dafiro Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/371 4.4.2019 2.4.2019 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland EU/1/13/875 4.4.2019 2.4.2019 Eliquis Bristol-Myers Squibb/Pfizer EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/11/691 4.4.2019 2.4.2019 Empliciti Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/16/1088 4.4.2019 2.4.2019 Exforge HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/569 4.4.2019 2.4.2019 Gazyvaro Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/14/937 4.4.2019 2.4.2019 Irbesartan Zentiva Zentiva k.s. U kabelovny 130, 10237 Praha 10, Česká republika EU/1/06/376 4.4.2019 2.4.2019 Karvea Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/97/049 4.4.2019 2.4.2019 Karvezide Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/98/085 4.4.2019 2.4.2019 Lumark IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland EU/1/15/1013 4.4.2019 2.4.2019 NULOJIX Bristol-Myers Squibb/Pfizer EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/11/694 4.4.2019 2.4.2019 Opdivo Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 4.4.2019 2.4.2019 Steglatro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1267 4.4.2019 2.4.2019 Steglujan Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1266 4.4.2019 2.4.2019 Sylvant Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/928 4.4.2019 2.4.2019 Vidaza Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/08/488 4.4.2019 2.4.2019 Yervoy Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/698 4.4.2019 2.4.2019 Zonisamide Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1093 4.4.2019 2.4.2019 Zykadia Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/999 4.4.2019 8.4.2019 Actraphane Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/02/229 10.4.2019 8.4.2019 BiResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/921 10.4.2019 8.4.2019 Capecitabine medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/12/802 10.4.2019 8.4.2019 DuoResp Spiromax Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/14/920 10.4.2019 8.4.2019 Iressa AstraZeneca AB 151 85 Södertälje, Sverige EU/1/09/526 10.4.2019 8.4.2019 Lantus Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/00/134 10.4.2019 8.4.2019 Lynparza AstraZeneca AB 151 85 Södertälje, Sverige EU/1/14/959 10.4.2019 8.4.2019 M-M-RVAXPRO MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/337 10.4.2019 8.4.2019 Orencia Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/07/389 10.4.2019 8.4.2019 Riarify Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/18/1275 10.4.2019 8.4.2019 Ritemvia Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 10 62 Budapest, Magyarország EU/1/17/1207 10.4.2019 8.4.2019 Stribild Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/830 10.4.2019 8.4.2019 Tybost Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/872 10.4.2019 8.4.2019 Viread Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/01/200 10.4.2019 8.4.2019 Zerit Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/96/009 10.4.2019 9.4.2019 Esbriet Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/11/667 11.4.2019 9.4.2019 Ifirmacombi Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/673 11.4.2019 9.4.2019 Rituzena Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1206 11.4.2019 9.4.2019 Trydonis Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/18/1274 11.4.2019 11.4.2019 Aprovel Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France EU/1/97/046 15.4.2019 11.4.2019 Cervarix GlaxoSmithKline Biologicals S.A. rue de l’Institut 89, 1330 Rixensart, Belgique EU/1/07/419 15.4.2019 11.4.2019 CoAprovel Sanofi Clir SNC 54 rue La Boétie, 75008 Paris, France EU/1/98/086 15.4.2019 11.4.2019 Copalia HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/575 15.4.2019 11.4.2019 Dafiro HCT Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/574 15.4.2019 11.4.2019 Ebilfumin Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/14/915 15.4.2019 11.4.2019 Exforge Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/06/370 15.4.2019 11.4.2019 Irbesartan/Hydrochlorothiazide Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/583 15.4.2019 11.4.2019 Irbesartan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/576 15.4.2019 11.4.2019 Lamivudine Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/566 15.4.2019 11.4.2019 Leganto UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/11/695 15.4.2019 11.4.2019 Lokelma AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1173 15.4.2019 11.4.2019 Neparvis Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/16/1103 15.4.2019 11.4.2019 Pemetrexed Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1034 15.4.2019 11.4.2019 Pregabalin Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1021 15.4.2019 11.4.2019 Spherox CO.DON AG Warthestraße 21, 14513 Teltow, Deutschland EU/1/17/1181 15.4.2019 11.4.2019 Starlix Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/174 15.4.2019 11.4.2019 Truxima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/16/1167 15.4.2019 11.4.2019 Zutectra Biotest Pharma GmbH Landsteinerstraße 5, 63303 Dreieich, Deutschland EU/1/09/600 15.4.2019 15.4.2019 Ecansya Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/12/763 17.4.2019 15.4.2019 Entresto Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/15/1058 17.4.2019 15.4.2019 Ifirmasta Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/08/480 17.4.2019 15.4.2019 Irbesartan HCT Zentiva Zentiva k.s. U kabelovny 130, 102 37 Praha 10, Česká republika EU/1/06/377 17.4.2019 15.4.2019 Yargesa Piramal Critical Care B.V. Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland EU/1/17/1176 17.4.2019 17.4.2019 Amlodipine/ Valsartan Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1092 24.4.2019 17.4.2019 Caelyx Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/96/011 24.4.2019 17.4.2019 Cimzia UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België EU/1/09/544 24.4.2019 17.4.2019 Clopidogrel Apotex Apotex Europe B.V. Archimedesweg 2, 2333 CN Leiden, Nederland EU/1/09/568 24.4.2019 17.4.2019 Clopidogrel HCS HCS bvba H. Kennisstraat 53, 2650 Edegem, België EU/1/10/651 24.4.2019 17.4.2019 Cuprymina SPARKLE S.r.l. Località Cavallino, 62010 Montecosaro (MC), Italia EU/1/12/784 24.4.2019 17.4.2019 Miglustat Dipharma Dipharma B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland EU/1/18/1346 24.4.2019 17.4.2019 Pandemic influenza vaccine H5N1 AstraZeneca AstraZeneca AB 151 85 Södertälje, Sverige EU/1/16/1089 24.4.2019 17.4.2019 Rydapt Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/17/1218 24.4.2019 17.4.2019 Semglee Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/18/1270 24.4.2019 17.4.2019 SonoVue Bracco International B.V. Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland EU/1/01/177 24.4.2019 17.4.2019 Zubsolv Orexo AB Box 303, 751 05 Uppsala, Sverige EU/1/17/1233 24.4.2019 24.4.2019 Orphacol Laboratoires CTRS 63 rue de l’Est, 92100 Boulogne-Billancourt, France EU/1/13/870 26.4.2019 26.4.2019 Aimovig Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1293 30.4.2019 26.4.2019 Ameluz Biofrontera Bioscience GmbH Hemmelrather Weg 201, 51377 Leverkusen, Deutschland EU/1/11/740 30.4.2019 26.4.2019 Kyprolis Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1060 30.4.2019 26.4.2019 Lonquex Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/13/856 30.4.2019 26.4.2019 Nuwiq Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/14/936 30.4.2019 26.4.2019 Oncaspar Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/15/1070 30.4.2019 26.4.2019 Picato LEO Laboratories Ltd 285 Cashel Road, Crumlin, Dublin 12, Ireland EU/1/12/796 30.4.2019 26.4.2019 RotaTeq MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France EU/1/06/348 30.4.2019 26.4.2019 Spectrila medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/15/1072 30.4.2019 29.4.2019 Abilify Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/04/276 1.5.2019 29.4.2019 ABILIFY MAINTENA Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/13/882 1.5.2019 29.4.2019 Aripiprazole Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1029 2.5.2019 29.4.2019 Humira AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/03/256 2.5.2019 29.4.2019 Kaletra AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/01/172 2.5.2019 29.4.2019 Lemtrada Sanofi Belgium Leonardo Da Vincilaan 19, B-1831 Diegem, België EU/1/13/869 2.5.2019 29.4.2019 Maviret AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/17/1213 2.5.2019 29.4.2019 Miglustat Gen.Orph Gen.Orph 185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France EU/1/17/1232 2.5.2019 29.4.2019 Natpar Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50 – 58 Baggot Street Lower, Dublin 2, Ireland EU/1/15/1078 1.5.2019 29.4.2019 Norvir AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/96/016 2.5.2019 29.4.2019 Repatha Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1016 1.5.2019 30.4.2019 Zydelig Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/14/938 3.5.2019

— 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 2.4.2019 Numient Amneal Pharma Europe Ltd 70 Sir John Rogerson’s Quay, Dublin 2, Ireland EU/1/15/1044 4.4.2019 10.4.2019 Rituzena Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1206 12.4.2019 11.4.2019 Topotecan Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/552 15.4.2019 15.4.2019 Airexar Spiromax Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/16/1123 17.4.2019

— 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 17.4.2019 Chanhold selamectin Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/19/236 Spot-on solution QP54AA05 24.4.2019 23.4.2019 Forceris toltrazuril/gleptoferron Ceva Santé Animale 10 avenue de la Ballastière, 33500 Libourne, France EU/2/19/235 Suspension for injection QP51AJ51 25.4.2019 26.4.2019 Felisecto Plus selamectin/sarolaner Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/19/238 Spot-on solution QP54AA55 30.4.2019 26.4.2019 ReproCyc ParvoFLEX Porcine parvovirosis vaccine (inactivated) Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/19/237 Suspension for injection QI09AA02 30.4.2019

— 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 8.4.2019 Versican Plus DHPPi/L4 Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/164 10.4.2019 8.4.2019 Versican Plus DHPPi/L4R Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/163 10.4.2019 8.4.2019 Versican Plus L4 Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/171 10.4.2019 11.4.2019 Convenia Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/06/059 15.4.2019 11.4.2019 Suvaxyn PRRS MLV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/215 15.4.2019 11.4.2019 Versican Plus Pi/L4 Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/172 15.4.2019 23.4.2019 Innovax-ILT Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/15/182 25.4.2019 26.4.2019 ERYSENG PARVO Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/14/167 30.4.2019 26.4.2019 ProZinc Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/2/13/152 30.4.2019

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 Domenico Scarlattilaan 6 1083 HS Amsterdam NEDERLAND

(1) OJ L 136, 30.4.2004, p. 1.