Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2020 to 30 April 2020

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

(2020/C 181/01)

— 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 1.4.2020 Arsenic trioxide Mylan arsenic trioxide Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1427 Concentrate and solvent for solution for infusion L01XX27 2.4.2020 1.4.2020 Nilemdo bempedoic acid FGK Representative Service GmbH Heimeranstraße 35, 80339 München, Deutschland EU/1/20/1425 Film-coated tablet C10AX15 2.4.2020 1.4.2020 Ruxience rituximab Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique Pleinlaan 17, 1050 Brussel, België EU/1/20/1431 Concentrate for solution for infusion L01XC02 6.4.2020 1.4.2020 Vaxchora Cholera vaccine (recombinant, live, oral) Emergent Netherlands B.V. Strawinskylaan 411, 1077 XX Amsterdam, Nederland EU/1/20/1423 Effervescent powder and powder for oral suspension. J07AE02 15.4.2020 3.4.2020 Budesonide/Formoterol Teva Pharma B.V. budesonide/formoterol fumarate dihydrate Teva Pharma B.V. Swensweg 5, 2031GA Haarlem, Nederland EU/1/19/1403 Inhalation powder R03AK07 7.4.2020 3.4.2020 Cinacalcet Accordpharma cinacalcet Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/20/1429 Film-coated tablet H05BX01 7.4.2020 3.4.2020 Rybelsus semaglutide Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/20/1430 Tablet A10BJ06 7.4.2020 3.4.2020 Trepulmix treprostinil sodium SciPharm Sàrl 7, Fausermillen, 6689 Mertert, Luxembourg EU/1/19/1419 Solution for infusion B01AC21 7.4.2020 17.4.2020 Tigecycline Accord tigecycline Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/19/1394 Powder for solution for infusion J01AA12 20.4.2020 23.4.2020 Fetcroja cefiderocol Shionogi B.V. Kingsfordweg 151, 1043 GR Amsterdam, Nederland EU/1/20/1434 Powder for concentrate for solution for infusion J01DI04 24.4.2020

— 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 1.4.2020 Advate Takeda Manufacturing Austria AG Industriestraße 67, 1221 Wien, Österreich EU/1/03/271 9.4.2020 1.4.2020 Alunbrig Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/18/1264 2.4.2020 1.4.2020 Defitelio Gentium S.r.I. Piazza XX Settembre, 2, 22079 Villa Guardia (CO), Italia EU/1/13/878 6.4.2020 1.4.2020 Dovato ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/19/1370 7.4.2020 1.4.2020 Dynastat Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique Pleinlaan 17, 1050 Brussel, België EU/1/02/209 8.4.2020 1.4.2020 Intrarosa Endoceutics S.A. Rue Belliard 40, 1040 Brussels, Belgium EU/1/17/1255 3.4.2020 1.4.2020 Isturisa Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/19/1407 2.4.2020 1.4.2020 Juluca ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/18/1282 7.4.2020 1.4.2020 Lonsurf Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/16/1096 2.4.2020 1.4.2020 Lutathera Advanced Accelerator Applications 20 rue Diesel, 01630 Saint-Genis-Pouilly, France EU/1/17/1226 6.4.2020 1.4.2020 Mirvaso Galderma International Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France EU/1/13/904 6.4.2020 1.4.2020 Mvasi Amgen Technology (Ireland) UC Pottery Road, Dun Laoghaire, Co. Dublin, Ireland EU/1/17/1246 3.4.2020 1.4.2020 Odefsey Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1112 2.4.2020 1.4.2020 Ondexxya Portola Netherlands B.V. Prins Bernhardplein 200, 1097 JB, Amsterdam, Netherlands EU/1/18/1345 10.4.2020 1.4.2020 RoActemra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/08/492 2.4.2020 1.4.2020 Synjardy Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/15/1003 3.4.2020 1.4.2020 TAVLESSE Instituto Grifols, S.A. Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa EU/1/19/1405 3.4.2020 1.4.2020 Trecondi medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/18/1351 2.4.2020 1.4.2020 Triumeq ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/14/940 7.4.2020 1.4.2020 Vemlidy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1154 2.4.2020 1.4.2020 Zoledronic acid Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/12/786 3.4.2020 3.4.2020 AFSTYLA CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/16/1158 7.4.2020 3.4.2020 Alecensa Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/16/1169 6.4.2020 3.4.2020 Avastin Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/04/300 6.4.2020 3.4.2020 Bortezomib Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1019 6.4.2020 3.4.2020 Elmiron bene-Arzneimittel GmbH Herterichstraße 1-3, 81479 München, Deutschland EU/1/17/1189 20.4.2020 3.4.2020 Glivec Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/01/198 8.4.2020 3.4.2020 Jinarc Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/15/1000 7.4.2020 3.4.2020 Lorviqua Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique Pleinlaan 17, 1050 Brussel, België EU/1/19/1355 8.4.2020 3.4.2020 Naglazyme BioMarin International Limited Shanbally, Ringaskiddy, County Cork P43 R298, Ireland EU/1/05/324 6.4.2020 3.4.2020 NULOJIX Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/11/694 6.4.2020 3.4.2020 Pregabalin Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/997 7.4.2020 3.4.2020 Pregabalin Mylan Pharma Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/998 7.4.2020 8.4.2020 Insuman Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland EU/1/97/030 23.4.2020 8.4.2020 Otezla Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/14/981 14.4.2020 8.4.2020 Pifeltro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1332 23.4.2020 8.4.2020 Pregabalin Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1027 14.4.2020 8.4.2020 Tamiflu Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/02/222 14.4.2020 8.4.2020 Tivicay ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/13/892 14.4.2020 8.4.2020 Venclyxto AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/16/1138 15.4.2020 8.4.2020 Vidaza Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/08/488 14.4.2020 8.4.2020 Xaluprine Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, Ireland EU/1/11/727 14.4.2020 14.4.2020 Repatha Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/15/1016 16.4.2020 17.4.2020 Cystagon Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/97/039 23.4.2020 17.4.2020 Ofev Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/979 20.4.2020 17.4.2020 Rubraca Clovis Oncology Ireland Limited Regus Dublin Airport, Skybridge House — Dublin Airport, Swords, Co. Dublin, K67 P6K2, Ireland EU/1/17/1250 20.4.2020 17.4.2020 Zerbaxa Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1032 23.4.2020 23.4.2020 Bevespi Aerosphere AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1339 5.5.2020 23.4.2020 Bridion Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/466 24.4.2020 23.4.2020 Carbaglu Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/02/246 5.5.2020 23.4.2020 Cresemba Basilea Pharmaceutica Deutschland GmbH Marie-Curie-Strasse 8, 79539 Loerrach, Baden-Wuerttemberg, Deutschland EU/1/15/1036 24.4.2020 23.4.2020 Cystadane Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/06/379 24.4.2020 23.4.2020 Deltyba Otsuka Novel Products GmbH Erika-Mann-Straße 21, 80636 München, Deutschland EU/1/13/875 27.4.2020 23.4.2020 Descovy Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1099 24.4.2020 23.4.2020 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/17/1210 24.4.2020 23.4.2020 Kanuma Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, France EU/1/15/1033 24.4.2020 23.4.2020 Lumark IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland EU/1/15/1013 30.4.2020 23.4.2020 Onivyde pegylated liposomal Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/16/1130 5.5.2020 23.4.2020 OPDIVO Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 24.4.2020 23.4.2020 Pedea Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/04/284 24.4.2020 23.4.2020 Respreeza CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/15/1006 27.4.2020 23.4.2020 Sustiva Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/99/110 24.4.2020 23.4.2020 Tysabri Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland EU/1/06/346 24.4.2020 23.4.2020 Ultibro Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/862 24.4.2020 23.4.2020 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/11/714 24.4.2020 28.4.2020 Abilify Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/04/276 29.4.2020 28.4.2020 ABILIFY MAINTENA Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/13/882 30.4.2020 28.4.2020 Aripiprazole Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/15/1029 6.5.2020 28.4.2020 Bexsero GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 29.4.2020 28.4.2020 Cayston Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/09/543 29.4.2020 28.4.2020 Cosentyx Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/980 30.4.2020 28.4.2020 Docetaxel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/611 29.4.2020 28.4.2020 Entyvio Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/923 7.5.2020 28.4.2020 Farydak Secura Bio Limited 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland EU/1/15/1023 30.4.2020 28.4.2020 Fycompa Eisai GmbH Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland EU/1/12/776 1.5.2020 28.4.2020 Humira AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland EU/1/03/256 29.4.2020 28.4.2020 Intelence Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/08/468 29.4.2020 28.4.2020 Kevzara Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1196 30.4.2020 28.4.2020 Kineret Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/02/203 30.4.2020 28.4.2020 Lokelma AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1173 5.5.2020 28.4.2020 Myalepta Amryt Pharmaceuticals DAC 90 Harcourt Street, Dublin 2, Ireland EU/1/18/1276 29.4.2020 28.4.2020 Nitisinone MDK MendeliKABS Europe Limited Unit 3D, North Point House, North Point Business Park, New Mallow Road 9, Cork, T23 AT2P, Ireland EU/1/17/1217 1.5.2020 28.4.2020 OCALIVA Intercept Pharma International Limited Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland EU/1/16/1139 29.4.2020 28.4.2020 Ruconest Pharming Group N.V. Darwinweg 24, 2333 CR Leiden, Nederland EU/1/10/641 29.4.2020 28.4.2020 Strensiq Alexion Europe SAS 103-105 rue Anatole France, 92300 Levallois-Perret, France EU/1/15/1015 29.4.2020 28.4.2020 Zynteglo bluebird bio (Netherlands) B.V. Stadsplateau 7, WTC Utrecht, 3521 AZ Utrecht, Nederland EU/1/19/1367 30.4.2020

— 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 14.4.2020 Osseor Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/04/287 15.4.2020 14.4.2020 Protelos Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France EU/1/04/288 15.4.2020

— 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 24.4.2020 Tulaven tulathromycin Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/20/251 Solution for injection QJ01FA94 27.4.2020 24.4.2020 Tulissin tulathromycin VIRBAC 1ère avenue 2065 m LID, 06516 Carros, France EU/2/20/252 Solution for injection QJ01FA94 27.4.2020 24.4.2020 Vectormune FP ILT + AE Fowlpox, avian infectious laryngotracheitis vaccine (live, recombinant) and avian encephalomyelitis vaccine (live) Ceva-Phylaxia Co. Ltd. Szállás u. 5, 1107 Budapest, Magyarország EU/2/20/250 Lyophilisate and solvent for suspension for injection Pending 27.4.2020

— 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 1.4.2020 Comfortis Elanco GmbH Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland EU/2/10/115 3.4.2020 1.4.2020 Nobivac LeuFel VIRBAC 1ère avenue 2065 m LID, 06516 Carros, France EU/2/17/217 3.4.2020 8.4.2020 Acticam Ecuphar NV Legeweg 157-i, 8020 Oostkamp, België EU/2/08/088 22.4.2020 8.4.2020 Fevaxyn Pentofel Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/96/002 15.4.2020 8.4.2020 Inflacam Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland EU/2/11/134 15.4.2020 8.4.2020 MiPet Easecto Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/220 16.4.2020 8.4.2020 RESPIPORC FLUpan H1N1 Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/17/209 14.4.2020 8.4.2020 Vectra 3D Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/13/156 14.4.2020 8.4.2020 Versican Plus DHPPi Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/169 15.4.2020 8.4.2020 Versican Plus DHPPi/L4 Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/164 15.4.2020 8.4.2020 Versican Plus DHPPi/L4R Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/163 15.4.2020 8.4.2020 Versican Plus L4 Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/171 15.4.2020 8.4.2020 Versican Plus Pi Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/168 15.4.2020 8.4.2020 Versican Plus Pi/L4 Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/172 15.4.2020 8.4.2020 Versican Plus Pi/L4R Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/173 15.4.2020 16.4.2020 Arti-Cell Forte Global Stem cell Technology (G.S.T.) NV Noorwegenstraat 4, 9940 Evergem, België EU/2/18/228 17.4.2020 24.4.2020 Canigen L4 Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/15/183 27.4.2020 24.4.2020 Innovax-ILT Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/15/182 28.4.2020 24.4.2020 SevoFlo Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/02/035 27.4.2020 24.4.2020 Sileo Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/2/15/181 29.4.2020

— 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 8.4.2020 Suvaxyn PCV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/099 15.4.2020

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 NETHERLANDS

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