Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2020 to 29 February 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 101/01)

— 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 authorization Number of the entry in the Community Register Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Date of notification 13.2.2020 Amsparity adalimumab Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/19/1415 Solution for injection L04AB04 17.2.2020 13.2.2020 Azacitidine Accord Azacitidine Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/19/1413 Powder for suspension for injection L01BC07 17.2.2020 13.2.2020 Beovu brolucizumab Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/19/1417 Solution for injection S01LA06 17.2.2020 13.2.2020 Dexmedetomidine Accord dexmedetomidine Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/19/1418 Concentrate for solution for infusion N05CM18 17.2.2020 13.2.2020 Recarbrio imipenem/cilastatin/relebactam Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/19/1420 Powder for solution for infusion J01DH56 17.2.2020

— 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 authorization Number of the entry in the Community Register Date of notification 4.2.2020 Ceprotin Takeda Manufacturing Austria AG Industriestraße 67, 1221 Wien, Österreich EU/1/01/190 6.2.2020 4.2.2020 CONTROLOC Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/515 6.2.2020 4.2.2020 ellaOne Laboratoire HRA Pharma 200 avenue de Paris, 92320 Chatillon, France EU/1/09/522 6.2.2020 4.2.2020 Ivabradine Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/17/1190 6.2.2020 4.2.2020 Lacosamide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/17/1230 6.2.2020 4.2.2020 LIFMIOR Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/16/1165 6.2.2020 4.2.2020 Mekinist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/931 6.2.2020 4.2.2020 PANTOZOL Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/517 6.2.2020 4.2.2020 Suboxone Indivior Europe Limited 27 Windsor Place, Dublin 2, Ireland EU/1/06/359 6.2.2020 4.2.2020 Ucedane Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland EU/1/17/1202 6.2.2020 4.2.2020 Ziagen ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/99/112 6.2.2020 4.2.2020 Zoely Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland EU/1/11/690 6.2.2020 6.2.2020 Aranesp Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/01/185 10.2.2020 6.2.2020 Bronchitol Pharmaxis Europe Limited 108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland EU/1/12/760 10.2.2020 6.2.2020 Fasenra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1252 10.2.2020 6.2.2020 Granpidam Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/16/1137 10.2.2020 6.2.2020 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/930 10.2.2020 6.2.2020 Neuraceq Life Radiopharma Berlin GmbH Max-Planck-Straße 4, 12489 Berlin, Deutschland EU/1/13/906 10.2.2020 6.2.2020 SOMAC Control Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland EU/1/09/516 10.2.2020 6.2.2020 Vokanamet Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/918 10.2.2020 10.2.2020 Inhixa Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland EU/1/16/1132 12.2.2020 11.2.2020 Alimta Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/04/290 13.2.2020 11.2.2020 ALPROLIX Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige EU/1/16/1098 13.2.2020 11.2.2020 Entecavir Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/17/1211 13.2.2020 11.2.2020 OCALIVA Intercept Pharma International Limited Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland EU/1/16/1139 13.2.2020 11.2.2020 Orkambi Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/15/1059 13.2.2020 11.2.2020 Pemetrexed Fresenius Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/16/1115 13.2.2020 11.2.2020 Rebetol Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/99/107 13.2.2020 11.2.2020 Symkevi Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland EU/1/18/1306 13.2.2020 11.2.2020 Zeffix GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland EU/1/99/114 13.2.2020 11.2.2020 Zevalin Ceft Biopharma s.r.o Trtinova 260/1 Cakovice, 196 00 Praha 9, Česká republika EU/1/03/264 13.2.2020 12.2.2020 Zoledronic acid Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/12/800 14.2.2020 13.2.2020 Aimovig Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/18/1293 17.2.2020 13.2.2020 Bosulif Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/13/818 17.2.2020 13.2.2020 Brineura BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/17/1192 17.2.2020 13.2.2020 Dificlir Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/11/733 17.2.2020 13.2.2020 Duloxetine Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1010 17.2.2020 13.2.2020 Ebixa H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark EU/1/02/219 17.2.2020 13.2.2020 IBRANCE Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/16/1147 17.2.2020 13.2.2020 Mvasi Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/17/1246 17.2.2020 13.2.2020 Quinsair Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/973 17.2.2020 13.2.2020 Sprycel Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/06/363 17.2.2020 13.2.2020 Tamiflu Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/02/222 17.2.2020 13.2.2020 Ventavis Bayer AG D-51368 Leverkusen, Deutschland EU/1/03/255 17.2.2020 17.2.2020 Adempas Bayer AG D-51368 Leverkusen, Deutschland EU/1/13/907 19.2.2020 17.2.2020 Atripla Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/07/430 19.2.2020 17.2.2020 Eliquis Bristol-Myers Squibb/Pfizer EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/11/691 19.2.2020 17.2.2020 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/97/050 19.2.2020 17.2.2020 Suliqua Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/16/1157 19.2.2020 17.2.2020 Tacforius Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/17/1244 2.3.2020 17.2.2020 Vyndaqel Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/11/717 19.2.2020 18.2.2020 Zypadhera Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/08/479 20.2.2020 21.2.2020 Cholib Mylan IRE Healthcare Ltd Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/13/866 25.2.2020 21.2.2020 Cometriq Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/13/890 25.2.2020 21.2.2020 Docetaxel Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/769 25.2.2020 21.2.2020 Eptifibatide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/15/1065 25.2.2020 21.2.2020 Holoclar Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/987 25.2.2020 21.2.2020 Imfinzi AstraZeneca AB 151 85 Södertälje, Sverige EU/1/18/1322 18.2.2020 21.2.2020 Lyrica Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/04/279 25.2.2020 21.2.2020 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/97/051 25.2.2020 21.2.2020 Resolor Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland EU/1/09/581 25.2.2020 21.2.2020 Trelegy Ellipta GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland EU/1/17/1236 25.2.2020 21.2.2020 Voriconazole Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/13/835 25.2.2020 21.2.2020 Zalasta Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/07/415 25.2.2020 21.2.2020 Zyprexa Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/022 25.2.2020 21.2.2020 Zyprexa Velotab Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/99/125 25.2.2020 24.2.2020 Docetaxel Kabi Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland EU/1/12/770 26.2.2020 24.2.2020 Lixiana Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/15/993 26.2.2020 24.2.2020 Slenyto RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France EU/1/18/1318 26.2.2020 25.2.2020 Aripiprazole Mylan Pharma Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1005 27.2.2020 28.2.2020 Advagraf Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/07/387 3.3.2020 28.2.2020 Bexsero GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia EU/1/12/812 3.3.2020 28.2.2020 Cegfila Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland EU/1/19/1409 3.3.2020 28.2.2020 Cuprymina A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L. Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia EU/1/12/784 3.3.2020 28.2.2020 Hetlioz Vanda Pharmaceuticals Germany GmbH Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland EU/1/15/1008 3.3.2020 28.2.2020 Januvia Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/383 3.3.2020 28.2.2020 Ledaga Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15, Ireland EU/1/16/1171 3.3.2020 28.2.2020 Modigraf Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/09/523 3.3.2020 28.2.2020 Pemetrexed Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España EU/1/15/1071 3.3.2020 28.2.2020 Pemetrexed Lilly Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1034 3.3.2020 28.2.2020 Simponi Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546 3.3.2020 28.2.2020 Voncento CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/13/857 3.3.2020 28.2.2020 Xerava Tetraphase Pharmaceuticals Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland EU/1/18/1312 3.3.2020 28.2.2020 Xeristar Esteve Pharmaceuticals S.A. Passeig de la Zona Franca, 109, 08038 Barcelona, España EU/1/04/297 3.3.2020 28.2.2020 Xolair Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/05/319 3.3.2020 28.2.2020 Zoledronic acid Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/13/834 3.3.2020 28.2.2020 Zydelig Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/14/938 3.3.2020

— 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 authorization Number of the entry in the Community Register Date of notification 11.2.2020 Picato LEO Laboratories Ltd 285 Cashel Road, Crumlin, Dublin 12, Ireland EU/1/12/796 13.2.2020

— 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 authorization Number of the entry in the Community Register Date of notification 4.2.2020 Clevor Orion Corporation Orionintie 1, 02200 Espoo, Suomi EU/2/17/222 6.2.2020 11.2.2020 Halagon Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België EU/2/16/201 13.2.2020 11.2.2020 Meloxidyl Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/06/070 13.2.2020 11.2.2020 Oxyglobin OPK Biotech Netherlands BV Teleportboulevard 140, 1043 EJ Amsterdam, Nederland EU/2/99/015 14.2.2020 11.2.2020 Palladia Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/100 13.2.2020 17.2.2020 Zulvac 1 Bovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/130 19.2.2020 17.2.2020 Zulvac 1 Ovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/131 19.2.2020 18.2.2020 Emdocam Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België EU/2/11/128 20.2.2020 18.2.2020 Zycortal Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/15/189 20.2.2020 26.2.2020 Porcilis ColiClos Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/12/141 28.2.2020

— 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 18.2.2020 Zulvac 1 Bovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/130 20.2.2020 18.2.2020 Zulvac 1 Ovis Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/11/131 20.2.2020

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.