Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2019 to 28 February 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 118/01)

— 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 14.2.2019 Zirabev bevacizumab Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/18/1344 Concentrate for solution for infusion L01XC07 18.2.2019 15.2.2019 Besremi ropeginterferon alfa-2b AOP Orphan Pharmaceuticals AG Wilhelminenstraβe 91/II f, 1160 Wien, Österreich EU/1/18/1352 Solution for injection L03AB15 19.2.2019 18.2.2019 Lusutrombopag Shionogi lusutrombopag Shionogi B.V. Kingsfordweg 151, 1043GR Amsterdam, Nederland EU/1/18/1348 Film-coated tablet B02BX07 20.2.2019 18.2.2019 Miglustat Dipharma miglustat Dipharma B.V. Prins Bernhardplein 200, 1097 JB Amsterdam, Netherlands EU/1/18/1346 Capsule, hard A16AX06 20.2.2019 18.2.2019 Rizmoic naldemedine Shionogi B.V. Kingsfordweg 151, 1043GR Amsterdam, Nederland EU/1/18/1291 Film-coated tablet A06AH05 20.2.2019 18.2.2019 Tobramycin PARI tobramycin PARI Pharma GmbH Moosstraße 3, 82319 Starnberg, Deutschland EU/1/18/1350 Nebuliser solution J01GB01 20.2.2019

— 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 6.2.2019 Accofil Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/14/946 8.2.2019 6.2.2019 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 8.2.2019 6.2.2019 Ammonaps Swedish Orphan Biovitrum International AB 112 76 Stockholm, Sverige EU/1/99/120 11.2.2019 6.2.2019 Axumin Blue Earth Diagnostics Ireland Ltd 6th Floor, 2 Grand Canal Square, Dublin 2, Ιreland EU/1/17/1186 8.2.2019 6.2.2019 Epivir ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland EU/1/96/015 8.2.2019 6.2.2019 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 8.2.2019 6.2.2019 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 8.2.2019 6.2.2019 Mirapexin Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/97/051 8.2.2019 6.2.2019 Mvasi Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/17/1246 8.2.2019 6.2.2019 Revolade Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/612 8.2.2019 6.2.2019 Sprycel Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/06/363 8.2.2019 6.2.2019 Taltz Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/15/1085 8.2.2019 6.2.2019 Terrosa Gedeon Richter Plc. Gyömrői út 19-21., 1103 Budapest, Magyarország EU/1/16/1159 8.2.2019 6.2.2019 Tolucombi Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/13/821 11.2.2019 6.2.2019 Zyprexa Velotab Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/99/125 8.2.2019 7.2.2019 Circadin RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France EU/1/07/392 15.2.2019 7.2.2019 Dacogen Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/12/792 11.2.2019 7.2.2019 Dasselta Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/11/739 11.2.2019 7.2.2019 Kisplyx Eisai GmbH Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland EU/1/16/1128 11.2.2019 7.2.2019 Lenvima Eisai GmbH Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland EU/1/15/1002 11.2.2019 7.2.2019 Raxone Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Straße 8, 79539 Lörrach, Deutschland EU/1/15/1020 11.2.2019 7.2.2019 Sifrol Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/97/050 11.2.2019 7.2.2019 Sycrest Organon N.V. Kloosterstraat 6, 5349 AB Oss, Nederland EU/1/10/640 11.2.2019 7.2.2019 Tarceva Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/05/311 11.2.2019 7.2.2019 Teysuno Nordic Group B.V. Siriusdreef 22, 2132 WT Hoofddorp, Nederland EU/1/11/669 11.2.2019 8.2.2019 Helicobacter Test INFAI INFAI GmbH Gottfried-Hagen-Straße 60-62, 51105 Köln, Deutschland EU/1/97/045 12.2.2019 12.2.2019 Buccolam Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België EU/1/11/709 14.2.2019 12.2.2019 Caspofungin Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/15/1081 15.2.2019 12.2.2019 Ebilfumin Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/14/915 14.2.2019 12.2.2019 Envarsus Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/935 14.2.2019 12.2.2019 Imraldi Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland EU/1/17/1216 14.2.2019 12.2.2019 Jinarc Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Noord-Holland, Nederland EU/1/15/1000 14.2.2019 12.2.2019 Liprolog Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/01/195 14.2.2019 12.2.2019 Yargesa Piramal Critical Care B.V. Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland EU/1/17/1176 14.2.2019 14.2.2019 Aripiprazole Mylan Pharma Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/15/1005 18.2.2019 14.2.2019 Bortezomib Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/16/1114 18.2.2019 14.2.2019 Fotivda EUSA Pharma (Netherlands) B.V. Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland EU/1/17/1215 18.2.2019 14.2.2019 Hemlibra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/18/1271 18.2.2019 14.2.2019 Imatinib Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/13/845 18.2.2019 14.2.2019 Jardiance Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/14/930 18.2.2019 14.2.2019 Mekinist Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/931 18.2.2019 14.2.2019 Modigraf Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/09/523 18.2.2019 14.2.2019 Pioglitazone Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/11/722 18.2.2019 14.2.2019 Quinsair Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/14/973 18.2.2019 14.2.2019 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 18.2.2019 14.2.2019 Sutent Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/06/347 18.2.2019 18.2.2019 Advagraf Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland EU/1/07/387 20.2.2019 18.2.2019 ATryn Laboratoire français du Fractionnement et des Biotechnologies 3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France EU/1/06/355 20.2.2019 18.2.2019 Bosulif Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/13/818 20.2.2019 18.2.2019 Pixuvri CTI Life Sciences Deutschland GmbH Universitätsstraβe 71, 50931 Köln, Deutschland EU/1/12/764 20.2.2019 18.2.2019 Simponi Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland EU/1/09/546 20.2.2019 18.2.2019 Zelboraf Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/12/751 20.2.2019 18.2.2019 Zyprexa Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/96/022 20.2.2019 20.2.2019 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 22.2.2019 20.2.2019 Bortezomib SUN Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/16/1102 22.2.2019 20.2.2019 Entyvio Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/14/923 22.2.2019 20.2.2019 Eurartesim Alfasigma S.p.A. Via Ragazzi del ‘99, n.5, 40133 Bologna, Italia EU/1/11/716 22.2.2019 20.2.2019 Ibandronic acid Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/12/798 22.2.2019 20.2.2019 Mepact Takeda France SAS Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France EU/1/08/502 22.2.2019 20.2.2019 Renvela Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/09/521 26.2.2019 20.2.2019 Simbrinza Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/933 22.2.2019 20.2.2019 Sustiva Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom EU/1/99/110 22.2.2019 20.2.2019 Vabomere Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/18/1334 25.2.2019 20.2.2019 VELCADE Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/04/274 22.2.2019 20.2.2019 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 22.2.2019 20.2.2019 Zytiga Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/11/714 22.2.2019 25.2.2019 AFSTYLA CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland EU/1/16/1158 27.2.2019 25.2.2019 Amlodipine/Valsartan Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/16/1092 27.2.2019 25.2.2019 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 27.2.2019 25.2.2019 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 27.2.2019 25.2.2019 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 27.2.2019 25.2.2019 Fasenra AstraZeneca AB 151 85 Södertälje, Sverige EU/1/17/1252 27.2.2019 25.2.2019 Fiasp Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/16/1160 27.2.2019 25.2.2019 Hetlioz Vanda Pharmaceuticals Germany GmbH Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland EU/1/15/1008 27.2.2019 25.2.2019 Miglustat Gen.Orph Gen.Orph 185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France EU/1/17/1232 27.2.2019 25.2.2019 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 27.3.2019 25.2.2019 Repaglinide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/11/743 27.2.2019 25.2.2019 Tecentriq Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/17/1220 27.2.2019 25.2.2019 Temozolomide Accord Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España EU/1/10/615 27.2.2019 25.2.2019 Zavicefta Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland EU/1/16/1109 27.2.2019 25.2.2019 Zyclara Meda AB Pipers väg 2A, 170 73 Solna, Sverige EU/1/12/783 27.2.2019 25.2.2019 Zypadhera Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/08/479 27.2.2019

— 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 14.2.2019 Imatinib Medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/13/876 18.2.2019 18.2.2019 Silgard Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom EU/1/06/358 20.2.2019 18.2.2019 Vantobra PARI Pharma GmbH Moosstraße 3, 82319 Starnberg, Deutschland EU/1/14/932 20.2.2019 20.2.2019 ATryn Laboratoire français du Fractionnement et des Biotechnologies 3 avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France EU/1/06/355 22.2.2019 25.2.2019 Altargo Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom EU/1/07/390 27.2.2019 25.2.2019 Arzerra Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/10/625 27.2.2019

— 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 5.2.2019 EVANT Coccidiosis vaccine live for chickens Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/18/233 Suspension and solvent for oral spray QI01AN01 7.2.2019 8.2.2019 Kriptazen halofuginone Virbac 1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France EU/2/18/234 Oral solution QP51AX08 12.2.2019

— 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 4.2.2019 CYTOPOINT Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/205 6.2.2019 4.2.2019 Zycortal Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/15/189 6.2.2019 5.2.2019 Bravecto Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/13/158 7.2.2019 5.2.2019 Equisolon Le Vet B.V. Wilgenweg 7, 3421 TV Oudewater, Nederland EU/2/14/161 7.2.2019 8.2.2019 Halagon Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België EU/2/16/201 12.2.2019 8.2.2019 STARTVAC Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/08/092 12.2.2019 8.2.2019 Vaxxitek HVT + IBD Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/02/032 12.2.2019 8.2.2019 Vectra Felis Ceva Santé Animale 10 avenue de la Ballastière, 33500 Libourne, France EU/2/14/165 12.2.2019 21.2.2019 BLUEVAC BTV8 CZ Veterinaria, S.A. La Relva s/n, P.O. Box 16, 36400 Porriño, España EU/2/11/122 25.2.2019 21.2.2019 Zulvac BTV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/207 25.2.2019

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 30 Churchill Place Canary Wharf London E14 5EU United Kingdom

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