Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2020 to 31 May 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 213/02)

— 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 18.5.2020 Zolgensma onasemnogene abeparvovec AveXis EU Limited Block B, The Crescent Building, Northwood, Santry, Dublin 9, D09 C6X8, Ireland EU/1/20/1443 Solution for infusion M09AX09 18.5.2020 20.5.2020 Fluad Tetra influenza vaccine (surface antigen, inactivated, adjuvanted) Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Netherlands EU/1/20/1433 Suspension for injection in pre-filled syringe (injection). J07BB02 26.5.2020 20.5.2020 Nepexto etanercept Mylan IRE Healthcare Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13 Ireland EU/1/20/1436 Solution for injection L04AB01 29.5.2020 30.5.2020 Atectura Breezhaler indacaterol/mometasone furoate Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1439 Inhalation powder, hard capsule R03AK14 2.6.2020 30.5.2020 Bemrist Breezhaler indacaterol/mometasone furoate Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/20/1441 Inhalation powder, hard capsule R03AK 2.6.2020 30.5.2020 Sarclisa isatuximab Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/20/1435 Concentrate for solution for infusion L01XC38 3.6.2020

— 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 4.5.2020 Axura Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland EU/1/02/218 8.5.2020 4.5.2020 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 12.5.2020 4.5.2020 Bronchitol Pharmaxis Europe Limited 108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland EU/1/12/760 5.5.2020 4.5.2020 Clopidogrel Apotex Apotex Europe B.V. Archimedesweg 2, 2333 CN Leiden, Nederland EU/1/09/568 6.5.2020 4.5.2020 Clopidogrel Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/09/559 5.5.2020 4.5.2020 Clopidogrel Teva Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/09/540 7.5.2020 4.5.2020 Cystadrops Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/15/1049 6.5.2020 4.5.2020 Ferriprox Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia EU/1/99/108 7.5.2020 4.5.2020 Grepid Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα EU/1/09/535 5.5.2020 4.5.2020 Ilumetri Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, España EU/1/18/1323 5.5.2020 4.5.2020 Pemetrexed Krka KRKA, d.d. Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/18/1283 12.5.2020 4.5.2020 Pemetrexed medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/15/1038 12.5.2020 4.5.2020 Raxone Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Straße 8, 79539 Lörrach, Deutschland EU/1/15/1020 14.5.2020 4.5.2020 Tafinlar Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/865 8.5.2020 4.5.2020 Wilzin Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/04/286 5.5.2020 4.5.2020 Xultophy Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/14/947 6.5.2020 5.5.2020 Naglazyme BioMarin International Limited Shanbally, Ringaskiddy, County Cork P43 R298, Ireland EU/1/05/324 6.5.2020 12.5.2020 ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/12/794 19.5.2020 12.5.2020 Clopidogrel Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/556 13.5.2020 12.5.2020 Movymia STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland EU/1/16/1161 13.5.2020 12.5.2020 Pemetrexed Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/15/1057 14.5.2020 12.5.2020 Segluromet Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1265 14.5.2020 12.5.2020 Steglatro Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1267 14.5.2020 12.5.2020 Steglujan Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/18/1266 14.5.2020 12.5.2020 Vedrop Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/09/533 13.5.2020 14.5.2020 Clopidogrel Krka d.d. KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/562 18.5.2020 14.5.2020 Firdapse SERB S.A. Avenue Louise 480, 1050 Bruxelles, Belgique/Louizalaan 480, 1050 Brussel, België EU/1/09/601 15.5.2020 14.5.2020 Yellox Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland EU/1/11/692 15.5.2020 18.5.2020 Signifor Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France EU/1/12/753 19.5.2020 20.5.2020 Daxas AstraZeneca AB 151 85 Södertälje, Sverige EU/1/10/636 28.5.2020 20.5.2020 Ivabradine Anpharm ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. ul. Annopol 6B, 03–236 Warszawa, Polska EU/1/15/1041 25.5.2020 20.5.2020 Jorveza Dr Falk Pharma GmbH Leinenweberstraße 5, 79041 Freiburg im Breisgau, Deutschland EU/1/17/1254 26.5.2020 20.5.2020 Lenvima Eisai GmbH Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland EU/1/15/1002 26.5.2020 20.5.2020 LIBTAYO Regeneron Ireland Designated Activity Company (DAC) Europa House, Harcourt Centre, Harcourt Street, Dublin 2, Ireland EU/1/19/1376 26.5.2020 20.5.2020 Nplate Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland EU/1/08/497 25.5.2020 20.5.2020 Odomzo Sun Pharmaceutical Industries Europe BV Polarisavenue 87, 2132 JH Hoofddorp, Nederland EU/1/15/1030 28.5.2020 20.5.2020 Onpattro Alnylam Netherlands B.V. Strawinskylaan 3051, 1077 ZX, Amsterdam, Nederland EU/1/18/1320 25.5.2020 20.5.2020 Pregabalin Zentiva Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika EU/1/15/1021 25.5.2020 20.5.2020 Revestive Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland EU/1/12/787 11.6.2020 20.5.2020 Tybost Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/13/872 25.5.2020

— Modification 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 20.5.2020 Emgality Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland EU/1/18/1330 27.5.2020

— 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 18.5.2020 Lydaxx tulathromycin VETOQUINOL S.A. Magny-Vernois, 70200 Lure, France EU/2/20/253 Solution for injection QJ01FA94 19.5.2020

— 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 4.5.2020 Apoquel Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/13/154 7.5.2020 4.5.2020 Loxicom Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate, Monaghan, Ireland EU/2/08/090 7.5.2020 12.5.2020 Equilis Prequenza Te Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/057 15.5.2020 18.5.2020 Equilis Prequenza Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/056 20.5.2020 18.5.2020 Equilis Te Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/05/055 20.5.2020 27.5.2020 CYTOPOINT Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/17/205 27.5.2020 27.5.2020 Porcilis PCV ID Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/15/187 2.6.2020

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.