Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2019 to 31 May 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 218/01)

— 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 3.5.2019 Palynziq pegvaliase BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland EU/1/19/1362 Solution for injection A16AB19 8.5.2019 3.5.2019 Waylivra volanesorsen Akcea Therapeutics Ireland Limited Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland EU/1/19/1360 Solution for injection Pending 8.5.2019 6.5.2019 Lorviqua lorlatinib Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België EU/1/19/1355 Film-coated tablet L01XE44 8.5.2019 6.5.2019 Pazenir paclitaxel Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/18/1317 Powder for dispersion for infusion L01CD01 8.5.2019 29.5.2019 Zynteglo autologous CD34+ cells encoding βΑ-T87Q-globin gene bluebird bio (Netherlands) B.V. Stadsplateau 7, 3521 AZ Utrecht, Nederland EU/1/19/1367 Dispersion for infusion Pending 4.6.2019

— 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 3.5.2019 Clopidogrel Krka d.d. Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/09/562 8.5.2019 3.5.2019 Episalvan Amryt AG Streiflingsweg 11, 75223 Niefern-Öschelbronn, Deutschland EU/1/15/1069 8.5.2019 3.5.2019 PREZISTA Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/06/380 8.5.2019 3.5.2019 Ryzodeg Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/12/806 8.5.2019 3.5.2019 Symtuza Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/17/1225 8.5.2019 3.5.2019 Yondelis Pharma Mar S.A. Avenida de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo, Madrid, España EU/1/07/417 8.5.2019 6.5.2019 Dupixent Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France EU/1/17/1229 9.5.2019 6.5.2019 Rezolsta Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/14/967 8.5.2019 6.5.2019 Ritonavir Mylan Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France EU/1/17/1242 9.5.2019 6.5.2019 Twynsta Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/10/648 8.5.2019 13.5.2019 Ferriprox Apotex B.V. Keizersgracht 311, 1016 EE, Amsterdam, Nederland EU/1/99/108 15.5.2019 13.5.2019 Imnovid Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/13/850 15.5.2019 13.5.2019 Mozobil Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland EU/1/09/537 15.5.2019 13.5.2019 Ozempic Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark EU/1/17/1251 15.5.2019 13.5.2019 Pradaxa Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/08/442 15.5.2019 13.5.2019 Ratiograstim ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/08/444 15.5.2019 13.5.2019 Revlimid Celgene Europe B.V. Winthontlaan 6 N, 3526 KV Utrecht, Nederland EU/1/07/391 15.5.2019 13.5.2019 Tevagrastim Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/08/445 15.5.2019 16.5.2019 Pemetrexed medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/15/1038 20.5.2019 16.5.2019 Xeplion Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België EU/1/11/672 20.5.2019 20.5.2019 Bondronat Atnahs Pharma Netherlands B.V. Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland EU/1/96/012 22.5.2019 20.5.2019 Epclusa Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland EU/1/16/1116 22.5.2019 20.5.2019 Kuvan BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland EU/1/08/481 22.5.2019 20.5.2019 TachoSil Takeda Austria GmbH St.-Peter-Strasse 25, 4020 Linz, Österreich EU/1/04/277 22.5.2019 22.5.2019 Adenuric Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg EU/1/08/447 27.5.2019 22.5.2019 Blitzima Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország EU/1/17/1205 27.5.2019 22.5.2019 Bonviva Atnahs Pharma Netherlands B.V. Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland EU/1/03/265 28.5.2019 22.5.2019 Competact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/354 27.5.2019 22.5.2019 Erbitux Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland EU/1/04/281 27.5.2019 22.5.2019 KEYTRUDA Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/15/1024 27.5.2019 22.5.2019 Tyverb Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/07/440 27.5.2019 27.5.2019 Opdivo Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland EU/1/15/1014 29.5.2019 27.5.2019 Tafinlar Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/13/865 29.5.2019 27.5.2019 Tandemact Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark EU/1/06/366 29.5.2019 27.5.2019 Trisenox Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/02/204 29.5.2019 27.5.2019 Xeloda Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/00/163 29.5.2019 27.5.2019 Xermelo Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France EU/1/17/1224 29.5.2019

— 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 13.5.2019 Nonafact Sanquin Plasma Products B.V. Plesmanlaan 125, 1066 CX Amsterdam, Nederland EU/1/01/186 15.5.2019

— 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 20.5.2019 Afoxolaner MERIAL afoxolaner Merial 29 avenue Tony Garnier, 69007 Lyon, France EU/2/19/240 Chewable tablet QP53BE01 22.5.2019 20.5.2019 Baycox Iron toltrazuril/gleptoferron Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland EU/2/19/239 Suspension for injection QP51AJ51 22.5.2019

— Issuing of a marketing authorisation (Article 38 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 authorisation Number of the entry in the Community Register Date of notification 13.5.2019 Horse Allo 20 Centauri Biotech SL Calle Asunción SN - 1oIzq (Meicende — Arteixo), 15142 A Coruña, España — 15.5.2019

— 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 13.5.2019 Cortavance VIRBAC S.A. 1ère Avenue - 2065 m — L.I.D., 06516 Carros Cedex, France EU/2/06/069 15.5.2019 27.5.2019 Innovax-ND-IBD Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland EU/2/17/213 29.5.2019 27.5.2019 VEPURED Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España EU/2/17/214 29.5.2019 29.5.2019 Suvaxyn PCV Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/09/099 4.6.2019 29.5.2019 Versican Plus Pi/L4R Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/173 4.6.2019

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 The Netherlands

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