Official Journal of the European Union

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2021 to 31 December 2021

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

(2022/C 96/01)

— 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 14.1.2021 Emselex zr pharma& GmbH Hietzinger Hauptstrasse 37, 1130 Wien, Österreich EU/1/04/294 2.9.2021 22.1.2021 Vizamyl GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge EU/1/14/941 1.2.2021 25.5.2021 Januvia Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/07/383 18.1.2022 5.7.2021 Helicobacter Test INFAI INFAI GmbH Riehler Straße 36, 50668 Köln, Deutschland EU/1/97/045 29.7.2021 9.7.2021 Vihuma Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige EU/1/16/1168 29.7.2021 16.7.2021 Atazanavir Mylan Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland EU/1/16/1091 31.8.2021 16.7.2021 Bondronat Atnahs Pharma Netherlands B.V. Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark EU/1/96/012 18.8.2021 16.7.2021 Glyxambi Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/16/1146 20.7.2021 16.7.2021 Mysildecard Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland EU/1/16/1134 8.9.2021 23.7.2021 Fluad Tetra Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland EU/1/20/1433 26.8.2021 23.7.2021 Flucelvax Tetra Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland EU/1/18/1326 26.8.2021 23.7.2021 Galafold Amicus Therapeutics Europe Limited Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15 AKK1, Ireland EU/1/15/1082 28.7.2021 23.7.2021 Sildenafil Actavis Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland EU/1/09/595 16.8.2021 23.7.2021 Xeljanz Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/17/1178 27.7.2021 28.7.2021 Leflunomide ratiopharm ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/10/654 1.9.2021 12.8.2021 Lenalidomide Mylan Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland EU/1/20/1490 23.9.2021 18.8.2021 Hemlibra Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland EU/1/18/1271 18.10.2021 18.8.2021 Palynziq BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland EU/1/19/1362 8.10.2021 20.8.2021 OBIZUR Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich EU/1/15/1035 16.9.2021 15.9.2021 Velmetia Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/08/456 17.9.2021 16.9.2021 Luminity Lantheus EU Limited Rocktwist House, Block 1, Western Business Park, Shannon, Co. Clare, V14 FW97, Ireland EU/1/06/361 19.10.2021 29.9.2021 Abilify Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland EU/1/04/276 9.12.2021 29.9.2021 Cegfila Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland EU/1/19/1409 13.10.2021 29.9.2021 Colobreathe Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland EU/1/11/747 4.10.2021 29.9.2021 elmiron bene-Arzneimittel GmbH Herterichstraße 1-3, 81479 München, Deutschland EU/1/17/1189 5.10.2021 29.9.2021 Praxbind Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/15/1056 5.10.2021 29.9.2021 VPRIV Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/10/646 30.9.2021 29.9.2021 Zoledronic acid medac medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland EU/1/12/779 15.10.2021 11.10.2021 Ibandronic acid Sandoz Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich EU/1/11/685 8.11.2021 19.10.2021 Natpar Takeda Pharmaceuticals International AG Ireland Branch Block 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, Ireland EU/1/15/1078 20.10.2021 19.10.2021 Rivastigmine HEXAL Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland EU/1/09/589 26.11.2021 22.10.2021 Gencebok Gennisium Pharma Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France EU/1/20/1465 9.11.2021 22.10.2021 Topotecan Hospira Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/10/633 25.10.2021 15.11.2021 Atazanavir Krka KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija EU/1/19/1353 3.12.2021 15.11.2021 Pregabalin Pfizer Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/14/916 14.12.2021 15.11.2021 Revatio Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland EU/1/05/318 22.12.2021 15.11.2021 Ulunar Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/14/917 17.11.2021 18.11.2021 Ocaliva Intercept Pharma International Limited Ormond Building, 31 — 36 Ormond Quay Upper, Dublin 7, Ireland EU/1/16/1139 1.12.2021 22.11.2021 Jylamvo Therakind (Europe) Limited Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland EU/1/17/1172 22.12.2021 26.11.2021 Glustin Takeda Pharma A/S Delta Park 45, 2665 Vallensbæk Strand, Danmark EU/1/00/151 9.12.2021 26.11.2021 Lixiana Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland EU/1/15/993 3.12.2021 9.12.2021 Imnovid Bristol Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland EU/1/13/850 7.1.2022 9.12.2021 Relistor Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland EU/1/08/463 14.12.2021 13.12.2021 AJOVY Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland EU/1/19/1358 15.12.2021 13.12.2021 Micardis Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland EU/1/98/090 14.1.2022 13.12.2021 Onbrez Breezhaler Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland EU/1/09/593 14.1.2022 16.12.2021 PREVYMIS Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland EU/1/17/1245 17.1.2022 20.12.2021 Trazimera Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België EU/1/18/1295 22.12.2021

— 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 29.11.2021 Glustin Takeda Pharma A/S Delta Park 45, 2665 Vallensbæk Strand, Danmark EU/1/00/151 9.12.2021

— 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 26.3.2021 Purevax RCPCh FeLV Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland EU/2/04/047 30.3.2021 13.7.2021 Coxevac Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France EU/2/10/110 5.8.2021 30.7.2021 Meloxoral Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/10/111 16.8.2021 30.7.2021 Prevomax Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland EU/2/17/211 16.8.2021 16.8.2021 Suvaxyn CSF Marker Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/14/179 7.9.2021 18.8.2021 Poulvac E. coli Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/12/140 18.10.2021 25.10.2021 Felisecto Plus Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique EU/2/19/238 24.11.2021

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.