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)
Date: 2022-02-28
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2022096EN.01000101.xml










28.2.2022   


EN


Official Journal of the European Union


C 96/1






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.