C 96/1

Iris Oifigiúil an Aontais Eorpaigh

Achoimre ar chinntí an Aontais Eorpaigh maidir le húdaruithe margaíochta i ndáil le táirgí íocshláinte ón 1 Eanáir 2021 go dtí an 31 Nollaig 2021

(Arna fhoilsiú de bhun Airteagal 13 nó Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle (1))

(2022/C 96/01)

— Údarú margaíochta a mhodhnú (Airteagal 13 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

Dáta an chinnidh Ainm an táirge íocshláinte Sealbhóir an údaraithe margaíochta Uimhir na hiontrála sa Chlár Comhphobail Dáta an fhógra 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 Vallensbaek 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

— Údarú margaíochta a tharraingt siar (Airteagal 13 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle)

Dáta an chinnidh Ainm an táirge íocshláinte Sealbhóir an údaraithe margaíochta Uimhir na hiontrála sa Chlár Comhphobail Dáta an fhógra 29.11.2021 Glustin Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark EU/1/00/151 9.12.2021

— Údarú margaíochta a mhodhnú (Airteagal 38 de Rialachán (CE) Uimh. 726/2004 ó Pharlaimint na hEorpa agus ón gComhairle): Glactha

Dáta an chinnidh Ainm an táirge íocshláinte Sealbhóir an údaraithe margaíochta Uimhir na hiontrála sa Chlár Comhphobail Dáta an fhógra 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

Aon duine ar mian leis féachaint ar an tuarascáil mheasúnaithe phoiblí maidir leis na táirgí íocshláinte atá i gceist agus na cinntí a bhaineann léi, iarrtar orthu teagmháil a dhéanamh le:

European Medicines Agency Domenico Scarlattilaan 6 1083 HS Amsterdam NETHERLANDS

(1) IO L 136, 30.4.2004, lch. 1.