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01/01/2020 - 00:00 – 31/12/2021 - 23:59 Remove 01/01/2020 - 00:00 – 31/12/2021 - 23:59 filter
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Human medicine European public assessment report (EPAR): Aspaveli
Pegcetacoplan, Hemoglobinuria, Paroxysmal
Date of authorisation: 13/12/2021,,
, Revision: 3, Authorised, Last updated: 06/09/2022
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Human medicine European public assessment report (EPAR): Artesunate Amivas
artesunate, Malaria
Date of authorisation: 22/11/2021,,
, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Qinlock
ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021,,
, Revision: 1, Authorised, Last updated: 13/12/2021
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Human medicine European public assessment report (EPAR): Voxzogo
Vosoritide, Achondroplasia
Date of authorisation: 26/08/2021,,
, Revision: 1, Authorised, Last updated: 24/02/2022
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Human medicine European public assessment report (EPAR): Minjuvi
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,,
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, Revision: 3, Authorised, Last updated: 13/06/2022
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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,,
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, Revision: 5, Authorised, Last updated: 21/12/2022
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Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,,
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, Revision: 2, Authorised, Last updated: 05/10/2022
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Human medicine European public assessment report (EPAR): Imcivree (updated)
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,,
, Revision: 6, Authorised, Last updated: 07/02/2023
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Human medicine European public assessment report (EPAR): Enspryng
satralizumab, Neuromyelitis Optica
Date of authorisation: 24/06/2021,, Revision: 1, Authorised, Last updated: 15/09/2021
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Human medicine European public assessment report (EPAR): Koselugo (updated)
Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021,,
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, Revision: 4, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Sogroya
Somapacitan, Growth
Date of authorisation: 31/03/2021,,
, Revision: 1, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,,
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, Revision: 4, Authorised, Last updated: 09/01/2023
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Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,,
, Revision: 3, Authorised, Last updated: 06/02/2023
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Human medicine European public assessment report (EPAR): Inrebic
fedratinib dihydrochloride monohydrate, Myeloproliferative Disorders; Primary Myelofibrosis
Date of authorisation: 08/02/2021,,
, Revision: 3, Authorised, Last updated: 08/12/2021
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Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,,
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, Revision: 5, Authorised, Last updated: 23/09/2022
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Human medicine European public assessment report (EPAR): Fintepla (updated)
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,,
, Revision: 4, Authorised, Last updated: 07/02/2023
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Human medicine European public assessment report (EPAR): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,,
, Revision: 5, Authorised, Last updated: 12/09/2022
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Human medicine European public assessment report (EPAR): Tecartus (updated)
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti-CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (brexucabtagene autoleucel), Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,,
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, Revision: 4, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Oxlumo
Lumasiran sodium, Hyperoxaluria, Primary
Date of authorisation: 19/11/2020,,
, Revision: 3, Authorised, Last updated: 13/10/2022
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Human medicine European public assessment report (EPAR): Nyxthracis (previously Obiltoxaximab SFL)
nyxthracis, Anthrax
Date of authorisation: 18/11/2020,,
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, Revision: 3, Authorised, Last updated: 15/12/2022
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Human medicine European public assessment report (EPAR): Adakveo (updated)
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,,
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, Revision: 3, Authorised, Last updated: 10/01/2023
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Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,, Revision: 1, Authorised, Last updated: 09/11/2021
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Human medicine European public assessment report (EPAR): Ayvakyt
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,,
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, Revision: 4, Authorised, Last updated: 18/05/2022
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Human medicine European public assessment report (EPAR): Idefirix (updated)
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,,
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, Revision: 3, Authorised, Last updated: 16/01/2023
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,,
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, Revision: 4, Authorised, Last updated: 12/10/2022