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Human medicine European public assessment report (EPAR): Uplizna (updated)
Inebilizumab, Neuromyelitis Optica
Date of authorisation: 25/04/2022,, Authorised, Last updated: 19/05/2022
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Human medicine European public assessment report (EPAR): Kimmtrak (new)
tebentafusp, Uveal Neoplasms
Date of authorisation: 01/04/2022,,
, Authorised, Last updated: 22/04/2022
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Human medicine European public assessment report (EPAR): Ngenla
somatrogon, Growth and Development
Date of authorisation: 14/02/2022,,
, Revision: 2, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Oxbryta
Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
Date of authorisation: 14/02/2022,,
, Revision: 1, Authorised, Last updated: 13/04/2022
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Human medicine European public assessment report (EPAR): Tavneos
Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022,,
, Authorised, Last updated: 27/01/2022
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Human medicine European public assessment report (EPAR): Voraxaze
glucarpidase, Metabolic Side Effects of Drugs and Substances
Date of authorisation: 11/01/2022,,
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, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Lonapegsomatropin Ascendis Pharma
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,,
, Authorised, Last updated: 16/03/2022
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Human medicine European public assessment report (EPAR): Aspaveli
Pegcetacoplan, Hemoglobinuria, Paroxysmal
Date of authorisation: 13/12/2021,,
, Revision: 1, Authorised, Last updated: 21/02/2022
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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: 11/04/2022
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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: 4, Authorised, Last updated: 07/04/2022
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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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, Authorised, Last updated: 28/07/2021
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Human medicine European public assessment report (EPAR): Imcivree
Setmelanotide, Obesity
Date of authorisation: 16/07/2021,,
, Revision: 2, Authorised, Last updated: 31/03/2022
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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
Selumetinib sulfate, Neurofibromatosis 1
Date of authorisation: 17/06/2021,,
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, Revision: 1, Authorised, Last updated: 10/11/2021
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Human medicine European public assessment report (EPAR): Sogroya
Somapacitan, Growth
Date of authorisation: 31/03/2021,,
, Authorised, Last updated: 15/04/2021
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Human medicine European public assessment report (EPAR): Evrysdi
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,,
, Revision: 1, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Pemazyre
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,,
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, Revision: 2, Authorised, Last updated: 02/03/2022
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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: 3, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,,
, Revision: 2, Authorised, Last updated: 04/11/2021
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Human medicine European public assessment report (EPAR): Libmeldy
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,,
, Revision: 3, Authorised, Last updated: 24/11/2021
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Human medicine European public assessment report (EPAR): Tecartus
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, Lymphoma, Mantle-Cell
Date of authorisation: 14/12/2020,,
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, Revision: 1, Authorised, Last updated: 15/10/2021