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Human medicine European public assessment report (EPAR): Sogroya (new)
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): Pemazyre (new)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,
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, Authorised, Last updated: 04/05/2021
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Human medicine European public assessment report (EPAR): Evrysdi (new)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,
, , Authorised, Last updated: 04/05/2021
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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,, , Authorised, Last updated: 03/03/2021
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Human medicine European public assessment report (EPAR): Lumoxiti
Moxetumomab pasudotox, Leukemia, Hairy Cell
Date of authorisation: 08/02/2021,, , Authorised, Last updated: 09/03/2021
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Human medicine European public assessment report (EPAR): Elzonris
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , 
, Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Fintepla
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Authorised, Last updated: 08/01/2021
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Human medicine European public assessment report (EPAR): Libmeldy
autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,, , Revision: 1, Authorised, Last updated: 09/03/2021
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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,, , , Authorised, Last updated: 25/01/2021
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Human medicine European public assessment report (EPAR): Oxlumo
Lumasiran sodium, Hyperoxaluria, Primary
Date of authorisation: 19/11/2020,, , Authorised, Last updated: 25/11/2020
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Human medicine European public assessment report (EPAR): Obiltoxaximab SFL
Obiltoxaximab, Anthrax
Date of authorisation: 18/11/2020,, , , Authorised, Last updated: 27/11/2020
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Human medicine European public assessment report (EPAR): Adakveo
Crizanlizumab, Anemia, Sickle Cell
Date of authorisation: 28/10/2020,, , , Authorised, Last updated: 24/11/2020
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Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,, Authorised, Last updated: 18/11/2020
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Human medicine European public assessment report (EPAR): Ayvakyt
avapritinib, Gastrointestinal Stromal Tumors
Date of authorisation: 24/09/2020,, , Revision: 1, Authorised, Last updated: 06/11/2020
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Human medicine European public assessment report (EPAR): Idefirix
Imlifidase, Desensitization, Immunologic, Kidney Transplantation
Date of authorisation: 25/08/2020,, , , Authorised, Last updated: 28/08/2020
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 2, Authorised, Last updated: 17/03/2021
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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 3, Authorised, Last updated: 06/05/2021
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Human medicine European public assessment report (EPAR): Hepcludex
Bulevirtide acetate, Hepatitis D, Chronic
Date of authorisation: 31/07/2020,, , , Revision: 1, Authorised, Last updated: 07/10/2020
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 3, Authorised, Last updated: 09/04/2021
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Human medicine European public assessment report (EPAR): Daurismo (updated)
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,, , Revision: 2, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Reblozyl (updated)
Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia
Date of authorisation: 25/06/2020,, , Revision: 1, Authorised, Last updated: 21/04/2021
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , , Revision: 2, Authorised, Last updated: 19/04/2021
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Human medicine European public assessment report (EPAR): Trepulmix
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 1, Authorised, Last updated: 22/03/2021
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Human medicine European public assessment report (EPAR): Givlaari
Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020,, , Revision: 1, Authorised, Last updated: 18/03/2021
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Human medicine European public assessment report (EPAR): Polivy
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, , , Revision: 2, Authorised, Last updated: 15/12/2020