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444 results
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Human medicine European public assessment report (EPAR): Spevigo (updated)
Spesolimab, Psoriasis
Date of authorisation: 09/12/2022,
, 
, Authorised, Last updated: 08/02/2023
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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): 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): Epidyolex (updated)
Cannabidiol, Lennox Gastaut Syndrome; Epilepsies, Myoclonic
Date of authorisation: 19/09/2019,, Revision: 12, Authorised, Last updated: 07/02/2023
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Human medicine European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan (updated)
emtricitabine, tenofovir disoproxil maleate, HIV Infections
Date of authorisation: 16/12/2016,
, Revision: 12, Authorised, Last updated: 06/02/2023
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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): Caprelsa (updated)
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,, Revision: 23, Authorised, Last updated: 01/02/2023
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 15, Authorised, Last updated: 01/02/2023
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Human medicine European public assessment report (EPAR): Skytrofa (previously Lonapegsomatropin Ascendis Pharma) (updated)
Lonapegsomatropin, Growth and Development
Date of authorisation: 11/01/2022,, , Revision: 3, Authorised, Last updated: 31/01/2023
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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,, , , Revision: 4, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Yescarta (updated)
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 11, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Rybrevant (updated)
amivantamab, Carcinoma, Non-Small-Cell Lung
Date of authorisation: 09/12/2021,, , Revision: 2, Authorised, Last updated: 30/01/2023
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Human medicine European public assessment report (EPAR): Zynlonta (updated)
loncastuximab tesirine, Lymphoma, Large B-Cell, Diffuse; Lymphoma, B-Cell
Date of authorisation: 20/12/2022,, , Authorised, Last updated: 26/01/2023
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Human medicine European public assessment report (EPAR): Fingolimod Mylan (updated)
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 18/08/2021,, Revision: 3, Authorised, Last updated: 26/01/2023
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Human medicine European public assessment report (EPAR): Coagadex (updated)
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,, , Revision: 9, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Paxlovid (updated)
nirmatrelvir, ritonavir, COVID-19 virus infection
Date of authorisation: 28/01/2022,, Revision: 8, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Dexmedetomidine Accord (updated)
dexmedetomidine, Premedication
Date of authorisation: 13/02/2020,, Revision: 6, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): NexoBrid (updated)
proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, , Revision: 14, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Trecondi (updated)
Treosulfan, Hematopoietic Stem Cell Transplantation
Date of authorisation: 20/06/2019,, Revision: 3, Authorised, Last updated: 25/01/2023
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Human medicine European public assessment report (EPAR): Filsuvez (updated)
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,, Revision: 1, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Trepulmix (updated)
Treprostinil sodium, Hypertension, Pulmonary
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 23/01/2023
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Human medicine European public assessment report (EPAR): Dasatinib Accord (updated)
dasatinib, Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Date of authorisation: 24/03/2022,, Revision: 1, Authorised, Last updated: 20/01/2023
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Human medicine European public assessment report (EPAR): Pemetrexed Baxter (updated)
pemetrexed disodium heptahydrate, Carcinoma, Non-Small-Cell Lung; Mesothelioma
Date of authorisation: 09/12/2022,, Authorised, Last updated: 19/01/2023
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Human medicine European public assessment report (EPAR): Praxbind (updated)
idarucizumab, Hemorrhage
Date of authorisation: 20/11/2015,, Revision: 11, Authorised, Last updated: 18/01/2023
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Human medicine European public assessment report (EPAR): Pirfenidone Viatris (updated)
Pirfenidone, Idiopathic Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases
Date of authorisation: 10/01/2023,, Authorised, Last updated: 17/01/2023