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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
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, Revision: 28, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Sylvant (updated)
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,, , Revision: 11, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Nexavar (updated)
sorafenib, Carcinoma, Hepatocellular, Carcinoma, Renal Cell
Date of authorisation: 19/07/2006,, Revision: 29, Authorised, Last updated: 12/05/2021
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Human medicine European public assessment report (EPAR): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,
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, Revision: 16, Authorised, Last updated: 11/05/2021
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,, , Revision: 19, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Ketoconazole HRA (updated)
Ketoconazole, Cushing Syndrome
Date of authorisation: 18/11/2014,, , , Revision: 10, Authorised, Last updated: 07/05/2021
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 05/07/2018,, , , Revision: 7, Authorised, Last updated: 06/05/2021
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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): 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): Translarna (updated)
Ataluren, Muscular Dystrophy, Duchenne
Date of authorisation: 31/07/2014,, , , Revision: 19, Authorised, Last updated: 05/05/2021
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,, , , Revision: 10, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Dacogen (updated)
Decitabine, Leukemia, Myeloid
Date of authorisation: 20/09/2012,, Revision: 14, Authorised, Last updated: 30/04/2021
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Human medicine European public assessment report (EPAR): Onivyde pegylated liposomal (previously known as Onivyde) (updated)
irinotecan anhydrous free-base, Pancreatic Neoplasms
Date of authorisation: 14/10/2016,, Revision: 8, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Blincyto (updated)
blinatumomab, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 23/11/2015,, , Revision: 12, Authorised, Last updated: 29/04/2021
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Human medicine European public assessment report (EPAR): Poteligeo (updated)
Mogamulizumab, Sezary Syndrome, Mycosis Fungoides
Date of authorisation: 22/11/2018,, , Revision: 2, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Bronchitol (updated)
mannitol, Cystic Fibrosis
Date of authorisation: 13/04/2012,, Revision: 16, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Soliris (updated)
Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 20/06/2007,, , Revision: 30, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Qarziba (previously Dinutuximab beta EUSA and Dinutuximab beta Apeiron) (updated)
dinutuximab beta, Neuroblastoma
Date of authorisation: 08/05/2017,, , 
, Revision: 9, Authorised, Last updated: 26/04/2021
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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: 6, Authorised, Last updated: 26/04/2021
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Human medicine European public assessment report (EPAR): Galafold (updated)
migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,, , Revision: 12, Authorised, Last updated: 23/04/2021
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 12, Authorised, Last updated: 23/04/2021
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 9, Authorised, Last updated: 23/04/2021
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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): Coagadex
Human coagulation factor X, Factor X Deficiency
Date of authorisation: 16/03/2016,, , Revision: 7, Authorised, Last updated: 09/04/2021