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380 results
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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,
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, Revision: 13, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Lamzede (updated)
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 6, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Natpar (updated)
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , 
, Revision: 14, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Namuscla (updated)
Mexiletine hydrochloride, Myotonic Disorders
Date of authorisation: 18/12/2018,, Revision: 5, Authorised, Last updated: 22/02/2023
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Human medicine European public assessment report (EPAR): Oxbryta (updated)
Voxelotor, Anemia; Anemia, Hemolytic; Anemia, Sickle Cell
Date of authorisation: 14/02/2022,, , Revision: 2, Authorised, Last updated: 20/02/2023
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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: 13, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Nulibry (updated)
fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors
Date of authorisation: 15/09/2022,, , Revision: 1, Authorised, Last updated: 20/02/2023
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Human medicine European public assessment report (EPAR): Amglidia
glibenclamide, Diabetes Mellitus
Date of authorisation: 24/05/2018,, Revision: 5, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Enhertu
trastuzumab deruxtecan, Breast Neoplasms
Date of authorisation: 18/01/2021,, , Revision: 10, Authorised, Last updated: 16/02/2023
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Human medicine European public assessment report (EPAR): Ondexxya
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,, , Revision: 13, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): Strensiq
asfotase alfa, Hypophosphatasia
Date of authorisation: 28/08/2015,, , , Revision: 16, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): NexoBrid
proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,, Revision: 14, Authorised, Last updated: 15/02/2023
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Human medicine European public assessment report (EPAR): Zejula
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 19, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 9, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Tavneos
Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022,, , Revision: 2, Authorised, Last updated: 13/02/2023
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Human medicine European public assessment report (EPAR): Sylvant
siltuximab, Giant Lymph Node Hyperplasia
Date of authorisation: 22/05/2014,
, , Revision: 12, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Epclusa
Sofosbuvir, velpatasvir, Hepatitis C, Chronic
Date of authorisation: 06/07/2016,, Revision: 19, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Harvoni
ledipasvir, Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 17/11/2014,, Revision: 27, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Sovaldi
Sofosbuvir, Hepatitis C, Chronic
Date of authorisation: 16/01/2014,, Revision: 27, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,, , , Revision: 14, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Spevigo
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
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 4, Authorised, Last updated: 09/02/2023
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Human medicine European public assessment report (EPAR): Imcivree
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): Evrysdi
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): Pandemic Influenza Vaccine H5N1 Baxter AG
influenza vaccine (whole virion, inactivated) containing antigen of: A/Vietnam/1203/2004 (H5N1), Influenza, Human; Immunization; Disease Outbreaks
Date of authorisation: 16/10/2009,, Revision: 8, Authorised, Last updated: 06/02/2023