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499 results
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Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,,
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, Revision: 7, Authorised, Last updated: 30/11/2020
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Human medicine European public assessment report (EPAR): Aplidin
, Last updated: 26/11/2020
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Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,,
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, Revision: 3, Authorised, Last updated: 24/11/2020
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Human medicine European public assessment report (EPAR): Vyndaqel
tafamidis, Amyloidosis
Date of authorisation: 16/11/2011,,
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, Revision: 17, Authorised, Last updated: 23/11/2020
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,,
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, Revision: 14, Authorised, Last updated: 20/11/2020
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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: 6, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Cablivi
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,,
, Revision: 4, Authorised, Last updated: 20/11/2020
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Human medicine European public assessment report (EPAR): Procysbi
mercaptamine bitartrate, Cystinosis
Date of authorisation: 05/09/2013,, Revision: 13, Authorised, Last updated: 17/11/2020
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Human medicine European public assessment report (EPAR): Besponsa
inotuzumab ozogamicin, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 28/06/2017,,
, Revision: 7, Authorised, Last updated: 16/11/2020
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Human medicine European public assessment report (EPAR): Xermelo
telotristat etiprate, Carcinoid Tumor, Neuroendocrine Tumors
Date of authorisation: 17/09/2017,,
, Revision: 11, Authorised, Last updated: 11/11/2020
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Human medicine European public assessment report (EPAR): Zolgensma
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 1, Authorised, Last updated: 09/11/2020
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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): Zejula
Niraparib (tosylate monohydrate), Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms
Date of authorisation: 16/11/2017,,
, Revision: 11, Authorised, Last updated: 06/11/2020
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Human medicine European public assessment report (EPAR): Defitelio
defibrotide, Hepatic Veno-Occlusive Disease
Date of authorisation: 18/10/2013,,
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, Revision: 12, Authorised, Last updated: 05/11/2020
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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial, Hypophosphatemic Rickets, X-Linked Dominant
Date of authorisation: 19/02/2018,,
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, Revision: 6, Authorised, Last updated: 04/11/2020
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Human medicine European public assessment report (EPAR): Alprolix
eftrenonacog alfa, Hemophilia B
Date of authorisation: 12/05/2016,,
, Revision: 5, Authorised, Last updated: 04/11/2020
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Human medicine European public assessment report (EPAR): NexoBrid
concentrate of proteolytic enzymes enriched in bromelain, Debridement
Date of authorisation: 18/12/2012,,
, Revision: 10, Authorised, Last updated: 03/11/2020
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Human medicine European public assessment report (EPAR): Spinraza
nusinersen sodium, Muscular Atrophy, Spinal
Date of authorisation: 30/05/2017,,
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, Revision: 10, Authorised, Last updated: 03/11/2020
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Human medicine European public assessment report (EPAR): Palynziq
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,,
, Revision: 1, Authorised, Last updated: 30/10/2020
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Human medicine European public assessment report (EPAR): Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain, Influenza, Human
Date of authorisation: 20/05/2016,,
, Revision: 6, Authorised, Last updated: 29/10/2020
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Human medicine European public assessment report (EPAR): Hetlioz
tasimelteon, Sleep Disorders, Circadian Rhythm
Date of authorisation: 03/07/2015,, Revision: 6, Authorised, Last updated: 29/10/2020
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Human medicine European public assessment report (EPAR): Bronchitol
mannitol, Cystic Fibrosis
Date of authorisation: 13/04/2012,, Revision: 15, Authorised, Last updated: 28/10/2020
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Human medicine European public assessment report (EPAR): Mozobil
Plerixafor, Multiple Myeloma, Hematopoietic Stem Cell Transplantation, Lymphoma
Date of authorisation: 30/07/2009,, Revision: 19, Authorised, Last updated: 27/10/2020
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Human medicine European public assessment report (EPAR): SomaKit TOC
edotreotide, Neuroendocrine Tumors, Radionuclide Imaging
Date of authorisation: 08/12/2016,,
, Revision: 6, Authorised, Last updated: 20/10/2020
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Human medicine European public assessment report (EPAR): Cystadrops
mercaptamine hydrochloride, Cystinosis
Date of authorisation: 18/01/2017,, Revision: 7, Authorised, Last updated: 16/10/2020