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Medicine
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,,
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, Revision: 6, Authorised, Last updated: 10/12/2020
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Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,,
, Revision: 1, Authorised, Last updated: 09/12/2020
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Human medicine European public assessment report (EPAR): Caprelsa
Vandetanib, Thyroid Neoplasms
Date of authorisation: 16/02/2012,,
, Revision: 18, Authorised, Last updated: 07/12/2020
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Human medicine European public assessment report (EPAR): Libtayo
Cemiplimab, Carcinoma, Squamous Cell
Date of authorisation: 28/06/2019,,
, Revision: 5, Authorised, Last updated: 07/12/2020
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Human medicine European public assessment report (EPAR): Onpattro
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,,
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, Revision: 8, Authorised, Last updated: 04/12/2020
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Human medicine European public assessment report (EPAR): Esbriet
Pirfenidone, Idiopathic Pulmonary Fibrosis
Date of authorisation: 27/02/2011,, Revision: 26, Authorised, Last updated: 03/12/2020
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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): 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): Isentress
Raltegravir, HIV Infections
Date of authorisation: 19/12/2007,, Revision: 37, 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): Cabometyx
cabozantinib (s)-malate, Carcinoma, Renal Cell
Date of authorisation: 09/09/2016,,
, Revision: 9, 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