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Medicine
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Human medicine European public assessment report (EPAR): Libmeldy (updated)
atidarsagene autotemcel, Leukodystrophy, Metachromatic
Date of authorisation: 17/12/2020,,
, Revision: 4, Authorised, Last updated: 24/06/2022
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Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,,
, Revision: 2, Authorised, Last updated: 22/06/2022
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Human medicine European public assessment report (EPAR): Givlaari (updated)
Givosiran, Porphyrias, Hepatic
Date of authorisation: 02/03/2020,,
, Revision: 4, Authorised, Last updated: 22/06/2022
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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: 17, Authorised, Last updated: 22/06/2022
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Human medicine European public assessment report (EPAR): Opsumit (updated)
Macitentan, Hypertension, Pulmonary
Date of authorisation: 20/12/2013,, Revision: 20, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Kanuma (updated)
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,,
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, Revision: 8, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Adcetris (updated)
Brentuximab vedotin, Lymphoma, Non-Hodgkin; Hodgkin Disease
Date of authorisation: 25/10/2012,,
, Revision: 33, Authorised, Last updated: 21/06/2022
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Human medicine European public assessment report (EPAR): Maviret (updated)
glecaprevir, pibrentasvir, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,,
, Revision: 16, Authorised, Last updated: 20/06/2022
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Human medicine European public assessment report (EPAR): Carvykti (updated)
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,,
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, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Kisplyx (updated)
lenvatinib mesilate, Carcinoma, Renal Cell
Date of authorisation: 25/08/2016,, Revision: 17, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Ninlaro (updated)
ixazomib citrate, Multiple Myeloma
Date of authorisation: 21/11/2016,,
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, Revision: 14, Authorised, Last updated: 17/06/2022
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Human medicine European public assessment report (EPAR): Kyprolis (updated)
carfilzomib, Multiple Myeloma
Date of authorisation: 19/11/2015,,
, Revision: 20, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,,
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, Revision: 3, Authorised, Last updated: 15/06/2022
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Human medicine European public assessment report (EPAR): Vidaza (updated)
azacitidine, Myelodysplastic Syndromes
Date of authorisation: 17/12/2008,, Revision: 25, Authorised, Last updated: 14/06/2022
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Human medicine European public assessment report (EPAR): Signifor (updated)
pasireotide, Acromegaly; Pituitary ACTH Hypersecretion
Date of authorisation: 24/04/2012,, Revision: 13, Authorised, Last updated: 14/06/2022
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Human medicine European public assessment report (EPAR): Minjuvi (updated)
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,,
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, Revision: 3, Authorised, Last updated: 13/06/2022
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Human medicine European public assessment report (EPAR): Palynziq (updated)
Pegvaliase, Phenylketonurias
Date of authorisation: 03/05/2019,,
, Revision: 6, Authorised, Last updated: 10/06/2022
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Human medicine European public assessment report (EPAR): Cabometyx (updated)
cabozantinib (s)-malate, Carcinoma, Renal Cell; Carcinomas, Hepatocellular
Date of authorisation: 09/09/2016,, Revision: 14, Authorised, Last updated: 09/06/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,,
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, Revision: 10, Authorised, Last updated: 08/06/2022
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Human medicine European public assessment report (EPAR): Polivy (updated)
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,,
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, Revision: 4, Authorised, Last updated: 08/06/2022
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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: 20, Authorised, Last updated: 07/06/2022
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Human medicine European public assessment report (EPAR): Symkevi (updated)
tezacaftor, ivacaftor, Cystic Fibrosis
Date of authorisation: 31/10/2018,,
, Revision: 10, Authorised, Last updated: 07/06/2022
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Human medicine European public assessment report (EPAR): Vosevi (updated)
Sofosbuvir, velpatasvir, voxilaprevi, Hepatitis C, Chronic
Date of authorisation: 26/07/2017,,
, Revision: 12, Authorised, Last updated: 02/06/2022
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Human medicine European public assessment report (EPAR): Bylvay (updated)
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,,
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, Revision: 1, Authorised, Last updated: 31/05/2022
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Human medicine European public assessment report (EPAR): Revestive
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,,
, Revision: 19, Authorised, Last updated: 23/05/2022