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Medicine
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Human medicine European public assessment report (EPAR): Procysbi (updated)
mercaptamine bitartrate, Cystinosis
Date of authorisation: 05/09/2013,
, Revision: 16, Authorised, Last updated: 26/05/2023
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Human medicine European public assessment report (EPAR): Livmarli (updated)
Maralixibat chloride, Alagille Syndrome
Date of authorisation: 09/12/2022,
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, Revision: 1, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Galafold (updated)
Migalastat hydrochloride, Fabry Disease
Date of authorisation: 25/05/2016,, , Revision: 16, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Lopinavir/Ritonavir Mylan (updated)
lopinavir, ritonavir, HIV Infections
Date of authorisation: 14/01/2016,
, Revision: 16, Authorised, Last updated: 25/05/2023
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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: 14, Authorised, Last updated: 25/05/2023
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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: 19, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Alofisel (updated)
darvadstrocel, Rectal Fistula
Date of authorisation: 23/03/2018,, , Revision: 10, Authorised, Last updated: 25/05/2023
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Human medicine European public assessment report (EPAR): Darunavir Mylan (updated)
darunavir, HIV Infections
Date of authorisation: 03/01/2017,, Revision: 13, Authorised, Last updated: 23/05/2023
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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,, , , Revision: 9, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Orphacol (updated)
cholic acid, Digestive System Diseases; Metabolism, Inborn Errors
Date of authorisation: 12/09/2013,
Date of refusal: 25/05/2012,, , , Revision: 13, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Hemlibra (updated)
Emicizumab, Hemophilia A
Date of authorisation: 23/02/2018,, Revision: 15, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Fingolimod Accord (updated)
fingolimod hydrochloride , Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 25/06/2020,, Revision: 3, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Ritonavir Mylan (updated)
ritonavir, HIV Infections
Date of authorisation: 09/11/2017,, Revision: 14, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Atazanavir Mylan (updated)
atazanavir (as sulfate), HIV Infections
Date of authorisation: 22/08/2016,, Revision: 14, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma (updated)
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Revision: 3, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Febuxostat Mylan (updated)
febuxostat, Hyperuricemia; Arthritis, Gouty; Gout
Date of authorisation: 15/06/2017,, Revision: 11, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Farydak (updated)
panobinostat lactate anhydrous, Multiple Myeloma
Date of authorisation: 28/08/2015,, Revision: 12, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Sirturo (updated)
bedaquiline fumarate, Tuberculosis, Multidrug-Resistant
Date of authorisation: 05/03/2014,, , 
, Revision: 21, Authorised, Last updated: 16/05/2023
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Human medicine European public assessment report (EPAR): Cablivi (updated)
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,, Revision: 8, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Imnovid (previously Pomalidomide Celgene) (updated)
Pomalidomide, Multiple Myeloma
Date of authorisation: 05/08/2013,, , Revision: 22, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Darunavir Krka (updated)
darunavir, HIV Infections
Date of authorisation: 26/01/2018,, Revision: 10, Authorised, Last updated: 15/05/2023
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Human medicine European public assessment report (EPAR): Bylvay (updated)
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,, , , Revision: 2, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Tibsovo (updated)
Ivosidenib, Leukemia, Myeloid, Acute; Cholangiocarcinoma
Date of authorisation: 04/05/2023,, , Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Pemazyre (updated)
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 5, Authorised, Last updated: 12/05/2023
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Human medicine European public assessment report (EPAR): Lenvima (updated)
lenvatinib mesilate, Thyroid Neoplasms
Date of authorisation: 28/05/2015,, , Revision: 18, Authorised, Last updated: 11/05/2023