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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,,
, Revision: 12, Authorised, Last updated: 07/06/2023
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Human medicine European public assessment report (EPAR): Tobi Podhaler (updated)
Tobramycin, Cystic Fibrosis; Respiratory Tract Infections
Date of authorisation: 20/07/2011,, Revision: 20, Authorised, Last updated: 05/06/2023
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Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,,
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, Revision: 11, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Oxervate (updated)
Recombinant human nerve growth factor, Keratitis
Date of authorisation: 06/07/2017,,
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, Revision: 2, Authorised, Last updated: 02/06/2023
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Human medicine European public assessment report (EPAR): Empliciti (updated)
Elotuzumab, Multiple Myeloma
Date of authorisation: 11/05/2016,, Revision: 12, Authorised, Last updated: 01/06/2023
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Human medicine European public assessment report (EPAR): Ondexxya (updated)
andexanet alfa, Drug-Related Side Effects and Adverse Reactions
Date of authorisation: 26/04/2019,,
, Revision: 15, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,,
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, Revision: 11, Authorised, Last updated: 30/05/2023
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Human medicine European public assessment report (EPAR): Qinlock (updated)
ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021,,
, Revision: 3, Authorised, Last updated: 30/05/2023
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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): 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): Kanuma (updated)
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,,
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, 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,,
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, 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): 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,,
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, 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): Rozlytrek (updated)
Entrectinib, Cancer; Carcinoma, Non-Small-Cell Lung
Date of authorisation: 31/07/2020,,
, Revision: 6, 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): Retsevmo (updated)
Selpercatinib, Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms
Date of authorisation: 11/02/2021,,
, Revision: 6, Authorised, Last updated: 12/05/2023
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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: 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