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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, , , , 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): 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): Tevagrastim (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008, , Revision: 17, Authorised, Last updated: 24/05/2023
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Human medicine European public assessment report (EPAR): Semglee (updated)

insulin glargine, Diabetes Mellitus
Date of authorisation: 23/03/2018, , , Revision: 8, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Nivestim (updated)

filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 07/06/2010, , Revision: 27, Authorised, Last updated: 23/05/2023
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Human medicine European public assessment report (EPAR): Kirsty (previously Kixelle) (updated)

insulin aspart, Diabetes Mellitus
Date of authorisation: 05/02/2021, , , Revision: 2, 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): Remsima (updated)

infliximab, Arthritis, Psoriatic; Spondylitis, Ankylosing; Colitis, Ulcerative; Psoriasis; Crohn Disease; Arthritis, Rheumatoid
Date of authorisation: 10/09/2013, , Revision: 34, Authorised, Last updated: 17/05/2023
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Human medicine European public assessment report (EPAR): Pombiliti (updated)

Cipaglucosidase alfa, Glycogen Storage Disease Type II
Date of authorisation: 20/03/2023, , , 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): Bekemv (updated)

Eculizumab, Hemoglobinuria, Paroxysmal
Date of authorisation: 19/04/2023, , 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, , , , 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): Rydapt (updated)

Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis
Date of authorisation: 18/09/2017, , Revision: 10, Authorised, Last updated: 11/05/2023
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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: 14, Authorised, Last updated: 10/05/2023