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242 results
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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: 35, 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): Ratiograstim (updated)
filgrastim, Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Date of authorisation: 15/09/2008,, Revision: 16, 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,, , 
, 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): 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): 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,, , , 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): 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): 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