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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,
, Revision: 10, Authorised, Last updated: 22/09/2023
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Human medicine European public assessment report (EPAR): Strimvelis
autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells, Severe Combined Immunodeficiency
Date of authorisation: 26/05/2016,
, , Revision: 9, Authorised, Last updated: 19/09/2023
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Human medicine European public assessment report (EPAR): Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
Chenodeoxycholic acid, Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
Date of authorisation: 10/04/2017,, , 
, Revision: 6, Authorised, Last updated: 18/09/2023
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Human medicine European public assessment report (EPAR): Mepsevii
vestronidase alfa, Mucopolysaccharidosis VII
Date of authorisation: 23/08/2018,, , , Revision: 7, Authorised, Last updated: 14/09/2023
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Human medicine European public assessment report (EPAR): Roctavian
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,, , 
, Revision: 3, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Pemazyre
pemigatinib, Cholangiocarcinoma
Date of authorisation: 26/03/2021,, , , Revision: 6, Authorised, Last updated: 12/09/2023
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Human medicine European public assessment report (EPAR): Ledaga
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 9, Authorised, Last updated: 11/09/2023
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Human medicine European public assessment report (EPAR): Natpar
parathyroid hormone, Hypoparathyroidism
Date of authorisation: 24/04/2017,, , , Revision: 16, Authorised, Last updated: 08/09/2023
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Human medicine European public assessment report (EPAR): Poteligeo
Mogamulizumab, Sezary Syndrome; Mycosis Fungoides
Date of authorisation: 22/11/2018,, Revision: 6, Authorised, Last updated: 06/09/2023
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Human medicine European public assessment report (EPAR): Qinlock
ripretinib, Gastrointestinal Stromal Tumors
Date of authorisation: 18/11/2021,, , Revision: 5, Authorised, Last updated: 30/08/2023
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Human medicine European public assessment report (EPAR): Enjaymo
sutimlimab, Hemolysis; Anemia, Hemolytic, Autoimmune
Date of authorisation: 15/11/2022,, , Revision: 3, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Cerdelga
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,, , Revision: 16, Authorised, Last updated: 28/08/2023
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Human medicine European public assessment report (EPAR): Kanuma
sebelipase alfa, Lipid Metabolism, Inborn Errors
Date of authorisation: 28/08/2015,, 
, , Revision: 10, Authorised, Last updated: 25/08/2023
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Human medicine European public assessment report (EPAR): Kinpeygo
budesonide, micronised, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , , Revision: 5, Authorised, Last updated: 21/08/2023
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Human medicine European public assessment report (EPAR): Deltyba
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 25, Authorised, Last updated: 14/08/2023
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Human medicine European public assessment report (EPAR): Arikayce liposomal
Amikacin sulfate, Respiratory Tract Infections
Date of authorisation: 27/10/2020,, Revision: 2, Authorised, Last updated: 04/08/2023
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Human medicine European public assessment report (EPAR): Idefirix
Imlifidase, Desensitization, Immunologic; Kidney Transplantation
Date of authorisation: 25/08/2020,, , , Revision: 4, Authorised, Last updated: 01/08/2023
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Human medicine European public assessment report (EPAR): Sogroya
Somapacitan, Growth
Date of authorisation: 31/03/2021,, , Revision: 2, Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Ztalmy
Ganaxolone, Epileptic Syndromes; Spasms, Infantile
Date of authorisation: 26/07/2023,, , Authorised, Last updated: 31/07/2023
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Human medicine European public assessment report (EPAR): Luxturna
voretigene neparvovec, Leber Congenital Amaurosis; Retinitis Pigmentosa
Date of authorisation: 22/11/2018,, , Revision: 7, Authorised, Last updated: 28/07/2023
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Human medicine European public assessment report (EPAR): Abecma
idecabtagene vicleucel, Multiple Myeloma; Neoplasms; Cancer; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Infectious Mononucleosis; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases
Date of authorisation: 18/08/2021,, , , Revision: 6, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Revestive
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,, , Revision: 22, Authorised, Last updated: 27/07/2023
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Human medicine European public assessment report (EPAR): Kaftrio
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,, , Revision: 15, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Carvykti
ciltacabtagene autoleucel, Multiple Myeloma
Date of authorisation: 25/05/2022,, , , Revision: 4, Authorised, Last updated: 26/07/2023
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Human medicine European public assessment report (EPAR): Rydapt
Midostaurin, Leukemia, Myeloid, Acute; Mastocytosis
Date of authorisation: 18/09/2017,, Revision: 11, Authorised, Last updated: 26/07/2023