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Human medicine European public assessment report (EPAR): Kaftrio (updated)
ivacaftor, tezacaftor, elexacaftor, Cystic Fibrosis
Date of authorisation: 21/08/2020,
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, Revision: 6, Authorised, Last updated: 28/01/2022
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Human medicine European public assessment report (EPAR): Kymriah (updated)
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 8, Authorised, Last updated: 28/01/2022
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Human medicine European public assessment report (EPAR): Tavneos (updated)
Avacopan, Microscopic Polyangiitis; Wegener Granulomatosis
Date of authorisation: 11/01/2022,, , Authorised, Last updated: 27/01/2022
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Human medicine European public assessment report (EPAR): Kalydeco (updated)
ivacaftor, Cystic Fibrosis
Date of authorisation: 23/07/2012,
, , Revision: 31, Authorised, Last updated: 26/01/2022
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Human medicine European public assessment report (EPAR): Obiltoxaximab SFL (updated)
Obiltoxaximab, Anthrax
Date of authorisation: 18/11/2020,, , 
, Revision: 1, Authorised, Last updated: 26/01/2022
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Human medicine European public assessment report (EPAR): Xermelo (updated)
telotristat etiprate, Carcinoid Tumor; Neuroendocrine Tumors
Date of authorisation: 17/09/2017,, , Revision: 12, Authorised, Last updated: 25/01/2022
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Human medicine European public assessment report (EPAR): Verkazia (updated)
ciclosporin, Conjunctivitis; Keratitis
Date of authorisation: 06/07/2018,, , Revision: 6, Authorised, Last updated: 25/01/2022
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Human medicine European public assessment report (EPAR): Ledaga (updated)
Chlormethine, Mycosis Fungoides
Date of authorisation: 03/03/2017,, Revision: 8, Authorised, Last updated: 24/01/2022
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Human medicine European public assessment report (EPAR): Strimvelis (updated)
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: 6, Authorised, Last updated: 24/01/2022
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Human medicine European public assessment report (EPAR): Ravicti (updated)
glycerol phenylbutyrate, Urea Cycle Disorders, Inborn
Date of authorisation: 26/11/2015,, , Revision: 14, Authorised, Last updated: 21/01/2022
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Human medicine European public assessment report (EPAR): Ocaliva (updated)
Obeticholic acid, Liver Cirrhosis, Biliary
Date of authorisation: 12/12/2016,, , 
, Revision: 12, Authorised, Last updated: 21/01/2022
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Human medicine European public assessment report (EPAR): Zynteglo (updated)
Autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiglobin BB305 lentiviral vector encoding the beta-A-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,, , , , Revision: 5, Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Voraxaze (updated)
glucarpidase, Metabolic Side Effects of Drugs and Substances
Date of authorisation: 11/01/2022,, , , Authorised, Last updated: 20/01/2022
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Human medicine European public assessment report (EPAR): Takhzyro (updated)
lanadelumab, Angioedemas, Hereditary
Date of authorisation: 22/11/2018,, , , Revision: 7, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Evrysdi (updated)
Risdiplam, Muscular Atrophy, Spinal
Date of authorisation: 26/03/2021,, , Revision: 1, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Onpattro (updated)
patisiran sodium, Amyloidosis, Familial
Date of authorisation: 27/08/2018,, , , Revision: 9, Authorised, Last updated: 19/01/2022
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Human medicine European public assessment report (EPAR): Xaluprine (previously Mercaptopurine Nova Laboratories) (updated)
6-mercaptopurine monohydrate, Leukemia, Lymphoid
Date of authorisation: 09/03/2012,, Revision: 13, Authorised, Last updated: 14/01/2022
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Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane) (updated)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,, Revision: 9, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Revision: 3, Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Artesunate Amivas (updated)
artesunate, Malaria
Date of authorisation: 22/11/2021,, , Authorised, Last updated: 13/01/2022
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Human medicine European public assessment report (EPAR): Scenesse (updated)
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , , Revision: 8, Authorised, Last updated: 12/01/2022
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Human medicine European public assessment report (EPAR): Revestive (updated)
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,, , Revision: 17, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Minjuvi (updated)
Tafasitamab, Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 26/08/2021,, , , Revision: 2, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Deltyba (updated)
Delamanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 27/04/2014,
Date of refusal: 25/07/2013,, , , Revision: 18, Authorised, Last updated: 11/01/2022
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Human medicine European public assessment report (EPAR): Cerdelga (updated)
eliglustat, Gaucher Disease
Date of authorisation: 19/01/2015,, , Revision: 13, Authorised, Last updated: 11/01/2022