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Human medicine European public assessment report (EPAR): Brineura (updated)
cerliponase alfa, Neuronal Ceroid-Lipofuscinoses
Date of authorisation: 30/05/2017,
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, Revision: 6, Authorised, Last updated: 16/08/2022
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Human medicine European public assessment report (EPAR): Upstaza (updated)
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , , Authorised, Last updated: 10/08/2022
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Human medicine European public assessment report (EPAR): Zejula (updated)
Niraparib (tosilate monohydrate), Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms
Date of authorisation: 16/11/2017,, , Revision: 18, Authorised, Last updated: 09/08/2022
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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: 8, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Signifor (updated)
pasireotide, Acromegaly; Pituitary ACTH Hypersecretion
Date of authorisation: 24/04/2012,, Revision: 14, Authorised, Last updated: 09/08/2022
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Human medicine European public assessment report (EPAR): Cometriq (updated)
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 25, Authorised, Last updated: 08/08/2022
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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: 8, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Sogroya (updated)
Somapacitan, Growth
Date of authorisation: 31/03/2021,, , Revision: 1, Authorised, Last updated: 01/08/2022
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Human medicine European public assessment report (EPAR): Elzonris (updated)
tagraxofusp, Lymphoma
Date of authorisation: 07/01/2021,, , , Revision: 4, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Cresemba (updated)
isavuconazole, Aspergillosis
Date of authorisation: 15/10/2015,, Revision: 14, Authorised, Last updated: 29/07/2022
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Human medicine European public assessment report (EPAR): Tegsedi (updated)
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,, , , Revision: 11, Authorised, Last updated: 28/07/2022
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Human medicine European public assessment report (EPAR): Xenpozyme (updated)
Olipudase alfa, Acid sphingomyelinase deficiency (ASMD) type A/B or type B
Date of authorisation: 24/06/2022,, , Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos) (updated)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,, Revision: 7, Authorised, Last updated: 27/07/2022
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Human medicine European public assessment report (EPAR): Fintepla (updated)
Fenfluramine hydrochloride, Epilepsies, Myoclonic
Date of authorisation: 18/12/2020,, , Revision: 3, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Cablivi (updated)
Caplacizumab, Purpura, Thrombotic Thrombocytopenic
Date of authorisation: 30/08/2018,, , Revision: 6, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Revestive (updated)
teduglutide, Malabsorption Syndromes
Date of authorisation: 30/08/2012,, , Revision: 20, Authorised, Last updated: 26/07/2022
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Human medicine European public assessment report (EPAR): Mylotarg (updated)
gemtuzumab ozogamicin, Leukemia, Myeloid, Acute
Date of authorisation: 19/04/2018,, , Revision: 10, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Zolgensma (updated)
onasemnogene abeparvovec, Muscular Atrophy, Spinal
Date of authorisation: 18/05/2020,, , 
, Revision: 6, Authorised, Last updated: 21/07/2022
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Human medicine European public assessment report (EPAR): Kinpeygo (updated)
budesonide, Glomerulonephritis, IGA
Date of authorisation: 15/07/2022,, , , Authorised, Last updated: 18/07/2022
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 7, Authorised, Last updated: 14/07/2022
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Human medicine European public assessment report (EPAR): Yescarta
axicabtagene ciloleucel, Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 23/08/2018,, , Revision: 8, Authorised, Last updated: 12/07/2022
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Human medicine European public assessment report (EPAR): Darzalex
Daratumumab, Multiple Myeloma
Date of authorisation: 20/05/2016,, , Revision: 19, Authorised, Last updated: 11/07/2022
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Human medicine European public assessment report (EPAR): Dovprela (previously Pretomanid FGK)
Pretomanid, Tuberculosis, Multidrug-Resistant
Date of authorisation: 31/07/2020,, , , Revision: 6, Authorised, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Zynteglo
Autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene, beta-Thalassemia
Date of authorisation: 29/05/2019,
, , , , , Revision: 5, Withdrawn, Last updated: 08/07/2022
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Human medicine European public assessment report (EPAR): Filsuvez
dry extract from birch bark (DER 5-10 : 1), extraction solvent n-heptane 95% (w/w), Epidermolysis Bullosa Dystrophica; Epidermolysis Bullosa, Junctional
Date of authorisation: 21/06/2022,, Authorised, Last updated: 04/07/2022