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200 results
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Human medicine European public assessment report (EPAR): Vyxeos liposomal (previously known as Vyxeos)
daunorubicin hydrochloride, cytarabine, Leukemia, Myeloid, Acute
Date of authorisation: 23/08/2018,
, Revision: 8, Authorised, Last updated: 10/11/2022
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Human medicine European public assessment report (EPAR): Roctavian
valoctocogene roxaparvovec,
Date of authorisation: 24/08/2022,
, , 
, Revision: 1, Authorised, Last updated: 09/11/2022
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Human medicine European public assessment report (EPAR): Crysvita
Burosumab, Hypophosphatemia, Familial; Hypophosphatemic Rickets, X-Linked Dominant; Osteomalacia
Date of authorisation: 19/02/2018,, , Revision: 10, Authorised, Last updated: 08/11/2022
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Human medicine European public assessment report (EPAR): Waylivra
Volanesorsen sodium, Hyperlipoproteinemia Type I
Date of authorisation: 03/05/2019,, , , Revision: 6, Authorised, Last updated: 08/11/2022
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Human medicine European public assessment report (EPAR): Tegsedi
inotersen sodium, Amyloidosis
Date of authorisation: 06/07/2018,, 
, , Revision: 12, Authorised, Last updated: 08/11/2022
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Human medicine European public assessment report (EPAR): Kymriah
tisagenlecleucel, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse
Date of authorisation: 22/08/2018,, , Revision: 13, Authorised, Last updated: 07/11/2022
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Human medicine European public assessment report (EPAR): Scenesse
afamelanotide, Protoporphyria, Erythropoietic
Date of authorisation: 22/12/2014,, , 
, Revision: 9, Authorised, Last updated: 04/11/2022
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Human medicine European public assessment report (EPAR): Raxone
idebenone, Optic Atrophy, Hereditary, Leber
Date of authorisation: 08/09/2015,, , , Revision: 8, Authorised, Last updated: 27/10/2022
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Human medicine European public assessment report (EPAR): Lamzede
velmanase alfa, alpha-Mannosidosis
Date of authorisation: 23/03/2018,, , , Revision: 5, Authorised, Last updated: 27/10/2022
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Human medicine European public assessment report (EPAR): Myalepta
Metreleptin, Lipodystrophy, Familial Partial
Date of authorisation: 29/07/2018,, , , Revision: 7, Authorised, Last updated: 27/10/2022
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Human medicine European public assessment report (EPAR): Obizur
susoctocog alfa, Hemophilia A
Date of authorisation: 11/11/2015,, , Revision: 10, Authorised, Last updated: 26/10/2022
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Human medicine European public assessment report (EPAR): Cometriq
cabozantinib, Thyroid Neoplasms
Date of authorisation: 21/03/2014,, Revision: 26, Authorised, Last updated: 25/10/2022
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 8, Authorised, Last updated: 25/10/2022
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Human medicine European public assessment report (EPAR): SomaKit TOC
edotreotide, Neuroendocrine Tumors; Radionuclide Imaging
Date of authorisation: 08/12/2016,, Revision: 12, Authorised, Last updated: 25/10/2022
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Human medicine European public assessment report (EPAR): Iclusig
ponatinib, Leukemia, Myeloid; Leukemia, Lymphoid
Date of authorisation: 01/07/2013,, , Revision: 24, Authorised, Last updated: 21/10/2022
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Human medicine European public assessment report (EPAR): Ravicti
glycerol phenylbutyrate, Urea Cycle Disorders, Inborn
Date of authorisation: 26/11/2015,, Revision: 15, Authorised, Last updated: 20/10/2022
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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: 22, Authorised, Last updated: 18/10/2022
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Human medicine European public assessment report (EPAR): Oxlumo
Lumasiran sodium, Hyperoxaluria, Primary
Date of authorisation: 19/11/2020,, , Revision: 3, Authorised, Last updated: 13/10/2022
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Human medicine European public assessment report (EPAR): Evkeeza
Evinacumab, Hypercholesterolemia
Date of authorisation: 17/06/2021,, , Revision: 2, Authorised, Last updated: 12/10/2022
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Human medicine European public assessment report (EPAR): Blenrep
belantamab mafodotin, Multiple Myeloma
Date of authorisation: 25/08/2020,, , , Revision: 4, Authorised, Last updated: 12/10/2022
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Human medicine European public assessment report (EPAR): Hetlioz
tasimelteon, Sleep Disorders, Circadian Rhythm
Date of authorisation: 03/07/2015,, Revision: 9, Authorised, Last updated: 11/10/2022
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Human medicine European public assessment report (EPAR): Granupas (previously Para-aminosalicylic acid Lucane)
Para-aminosalicylic acid, Tuberculosis
Date of authorisation: 07/04/2014,, Revision: 10, Authorised, Last updated: 11/10/2022
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Human medicine European public assessment report (EPAR): Bylvay
Odevixibat, Cholestasis, Intrahepatic
Date of authorisation: 16/07/2021,, , , Revision: 2, Authorised, Last updated: 05/10/2022
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Human medicine European public assessment report (EPAR): Upstaza
Eladocagene exuparvovec, Amino Acid Metabolism, Inborn Errors
Date of authorisation: 18/07/2022,, , , Revision: 2, Authorised, Last updated: 30/09/2022
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Human medicine European public assessment report (EPAR): Nulibry
fosdenopterin hydrobromide dihydrate, Metal Metabolism, Inborn Errors
Date of authorisation: 15/09/2022,, , Authorised, Last updated: 30/09/2022