Fezolinetant Medicine 07 June 2022 Extended indication Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Therapeutic value No estimate possible yet Total cost Registration phase Positive CHMP opinion Product Active substance Fezolinetant Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. Current proprietary name Already available biosimilars / generics Proprietary name unknown Manufacturer Astellas Portfolio holder Astellas Mechanism of action Receptor antagonist Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Neurokinine-3-receptor antagonist Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date August 2022 Expected Registration December 2023 Orphan drug No Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie oktober 2023 Therapeutic value Current treatment options De standaard geneesmiddelbehandeling voor vasomotorische symptomen in de menopauze is hormoontherapie met een combinatie van oestrogeen en progesteron, of oestrogeen alleen. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks De lijstprijs zal eind 2023 bekend zijn. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References adisinsght Additional remarks Other information Additional remarks