Fezolinetant Medicine 07 June 2022 Extended indication Behandeling van matige tot ernstige menopauze gerelateerde vasomotorische symptomen Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Fezolinetant Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Metabolic diseases Extended indication Behandeling van matige tot ernstige menopauze gerelateerde vasomotorische symptomen 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 September 2022 Expected Registration October 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 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