Prasterone Medicine 09 January 2018 Extended indication Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms. Therapeutic value No judgement Total cost Registration phase Registered Product Active substance Prasterone Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Hormonal disorders Extended indication Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms. Current proprietary name Already available biosimilars / generics Proprietary name Intrarosa Manufacturer EndoCeutics Portfolio holder Mechanism of action Unknown Route of administration Vaginal Therapeutical formulation Pessary Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date February 2016 Expected Registration January 2018 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie november 2017, geregistreerd per januari 2018. Therapeutic value Current treatment options Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 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 Unknown Indication extensions References Additional remarks Other information Additional remarks