Prasterone Intrarosa Active substance PrasteroneDomain Metabolism and EndocrinologyReason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)Main indication Hormonal disordersExtended indication Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms. 1. Product Proprietary name IntrarosaManufacturer EndoCeuticsMechanism of action Hormonal therapyRoute of administration VaginalTherapeutical formulation PessaryBudgetting framework Extramural (GVS) 2. Registration Registration route Centralised (EMA)Type of trajectory Normal trajectorySubmission date February 2016Expected Registration January 2018Orphan drug NoRegistration phase RegisteredAdditional comments Positieve CHMP opinie november 2017, geregistreerd per januari 2018. 3. Therapeutic value Therapeutic value No judgementDuration of treatment Not found 4. Expected patient volume per year There is currently nothing known about the expected patient volume. 5. Expected cost per patient per year There is currently nothing known about the expected cost. 6. Potential total cost per year There is currently nothing known about the possible total cost. 7. Off label use There is currently nothing known about off label use. 8. Indication extension There is currently nothing known about indication extensions. 9. Other information There is currently no futher information available.