Extended indication Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women havin
Therapeutic value No judgement
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.
Proprietary name Intrarosa
Manufacturer EndoCeutics
Route of administration Vaginal
Therapeutical formulation Pessary
Budgetting framework Extramural (GVS)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2016
Expected Registration January 2018
Orphan drug No
Registration phase Registered
Additional remarks Positieve CHMP opinie november 2017, geregistreerd per januari 2018.

Therapeutic value

Therapeutic value No judgement

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

There is currently nothing known about the expected cost.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.