Prasterone

Active substance
Prasterone
Domain
Metabolism and Endocrinology
Reason of inclusion in Horizonscan Geneesmiddelen
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.

1. Product

Proprietary name
Intrarosa
Manufacturer
EndoCeutics
Mechanism of action
Hormonal therapy
Route of administration
Vaginal
Therapeutical formulation
Pessary
Budgetting framework
Extramural (GVS)

2. 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 comments
Positieve CHMP opinie november 2017, geregistreerd per januari 2018.

3. Therapeutic value

Therapeutic value
No judgement
Duration 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.