← Drug database

Intrarosa (prasterone)

Region
🇪🇺 EU
Active substance
prasterone
Company
Endoceutics S.A.
Status
Authorised
Therapeutic area
Postmenopause
CHMP opinion
Thu 09 Nov 2017
EU approval
Mon 08 Jan 2018
Application
EMEA/H/C/004138
ATC
G03XX01
Official record
www.ema.europa.eu

Indication

Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.

Regulatory milestones

No milestones recorded in the last year.

Follow Intrarosa

Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.

Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.