Intrarosa

RSS

prasterone

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Intrarosa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Intrarosa.

For practical information about using Intrarosa, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 20/01/2022

Authorisation details

Product details
Name
Intrarosa
Agency product number
EMEA/H/C/004138
Active substance
Prasterone
International non-proprietary name (INN) or common name
prasterone
Therapeutic area (MeSH)
Postmenopause
Anatomical therapeutic chemical (ATC) code
G03XX01
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Endoceutics S.A.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
08/01/2018
Contact address

Rue Belliard 40
1040 Brussels
Belgium

Product information

20/01/2022 Intrarosa - EMEA/H/C/004138 - IB/0018

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Other sex hormones and modulators of the genital system

Therapeutic indication

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

Assessment history

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