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 17/06/2019

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)
Menopause
Anatomical therapeutic chemical (ATC) code
G03
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
3
Date of issue of marketing authorisation valid throughout the European Union
08/01/2018
Contact address

Rue Belliard 40
1040 Brussels
Belgium

Product information

16/04/2019 Intrarosa - EMEA/H/C/004138 - IAIN/0006/G

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

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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