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 05/11/2018

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 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 Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
07/01/2018
Contact address
Salisbury House
London Wall
London EC2M 5PS
United Kingdom

Product information

03/10/2018 Intrarosa - EMEA/H/C/004138 - IAIN/0002/G

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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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