Intrarosa
prasterone
Table of contents
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.
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Intrarosa : EPAR - Summary for the public (PDF/77.5 KB)
First published: 14/02/2018
Last updated: 14/02/2018 -
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Intrarosa : EPAR - Risk-management-plan summary (PDF/104.18 KB)
First published: 14/02/2018
Last updated: 14/02/2018
EMA/70766/2018
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) |
Postmenopause
|
Anatomical therapeutic chemical (ATC) code |
G03XX01
|
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 | |
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Marketing-authorisation holder |
Endoceutics S.A.
|
Revision |
6
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Date of issue of marketing authorisation valid throughout the European Union |
08/01/2018
|
Contact address |
Rue Belliard 40 |
Product information
15/09/2022 Intrarosa - EMEA/H/C/004138 - R/0022
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.