Senshio

RSS

ospemifene

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

Overview

This is a summary of the European public assessment report (EPAR) for Senshio. 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 Senshio.

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

This EPAR was last updated on 04/11/2019

Authorisation details

Product details
Name
Senshio
Agency product number
EMEA/H/C/002780
Active substance
ospemifene
International non-proprietary name (INN) or common name
ospemifene
Therapeutic area (MeSH)
Postmenopause
Anatomical therapeutic chemical (ATC) code
G03XC05
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
Shionogi B.V.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
14/01/2015
Contact address

Kingsfordweg 151
1043GR Amsterdam
The Netherlands

Product information

21/10/2019 Senshio - EMEA/H/C/002780 - R/0028

Contents

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

Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women who are not candidates for local vaginal oestrogen therapy.

Assessment history

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