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 13/11/2018

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 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 Limited
Revision
6
Date of issue of marketing authorisation valid throughout the European Union
14/01/2015
Contact address
33 Kingsway
Holborn
London WC2B 6UF
United Kingdom

Product information

23/07/2018 Senshio - EMEA/H/C/002780 - IB/0023

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

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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