Senshio

RSS

ospemifene

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

Overview

Senshio is a medicine used to treat moderate to severe symptoms of vulvovaginal atrophy (dryness, irritation and soreness around the genital area, and painful sexual intercourse) in women who have been through the menopause. It is used in women who cannot use oestrogen therapy applied in the vagina. 

Senshio contains the active substance ospemifene.

This EPAR was last updated on 07/01/2020

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
9
Date of issue of marketing authorisation valid throughout the European Union
14/01/2015
Contact address

Kingsfordweg 151
1043GR Amsterdam
The Netherlands

Product information

22/11/2019 Senshio - EMEA/H/C/002780 - PSUSA/00010340/201902

Contents

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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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