Esmya

RSS

ulipristal

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

Overview

An overview of Esmya and why it is authorised in the EU

This EPAR was last updated on 08/08/2018

Authorisation details

Product details
Name
Esmya
Agency product number
EMEA/H/C/002041
Active substance
ulipristal acetate
International non-proprietary name (INN) or common name
ulipristal
Therapeutic area (MeSH)
Leiomyoma
Anatomical therapeutic chemical (ATC) code
G03XB02
Publication details
Marketing-authorisation holder
Gedeon Richter Ltd 
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
22/02/2012
Contact address
Gedeon Richter Ltd
Gyömroi út 19-21
HU-1103 Budapest
Hungary

Product information

25/07/2018 Esmya - EMEA/H/C/002041 - A20/0043

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

Ulipristal acetate is indicated for pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.

Assessment history

Changes since initial authorisation of medicine

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