Esmya

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ulipristal

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

Overview

Esmya is a medicine used to treat moderate to severe symptoms of uterine fibroids in adult women who have not yet reached the menopause. Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus).

Esmya can be given:

  • as a single treatment course in women before they have surgery for their fibroids;
  • as intermittent treatment for women in whom surgery is not suitable.

The medicine contains the active substance ulipristal acetate.

This EPAR was last updated on 19/11/2018

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
14
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

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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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