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.
Esmya : EPAR - Medicine overview (PDF/85.29 KB)Adopted
First published: 15/03/2012
Last updated: 08/08/2018
Esmya : EPAR - Risk-management-plan summary (PDF/69.19 KB)
First published: 19/11/2018
Last updated: 23/01/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Gedeon Richter Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
25/07/2018 Esmya - EMEA/H/C/002041 - A20/0043
- 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
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Sex hormones and modulators of the genital system
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.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 202004/09/2020
PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids18/05/2018