An overview of Esmya and why it is authorised in the EU
Esmya : EPAR - Medicine overview (PDF/85.29 KB)Adopted
First published: 15/03/2012
Last updated: 08/08/2018
|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.
PRAC recommends new measures to minimise risk of rare but serious liver injury with Esmya for fibroids18/05/2018