Basic Information
Esmya
Regulatory Information
EMEA/H/C/002041
February 22, 2012
December 15, 2011
16
February 3, 2021
Company Information
Hungary
Gedeon Richter Ltd Gyömroi út 19-21 HU-1103 Budapest
Gedeon Richter PLC. , Dorog
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
Esmya is a medicine for treating moderate to severe symptoms of uterine fibroids. Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus). Esmya is for use only in women who have not yet reached the menopause and in whom fibroid embolisation (a non-surgical procedure to block off the arteries that feed the fibroids) or surgery are not suitable or have not worked. The medicine contains the active substance ulipristal acetate.