Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 14 August 2018

Indication(s)

Ulipristal acetate is indicated for one treatment course of 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 who are not eligible for surgery.

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Category Value
Agency product number EMEA/H/C/002041
Orphan designation No
Date First Approved 23-02-2012
Type Medicinal product subject to medical prescription
Marketing authorisation holder Gedeon Richter Ltd.