following a full submission:
ulipristal acetate (Esmya®) is accepted for use within NHS Scotland.
Indication under review: for the intermittent treatment of moderate to severe symptoms of
uterine fibroids in adult women of reproductive age.
A phase III study demonstrated that treatment with the licensed dose of ulipristal acetate
controlled uterine bleeding in approximately three-quarters of patients with symptomatic
uterine fibroids after four intermittent treatment courses.
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Medicine details
- Medicine name:
- ulipristal acetate (Esmya)
- SMC ID:
- 1128/16
- Indication:
for the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
- Pharmaceutical company
- Gedeon Richter UK Ltd
- BNF chapter
- Endocrine system
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 07 February 2016
On 18 February 2021, the MHRA published a statement that ulipristal acetate 5mg should only be used for intermittent treatment of moderate to severe symptoms of uterine fibroids before menopause and when surgical procedures (including uterine fibroid embolisation) are not suitable or have failed. Please note that the product should only be used in line with the MHRA statement.