Medicine withdrawn
On 18 March 2020, the licence for ulipristal acetate 5mg (Esmya), for the pre-operative treatment of moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age, was suspended. On 18 February 2021, the licence for this indication was withdrawn.
Medicine details
- Medicine name:
- ulipristal acetate (Esmya)
- SMC ID:
- 834/13
- Indication:
For pre-operative 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
- Withdrawn
- Date advice published
- 11 February 2013
On 18 March 2020, the Medicines and Healthcare Products Regulatory Agency (MHRA) advised that the licence for ulipristal acetate 5mg tablets (Esmya) had been suspended while a safety review was conducted following cases of liver injury requiring liver transplant in women. On 18 February 2021, the MHRA published a statement that ulipristal acetate 5mg should no longer be prescribed for controlling symptoms of uterine fibroids while waiting for urgical treatment. Please see the MHRA statement for further information. In line with SMC process, the SMC advice has been removed from the website.