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ulipristal acetate (Esmya®)

 

Following a full submission

AWMSG advice

Status: Recommended

Ulipristal acetate (Esmya®) is recommended as an option for use within NHS Wales for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women who have not reached menopause when uterine fibroid embolisation and/or surgical treatment options are not suitable or have failed.

 Final Recommendation: ulipristal acetate (Esmya) 2767 (PDF, 385Kb)
 Appraisal Report: ulipristal acetate (Esmya) 2767 (PDF, 1.7Mb)

Medicine details

Medicine name ulipristal acetate (Esmya®)
Formulation 5 mg tablet
Reference number 2767
Indication

Intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women who have not reached menopause when uterine fibroid embolisation and/or surgical treatment options are not suitable or have failed

Company Gedeon Richter UK Ltd
BNF chapter Obstetrics, gynaecology & urinary tract disorders
Assessment type Full
Status Recommended
Advice number 0716
NMG meeting date 10/02/2016
AWMSG meeting date 23/03/2016
Ratification by Welsh Government 05/04/2016
Date of issue 12/04/2016
Date of last review February 2021
Further information

This advice incorporates and replaces the AWMSG recommendation on ulipristal acetate for the pre-operative treatment of moderate to severe symptoms of uterine fibroids (Advice number 1913, originally published July 2013).

This advice has been updated to align with the restriction made to the licence indication by the European Medicines Agency in February 2021.

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