UPA medicine for uterine fibroids remains available in a number of Latin American and CIS countries
December 2024. The marketing authorisation for Esmya was withdrawn in July from the European Economic Area and Belarus, Moldova, Serbia, Ukraine and the United Kingdom, at the request of the marketing-authorisation holder. (See announcement on the European’s Medicines Agency’s website here).
The withdrawal was due to commercial reasons and there is no change in the safety profile of the drug (it was not a recall). This product remains available in Colombia, Ecuador and Mexico, as well as in the Russian Federation and Uzbekistan.
Esmya contains the active substance ulipristal acetate (UPA), presented in 5 mg tablets, and is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women who have not reached menopause, when uterine fibroid embolization and/or surgical treatment options are not suitable or have failed. The active substance ulipristal acetate is used for other indications, such as oral emergency contraception in tablets of 30 mg.
