Flash VIG-news: ESMYA® (ulipristal acetate 5 mg): revocation of the marketing authorisation

Source: FAMHP

October 29, 2020

After reviewing the benefit-risk ratio of the medicinal product ESMYA®, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the definitive revocation of its marketing authorisation (MA).

ESMYA® was indicated for the treatment of moderate to severe symptoms of uterine fibroids in adult women of childbearing potential.

Following a new case of severe liver damage requiring liver transplantation, despite the risk minimisation measures implemented since 2018, the use of ESMYA® was suspended in Europe in March 2020. Since then, the PRAC has reviewed the benefit-risk balance of this medicinal product. Read more.