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Esmya® (ulipristal acetate) for treatment of uterine fibroids: risk of serious liver injury

Date 2018.05.22
Active substance ulipristal acetate

03.08.2018 - Conclusion of the procedure

The European risk assessment procedure for Esmya® has been completed following the EU Commission's decision.

This procedure was triggered by reports of severe liver damage, including acute liver failure, in patients treated with Esmya®. The Commission's decision contains indication restrictions, new contraindications and requirements for the necessary monitoring of liver function.

05.06.2018 - CHMP opinion

New measures to minimise risk of rare but serious liver injury

The EMA has concluded its review of the medicinal product for treatment of uterine fibroids.

22.05.2018 – PRAC recommendation

After completion of its review, the PRAC requires regular liver function tests during treatment.

09.02.2018 - Under evaluation

Until the EMA has concluded its review, patients taking Esmya® for treatment of uterine fibroids should have regular liver function tests. No new patients should be started on Esmya®.

01.12.2017 - Procedure started

The European Medicines Agency EMA has initiated a review procedure concerning the medicinal product Esmya® with the active substance ulipristal acetate.

To the risk assessment procedure (available in German only)

For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):