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.

Further information

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

Esmya

To the risk assessment procedure (available in German only)