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Esmya® (ulipristal acetate) for treatment of uterine fibroids: risk of serious liver injury
2018.08.03
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.
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)