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2018.08.03
Active substance: ulipristal acetate
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.
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.
After completion of its review, the PRAC requires regular liver function tests during treatment.
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®.
The European Medicines Agency EMA has initiated a review procedure concerning the medicinal product Esmya® with the active substance ulipristal acetate.
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)