BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Dear Doctor Letter (Rote-Hand-Brief) on Esmya® 5 mg tablets (ulipristal acetate): restrictions of use, warnings regarding serious liver injury as well as recommendations for monitoring liver function

Active substance: Ulipristal acetate

After reports of serious liver damage, including acute liver failure, in patients treated with Esmya® temporary measures have been taken.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 161KB, File is accessible