Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg for uterine fibroids: not to be used during ongoing review of liver injury risk
2020.03.23
Active substance: ulipristal acetate
Gedeon Richter Pharma GmbH in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) informs that Ulipristal acetate 5 mg is temporarily withdrawn from the market during the ongoing review and should not be initiated in new patients. For patients on treatment with ulipristal acetate 5 mg the treatment must be stopped.
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN