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Direct Healthcare Professional Communication (DHPC) on ulipristal acetate 5 mg: indications for uterine fibroids restricted due to concerns of severe liver injury
2021.02.01
Active substance: ulipristal acetate
The marketing authorisation holder in agreement with the European Medicines Agency (EMA), and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you about cases of serious liver injury (including those necessitating liver transplantation) which have followed the use of ulipristal acetate 5 mg for treating moderate to severe symptoms of uterine fibroids.
The use of ulipristal acetate 5 mg must now be considered only for intermittent treatment of moderate to severe symptoms of uterine fibroids in women who have not reached menopause and when uterine fibroid embolisation or surgery are not suitable or have failed.
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