EMA's PRAC starts two safety referrals and reaches conclusion on re-examination

1 December 2017

The European Medicines Agency today released highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) meeting that was held November 27-30, 2017.

PRAC starts review of Esmya for treatment of uterine fibroids

The PRAC has started a review of Esmya (ulipristal acetate), a medicine used to treat uterine fibroids (non-cancerous tumors of the womb). This follows four reports of serious liver injury, three of which ended in liver transplantation, in patients treated with this medicine.

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