Richter Plc. announced today that the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee
(PRAC) has initiated the implementation of temporary precautionary measures as
a part of its review procedure on drug induced liver injury potentially related
to Esmya (ulipristal acetate). PRAC considers that until a thorough assessment
of the available data is performed within the ongoing review, temporary
measures are needed to minimise potential risks to patients.