Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9-12 July 2018

July 13, 2018 – Following a review of data showing a possible risk of earlier death and an increase in fractures with Radium-223 dichloride, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended restricting the use of this cancer medicine to patients who have had two previous treatments for metastatic prostate cancer or who cannot receive other treatments. The PRAC also confirmed its previous interim recommendation … (leggi tutto)