European Medicines Agency recommends a variation to the terms of the marketing authorisation for denosumab

The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product denosumab (Prolia). "Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures." Read more here.