Prognia
Drug Database
🇪🇺EU · EMAAuthorisedATC: M05BX04

Evfraxy(denosumab)

Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal

Marketing Authorisation Holder: Biosimilar Collaborations Ireland Limited

EMA Authorisation: 30/06/2025

INN: denosumab

Indication

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Evfraxy significantly reduces the risk of vertebral, non-vertebral and hip fractures.Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures (see section 5.1). In men with prostate cancer receiving hormone ablation, Evfraxy significantly reduces the risk of vertebral fractures.Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture (see section 5.1).

Official EMA Resources

View on EMA (ema.europa.eu)

AI Drug & Interaction Analysis

Free account required

Ask Prognia AI about Evfraxy — dosing recommendations, drug interactions, and current guideline evidence from ESC, EMA, NICE and more.

Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.