Prognia
Drug Database
🇪🇺EU · EMAAuthorisedATC: M05BX04

Acvybra(denosumab)

Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal

Marketing Authorisation Holder: Reddy Holding GmbH

EMA Authorisation: 17/11/2025

INN: denosumab

Indication

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Acvybra 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. In men with prostate cancer receiving hormone ablation, Acvybra 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.

Official EMA Resources

View on EMA (ema.europa.eu)

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