60 mg/ mL
Trade Name
Densibon
Solution for injection in pre-filled syringe
Request Type
New Registration
Drug Type
Biological Drug
Approval Date
SFDA Approved Use
Denosumab is intended for the following indications:
• Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women it 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, it 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.
• Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women it 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, it 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.