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SMC ID Date Medicine Submission Type Indication
SMC2117 10/09/2018 denosumab (Prolia) Non submission Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
SMC2110 13/08/2018 denosumab (Xgeva) Non submission

prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with haematological malignancies involving bone.
1119/15 07/12/2015 denosumab (Xgeva) Non submission Adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity
1013/14 10/11/2014 denosumab (Prolia) Non submission Osteoporosis in men at increased risk of fractures
752 /11 12/12/2011 denosumab (Xgeva) Non submission

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours.
651/10 13/12/2010 denosumab (Prolia) Full Osteoporosis in postmenopausal women at increased risk of fractures
670/10 13/12/2010 denosumab (Prolia) Non submission Bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures

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