M05BX04 - search results

Singapore - English - HSA (Health Sciences Authority)

xgeva solution for injection 120 mgvial

amgen biotechnology singapore pte ltd - denosumab - injection, solution - 120 mg/vial - denosumab 120 mg/vial

prolia 60 mg

amgen europe b.v. - denosumab - solution for injection - denosumab 60 mg / 1 ml - denosumab - denosumab - treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. in postmenopausal women prolia 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, prolia significantly reduces the risk of vertebral fractures.treatment of bone loss associated with long-term systemic glucocorticoid therapy of a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 3 months, in adult patients at high risk of fracture.

Israel - English - Ministry of Health

xgeva

amgen europe b.v. - denosumab - solution for injection - denosumab 120 mg / 1.7 ml - denosumab - denosumab - prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with multiple myeloma and in adults with bone metastases from solid tumours.treatment of adult and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

European Union - English - EMA (European Medicines Agency)

prolia

amgen europe b.v. - denosumab - bone resorption; osteoporosis, postmenopausal - drugs for treatment of bone diseases - treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. in postmenopausal women prolia 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, prolia significantly reduces the risk of vertebral fractures.

European Union - English - EMA (European Medicines Agency)

xgeva

amgen europe b.v. - denosumab - fractures, bone; neoplasm metastasis - drugs for treatment of bone diseases - prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1).treatment of 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.