欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Zoledronic Acid Hospira
适用类别Human
治疗领域Hypercalcemia
通用名/非专利名称zoledronic acid
活性成分zoledronic acid monohydrate
产品号EMEA/H/C/002365
患者安全信息No
许可状态Authorised
ATC编码M05BA08
是否额外监管No
是否仿制药或hybrid药物Yes
是否生物类似药No
是否附条件批准No
是否特殊情形No
是否加速审评No
是否罕用药No
上市许可日期2012/11/19
上市许可开发者/申请人/持有人Pfizer Europe MA EEIG
人用药物治疗学分组Drugs for treatment of bone diseases
兽用药物治疗学分组
欧盟委员会决定日期2021/10/01
修订号18
治疗适应症4 mg / 5 ml and 4 mg / 100 ml: Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 5 mg / 100 ml: Treatment of osteoporosis: in post-menopausal women; in men; at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy: in post-menopausal women; in men; at increased risk of fracture. Treatment of Paget's disease of the bone in adults.
适用物种
兽用药物ATC编码
首次发布日期2018/02/12
最后更新日期2021/11/09
产品说明书https://www.ema.europa.eu/en/documents/product-information/zoledronic-acid-hospira-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-hospira
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