欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Zometa
适用类别Human
治疗领域Cancer;Fractures, Bone
通用名/非专利名称zoledronic acid
活性成分zoledronic acid;zoledronic acid monohydrate
产品号EMEA/H/C/000336
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No
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2001/03/20
上市许可开发者/申请人/持有人Phoenix Labs Unlimited Company
人用药物治疗学分组Drugs for treatment of bone diseases
兽用药物治疗学分组
审评意见日期2000/12/14
欧盟委员会决定日期2024/09/05
修订号40
治疗适应症Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone; treatment of tumour-induced hypercalcaemia (TIH); 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).
适用物种
兽用药物ATC编码
首次发布日期2018/07/13
最后更新日期2025/08/11
产品说明书https://www.ema.europa.eu/en/documents/product-information/zometa-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/zometa
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