| 商品名称 | Aclasta |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Osteoporosis; Osteitis Deformans; Osteoporosis, Postmenopausal |
| 通用名/非专利名称 | zoledronic acid |
| 活性成分 | zoledronic acid |
| 产品号 | EMEA/H/C/000595 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | M05BA08 |
| 是否额外监管 | no |
| 是否仿制药 | 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 |
| 批准上市日期 | 2005/04/15 |
| 上市许可持有人/公司名称 | Sandoz Pharmaceuticals d.d. |
| 人用药物治疗分组 | Drugs for treatment of bone diseases |
| 决定日期 | 2023/01/16 |
| 修订号 | 31 |
| 适应症 | 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 and in men at increased risk of fracture., , Treatment of Paget's disease of the bone., |
| 首次发布日期 | 2017/03/23 |
| 修订日期 | 2023/01/16 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/aclasta-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/aclasta |