| 商品名称 | Zoledronic acid Teva Generics |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Osteoporosis;Osteitis Deformans |
| 通用名/非专利名称 | zoledronic acid |
| 活性成分 | zoledronic acid monohydrate |
| 产品号 | EMEA/H/C/002805 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| 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 | 2014/03/27 |
| 上市许可开发者/申请人/持有人 | Teva Generics B.V |
| 人用药物治疗学分组 | Bisphosphonates |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2014/01/23 |
| 欧盟委员会决定日期 | 2015/07/13 |
| 修订号 | 2 |
| 治疗适应症 | Treatment of osteoporosis in post-menopausal women in adult men at increased risk of fracture, including those with recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women in adult 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 | 2015/07/13 |
| 最后更新日期 | 2016/08/08 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/zoledronic-acid-teva-generics-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/zoledronic-acid-teva-generics |