| 商品名称 | Bondenza (previously Ibandronic Acid Roche) |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Osteoporosis, Postmenopausal |
| 通用名/非专利名称 | ibandronic acid |
| 活性成分 | ibandronic acid |
| 产品号 | EMEA/H/C/000502 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | M05BA06 |
| 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 | 2004/02/23 |
| 上市许可开发者/申请人/持有人 | Roche Registration Ltd. |
| 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 | 2012/11/15 |
| 修订号 | 16 |
| 治疗适应症 | Treatment of osteoporosis in post-menopausal women at increased risk of fracture. A reduction in the risk of vertebral fractures has been demonstrated. Efficacy on femoral-neck fractures has not been established. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2012/11/15 |
| 最后更新日期 | 2013/05/13 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/bondenza-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/bondenza |