| 商品名称 | Osseor |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Osteoporosis, Postmenopausal |
| 通用名/非专利名称 | strontium ranelate |
| 活性成分 | strontium ranelate |
| 产品号 | EMEA/H/C/000561 |
| 患者安全信息 | no |
| 授权状态 | Withdrawn |
| ATC编码 | M05BX03 |
| 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 | 2004/09/20 |
| 上市许可持有人/公司名称 | Les Laboratoires Servier |
| 人用药物治疗分组 | Drugs for treatment of bone diseases |
| 决定日期 | 2018/05/22 |
| 修订号 | 19 |
| 适应症 | Treatment of severe osteoporosis in postmenopausal women at high risk for fracture to reduce the risk of vertebral and hip fractures.Treatment of severe osteoporosis in adult men at increased risk of fracture.The decision to prescribe strontium ranelate should be based on an assessment of the individual patient's overall risks. |
| 首次发布日期 | 2016/09/15 |
| 修订日期 | 2020/05/19 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/osseor-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/osseor |