| 商品名称 | Protelos |
|---|---|
| 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/000560 |
| 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| 授权状态 | Withdrawn |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 | 2020/05/15 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/protelos-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/protelos |