| 商品名称 | Sondelbay |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Osteoporosis |
| 通用名/非专利名称 | teriparatide |
| 活性成分 | teriparatide |
| 产品号 | EMEA/H/C/005827 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | H05AA02 |
| 是否额外监管 | Yes |
| 是否仿制药或hybrid药物 | No |
| 是否生物类似药 | Yes |
| 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 | 2022/03/24 |
| 上市许可开发者/申请人/持有人 | Accord Healthcare S.L.U. |
| 人用药物治疗学分组 | Calcium homeostasis |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2022/01/27 |
| 欧盟委员会决定日期 | 2025/07/21 |
| 修订号 | 3 |
| 治疗适应症 | Sondelbay is indicated in adults. Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non-vertebral fractures but not hip fractures have been demonstrated. Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2022/06/16 |
| 最后更新日期 | 2025/07/22 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/sondelbay-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/sondelbay |