| 商品名称 | Tasermity |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hyperphosphatemia;Renal Dialysis |
| 通用名/非专利名称 | sevelamer hydrochloride |
| 活性成分 | sevelamer hydrochloride |
| 产品号 | EMEA/H/C/003968 |
| 患者安全信息 | No |
| 许可状态 | Lapsed |
| ATC编码 | V03AE02 |
| 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 | 2015/02/25 |
| 上市许可开发者/申请人/持有人 | Genzyme Europe BV |
| 人用药物治疗学分组 | All other therapeutic products |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2017/12/15 |
| 修订号 | 4 |
| 治疗适应症 | Tasermity is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Sevelamer hydrochloride should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/12/15 |
| 最后更新日期 | 2018/03/27 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tasermity-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tasermity |