| 商品名称 | Simulect |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Graft Rejection;Kidney Transplantation |
| 通用名/非专利名称 | basiliximab |
| 活性成分 | basiliximab |
| 产品号 | EMEA/H/C/000207 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AC02 |
| 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 | 1998/10/09 |
| 上市许可开发者/申请人/持有人 | Novartis Europharm Limited |
| 人用药物治疗学分组 | Immunosuppressants |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 1998/06/23 |
| 欧盟委员会决定日期 | 2024/12/16 |
| 修订号 | 29 |
| 治疗适应症 | Simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/04/12 |
| 最后更新日期 | 2024/12/18 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/simulect-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/simulect |