| 商品名称 | Rapamune |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Graft Rejection;Kidney Transplantation |
| 通用名/非专利名称 | sirolimus |
| 活性成分 | sirolimus |
| 产品号 | EMEA/H/C/000273 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | L04AH01 |
| 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 | 2001/03/13 |
| 上市许可开发者/申请人/持有人 | Pfizer Europe MA EEIG |
| 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 | 2000/11/16 |
| 欧盟委员会决定日期 | 2025/09/11 |
| 修订号 | 49 |
| 治疗适应症 | Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with ciclosporin microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if ciclosporin microemulsion can be progressively discontinued. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/08/02 |
| 最后更新日期 | 2025/09/17 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/rapamune-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/rapamune |