| 商品名称 | Caspofungin Accord |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Candidiasis;Aspergillosis |
| 通用名/非专利名称 | caspofungin |
| 活性成分 | caspofungin acetate |
| 产品号 | EMEA/H/C/004134 |
| 患者安全信息 | No |
| 许可状态 | Expired |
| ATC编码 | J02AX04 |
| 是否额外监管 | No |
| 是否仿制药或hybrid药物 | Yes |
| 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 | 2016/02/11 |
| 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 | Antimycotics for systemic use |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2020/02/06 |
| 修订号 | 6 |
| 治疗适应症 | Treatment of invasive candidiasis in adult or paediatric patients. Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy. Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2016/12/20 |
| 最后更新日期 | 2021/08/20 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/caspofungin-accord-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/caspofungin-accord |