| 商品名称 | Mycamine |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Candidiasis |
| 通用名/非专利名称 | micafungin |
| 活性成分 | micafungin |
| 产品号 | EMEA/H/C/000734 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J02AX05 |
| 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 | 2008/04/25 |
| 上市许可开发者/申请人/持有人 | Sandoz Pharmaceuticals d.d. |
| 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 | 2025/08/04 |
| 修订号 | 22 |
| 治疗适应症 | Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly treatment of invasive candidiasis; treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. Children (including neonates) and adolescents < 16 years of age treatment of invasive candidiasis. prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2018/02/19 |
| 最后更新日期 | 2025/10/13 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/mycamine-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/mycamine |