| 商品名称 | Tecovirimat SIGA |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Poxviridae Infections;Cowpox;Monkeypox;Vaccinia;Smallpox |
| 通用名/非专利名称 | tecovirimat monohydrate |
| 活性成分 | tecovirimat |
| 产品号 | EMEA/H/C/005248 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AX24 |
| 是否额外监管 | Yes |
| 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 | Yes |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2022/01/06 |
| 上市许可开发者/申请人/持有人 | SIGA Technologies Netherlands B.V. |
| 人用药物治疗学分组 | Antivirals for systemic use |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2021/11/11 |
| 欧盟委员会决定日期 | 2026/05/28 |
| 修订号 | 6 |
| 治疗适应症 | Tecovirimat SIGA is indicated for the treatment of the following viral infections in adults and children with body weight at least 13kg: Smallpox Cowpox Tecovirimat SIGA is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13kg . Tecovirimat SIGA should be used in accordance with official recommendations. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2021/11/10 |
| 最后更新日期 | 2026/06/15 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/tecovirimat-siga-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/tecovirimat-siga |