| 商品名称 | Dectova |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Influenza, Human |
| 通用名/非专利名称 | zanamivir |
| 活性成分 | zanamivir |
| 产品号 | EMEA/H/C/004102 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AH01 |
| 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 | 2019/04/26 |
| 上市许可开发者/申请人/持有人 | GlaxoSmithKline Trading Services Limited |
| 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 | 2019/04/26 |
| 欧盟委员会决定日期 | 2025/11/10 |
| 修订号 | 8 |
| 治疗适应症 | Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ?6 months) when: The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or Other anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient. Dectova should be used in accordance with official guidance. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2019/06/07 |
| 最后更新日期 | 2025/11/10 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/dectova-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/dectova |