| 商品名称 | Veklury |
|---|---|
| 适用类别 | Human |
| 治疗领域 | COVID-19 virus infection |
| 通用名/非专利名称 | remdesivir |
| 活性成分 | remdesivir |
| 产品号 | EMEA/H/C/005622 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J05AB16 |
| 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 | 2020/07/03 |
| 上市许可开发者/申请人/持有人 | Gilead Sciences Ireland UC |
| 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 | 2020/06/25 |
| 欧盟委员会决定日期 | 2025/12/22 |
| 修订号 | 31 |
| 治疗适应症 | Veklury is indicated for the treatment of coronavirus disease 2019 (COVID 19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg): with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see section 5.1) |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2020/07/06 |
| 最后更新日期 | 2026/01/06 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/veklury-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/veklury |