| 商品名称 | Ronapreve |
|---|---|
| 适用类别 | Human |
| 治疗领域 | COVID-19 virus infection |
| 通用名/非专利名称 | casirivimab;imdevimab |
| 活性成分 | casirivimab;imdevimab |
| 产品号 | EMEA/H/C/005814 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J06BD07 |
| 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 | No |
| 是否加速审评 | No |
| 是否罕用药 | No |
| 上市许可日期 | 2021/11/12 |
| 上市许可开发者/申请人/持有人 | Roche Registration GmbH |
| 人用药物治疗学分组 | Immune sera and immunoglobulins |
| 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 | 2025/04/03 |
| 修订号 | 9 |
| 治疗适应症 | Ronapreve is indicated for:- Treatment of COVID-19 in adults, adolescents and children aged 2 years and older weighing at least 10 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.- Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result. - Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.Ronapreve should be used in accordance with official recommendations where available and based on information on the activity of casirivimab and imdevimab against presently circulating viral variants. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2021/11/12 |
| 最后更新日期 | 2025/04/09 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/ronapreve-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/ronapreve |