| 商品名称 | COVID-19 Vaccine (inactivated, adjuvanted) Valneva |
|---|---|
| 适用类别 | Human |
| 治疗领域 | COVID-19 virus infection |
| 通用名/非专利名称 | COVID-19 vaccine (inactivated, adjuvanted, adsorbed) |
| 活性成分 | COVID-19 vaccine (inactivated, adjuvanted, adsorbed) |
| 产品号 | EMEA/H/C/006019 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J07BX03 |
| 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 | 2022/06/24 |
| 上市许可开发者/申请人/持有人 | Valneva Austria GmbH |
| 人用药物治疗学分组 | Vaccines |
| 兽用药物治疗学分组 | |
| 审评意见日期 | 2022/06/23 |
| 欧盟委员会决定日期 | 2023/10/12 |
| 修订号 | 6 |
| 治疗适应症 | COVID-19 Vaccine (inactivated, adjuvanted) Valneva is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age. The use of this vaccine should be in accordance with official recommendations. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2022/06/27 |
| 最后更新日期 | 2023/12/01 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/covid-19-vaccine-inactivated-adjuvanted-valneva-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-inactivated-adjuvanted-valneva |