| 商品名称 | VidPrevtyn Beta |
|---|---|
| 适用类别 | Human |
| 治疗领域 | COVID-19 virus infection |
| 通用名/非专利名称 | COVID-19 Vaccine (recombinant, adjuvanted) |
| 活性成分 | SARS-CoV-2 prefusion Spike delta TM protein, recombinant (B.1.351 strain) |
| 产品号 | EMEA/H/C/005754 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J07BN04 |
| 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 | 2022/11/10 |
| 上市许可开发者/申请人/持有人 | Sanofi Pasteur |
| 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 | 2022/11/10 |
| 欧盟委员会决定日期 | 2024/03/11 |
| 修订号 | 4 |
| 治疗适应症 | VidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received an mRNA or adenoviral vector COVID-19 vaccine (see sections 4.2 and 5.1 in product information document). 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 | 2022/11/11 |
| 最后更新日期 | 2024/07/30 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/vidprevtyn-beta-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/vidprevtyn-beta |