| 商品名称 | Bimervax |
|---|---|
| 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 virus recombinant spike (S) protein receptor binding domain (RBD) fusion heterodimer – B.1.351-B.1.1.7 strains |
| 产品号 | EMEA/H/C/006058 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | J07BN |
| 是否额外监管 | yes |
| 是否仿制药 | 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 |
| 批准上市日期 | 2023/03/30 |
| 上市许可持有人/公司名称 | Hipra Human Health S.L. |
| 人用药物治疗分组 | Vaccines |
| 决定日期 | 2023/08/18 |
| 修订号 | 2 |
| 适应症 | Bimervax is indicated as a booster for active immunisation to prevent COVID-19 in individuals 16 years of age and older who have previously received a mRNA COVID-19 vaccine |
| 首次发布日期 | 2023/03/31 |
| 修订日期 | 2023/09/01 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/bimervax-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/bimervax |