| 商品名称 | Jcovden (previously COVID-19 Vaccine Janssen) |
|---|---|
| 适用类别 | Human |
| 治疗领域 | COVID-19 virus infection |
| 通用名/非专利名称 | COVID-19 vaccine (Ad26.COV2-S [recombinant]) |
| 活性成分 | adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S) |
| 产品号 | EMEA/H/C/005737 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | J07BN02 |
| 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 | 2021/03/11 |
| 上市许可持有人/公司名称 | Janssen-Cilag International NV |
| 人用药物治疗分组 | Vaccines |
| 审评意见发布日期 | 2021/03/11 |
| 决定日期 | 2023/06/29 |
| 修订号 | 30 |
| 适应症 | Jcovden is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.The use of this vaccine should be in accordance with official recommendations. |
| 首次发布日期 | 2021/03/11 |
| 修订日期 | 2023/10/10 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/jcovden-previously-covid-19-vaccine-janssen-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/jcovden-previously-covid-19-vaccine-janssen |