| 商品名称 | PreHevbri |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hepatitis B |
| 通用名/非专利名称 | hepatitis B surface antigen |
| 活性成分 | hepatitis B surface antigen |
| 产品号 | EMEA/H/C/005466 |
| 患者安全信息 | No |
| 许可状态 | Withdrawn |
| ATC编码 | J07BC01 |
| 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 | 2022/04/25 |
| 上市许可开发者/申请人/持有人 | VBI Vaccines B.V. |
| 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 | 2022/02/24 |
| 欧盟委员会决定日期 | 2024/11/25 |
| 修订号 | 3 |
| 治疗适应症 | PreHevbri is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults. It can be expected that hepatitis D will also be prevented by immunisation with PreHevbri as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. The use of PreHevbri should be in accordance with official recommendations. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2022/02/22 |
| 最后更新日期 | 2025/01/10 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/prehevbri-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/prehevbri |