| 商品名称 | Heplisav B |
|---|---|
| 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/005063 |
| 患者安全信息 | no |
| 授权状态 | Authorised |
| ATC编码 | J07BC01 |
| 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 | 2021/02/18 |
| 上市许可持有人/公司名称 | Dynavax GmbH |
| 人用药物治疗分组 | Vaccines |
| 审评意见发布日期 | 2020/12/10 |
| 决定日期 | 2023/10/19 |
| 修订号 | 5 |
| 适应症 | Heplisav B is indicated for the active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The use of Heplisav B should be in accordance with official recommendations.It can be expected that hepatitis D will also be prevented by immunisation with Heplisav B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. |
| 首次发布日期 | 2021/03/01 |
| 修订日期 | 2023/10/24 |
| 产品信息 | https://www.ema.europa.eu/en/documents/product-information/heplisav-b-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/heplisav-b |