| 商品名称 | HBVaxPro |
|---|---|
| 适用类别 | Human |
| 治疗领域 | Hepatitis B;Immunization |
| 通用名/非专利名称 | hepatitis B vaccine (recombinant DNA) |
| 活性成分 | hepatitis B, recombinant surface antigen |
| 产品号 | EMEA/H/C/000373 |
| 患者安全信息 | No |
| 许可状态 | Authorised |
| ATC编码 | J07BC01 |
| 是否额外监管 | Nei |
| 是否仿制药或hybrid药物 | Nei |
| 是否生物类似药 | Nei |
| 是否附条件批准 | Nei |
| 是否特殊情形 | Nei |
| 是否加速审评 | Nei |
| 是否罕用药 | Nei |
| 上市许可日期 | 2001/04/27 |
| 上市许可开发者/申请人/持有人 | Merck Sharp & Dohme B.V. |
| 人用药物治疗学分组 | Vaccines |
| 兽用药物治疗学分组 | |
| 欧盟委员会决定日期 | 2025/11/07 |
| 修订号 | 35 |
| 治疗适应症 | 5 micrograms HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. 10 micrograms HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. 40 micrograms HBVaxPro is indicated for the active immunisation against hepatitis-B-virus infection caused by all known subtypes in predialysis and dialysis adult patients. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. |
| 适用物种 | |
| 兽用药物ATC编码 | |
| 首次发布日期 | 2017/12/18 |
| 最后更新日期 | 2025/11/07 |
| 产品说明书 | https://www.ema.europa.eu/en/documents/product-information/hbvaxpro-epar-product-information_en.pdf |
| 公共评估报告 | https://www.ema.europa.eu/en/medicines/human/EPAR/hbvaxpro |