法规知识库 · EMA 集中审评
HBVaxPro
hepatitis B, recombinant surface antigen · EMEA/H/C/000373 · 已授权
获批上市许可
2001-04-27
欧委会决定日
2025-11-07
持有人 / 申请人
Merck Sharp & Dohme B.V.
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC:J07BC01
治疗领域:Hepatitis B;Immunization
药理分类:Vaccines
修订号:35 · 最新影响 PI 的程序:N/0000310649
适应症(原文):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.
关键日期时间轴
来自 EMA medicines JSON 日期字段;缺失字段不展示,不补推结论。
2025-11-07 · 欧委会决定
2001-04-27 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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HBVaxPro : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-11-07
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HBVaxPro : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-06-06
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HBVaxPro-H-C-000373-II-0076 : EPAR - Assessment report variation
variation-report · 2022-07-18 · EMA/648435/2022
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HBVaxPro-H-C-000373-P46-060 : EPAR - Assessment Report
variation-report · 2021-09-09 · EMA/500196/2021
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HBVaxPro-H-C-373-P46-0058 : EPAR - Assessment Report
variation-report · 2015-12-07 · EMA/815975/2015
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HBVaxPro-H-C-373-P46-0052 : EPAR - Assessment Report
variation-report · 2014-08-19 · EMA/480078/2014
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HBVaxPro : EPAR - Summary for the public
overview · 2011-07-25
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HBVaxPro : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2006-09-05
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HBVaxPro : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-09-05
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HBVaxPro-H-C-373-A20-0015 : EPAR - Scientific Conclusion
scientific-conclusion · 2006-09-05
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HBVaxPro : EPAR - Scientific Discussion
scientific-discussion · 2006-09-05
数据来自 EMA 官方 JSON;最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。