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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。

  1. 2025-11-07 · 欧委会决定

  2. 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 11产品信息 2其他 0

EPAR / 审评资料

  • 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

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产品信息

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。