法规知识库 · EMA 集中审评
Hexyon
filamentous haemagglutinin;Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate);hepatitis B surface antigen;pertussis toxoid;poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells;poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells;poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells;tetanus protein;tetanus toxoid adsorbed on aluminium hydroxide, hydrated;Diphtheria toxoid · EMEA/H/C/002796 · 已授权
获批上市许可
2013-04-17
欧委会决定日
2026-10-01
持有人 / 申请人
Sanofi Winthrop Industrie
终止日期字段
无
从产品到官方文件
文件记录
20
官方索引 20
EPAR / 审评
18
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J07CA09
治疗领域：Hepatitis B;Tetanus;Immunization;Meningitis, Haemophilus;Whooping Cough;Poliomyelitis;Diphtheria
药理分类：Vaccines
修订号：38 · 最新影响 PI 的程序：VR/0000349600
适应症（原文）：Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of this vaccine should be in accordance with official recommendations.
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。
2026-10-01 · 欧委会决定
2013-04-17 · 获批上市许可
2013-02-22 · 拒绝上市许可
2013-02-21 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
- 打开官方文件 ↗
Hexyon : EPAR - Risk management plan
rmp · 2026-10-05
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Hexyon : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-05
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Hexyon-VR-0000295915 : EPAR - Assessment report - Variation
variation-report · 2026-08-07 · EMADOC-1700519818-2678750
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Hexyon-PAM-0000273909 : EPAR - Assessment report
variation-report · 2025-09-10 · EMADOC-1700519818-2153843
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Hexyon : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-12-11
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Hexyon-H-C-002796-WS1965-G : EPAR - Assessment report - Variation
variation-report · 2024-06-11 · EMA/181341/2024
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Hexyon-H-C-2702-WS-0676: EPAR - Assessment Report - Variation
variation-report · 2021-01-13 · EMA/707880/2020
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Hexyon-H-C-2796-P46-033 : EPAR - Assessment Report
variation-report · 2020-02-21 · EMA/89372/2020
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Hexyon-H-W-2495-P46-020 : EPAR - Assessment Report
variation-report · 2017-10-27 · EMA/CHMP/764619/2016
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Hexyon-H-W-2495-P46-022 : EPAR - Assessment Report
variation-report · 2017-10-27 · EMA/CHMP/345017/2017
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Hexyon-H-C-2796-P46-0019 : EPAR - Assessment Report
variation-report · 2017-05-02 · EMA/237990/2017
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Hexyon : EPAR - Summary for the public
overview · 2016-07-06 · EMA/137344/2013
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Hexyon-H-C-2796-P46-0004 : EPAR - Assessment Report
variation-report · 2016-06-06 · EMA/389548/2016
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Hexyon-H-C-2496-P46-0006 : EPAR - Assessment Report
variation-report · 2016-04-25 · EMA/245070/2016
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Hexyon-H-C-2796-P46-0013 : EPAR - Assessment Report
variation-report · 2016-04-11 · EMA/245070/2016
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Hexyon-H-C-2796-WS-0702 : EPAR - Assessment Report - Variation
variation-report · 2015-07-16 · EMA/CHMP/329785/2015
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Hexyon-H-C-2796-P46-0003: EPAR - Assessment Report
variation-report · 2014-11-27 · EMA/735630/2014
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Hexyon : EPAR - Public assessment report
assessment-report · 2013-07-12 · EMA/373968/2013
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。