法规知识库 · EMA 集中审评
Bimervax
COVID-19 Vaccine (recombinant, adjuvanted) · EMEA/H/C/006058 · 已授权
获批上市许可
2023-03-30
欧委会决定日
2026-10-20
持有人 / 申请人
Hipra Human Health S.L.
终止日期字段
无
从产品到官方文件
文件记录
10
官方索引 10
EPAR / 审评
8
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J07BN
治疗领域：COVID-19 virus infection
药理分类：Vaccines
修订号：17 · 最新影响 PI 的程序：VR/0000378046
适应症（原文）：Bimervax is indicated as a booster for active immunisation to prevent COVID-19 in individuals 12 years of age and older who have previously received a mRNA COVID-19 vaccine (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations. Bimervax XBB.1.16 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. Bimervax LP.8.1 is indicated for active immunisation to prevent COVID-19 caused by SARS CoV-2 in individuals 12 years of age and older. 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。
2026-10-20 · 欧委会决定
2023-03-30 · 获批上市许可
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
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Bimervax : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-20
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Bimervax-PAM-0000331983 : EPAR - Assessment report
variation-report · 2026-07-16 · EMADOC-1700519818-3306580
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Bimervax : EPAR - Medicine overview
overview · 2025-11-11 · EMADOC-1700519818-2486748
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Bimervax-VR-0000257408 : EPAR - Assessment report - Variation
variation-report · 2025-10-21 · EMADOC-1700519818-2307180
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Bimervax : EPAR - Risk-management-plan
rmp · 2025-06-11
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Bimervax : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-30
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Bimervax-H-C-006058-X-0014-G : EPAR - Assessment report - Variation
variation-report · 2025-01-29 · EMA/510906/2024
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Bimervax : EPAR - Public assessment report
assessment-report · 2023-06-15 · EMA/175278/2023
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。