法规知识库 · EMA 集中审评
Spikevax (previously COVID-19 Vaccine Moderna)
single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 · EMEA/H/C/005791 · 已授权
获批上市许可
2021-01-06
欧委会决定日
2026-10-29
持有人 / 申请人
Moderna Biotech Spain, S.L.
终止日期字段
无
从产品到官方文件
文件记录
33
官方索引 33
EPAR / 审评
30
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：J07BN01
治疗领域：COVID-19 virus infection
药理分类：Vaccines
修订号：65 · 最新影响 PI 的程序：VR/0000371918
适应症（原文）：Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax bivalent Original/Omicron BA.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against COVID-19. The use of this vaccine should be in accordance with official recommendations. Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax LP.8.1 is indicated for active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. Spikevax XFG is indicated for active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 6 months 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。
2026-10-29 · 欧委会决定
2021-01-06 · 获批上市许可
2021-01-04 · 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
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Spikevax-VR-0000335829 : EPAR - Assessment report - Variation
variation-report · 2026-10-30 · EMADOC-1700519818-3009772
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Spikevax : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-30
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Spikevax (previously COVID-19 Vaccine Moderna): EPAR - Risk-management-plan
rmp · 2026-10-30
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Spikevax (previously COVID-19 Vaccine Moderna): EPAR - Medicine overview
overview · 2026-10-14 · EMADOC-1829012207-27805
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Spikevax-VR-0000264109 : EPAR - Assessment report - Variation
variation-report · 2026-02-24 · EMADOC-1700519818-2079527
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Spikevax-PAM-0000291853 : EPAR - Assessment report
variation-report · 2025-11-19 · EMADOC-1700519818-2360320
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Spikevax-VR-0000272245 : EPAR - Assessment report - Variation
variation-report · 2025-08-14 · EMADOC-1700519818-2137510
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Spikevax (previously COVID-19 Vaccine Moderna): EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-05-05
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Spikevax-VR-0000245103 : EPAR - Assessment report - Variation
variation-report · 2025-04-16 · EMADOC-1700519818-1857217
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-II-0149 : EPAR - Assessment Report - Variation
variation-report · 2025-03-10 · EMA/87565/2025
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-005791-P46-136 : EPAR - Assessment Report
variation-report · 2024-08-14 · EMA/372442/2024
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-005791-II-0111-G : EPAR - Assessment report - Variation
variation-report · 2023-11-21 · EMA/429527/2023
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Spikevax (previously COVID-19 Vaccine Moderna)-H/C/PSUSA/00010897/202212: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-09-07 · EMA/371629/2023
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-005791-II-0104-G : EPAR - Assessment Report - Variation
variation-report · 2023-09-06 · EMA/384132/2023
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-005791-II-0097-G : EPAR - Assessment Report - Variation
variation-report · 2023-05-31 · EMA/230596/2023
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-005791-II-0083-G : EPAR - Assessment Report - Variation
variation-report · 2023-02-09 · EMA/3578/2023
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-005791-II-0075-G : EPAR - Assessment Report - Variation
variation-report · 2022-12-16 · EMA/896245/2022
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-005791-II-0057 : EPAR - Assessment Report - Variation
variation-report · 2022-12-13 · EMA/686295/2022
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-005791-II-0067 : EPAR - Assessment Report - Variation
variation-report · 2022-11-28 · EMA/895850/2022
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-II-84-G : EPAR - Assessment Report - Variation
variation-report · 2022-11-23 · EMA/884918/2022
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-R-0074: EPAR - Assessment report - Renewal
variation-report · 2022-10-28 · EMA/850007/2022
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-PSUSA-00010897-202112: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-08-25 · EMA/708151/2022
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-II-41 : EPAR - Assessment Report - Variation
variation-report · 2022-04-19 · EMA/137337/2022 – Rev.1
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-II-42 : EPAR - Assessment Report - Variation
variation-report · 2022-03-25 · EMA/137482/2022
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-PSUSA-00010897-202106: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-02-16 · EMA/104540/2022
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-II-34 : EPAR - Assessment Report - Variation
variation-report · 2021-11-26 · EMA/618924/2021
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-R-0025: EPAR - Assessment report - Renewal
variation-report · 2021-10-29 · EMA/571969/2021
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-II-31 : EPAR - Assessment Report - Variation
variation-report · 2021-10-29 · EMA/572648/2021
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Spikevax (previously COVID-19 Vaccine Moderna)-H-C-5791-II-0021 : EPAR - Assessment report - Variation
variation-report · 2021-08-09 · EMA/439844/2021
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Spikevax (previously COVID-19 Vaccine Moderna) : EPAR - Public assessment report
assessment-report · 2021-01-20 · EMA/15689/2021
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。