法规知识库 · EMA 集中审评
Comirnaty
single-stranded, 5’-capped messenger RNA 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/005735 · 已授权
获批上市许可
2020-12-21
欧委会决定日
2026-11-03
持有人 / 申请人
BioNTech Manufacturing GmbH
终止日期字段
无
从产品到官方文件
文件记录
37
官方索引 37
EPAR / 审评
35
assessment / overview 等
产品信息
2
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：64 · 最新影响 PI 的程序：VR/0000378722
适应症（原文）：Comirnaty LP.8.1 dispersion for injection 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. Comirnaty XFG dispersion for injection 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。
2026-11-03 · 欧委会决定
2020-12-21 · CHMP 意见通过
2020-12-21 · 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
- 打开官方文件 ↗
Comirnaty : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-11-06
- 打开官方文件 ↗
Comirnaty : EPAR - Risk management plan
rmp · 2026-11-06
- 打开官方文件 ↗
Comirnaty-VR-0000332196 : EPAR - Assessment report - Variation
variation-report · 2026-05-29 · EMADOC-1700519818-2925080
- 打开官方文件 ↗
Comirnaty-VR-0000320534 : EPAR - Assessment report - Variation
variation-report · 2026-05-29 · EMADOC-1700519818-3039666
- 打开官方文件 ↗
Comirnaty-VR-0000302705 : EPAR - Assessment report - Variation
variation-report · 2026-05-05 · EMADOC-1700519818-2492155
- 打开官方文件 ↗
Comirnaty-PAM-0000316475 : EPAR - Assessment report
variation-report · 2026-04-07 · EMADOC-1700519818-2693539
- 打开官方文件 ↗
Comirnaty-PAM-0000309529 : EPAR - Assessment report
variation-report · 2026-03-17 · EMADOC-1700519818-2611525
- 打开官方文件 ↗
Comirnaty : EPAR - Medicine overview
overview · 2025-09-10 · EMADOC-1829012207-27807
- 打开官方文件 ↗
Comirnaty-VR-0000231586 : EPAR - Assessment report - Variation
variation-report · 2025-03-25 · EMADOC-1700519818-1717428
- 打开官方文件 ↗
Comirnaty-VR-0000224683 : EPAR - Assessment report
variation-report · 2025-01-23 · EMADOC-1700519818-1645300
- 打开官方文件 ↗
Comirnaty : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-11-28
- 打开官方文件 ↗
Comirnaty-H-C-005735-P46-070 : EPAR - Assessment report
variation-report · 2024-08-19 · EMA/379189/2024
- 打开官方文件 ↗
Comirnaty-H-C-005735-II-0188-G : EPAR - Assessment report - Variation
variation-report · 2023-12-15 · EMA/CHMP/446369/2023
- 打开官方文件 ↗
Comirnaty : EPAR - Public assessment report
assessment-report · 2023-10-23 · EMA/707383/2020 Corr.2
- 打开官方文件 ↗
Comirnaty-H-C-005735-P46-067 : EPAR - Assessment report
variation-report · 2023-10-10 · EMA/440372/2023
- 打开官方文件 ↗
Comirnaty-H-C-005735-II-0183 : EPAR - Assessment report - variation
variation-report · 2023-10-10 · EMA/417361/2023
- 打开官方文件 ↗
Comirnaty-H-C-PSUSA-00010898-202212 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
variation-report · 2023-09-11 · EMA/355994/2023
- 打开官方文件 ↗
Comirnaty-H-C-005735-X-0176 : EPAR - Assessment report - Extension
variation-report · 2023-08-11 · EMA/355550/2023
- 打开官方文件 ↗
Comirnaty-H-C-005735-X-0180 : EPAR - Assessment report - Extension
variation-report · 2023-08-11 · EMA/355551/2023
- 打开官方文件 ↗
Comirnaty-H-C-005735-II-0177-G : EPAR - Assessment report - Variation
variation-report · 2023-08-10 · EMA/355553/2023
- 打开官方文件 ↗
Comirnaty-H-C-005735-P46-046: EPAR - Assessment report
variation-report · 2023-03-01 · EMA/287266/2022
- 打开官方文件 ↗
Comirnaty-H-C-005735-II-0129 : EPAR - Assessment report - Variation
variation-report · 2022-12-08 · EMA/890825/2022
- 打开官方文件 ↗
Comirnaty-H-C-005735-II-0140 : EPAR - Assessment report - Variation
variation-report · 2022-12-07 · EMA/890789/2022
- 打开官方文件 ↗
Comirnaty-H-C-5735-X-0147 : EPAR - Assessment report - Extension
variation-report · 2022-11-25 · EMA/889536/2022
- 打开官方文件 ↗
Comirnaty-H-C-005735-II-0143 : EPAR - Assessment report - Variation
variation-report · 2022-11-25 · EMA/895061/2022
- 打开官方文件 ↗
Comirnaty-H-C-005735-X-0138 : EPAR - Assessment report - Extension
variation-report · 2022-11-25 · EMA/890761/2022
- 打开官方文件 ↗
Comirnaty-H-C-5735-R-0137 : EPAR - Assessment report - Renewal
variation-report · 2022-10-28 · EMA/853699/2022
- 打开官方文件 ↗
Comirnaty-H-C-5735-II-0093 : EPAR - Assessment report - Variation
variation-report · 2022-08-23 · EMA/134008/2022
- 打开官方文件 ↗
Comirnaty-H-C-5735-II-0111 : EPAR - Assessment report - Variation
variation-report · 2022-08-23 · EMA/134030/2022
- 打开官方文件 ↗
Comirnaty-H-C-5735-X-0077 : EPAR - Assessment report - Extension
variation-report · 2022-01-07 · EMA/719541/2021 Corr.
- 打开官方文件 ↗
Comirnaty-H-C-5735-R-0046 : EPAR - Assessment report - Renewal
variation-report · 2021-11-15 · EMA/596333/2021
- 打开官方文件 ↗
Comirnaty-H-C-5735-X-0044-G : EPAR - Assessment report - Extension
variation-report · 2021-11-15 · EMA/594686/2021
- 打开官方文件 ↗
Comirnaty-H-C-5735-II-0062 : EPAR - Assessment report - Variation
variation-report · 2021-10-28 · EMA/472994/2021
- 打开官方文件 ↗
Comirnaty-H-C-5735-II-0067 : EPAR - Assessment report - Variation
variation-report · 2021-10-28 · EMA/497785/2021
- 打开官方文件 ↗
Comirnaty-H-C-5735-II-0030 : EPAR - Assessment report - Variation
variation-report · 2021-08-24 · EMA/CHMP/282047/2021 Rev.1
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。