法规知识库 · EMA 集中审评
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
ChAdOx1-SARS-COV-2 · EMEA/H/C/005675 · 已撤市
获批上市许可
2021-01-29
欧委会决定日
2024-03-07
持有人 / 申请人
AstraZeneca AB
终止日期字段
2024-03-27
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
10
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：J07BN02
治疗领域：COVID-19 virus infection
药理分类：Vaccines
修订号：32 · 最新影响 PI 的程序：II/0096
适应症（原文）：Vaxzevria is indicated for active immunisation to prevent COVID 19 caused by SARS CoV 2, in individuals 18 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。
2024-03-27 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2024-03-07 · 欧委会决定
2021-01-29 · CHMP 意见通过
2021-01-29 · 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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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-PSUSA-00010912-202212 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2024-05-07 · EMA/317895/2023
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-PSUSA-00010912-202206: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2024-05-07 · EMA/38839/2023
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-5675-R-0079 : EPAR - Assessment report - Renewal
variation-report · 2024-05-07 · EMA/865685/2022
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-PSUSA-00010912-202112 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
scientific-conclusion · 2024-05-07 · EMA/666408/2022
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-5675-II-0052 : EPAR - Assessment report - Variation
variation-report · 2024-05-07 · EMA/351687/2022
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca)-H-C-5675-R-0037 : EPAR - Assessment report - Renewal
variation-report · 2024-05-07 · EMA/622071/2021
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-05-07
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Risk-management-plan
rmp · 2024-05-07
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Medicine overview
overview · 2024-05-07 · EMA/609262/2021
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - Public assessment report
assessment-report · 2024-05-07 · EMA/94907/2021
产品信息
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Vaxzevria : EPAR - Product information
product-information · 2024-05-07
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca) : EPAR - All authorised presentation
all-authorised-presentations · 2024-05-07
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COVID-19 Vaccine AstraZeneca - Product Information as approved by the CHMP on 29 January 2021, pending endorsement by the European Commission
product-information · 2021-01-29
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。