法规知识库 · EMA 集中审评
Prevenar 20 (previously Apexxnar)
Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 3;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6A;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 8;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 10A;Pneumococcal polysaccharide serotype 11A;pneumococcal polysaccharide serotype 12F;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 15b;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 22F;Pneumococcal polysaccharide serotype 23F;Pneumococcal polysaccharide serotype 33F · EMEA/H/C/005451 · 已授权
获批上市许可
2022-02-14
欧委会决定日
2025-10-23
持有人 / 申请人
Pfizer Europe MA EEIG
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J07AL02
治疗领域：Pneumococcal Infections
药理分类：Vaccines
修订号：13 · 最新影响 PI 的程序：VR/0000291245
适应症（原文）：Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. Apexxnar should be used 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。
2025-10-23 · 欧委会决定
2022-02-14 · 获批上市许可
2021-12-16 · 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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Prevenar 20-PAM/0000355389 : EPAR - Assessment report
variation-report · 2026-10-20 · EMADOC-1700519818-3232147
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Prevenar 20 (previously Apexxnar) : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-11-18
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Prevenar 20 (previously Apexxnar) : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-24
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Prevenar 20 : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2025-02-19 · EMA/CHMP/58317/2025
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Prevenar 20 (previously Apexxnar) : EPAR - Risk management plan
rmp · 2024-04-26
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Prevenar 20 (previously Apexxnar)-H-C-005451-II-0012 : EPAR - Assessment report - Variation
variation-report · 2024-03-12 · EMA/66027/2024
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Prevenar 20 (previously Apexxnar) : EPAR - Medicine Overview
overview · 2024-03-12 · EMA/80599/2024
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Apexxnar-H-C-5451-P46-006 : EPAR - Assessment Report
variation-report · 2023-11-27 · EMA/534930/2023
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Apexxnar-H-C-5451-P46-005 : EPAR - Assessment Report
variation-report · 2023-02-16 · EMA/CHMP/11057/2023
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Apexxnar : EPAR - Risk management plan summary
rmp-summary · 2023-01-16
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Apexxnar : EPAR - Public Assessment Report
assessment-report · 2022-03-02 · EMA/12384/2022
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。