法规知识库 · EMA 集中审评
Prevenar 13
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 9V;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19A;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F · EMEA/H/C/001104 · 已授权
获批上市许可
2009-12-09
欧委会决定日
2026-01-15
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
40
官方索引 40
EPAR / 审评
38
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J07AL02
治疗领域：Pneumococcal Infections;Immunization
药理分类：Vaccines
修订号：51 · 最新影响 PI 的程序：VR/0000309455
适应症（原文）：Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age. Active immunisation for the prevention of invasive disease caused by Streptococcus pneumoniae in adults ?18 years of age and the elderly. See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes. The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
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。
2026-01-15 · 欧委会决定
2009-12-09 · 获批上市许可
2009-09-24 · 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 13 : EPAR - Assessment report
variation-report · 2026-09-22 · PAM/0000355407
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Prevenar 13 : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-02-05
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Prevenar 13 : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-04-24
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Prevenar 13-H-C-001104-P46-073 : EPAR - Assessment Report
variation-report · 2025-03-20 · EMA/101185/2025
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Prevenar 13-H-C-001104-P46-072 : EPAR - Assessment Report
variation-report · 2024-03-08 · EMA/106819/2024
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Prevenar 13 : EPAR - Risk management plan summary
rmp-summary · 2024-01-30
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Prevenar 13-H-C-1104-P46-0071 : EPAR - Assessment Report
variation-report · 2023-11-27 · EMA/535535/2023
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Prevenar 13-H-C-1104-P46-068: EPAR - Assessment Report
variation-report · 2023-08-10 · EMA/CHMP/107792/2023
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Prevenar 13-H-C-1104-P46-0069: EPAR - Assessment Report
variation-report · 2023-08-10 · EMEA/H/C/001104/P46/069
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Prevenar 13-H-C-1104-P46-0070: EPAR - Assessment Report
variation-report · 2023-08-10 · EMA/CHMP/107799/2023
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Prevenar 13-H-C-1104-P46-066 : EPAR - Assessment Report
variation-report · 2023-02-15 · EMA/67312/2023
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Prevenar 13-H-C-1104-P46-067 : EPAR - Assessment Report
variation-report · 2023-02-15 · EMA/67314/2023
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Prevenar 13-H-C-1104-P46-064 : EPAR - Assessment Report
variation-report · 2021-07-13 · EMA/395946/2021
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Prevenar 13-H-C-1104-PSUSA-00009263-202001: EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2021-01-08 · EMA/10426/2021
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Prevenar 13-H-C-1104-P46-063 : EPAR - Assessment Report
variation-report · 2020-11-27 · EMA/CHMP/495335/2020
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Prevenar 13-H-C-1104-P46-0062 : EPAR - Assessment Report
variation-report · 2020-10-05 · EMA/523288/2020
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Prevenar 13-H-C-1104-P46-060 : EPAR - Assessment Report
variation-report · 2019-11-05 · EMA/595425/2019
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Prevenar 13-H-C-1104-P46-0059 : EPAR - Assessment Report
variation-report · 2016-08-18 · EMA/CHMP/536289/2016
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Prevenar 13-H-C-1104-P46-057.1 : EPAR - Assessment Report
variation-report · 2015-08-27 · EMA/577712/2015
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Prevenar 13-H-C-1104-P46-0058 : EPAR - Assessment report
variation-report · 2015-08-06 · EMA/393028/2015
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Prevenar 13 : EPAR - Summary for the public
overview · 2015-05-12
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Prevenar 13-H-C-1104-P46-0056 : EPAR - Assessment Report
variation-report · 2015-03-19 · EMA/189944/2015
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Prevenar 13-H-C-1104-P46-0038 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/135763/2015
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Prevenar 13-H-C-1104-P46-0049 and 0050 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/126460/2015
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Prevenar 13-H-C-1104-P46-0042 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/126275/2015
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Prevenar 13-H-C-1104-P46-0041 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/126200/2015
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Prevenar 13-H-C-1104-P46-0036 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/135529/2015
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Prevenar 13-H-C-1104-P46-0035 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/135475/2015
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Prevenar 13-H-C-1104-P46-0044 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/126295/2015
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Prevenar 13-H-C-1104-P46-0037 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/135618/2015
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Prevenar 13-H-C-1104-P46-0009 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/125452/2015
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Prevenar 13-H-C-1104-P46-0017.1 : EPAR - Assessment Report
variation-report · 2015-03-02 · EMA/125685/2015
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Prevenar 13-H-C-1104-II-0098 : EPAR - Assessment Report - Variation
variation-report · 2014-08-13 · EMA/CHMP/495981/2014
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Prevenar 13-H-C-1104-PSUV-0090 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-02-19 · EMA/CHMP/771740/2013
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Prevenar 13-H-C-1104-II-0071: EPAR - Assessment Report - Variation
variation-report · 2013-10-16 · EMA/CHMP/795127/2013
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Prevenar 13-H-C-1104-II-0055: EPAR - Assessment Report - Variation
variation-report · 2013-02-28 · EMA/89713/2013
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Prevenar 13-H-C-1104-II-0028 : EPAR - Assessment Report - Variation
variation-report · 2011-12-20
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Prevenar 13 : EPAR - Public assessment report
assessment-report · 2010-01-08
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。