法规知识库 · EMA 集中审评
Prevenar
pneumococcal oligosaccharide serotype 18C;Pneumococcal polysaccharide serotype 19F;Pneumococcal polysaccharide serotype 23F;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 14 · EMEA/H/C/000323 · 已撤市
获批上市许可
2001-02-02
欧委会决定日
2015-06-22
持有人 / 申请人
Pfizer Limited
终止日期字段
2017-11-21
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
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：23 · 最新影响 PI 的程序：PSUSA/00002452/201408
适应症（原文）：Active immunisation against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age. The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as 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。
2017-11-21 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2015-06-22 · 欧委会决定
2001-02-02 · 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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Prevenar-H-C-PSUSA-00002452-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2017-11-24 · EMA/CHMP/722875/2014
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Prevenar-H-C-323-P46-0130 : EPAR - Assessment Report
variation-report · 2017-11-24 · EMA/124579/2015
- 打开官方文件 ↗
Prevenar-H-C-323-P46-0132 : EPAR - Assessment Report
variation-report · 2017-11-24 · EMA/125121/2015
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Prevenar-H-C-323-P46-0129 : EPAR - Assessment Report
variation-report · 2017-11-24 · EMA/123675/2015
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Prevenar : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2017-11-24
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Prevenar : EPAR - Summary for the public
overview · 2017-11-24
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Prevenar-H-C-323-II-76 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2017-11-24
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Prevenar-H-C-323-II-80 : EPAR - Scientific Discussion - Variation
scientific-discussion-variation · 2017-11-24
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Prevenar : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2017-11-24
- 打开官方文件 ↗
Prevenar : EPAR - Scientific Discussion
scientific-discussion · 2017-11-24
- 打开官方文件 ↗
Prevenar : EPAR - Steps taken after authorisation when a cutoff date has been used
steps-after-cutoff · 2017-11-24
- 打开官方文件 ↗
Prevenar-13-H-C-1104-II-0111 : EPAR - Assessment Report - Variation
variation-report · 2015-05-12 · EMA/CHMP/626561/2014
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。