法规知识库 · EMA 集中审评
Synflorix
Pneumococcal polysaccharide serotype 23F;Pneumococcal polysaccharide serotype 4;Pneumococcal polysaccharide serotype 5;Pneumococcal polysaccharide serotype 6B;Pneumococcal polysaccharide serotype 7F;Pneumococcal polysaccharide serotype 9V;Pneumococcal polysaccharide serotype 1;Pneumococcal polysaccharide serotype 14;Pneumococcal polysaccharide serotype 18C;Pneumococcal polysaccharide serotype 19F · EMEA/H/C/000973 · 已授权
获批上市许可
2009-03-29
欧委会决定日
2026-05-19
持有人 / 申请人
GlaxoSmithKline Biologicals S.A.
终止日期字段
无
从产品到官方文件
文件记录
29
官方索引 29
EPAR / 审评
27
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J07AL52
治疗领域：Pneumococcal Infections;Immunization
药理分类：Vaccines
修订号：37 · 最新影响 PI 的程序：VR/0000341456
适应症（原文）：Active immunisation against invasive disease and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks up to five years of age. See sections 4.4 and 5.1 in product information for information on protection against specific pneumococcal serotypes. The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups 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。
2026-05-19 · 欧委会决定
2009-03-29 · 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
- 打开官方文件 ↗
Synflorix : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-05-19
- 打开官方文件 ↗
Synflorix : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-05-19
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Synflorix-H-C-973-P46-0072 : EPAR - Assessment Report
variation-report · 2023-01-30 · EMA/32444/2023
- 打开官方文件 ↗
Synflorix : EPAR - Risk-management-plan summary
rmp-summary · 2020-04-01
- 打开官方文件 ↗
Synflorix : EPAR - Summary for the public
overview · 2018-01-09
- 打开官方文件 ↗
Synflorix-H-C-973-P46-058 : EPAR - Assessment Report
variation-report · 2017-01-10 · EMA/2042/2016
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Synflorix-H-C-973-P46-0062 : EPAR - Assessment Report
variation-report · 2016-11-15 · EMA/713031/2016
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Synflorix-H-C-973-P46-059 : EPAR - Assessment Report
variation-report · 2016-10-20 · EMA/657652/2016
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Synflorix-H-C-973-P46-0061 : EPAR - Assessment Report
variation-report · 2016-03-11 · EMA/190189/2016
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Synflorix-H-C-973-P46-0057 : EPAR - Assessment Report
variation-report · 2016-01-29 · EMA/579957/2015
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Synflorix-H-C-973-II-0092 : EPAR - Assessment Report - Variation
variation-report · 2015-06-15 · EMA/CHMP/253767/2015
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Synflorix-H-C-973-P46-0040 : EPAR - Assessment Report
variation-report · 2015-04-10 · EMA/233920/2015
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Synflorix-H-C-973-P46-0056 : EPAR - Assessment Report
variation-report · 2015-03-20 · EMA/190018/2015
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Synflorix-H-C-973-P46-0012-1 : EPAR - Assessment Report
variation-report · 2015-02-20 · EMA/98246/2015 Rev. 1
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Synflorix-H-C-973-P46-0042-43 : EPAR - Assessment Report
variation-report · 2015-02-20 · EMA/85312/2015 Rev. 1
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Synflorix-H-C-973-P46-0041 : EPAR - Assessment Report
variation-report · 2015-02-20 · EMA/89785/2015 Rev. 1
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Synflorix-H-C-973-P46-0048 : EPAR - Assessment Report
variation-report · 2015-02-20 · EMA/97288/2015 Rev. 1
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Synflorix-H-C-973-P46-0049 : EPAR - Assessment Report
variation-report · 2015-02-20 · EMA/97616/2015 Rev. 1
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Synflorix-H-C-973-P46-0053 : EPAR - Assessment Report
variation-report · 2015-02-20 · EMA/99784/2015 Rev. 1
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Synflorix-H-C-973-P46-0050 : EPAR - Assessment Report
variation-report · 2015-02-20 · EMA/99712/2015 Rev. 1
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Synflorix-H-C-973-P46-0044 : EPAR - Assessment Report
variation-report · 2015-02-20 · EMA/96594/2015 Rev. 1
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Synflorix-H-C-973-P46-0017 : EPAR - Assessment Report
variation-report · 2015-02-20 · EMA/96321/2015 Rev. 1
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Synflorix-H-C-973-II-0052 : EPAR - Assessment Report - Variation
variation-report · 2014-02-18 · EMA/73592/2014
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Synflorix-H-C-973-II-0020 : EPAR - Assessment Report - Variation
variation-report · 2011-10-25 · EMA/736592/2011
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Synflorix-H-C-973-II-0014 : EPAR - Assessment Report - Variation
variation-report · 2011-10-25 · EMA/795221/2011
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Synflorix-H-C-973-II-0016 : EPAR - Assessment Report - Variation
variation-report · 2011-10-25 · EMA/830044/2011
- 打开官方文件 ↗
Synflorix : EPAR - Public assessment report
assessment-report · 2009-05-12
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。