法规知识库 · EMA 集中审评
Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14) · EMEA/H/C/001206 · 已授权
获批上市许可
2009-10-10
欧委会决定日
2025-02-12
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
11
官方索引 11
EPAR / 审评
9
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J07BB02
治疗领域：Influenza, Human;Immunization;Disease Outbreaks
药理分类：Vaccines
修订号：12 · 最新影响 PI 的程序：IB/0091/G
适应症（原文）：Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.
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。
2025-02-12 · 欧委会决定
2009-10-10 · 获批上市许可
说明书、EPAR 与其他文件
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EPAR / 审评资料
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Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals): EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-12-17
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Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals): EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-12-17
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Adjupanrix-H-C-001206-II-0074 : EPAR - Assessment report - Variation
variation-report · 2022-06-08 · EMA/CHMP/205556/2022
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Adjupanrix : EPAR - Risk-management-plan summary
rmp-summary · 2019-11-06
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Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)-H-C-1206-P46-0032 : EPAR - Assessment Report
variation-report · 2015-02-19 · EMA/119411/2015
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Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)-H-C-1206-P46-0033 : EPAR - Assessment Report
variation-report · 2014-09-29 · EMA/544203/2014
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Adjupanrix-H-C-1206-PSUV-0032 (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) : EPAR - Scientific conclusions and grounds recommending the variation to t...
scientific-conclusion · 2014-05-13 · EMA/252531/2014
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Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals): EPAR - Summary for the public
overview · 2013-01-24
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Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals : EPAR - Public assessment report
assessment-report · 2009-12-17
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。