法规知识库 · EMA 集中审评
Prepandemic 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/001015 · 已撤市
获批上市许可
2008-09-26
欧委会决定日
2011-10-03
持有人 / 申请人
GlaxoSmithKline Biologicals S.A.
终止日期字段
2011-11-03
从产品到官方文件
文件记录
6
官方索引 6
EPAR / 审评
4
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：3 · 最新影响 PI 的程序：II/0013
适应症（原文）：Active immunisation against H5N1 subtype of Influenza A virus. This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1). Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg 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。
2011-11-03 · 上市许可终止（撤市/失效/撤销等）
Withdrawn
2011-10-03 · 欧委会决定
2008-09-26 · 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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Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2012-03-21
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Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public
overview · 2012-03-21
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Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals-H-C-1051-II-01 : EPAR - Assessment Report - Variation
variation-report · 2012-03-21 · EMEA/CHMP/352156/2009
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Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Public assessment report
assessment-report · 2012-03-21
产品信息
- 打开官方文件 ↗
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information
product-information · 2012-03-21
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Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations
all-authorised-presentations · 2012-03-21
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。