法规知识库 · EMA 集中审评
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1) · EMEA/H/C/002269 · 已过期
获批上市许可
2010-11-29
欧委会决定日
2015-07-28
持有人 / 申请人
Novartis Vaccines and Diagnostics S.r.l.
终止日期字段
2015-11-28
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：2 · 最新影响 PI 的程序：PSUSA/10008
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 the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain. Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic should be used in accordance with official recommendations.
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。
2015-11-28 · 上市许可终止（撤市/失效/撤销等）
Expired
2015-07-28 · 欧委会决定
2010-11-29 · 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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Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics-H-C-PSUSA-00010008/201410 : EPAR - Scientific conclusions and grounds recommending the variation to the te...
scientific-conclusion · 2015-09-11
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Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2015-09-11
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Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public
overview · 2011-01-24 · EMA/CHMP/670965/2010
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Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Public assessment report
assessment-report · 2011-01-24
产品信息
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Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information
product-information · 2015-09-11
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Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations
all-authorised-presentations · 2011-01-24
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。