法规知识库 · EMA 集中审评
Zavicefta
avibactam sodium;ceftazidime pentahydrate · EMEA/H/C/004027 · 已授权
获批上市许可
2016-06-23
欧委会决定日
2025-05-20
持有人 / 申请人
Pfizer Ireland Pharmaceuticals Unlimited Company
终止日期字段
无
从产品到官方文件
文件记录
13
官方索引 13
EPAR / 审评
11
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J01DD52
治疗领域：Pneumonia, Bacterial;Soft Tissue Infections;Pneumonia;Urinary Tract Infections;Gram-Negative Bacterial Infections
药理分类：Antibacterials for systemic use
修订号：20 · 最新影响 PI 的程序：VR/0000247225
适应症（原文）：Zavicefta is indicated in adults and paediatric patients aged 3 months and older for the treatment of the following infections: Complicated intra-abdominal infection (cIAI) Complicated urinary tract infection (cUTI), including pyelonephritis Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP) Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Zavicefta is also indicated for the treatment of infections due to aerobic Gram-negative organisms in adults and paediatric patients aged 3 months and older with limited treatment options. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
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。
2025-05-20 · 欧委会决定
2016-06-23 · 获批上市许可
2016-04-28 · CHMP 意见通过
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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Zavicefta : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-11-14
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Zavicefta : EPAR - Risk management plan
rmp · 2025-11-13
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Zavicefta : EPAR - Medicine overview
overview · 2024-11-14 · EMA/490485/2024
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Zavicefta-H-C-004027-II-0035 : EPAR - Assessment Report - Variation
variation-report · 2024-11-12 · EMA/463695/2024
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Zavicefta-H-C-004027-P46-005 : EPAR - Assessment Report - Variation
variation-report · 2023-09-27 · EMA/433189/2023
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Zavicefta-H-C-4027-P46-004 : EPAR - Assessment Report
variation-report · 2022-07-05 · EMA/620421/2022
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Zavicefta-H-C-4027-II-0019 : EPAR - Assessment Report - Variation
variation-report · 2021-08-25 · EMA/437085/2020
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Zavicefta-H-C-4027-II-0015 : EPAR - Assessment Report - Variation
variation-report · 2020-11-20 · EMA/543616/2020
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Zavicefta : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2020-05-20
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Zavicefta-H-C-4027-P46-0003 : EPAR - Assessment Report
variation-report · 2018-09-05 · EMA/PRAC/595509/2018
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Zavicefta : EPAR - Public assessment report
assessment-report · 2016-07-14 · EMA/CHMP/377887/2016
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。