法规知识库 · EMA 集中审评
Dificlir
fidaxomicin · EMEA/H/C/002087 · 已授权
获批上市许可
2011-12-05
欧委会决定日
2023-12-01
持有人 / 申请人
Tillotts Pharma GmbH
终止日期字段
无
从产品到官方文件
文件记录
9
官方索引 9
EPAR / 审评
7
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：A07AA12
治疗领域：Clostridium Infections
药理分类：Antidiarrheals, intestinal antiinflammatory / antiinfective agents
修订号：18 · 最新影响 PI 的程序：IB/0052/G
适应症（原文）：Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg. Consideration should be given to official guidelines on the appropriate use of antibacterial agents. Dificlir granules for oral suspension is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age. Consideration should be given to official guidelines 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。
2023-12-01 · 欧委会决定
2011-12-05 · 获批上市许可
2011-09-22 · 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
- 打开官方文件 ↗
Dificlir : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2024-09-30
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Dificlir-H-C-002087-X-0034-G : EPAR - Assessment Report - Extension
variation-report · 2020-03-11 · EMA/4852/2020
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Dificlir : EPAR - Risk-management-plan summary
rmp-summary · 2020-03-11
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Dificlir : EPAR - Medicine overview
overview · 2020-03-11 · EMA/31758/2020
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Dificlir-H-C-2087-P46-0022 : EPAR - Assessment Report
variation-report · 2015-02-16 · EMA/773298/2014
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Dificlir-EMEA-H-C-2087-PSUV-0015: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2014-04-25 · EMA/223574/2014
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Dificlir : EPAR - Public assessment report
assessment-report · 2011-12-19 · EMA/857570/2011
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。