法规知识库 · EMA 集中审评
Vfend
voriconazole · EMEA/H/C/000387 · 已授权
获批上市许可
2002-03-19
欧委会决定日
2026-06-04
持有人 / 申请人
Pfizer Europe MA EEIG
终止日期字段
无
从产品到官方文件
文件记录
16
官方索引 16
EPAR / 审评
13
assessment / overview 等
产品信息
3
PI / presentations
其他
0
RMP / PIP 等
ATC：J02AC03
治疗领域：Candidiasis;Mycoses;Aspergillosis
药理分类：Antimycotics for systemic use
修订号：59 · 最新影响 PI 的程序：VR/0000326239
适应症（原文）：Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of in candidaemianon-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Vfend should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
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。
2026-06-04 · 欧委会决定
2002-03-19 · 获批上市许可
2001-12-13 · 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 ↗
Vfend : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-07-21
- 打开官方文件 ↗
Vfend : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2026-04-14
- 打开官方文件 ↗
Vfend : EPAR - Summary for the public
overview · 2026-02-20
- 打开官方文件 ↗
Vfend : EPAR - Risk Management Plan
rmp-summary · 2023-11-09
- 打开官方文件 ↗
Vfend-H-C-PSUSA-00003127-202102 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-01-18 · EMA/616868/2021
- 打开官方文件 ↗
Vfend-H-C-PSUSA-00003127-201802 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2019-01-24 · EMA/36803/2019
- 打开官方文件 ↗
Vfend-H-C-PSUSA-00003127-201502 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-01-29 · EMA/829978/2015
- 打开官方文件 ↗
Vfend-H-C-387-P46-089.1 : EPAR - Assessment Report
variation-report · 2015-05-13 · EMA/309129/2015
- 打开官方文件 ↗
Vfend : EPAR - Paediatric investigation plan compliance statement
pip-compliance · 2014-08-28
- 打开官方文件 ↗
Vfend-H-C-387-II-0097 : EPAR - Assessment Report - Variation
variation-report · 2014-08-14 · EMA/CHMP/379202/2014
- 打开官方文件 ↗
Vfend : EPAR - Scientific Discussion
scientific-discussion · 2006-11-07
- 打开官方文件 ↗
Vfend-H-C-387-X-0009 : EPAR - Scientific Discussion - Extension
scientific-discussion-variation · 2006-11-07
- 打开官方文件 ↗
Vfend : EPAR - Procedural steps taken before authorisation
procedural-steps-before · 2006-11-07
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。