法规知识库 · EMA 集中审评
Voriconazole Hikma (previously Voriconazole Hospira)
voriconazole · EMEA/H/C/003737 · 已授权
获批上市许可
2015-05-27
欧委会决定日
2026-10-22
持有人 / 申请人
Hikma Farmaceutica (Portugal) S.A.
终止日期字段
无
从产品到官方文件
文件记录
7
官方索引 7
EPAR / 审评
5
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J02AC03
治疗领域：Bacterial Infections and Mycoses;Aspergillosis;Candidiasis
药理分类：Antimycotics for systemic use
修订号：17 · 最新影响 PI 的程序：VR/0000369223
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 candidaemia in non-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. Voriconazole 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。
2026-10-22 · 欧委会决定
2015-05-27 · 获批上市许可
2015-03-26 · 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 ↗
Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-10-23
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Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Procedural steps taken and scientific information after authorisation (archived)
procedural-steps-after · 2025-01-20
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Voriconazole Hikma (previously Voriconazole Hospira): EPAR - Summary for the public
overview · 2017-03-01
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Voriconazole Hospira : EPAR - Public assessment report
assessment-report · 2015-06-25 · EMA/CHMP/151531/2015
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Voriconazole Hospira : EPAR - Risk-management-plan summary
rmp-summary · 2015-06-25
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。