法规知识库 · EMA 集中审评
Cresemba
isavuconazole · EMEA/H/C/002734 · 已授权
获批上市许可
2015-10-15
欧委会决定日
2025-07-17
持有人 / 申请人
Basilea Pharmaceutica Deutschland GmbH
终止日期字段
无
从产品到官方文件
文件记录
12
官方索引 12
EPAR / 审评
10
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J02AC05
治疗领域：Aspergillosis
药理分类：Antimycotics for systemic use;Triazole and triazole derivatives
修订号：21 · 最新影响 PI 的程序：PSUSA/00010426/202409
适应症（原文）：Powder for concentrate for solution for infusion: Cresemba is indicated in patients from 1 year of age and older for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Hard capsules: Cresemba hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis mucormycosis in patients for whom amphotericin B is inappropriate (see sections 4.4 and 5.1) Consideration should be given to official guidance on the appropriate use of antifungal agents. Cresemba 40 mg hard capsules are intended to be used for paediatric patients.
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。
2025-07-17 · 欧委会决定
2015-10-15 · 获批上市许可
2005-07-23 · 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 ↗
Cresemba : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-07-24
- 打开官方文件 ↗
Cresemba : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-03-27
- 打开官方文件 ↗
Cresemba : EPAR - Medicine overview
overview · 2024-10-01 · EMA/317020/2024
- 打开官方文件 ↗
Cresemba : EPAR - Risk management plan
rmp · 2024-10-01
- 打开官方文件 ↗
Cresemba-H-C-002734-X-0042-G : EPAR - Assessment report
variation-report · 2024-09-11 · EMA/330882/2024
- 打开官方文件 ↗
Cresemba : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan
pip-compliance · 2024-09-11 · EMA/CHMP/298354/2024
- 打开官方文件 ↗
Cresemba-H-C-002734-P46-007 : EPAR - Assessment report
variation-report · 2023-11-13 · EMA/492925/2023
- 打开官方文件 ↗
Cresemba-H-C-002734-P46-006 : EPAR - Assessment report
variation-report · 2023-10-26 · EMA/CHMP/304783/2020
- 打开官方文件 ↗
Cresemba-H-C-PSUSA-00010426-202109 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-discussion-variation · 2022-07-29 · EMA/669852/2022
- 打开官方文件 ↗
Cresemba : EPAR - Public assessment report
assessment-report · 2015-10-29 · EMA/596950/2015
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。