法规知识库 · EMA 集中审评
Mycamine
micafungin · EMEA/H/C/000734 · 已授权
获批上市许可
2008-04-25
欧委会决定日
2025-08-04
持有人 / 申请人
Sandoz Pharmaceuticals d.d.
终止日期字段
无
从产品到官方文件
文件记录
11
官方索引 11
EPAR / 审评
9
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：J02AX05
治疗领域：Candidiasis
药理分类：Antimycotics for systemic use
修订号：22 · 最新影响 PI 的程序：N/0000290203
适应症（原文）：Mycamine is indicated for: Adults, adolescents ≥ 16 years of age and elderly treatment of invasive candidiasis; treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate; prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. Children (including neonates) and adolescents < 16 years of age treatment of invasive candidiasis. prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/µl) for 10 or more days. The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.
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。
2025-08-04 · 欧委会决定
2008-04-25 · 获批上市许可
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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Mycamine : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2025-10-13
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Mycamine : EPAR - Risk management plan
rmp · 2025-10-13
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Mycamine : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2025-08-04
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Mycamine-H-C-734-P46-040 : EPAR - Assessment Report
variation-report · 2019-09-10 · EMA/494096/2019
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Mycamine-H-C-734-P46-0038 : EPAR - Assessment Report
variation-report · 2016-01-19 · EMA/CHMP/804861/2015
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Mycamine-PSUSA-00002051-201410 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2015-10-09 · EMA/CHMP/412406/2015
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Mycamine : EPAR - Conditions imposed on member states for safe and effective use
conditions-member-states · 2011-09-26
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Mycamine : EPAR - Summary for the public
overview · 2011-09-14
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Mycamine : EPAR - Public assessment report
assessment-report · 2008-05-08
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。