欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NO/H/0288/001
药品名称
Anidulafungin Mylan
活性成分
anidulafungin 100.0 mg
剂型
Powder for concentrate for solution for infusion
上市许可持有人
Mylan S.A.S.
参考成员国 - 产品名称
Norway (NO)
Anidulafungin Mylan
互认成员国 - 产品名称
Denmark (DK)
Belgium (BE)
Anidulafungin Mylan 100 mg poeder voor concentraat voor oplossing voor infusie
United Kingdom (Northern Ireland) (XI)
Italy (IT)
Czechia (CZ)
Anidulafungin Mylan
许可日期
2019/11/28
最近更新日期
2023/10/12
药物ATC编码
J02AX06 anidulafungin
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PubAR
|
Public Assessment Report
Date of last change:2024/09/06
Final Product Information
|
SPC_ Labelling and Package leaflet
Date of last change:2024/09/06
PubAR Summary
|
Summary Public Assessment Report
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase