欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2810/001
药品名称
Metronidazol Isab
活性成分
Metronidazole 5.0 mg/ml
剂型
Solution for infusion
上市许可持有人
Laboratórios Basi - Indústria Farmacêutica, S.A
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Latvia (LV)
Lithuania (LT)
-
Estonia (EE)
许可日期
2024/03/13
最近更新日期
2025/07/07
药物ATC编码
J01XD01 metronidazole
申请类型
TypeLevel1:
Abridged
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
Final PL
|
common_pl_proposedclean
Date of last change:2025/07/07
Final SPC
|
common_spc_proposedclean
Date of last change:2025/07/07
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase