欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1810/001
药品名称
Fotaxil
活性成分
cefotaxime 1.0 g
剂型
Powder for solution for infusion/injection
上市许可持有人
Medochemie Ltd.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Lithuania (LT)
MOXICEF 1 g milteliai injekciniam ar infuziniam tirpalui
Bulgaria (BG)
Fotaxil
Romania (RO)
Slovenia (SI)
Malta (MT)
许可日期
2018/05/02
最近更新日期
2024/05/21
药物ATC编码
J01DD01 cefotaxime
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
|
PIL_Cefotaxime_DCP_Feb 2024_clean
Date of last change:2024/09/06
Final SPC
|
SPC_Cefotaxime_DCP_Feb 2024_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase