欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0420/001
药品名称
Meropenem Color
活性成分
meropenem trihydrate 570.0 mg
剂型
Powder for solution for infusion/injection
上市许可持有人
Color Pharma, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Poland (PL)
Spain (ES)
Romania (RO)
Meropenem GSK 500 mg, pulbere pentru solutie injectabila sau perfuzabila
Germany (DE)
许可日期
2011/05/24
最近更新日期
2024/03/19
药物ATC编码
J01DH02 meropenem
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 Labelling
|
common_outer_en_1000mg
Date of last change:2024/09/06
Final Labelling
|
common_outer_en_500mg
Date of last change:2024/09/06
Final PL
|
common_pl_en
Date of last change:2024/09/06
Final SPC
|
common_spc_en
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase