欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0449/002
药品名称
Cefepima Accord
活性成分
cefepime dihydrochloride 2000.0 mg
剂型
Powder for solution for injection
上市许可持有人
Accord Healthcare Limited
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Austria (AT)
Belgium (BE)
Croatia (HR)
Czechia (CZ)
Cefepime Accord
France (FR)
Germany (DE)
Cefepime Accord 2 g Pulver zur Herstellung einer Injektions/Infusionslösung
Poland (PL)
Slovenia (SI)
Spain (ES)
许可日期
2011/07/19
最近更新日期
2024/04/09
药物ATC编码
J01DE01 cefepime
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
PAR
|
52019_52020_20140912_PAR_JOR
Date of last change:2014/11/11
Final SPC
|
common-spc-cefepime_clear
Date of last change:2014/05/08
Final Labelling
|
Final approved PI-interpack Cefepime 1 g
Date of last change:2011/07/20
Final Labelling
|
Final approved PI-interpack Cefepime 2 g
Date of last change:2011/07/20
Final PL
|
Final approved PI-PIL Cefepime 1 g
Date of last change:2011/07/20
Final PL
|
Final approved PI-PIL Cefepime 2 g
Date of last change:2011/07/20
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase