欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2158/001
药品名称
Cefotaxim "MIP"
活性成分
cefotaxime sodium salt 1.0 g
剂型
Powder for solution for infusion/injection
上市许可持有人
MIP Pharma GmbH
参考成员国 - 产品名称
Denmark (DK)
Cefotaxim "MIP"
互认成员国 - 产品名称
Germany (DE)
Cefotaxim IPP 1 g Pulver zur Herstellung einer Injektions- oder Infusionslösung
United Kingdom (Northern Ireland) (XI)
Sweden (SE)
47757
Norway (NO)
Cefotaxim IPP
Finland (FI)
Latvia (LV)
Lithuania (LT)
Cefotaxime MIP 1 g milteliai injekciniam arba infuziniam tirpalui
Estonia (EE)
CEFOTAXIME MIP 1G
Hungary (HU)
CEFOTAXIM MIP 1 g por oldatos injekcióhoz vagy infúzióhoz
Bulgaria (BG)
Cefotaxim IPP
Romania (RO)
Cefotaxim MIP 1 g pulbere pentru soluţie injectabilă/perfuzabilă
许可日期
2013/06/21
最近更新日期
2024/04/18
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
|
common-pl-clean
Date of last change:2019/07/11
Final SPC
|
common-spc-clean
Date of last change:2019/07/11
Final Labelling
|
common-pl-clean
Date of last change:2018/10/04
PAR
|
Final PAR Scientific discussion Cefotaxim MIP DKH2158_001-002_DC
Date of last change:2014/05/08
市场状态
Positive
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