欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2130/001
药品名称
Mifomet
活性成分
metformin hydrochloride 850.0 mg
Sitagliptin Hydrochloride monohydrate 50.0 mg
剂型
Film-coated tablet
上市许可持有人
Bausch Health Ireland Ltd
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
FORDIABIK COMBO
Poland (PL)
Hungary (HU)
Mifomet 50 mg/850 mg filmtabletta
Bulgaria (BG)
Czechia (CZ)
Fordiabik Combo
Slovakia (SK)
许可日期
2022/05/18
最近更新日期
2023/04/21
药物ATC编码
A10BD07 metformin and sitagliptin
申请类型
TypeLevel1:
Known Active Substance
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
|
Final PL
Final SPC
|
Final SPC
PAR
|
SE_H_2130_01_02_DC
PAR Summary
|
SE_H_2130_01_02_DC_2
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase