欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2130/002
药品名称
Mifomet
活性成分
Metformin hydrochloride 1000.0 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
Bulgaria (BG)
Czechia (CZ)
Fordiabik Combo
Slovakia (SK)
Germany (DE)
FORDIABIK COMBO
Poland (PL)
Hungary (HU)
Mifomet 50 mg/1000 mg filmtabletta
许可日期
2022/05/18
最近更新日期
2025/04/23
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
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Final PL
Final SPC
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Final SPC
PubAR
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PAR
PubAR Summary
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PAR Summary
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase