欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2115/002
药品名称
Sitagliptin/Metformin Grindeks
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
Grindeks AS, Latvia
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Ireland (IE)
Estonia (EE)
Austria (AT)
Hungary (HU)
France (FR)
Bulgaria (BG)
Sitagliptin/Metformin Grindeks
Spain (ES)
Czechia (CZ)
SItagliptin/Metfromin Grindeks
Portugal (PT)
Romania (RO)
Sitagliptin/Metformin Grindeks 50/1000 mg comprimate filmate
Italy (IT)
Slovakia (SK)
Greece (GR)
Slovenia (SI)
Germany (DE)
Sitagliptin/Metformin Grindeks 50/1000 mg Filmtabletten
Norway (NO)
Croatia (HR)
Denmark (DK)
Sitagliptin/Metformin Grindeks
Finland (FI)
Belgium (BE)
Poland (PL)
Sitagliptin + Metformin Grindeks
Netherlands (NL)
Latvia (LV)
Luxembourg (LU)
Lithuania (LT)
-
许可日期
2022/01/24
最近更新日期
2024/08/22
药物ATC编码
A10BD07 metformin and sitagliptin
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
|
Final SPC
|
PAR
|
SE_H_2115
PAR Summary
|
SE_H_2115_2
市场状态
Positive
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