欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/2670/002
药品名称
Daltex
活性成分
metformin hydrochloride 1000.0 mg
vildagliptin 50.0 mg
剂型
Film-coated tablet
上市许可持有人
Medochemie Ltd. 1 – 10 Constantinoupoleos Str. 3011 Limassol Cyprus
参考成员国 - 产品名称
Denmark (DK)
Daltex
互认成员国 - 产品名称
Portugal (PT)
Slovenia (SI)
Spain (ES)
Greece (GR)
DALMEVIN PLUS
Latvia (LV)
Daltex 50 mg/1000 mg apvalkotās tabletes
Estonia (EE)
DALTEX
Bulgaria (BG)
Damlevin plus
Cyprus (CY)
DALMEVIN PLUS 50MG/1000MG FC TABS
Czechia (CZ)
DALMEVIN PLUS 50mg/1000mg potahované tablety
Romania (RO)
DALTEX 50 mg/ 1000 mg comprimate filmate
Slovakia (SK)
DALTEX 50 mg/ 1000 mg filmom obalené tablety
Malta (MT)
Daltex
Croatia (HR)
Daltex 50 mg/1000 mg filmom obložene tablete
许可日期
2017/08/14
最近更新日期
2023/11/27
药物ATC编码
A10BD08 metformin and vildagliptin
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Additional Strength/Form
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 Product Information
|
131_vldmtf_impack_20160524
Date of last change:2024/09/06
Final Product Information
|
131_vldmtf_outer_20170731_clean
Date of last change:2024/09/06
Final Product Information
|
131_vldmtf_pl_20170731_clean
Date of last change:2024/09/06
Final Product Information
|
131_vldmtf_smpc_20170807_clean
Date of last change:2024/09/06
PubAR
|
Final PAR Daltex film coated tablets DKH2670_001_002_DC
Date of last change:2024/09/06
PubAR Summary
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Final sPAR Daltex film coated tablets DKH2670_001_002_DC
Date of last change:2024/09/06
Final PL
|
pl_clean
Date of last change:2024/09/06
Final SPC
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smpc_tracked
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase