欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
LV/H/0289/001
药品名称
Vildagliptin Olpha 50 mg tablets
活性成分
vildagliptin 50.0 mg
剂型
Tablet
上市许可持有人
Olpha AS Rupnicu Iela 5, Olaine 2114, Latvia
参考成员国 - 产品名称
Latvia (LV)
互认成员国 - 产品名称
Lithuania (LT)
Vildagliptin Olpha 50 mg tabletės
Estonia (EE)
Czechia (CZ)
Vildagliptin Olainfarm
Slovakia (SK)
Germany (DE)
Vildagliptin Olainfarm 50 mg Tabletten
France (FR)
Italy (IT)
Poland (PL)
Vildagliptin Olainfarm
许可日期
2025/04/23
最近更新日期
2025/04/23
药物ATC编码
A10BH02 vildagliptin
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
PubAR Summary
|
LV_H_0289_001_DC_PAR_Summary
Date of last change:2025/09/05
PubAR
|
LV_H_0289_001_DC_PAR_Scientific
Date of last change:2025/09/05
Final SPC
|
LV_H_0289_001_DC_SmPC_FINAL
Date of last change:2025/04/23
Final PL
|
LV_H_0289_001_DC_PIL_FINAL
Date of last change:2025/04/23
Final Labelling
|
LV_H_0289_001_DC_LAB_FINAL
Date of last change:2025/04/23
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase