欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/1007/001
药品名称
GLIPTERIN
活性成分
sitagliptin hydrochloride monohydrate 25.0 mg
剂型
Film-coated tablet
上市许可持有人
PHARMEXTRACTA SPA
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
Netherlands (NL)
Sitagliptine Zillen Farma
许可日期
2022/02/09
最近更新日期
2025/07/30
药物ATC编码
A10BH01 sitagliptin
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final Labelling
|
Final labelling_Final labelling
Date of last change:2024/09/06
Final PL
|
Final PL_common_pl_clean_1_3
Date of last change:2024/09/06
Final SPC
|
Final SmPC_common_spc_1_3_clean
Date of last change:2024/09/06
PubAR Summary
|
NL_H_5499_001_003_DC Sitagliptine Zillen Farma sPAR EN
Date of last change:2024/09/06
PubAR
|
PAR_5499_Sitagliptine Zillen Farma_31_5_2022
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase