欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/3232/003
药品名称
Sitagliptin Pharmazac
活性成分
SITAGLIPTIN hydrochloride 100.0 mg
剂型
Film-coated tablet
上市许可持有人
Pharmazac SA 31 Naousis Str. 104 47 Athens Greece
参考成员国 - 产品名称
Denmark (DK)
Meliglix
互认成员国 - 产品名称
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
Romania (RO)
Sitagliptin Pharmazac 100 mg comprimate filmate
Slovenia (SI)
Latvia (LV)
Lithuania (LT)
Estonia (EE)
Cyprus (CY)
Meliglix film coated tablets 100 mg
Germany (DE)
许可日期
2022/03/16
最近更新日期
2024/07/17
药物ATC编码
A10BH01 sitagliptin
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 Labelling
|
common_outer_clean DK_H_3232_001_003_IB_002 Meliglix
Date of last change:2024/09/06
Final PL
|
common_pl_clean DK_H_3232_001_003_IB_002 Meliglix
Date of last change:2024/09/06
Final SPC
|
common_spc_clean DK_H_3232_001_003_IB_002 Meliglix
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase