欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3361/002
药品名称
Frekidir
活性成分
Sitagliptin hydrochloride 50.0 mg
剂型
Film-coated tablet
上市许可持有人
Pharmathen S.A. Dervenakion 6 Pallini Attiki 153 51 Greece
参考成员国 - 产品名称
Denmark (DK)
Frekidir
互认成员国 - 产品名称
Italy (IT)
Greece (GR)
Sweden (SE)
Norway (NO)
Finland (FI)
Germany (DE)
Soltamin 50 mg Filmtabletten
Netherlands (NL)
France (FR)
Spain (ES)
许可日期
2023/06/28
最近更新日期
2024/10/15
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_LAB_clean_Sitagliptin fc tabs 25_ 50 _ 100mg
Date of last change:2024/09/06
Final PL
|
common_PIL_Sitagliptin fc tabs 25_ 50 _ 100mg_d30_ib002g_clean
Date of last change:2024/09/06
Final SPC
|
common_SPC_clean_Sitagliptin fc tabs 25_ 50 _ 100mg
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase