欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	NL/H/4249/001
药品名称	Sitagliptine Amarox film-coated tablets
活性成分	SITAGLIPTIN hydrochloride 25.0 mg
剂型	Film-coated tablet
上市许可持有人	Amarox Pharma B.V. Rouboslaan 32 2252TR Voorschoten The Netherlands
参考成员国 - 产品名称	Netherlands (NL) Sitagliptine Amarox filmomhulde tabletten
互认成员国 - 产品名称	Germany (DE) Sitagliptin Amarox 25 mg Filmtabletten United Kingdom (Northern Ireland) (XI)
许可日期	2019/02/21
最近更新日期	2023/12/20
药物ATC编码	A10BH01 sitagliptin
申请类型	TypeLevel1：Abridged TypeLevel2：Multiple (Copy) 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	Final SPC \| common-spc-cleanDate of last change:2021/02/22 Final PL \| common-pl-cleanDate of last change:2021/02/22 PAR Summary \| 190926 NL.H.4249.001-003.DC Sitagliptine Amarox summary ENDate of last change:2019/09/26 PAR \| 190926 NL.H.4249.001-003.DC Sitagliptine Amarox PARDate of last change:2019/09/26 Final Labelling \| Binder1 final labellingDate of last change:2019/02/22
市场状态	Positive