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

MR编号	NL/H/4425/002
药品名称	Saxagliptin HCl Sandoz 5 mg, filmcoated tablets
活性成分	Saxagliptin Hydrochloride Dihydrate 5.58 mg
剂型	Film-coated tablet
上市许可持有人	Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands
参考成员国 - 产品名称	Netherlands (NL) Saxagliptine HCl Sandoz 5 mg, filmomhulde tabletten
互认成员国 - 产品名称	Germany (DE) Saxagliptin Hexal 5 mg Filmtabletten United Kingdom (Northern Ireland) (XI) France (FR)
许可日期	2019/05/03
最近更新日期	2024/03/06
药物ATC编码	A10BH03 saxagliptin
申请类型	TypeLevel1：Known Active Substance 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 PL \| NLH4425_common-pil-cleanDate of last change:2021/02/15 Final SPC \| NLH4425_common-spc-cleanDate of last change:2021/02/15 Final Labelling \| NLH4425_common-outerDate of last change:2021/02/15 PAR \| PAR_NL_H_4425_DC_saxagliptine_31 jul 2019Date of last change:2019/08/07 PAR Summary \| PAR_NL_H_4425_DC_saxagliptine_31 jul 2019 summary EngDate of last change:2019/08/07
市场状态	Positive