山东新华制药股份:恩格列净片(10mg)取得药品注册证书

格隆汇
21 Jan

格隆汇1月21日丨山东新华制药股份(00719.HK)公布,近日,公司收到国家药品监督管理局核准签发的恩格列净片(10mg)(以下简称"本品")《药品注册证书》,本品符合药品注册的有关要求,批准注册。2023年6月,新华制药向国家药品监督管理局药品审评中心(CDE)递交恩格列净片(10mg)上市许可注册申报资料并获受理,2025年1月获得《药品注册证书》,审评结论为批准注册。恩格列净是由勃林格殷...

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