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

MR编号	DK/H/2627/005
药品名称	Ariadigne
活性成分	quetiapine 50.0 mg
剂型	Prolonged-release tablet
上市许可持有人	Pharmathen S.A. 6, Dervenakion str. Pallini, Attiki, 153 51 Greece
参考成员国 - 产品名称	Denmark (DK) Ariadigne
互认成员国 - 产品名称	Poland (PL) Bonogren SR Czechia (CZ) Derin Prolong, 400 mg Slovakia (SK) Derin Prolong 400 mg
许可日期	2017/02/01
最近更新日期	2022/10/14
药物ATC编码	N05AH04 quetiapine
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 Product Information \| Quetiapine 2627_IA005 var_ common_PIL_cleanDate of last change:2022/06/02 Final Product Information \| Quetiapine 2627_IA005 var_ common_SPC_cleanDate of last change:2022/06/02 Final PL \| common-pl-en-ib003-cleanDate of last change:2021/01/06 Final SPC \| common-spc-en-ib003-cleanDate of last change:2021/01/06 Final Labelling \| common-outer-en-ib003-cleanDate of last change:2021/01/06 PAR Summary \| Final sPAR Ariadigne prolonged-release tablets DKH2627_001-005_DCDate of last change:2018/05/15 PAR \| Final PAR Ariadigne prolonged-release tablets DKH2627_001-005_DCDate of last change:2018/05/15
市场状态	Positive