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

MR编号	DK/H/2455/006
药品名称	Pregabalin "Aristo"
活性成分	pregabalin 200.0 mg
剂型	Capsule, hard
上市许可持有人	Aristo Pharma Gmb Wallenroder Strasse 8-10 Wittenau 13435 Berlin Germany
参考成员国 - 产品名称	Denmark (DK) Pregabalin "Aristo"
互认成员国 - 产品名称	Spain (ES) Portugal (PT) Italy (IT)
许可日期	2015/05/13
最近更新日期	2023/11/08
药物ATC编码	N03AX16 pregabalin
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 SPC \| Pregabalin Aristo_ h_rde kapsler 25 mg_ 50 mg_ 75 mg_ 100 mg_ 150 mg_ 200 mg_ 225 mg og 300 mgDate of last change:2023/09/13 Final PL \| V 020 common_pl_pregabalin_all_cleanDate of last change:2023/06/28 Final Product Information \| common-pl-Pregabalin Aristo-clean-AV-03122018Date of last change:2019/03/18 Final Product Information \| common-outer-Pregabalin Aristo-clean-AV-03122018Date of last change:2019/03/18 Final Product Information \| common-spc-Pregabalin Aristo-clean-AV-03122018Date of last change:2019/03/18 PAR Summary \| Final Summary PAR Pregabalin Aristo DKH2455_001-008_DCDate of last change:2015/11/23 PAR \| Final PAR Pregabalin Aristo DKH2455_001-008_DCDate of last change:2015/11/23 Final Labelling \| Final labelling DK_H_2455_001-008_DC Pregabalin AristoDate of last change:2015/05/13
市场状态	Positive