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

MR编号	DK/H/2877/003
药品名称	Amisulprid "Medochemie Romania"
活性成分	Amisulpride 200.0 mg
剂型	Tablet
上市许可持有人	Medochemie Romania S.R.L. Strada Prof. Dr. Cantacuzino Ioan 1 011437 Bucureşti Romania
参考成员国 - 产品名称	Denmark (DK) Suprol
互认成员国 - 产品名称	Netherlands (NL) Aktiprol 200 mg tabletten Italy (IT)
许可日期	2019/04/17
最近更新日期	2025/09/05
药物ATC编码	N05AL05 amisulpride
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 PL \| common_pl_IB_011_G_cleanDate of last change:2025/09/05 Final Labelling \| common_label_IB_011_G_cleanDate of last change:2025/09/05 Final SPC \| common_spc_IB_011_G_cleanDate of last change:2025/09/05 Final Product Information \| DK_H_2877_001_004_DC _ common_combined_labelfeb2019clean _ seq 0003Date of last change:2024/09/06 Final Product Information \| DK_H_2877_001_004_DC _ common_combined_pilmarch2019clean _ seq 0004Date of last change:2024/09/06 Final Product Information \| DK_H_2877_001_004_DC _ common_combined_spcmarch2019clean _ seq 0004Date of last change:2024/09/06 PubAR \| PAR _ Amisulpride _ DK_H_2877_001_004_DCDate of last change:2024/09/06 PubAR Summary \| sPAR _ Amisulpride _ DK_H_2877_001_004_DCDate of last change:2024/09/06
市场状态	Positive