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

MR编号	DK/H/2509/002
药品名称	Silocalm
活性成分	clobazam 2.0 mg/ml
剂型	Oral suspension
上市许可持有人	Ethypharm 194, Bureaux de Ia Colline, Bâtiment D 92213, Saint-Cloud Cedex France
参考成员国 - 产品名称	Denmark (DK) Silocalm
互认成员国 - 产品名称	Germany (DE) Epaclob 2 mg/ml Suspension zum Einnehmen Ireland (IE) Spain (ES) Italy (IT)
许可日期	2016/09/07
最近更新日期	2023/10/23
药物ATC编码	N05BA09 clobazam
申请类型	TypeLevel1：Abridged TypeLevel2：Additional Strength/Form TypeLevel3：Other Generic application Art 10.3 Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final PL \| common_pil_cleanDate of last change:2023/08/16 Final SPC \| common_spc_cleanDate of last change:2023/08/16 Final Product Information \| common-label-clean-1mgDate of last change:2020/09/16 Final Product Information \| common-label-clean-2mgDate of last change:2020/09/16 Final Product Information \| common-carton-cleanDate of last change:2020/09/16 Final Product Information \| Dk_2509_IB_007_PIL cleanDate of last change:2020/09/16 Final Product Information \| common-spc-cleanDate of last change:2020/09/16 Final Labelling \| common-label-tracked-1mgDate of last change:2019/03/11 Final Labelling \| common-carton-trackedDate of last change:2019/03/11 Final Labelling \| common-label-tracked-2mgDate of last change:2019/03/11 PAR Summary \| Final sPAR Silocalm oral suspension DKH2509_001-002_DCDate of last change:2017/04/05 PAR \| Final PAR Silocalm oral suspension DKH2509_001-002_DCDate of last change:2017/04/05
市场状态	Positive