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

MR编号	NL/H/3006/005
药品名称	Cholecomb calcium 20 mg/10 mg harde capsules
活性成分	ezetimibe 10.0 mg rosuvastatin calcium 20.0 mg
剂型	Capsule, hard
上市许可持有人	Egis Pharmaceuticals PLC Keresztúri út 30-38. H-1106 Budapest Hungary
参考成员国 - 产品名称	Netherlands (NL) Cholecomb calcium 20 mg/10 mg harde capsules
互认成员国 - 产品名称
许可日期	2018/03/02
最近更新日期	2023/12/15
药物ATC编码	C10BA06 rosuvastatin and ezetimibe
申请类型	TypeLevel1：Line Extension TypeLevel2：Additional Strength/Form TypeLevel3：Fixed combination Art 10b Dir 2001/83/EC TypeLevel4：Chemical Substance TypeLevel5：Prescription Only
附件文件下载	Final PL \| pl_rosuCa_eze_common_cleanDate of last change:2023/11/09 Final SPC \| spc_rosuCa_eze_common_cleanDate of last change:2023/11/09 PAR Summary \| summaryPAR_NL.H.3006.004005.DC_Ultrizor(line-ext)_12 sep 2019_ENDate of last change:2019/09/19 PAR \| PAR_NL.H.3006.004005.DC_Cholecomb calcium (line-ext)_12 sep 2019Date of last change:2019/09/19 Final Product Information \| 2019_03_rosuCa+eze_FDC_SmPC_PSUFU_prop_cleanDate of last change:2019/09/18 Final Product Information \| 2019_03_rosuZn+eze_10-20_PIL_PSUFU_prop_cleanDate of last change:2019/09/18 Final Product Information \| 2019_03_rosuCa+eze_FDC_PIL_PSUFU_prop_cleanDate of last change:2019/09/18 Final Product Information \| 2019_03_rosuZn+eze_40_SmPC_PSUFU_prop_cleanDate of last change:2019/09/18 Final Product Information \| 2019_03_rosuZn+eze_10-20_SmPC_PSUFU_prop_cleanDate of last change:2019/09/18 Final Product Information \| 2019_03_rosuZn+eze_40_PIL_PSUFU_prop_cleanDate of last change:2019/09/18 Final Labelling \| common-interpack-cleanDate of last change:2018/05/23
市场状态	Positive