欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0767/002
药品名称
Alendronat/Cholecalciferol "BGR"
活性成分
alendronic acid 70.0 mg
cholecalciferol 140.0 µg
剂型
Tablet
上市许可持有人
BIOGARAN 15 Boulevard Charles de Gaulle FR 92707
参考成员国 - 产品名称
France (FR)
互认成员国 - 产品名称
许可日期
2017/05/04
最近更新日期
2022/10/06
药物ATC编码
M05BB03 alendronic acid and colecalciferol
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final SPC
|
SPC-R005-clean-Pro-V1.00
Date of last change:2021/03/25
Final PL
|
PackageLeaflet-R005-Clean-Pro-V1.00
Date of last change:2021/03/25
PAR Summary
|
Final sPAR Alendronat Cholecalciferol BGR DKH2582_001-002_DC
Date of last change:2018/05/29
PAR
|
Final PAR Alendronat Cholecalciferol BIOGARAN DKH2582_001-002_DC
Date of last change:2018/05/29
Final Labelling
|
labelling Alendronate-colecalciferol 70 mg-2800 IU_d200-clean - seq 0004
Date of last change:2017/06/09
Final Labelling
|
labelling Alendronate-colecalciferol 70 mg-5600 IU_d200-clean - seq 0004
Date of last change:2017/06/09
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase