欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FR/H/0767/001
药品名称
Alendronat/Cholecalciferol "BGR"
活性成分
alendronic acid 70.0 mg
cholecalciferol 70.0 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
PubAR
|
Final PAR Alendronat Cholecalciferol BIOGARAN DKH2582_001_002_DC
Date of last change:2024/09/06
PubAR Summary
|
Final sPAR Alendronat Cholecalciferol BGR DKH2582_001_002_DC
Date of last change:2024/09/06
Final Labelling
|
labelling Alendronate_colecalciferol 70 mg_2800 IU_d200_clean _ seq 0004
Date of last change:2024/09/06
Final Labelling
|
labelling Alendronate_colecalciferol 70 mg_5600 IU_d200_clean _ seq 0004
Date of last change:2024/09/06
Final PL
|
PackageLeaflet_R005_Clean_Pro_V1_00
Date of last change:2024/09/06
Final SPC
|
SPC_R005_clean_Pro_V1_00
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase