欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
RO/H/0218/001
药品名称
Alendronat/Cholecalciferol "Zentiva"
活性成分
alendronic acid 70.0 mg
cholecalciferol 70.0 µg
剂型
Tablet
上市许可持有人
Zentiva k.s. U Kabelovny 130 10237 Prague Czech Republic
参考成员国 - 产品名称
Romania (RO)
互认成员国 - 产品名称
Denmark (DK)
Alendronate Cholecalciferol "Zentiva"
France (FR)
Portugal (PT)
Italy (IT)
Latvia (LV)
Alendronic acid/Colecalciferol Zentiva 70 mg/2800 SV tabletes
许可日期
2017/05/04
最近更新日期
2023/06/19
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 Product Information
|
ALENDRONATE_CHOLECALCIFEROL_tbl_EN_DK_H_2577 Orig 180809cl
Date of last change:2019/01/08
PAR Summary
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Final sPAR Alendronat Cholecalciferol Zentiva DKH2577_001_002_DC
Date of last change:2018/05/29
PAR
|
Final PAR Alendronat Cholecalciferol Zentiva DKH2577_001_002_DC
Date of last change:2018/05/29
Final Labelling
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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
Final PL
|
PL_Alendronate_Cholecalciferol_d200_clean _ seq 0004
Date of last change:2017/06/09
Final SPC
|
SmPC_Alendronate_Cholecalciferol_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