欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2586/002
药品名称
Fosastad
活性成分
alendronic acid 70.0 mg
cholecalciferol 140.0 µg
剂型
Tablet
上市许可持有人
STADA Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany
参考成员国 - 产品名称
Denmark (DK)
Fosastad
互认成员国 - 产品名称
Sweden (SE)
Finland (FI)
许可日期
2017/05/03
最近更新日期
2024/01/15
药物ATC编码
M05BB03 alendronic acid and colecalciferol
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
1.3.1-SPC-common-DK-H-2586-001-002-DC-cl
Date of last change:2021/08/24
Final PL
|
1.3.1-PIL-common-DK-H-2586-001-002-DC-cl
Date of last change:2021/08/24
Final Labelling
|
lab-Alendronate-cholecalciferol 001-cl
Date of last change:2019/02/27
Final Labelling
|
lab-Alendronate-cholecalciferol 002-cl
Date of last change:2019/02/27
PAR Summary
|
Final sPAR Fosastad DKH2586_001-002_DC
Date of last change:2018/05/29
PAR
|
Final PAR Fosastad DKH2586_001-002_DC
Date of last change:2018/05/29
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase