欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0882/001
药品名称
Alendronat "Mylan"
活性成分
alendronic acid 10.0 mg
剂型
Tablet
上市许可持有人
Mylan AB P.O. BOX 23033 S-10435 Stockholm Sweden
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Belgium (BE)
Alendronate Viatris 10 mg tabletten
许可日期
2006/02/20
最近更新日期
2024/05/30
药物ATC编码
M05BA04 alendronic acid
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
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 Product Information
|
common-combined-dk0882-10mg-v065-rtq-clean
Date of last change:2020/11/30
Final PL
|
common PIL 10mg MRP via DK clean
Date of last change:2011/05/02
Final PL
|
common PIL 10mg MRP via DK- tracked
Date of last change:2011/05/02
Final PL
|
common PIL 70mg MRP via DK- tracked
Date of last change:2011/05/02
Final SPC
|
SmPC 10mg MRP via DK clean
Date of last change:2011/05/02
Final SPC
|
SmPC 10mg MRP via DK tracked Var037
Date of last change:2011/05/02
Final SPC
|
SmPC 70mg MRP via DK clean
Date of last change:2011/05/02
Final SPC
|
SmPC 70mg MRP via DK tracked Var037
Date of last change:2011/05/02
Final PL
|
common PIL 70mg MRP via DK clean
Date of last change:2011/05/02
市场状态
Positive
©2006-2024
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European Union HMA Authorisation of Medicines DataBase