欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/0788/002
药品名称
Alendratol 10 mg
活性成分
alendronic acid 10.0 mg
剂型
Tablet
上市许可持有人
Ranbaxy (UK) limited UK
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Belgium (BE)
许可日期
2007/05/28
最近更新日期
2012/07/09
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 Labelling
|
NLH0788 _ common Label 10 mg _ final version
Date of last change:2024/09/06
Final PL
|
NLH0788 _ common PL 10 mg _ final version
Date of last change:2024/09/06
Final SPC
|
NLH0788 _ common SPC 10 mg _ final version
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase