欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0542/002
药品名称
Montelucaste Amneal
活性成分
montelukast sodium salt 5.0 mg
剂型
Chewable tablet
上市许可持有人
Amneal Pharma Europe Limited 70 Sir John Rogerson's Quay Dublin 2
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Norway (NO)
许可日期
2012/04/12
最近更新日期
2018/08/17
药物ATC编码
R03DC03 montelukast
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
PAR
|
53677_53819_53820_20140808_PAR_GBB
Date of last change:2014/08/29
Final Product Information
|
common-spc-5mgclean
Date of last change:2014/06/20
Final Product Information
|
common-spc-4mgclean
Date of last change:2014/06/20
Final Product Information
|
common-pl-5mgclean
Date of last change:2014/06/20
Final Product Information
|
common-pl-4mgclean
Date of last change:2014/06/20
Final Product Information
|
common-interpack-clean
Date of last change:2014/06/20
Final SPC
|
Clean_SPC - 5 mg
Date of last change:2012/04/25
Final PL
|
Clean_PIL_-_Montelukast_Pfizer_5mg_chewable_Tablets_12-04-2012
Date of last change:2012/04/25
市场状态
Positive
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