欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2461/002
药品名称
Respilukas
活性成分
Montelukast sodium salt 5.0 mg
剂型
Chewable tablet
上市许可持有人
Teva Denmark A/S Parallelvej 10-12, 2800 Kgs. Lyngby Denmark
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Denmark (DK)
许可日期
2012/08/02
最近更新日期
2024/10/25
药物ATC编码
R03DC03 montelukast
R03D OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R03DC Leukotriene receptor antagonists
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
PubAR
|
Final PAR Scientific discussion Respilukas DKH2099_001_002_DC
Date of last change:2024/09/06
Final Labelling
|
Montelukast 4 mg chewable tablets DK_H_2099_001_OuP_17_01_18
Date of last change:2024/09/06
Final Labelling
|
Montelukast 5 mg chewable tablets DK_H_2099_002_OuP_17_01_18
Date of last change:2024/09/06
Final PL
|
Montelukast_PT_H_2461_002_PIL_19_12_23
Date of last change:2024/09/06
Final SPC
|
Montelukast_PT_H_2461_002_SmPC_02_08_23
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase