欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1518/002
药品名称
Bufoler Easyhaler
活性成分
budesonide 320.0 µg
formoterol fumarate 9.0 µg
剂型
Inhalation powder
上市许可持有人
Orion Corporation Finland
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Netherlands (NL)
许可日期
2015/12/16
最近更新日期
2024/06/13
药物ATC编码
R03AK07 formoterol and budesonide
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE_H_1518_002_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1518_002_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1518_002_PAR
Date of last change:2024/09/06
PubAR Summary
|
SE_H_1518_002_PAR Summary
Date of last change:2024/09/06
市场状态
Positive
©2006-2024
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase