欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
EE/H/0224/002
药品名称
Flusamer
活性成分
fluticasone propionate 500.0 µg/dose
salmeterol xinafoate 50.0 µg/dose
剂型
Inhalation powder, pre-dispensed
上市许可持有人
Elpen Pharmaceutical Co. Inc, Greece
参考成员国 - 产品名称
Estonia (EE)
FLUSAMER
互认成员国 - 产品名称
Lithuania (LT)
Flamerio 50 mikrogramų/500 mikrogramų/dozėje dozuoti įkvepiamieji milteliai
Romania (RO)
FLUSAMER 50 micrograme/500 micrograme/doză pulbere de inhalat cu doze prestabilite
许可日期
2011/12/01
最近更新日期
2024/01/08
药物ATC编码
R03AK06 salmeterol and fluticasone
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
Final Labelling
|
common_labelling_v006gtracked
Date of last change:2024/09/06
Final PL
|
common_pil_tracked_v006
Date of last change:2024/09/06
Final SPC
|
common_smpc_tracked_v006_corr
Date of last change:2024/09/06
PubAR
|
EE_H_0224_002_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase