欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1590/002
药品名称
Salmex
活性成分
fluticasone propionate 50.0 mcg
salmeterol xinafoat 250.0 mcg
剂型
Inhalation powder, pre-dispensed
上市许可持有人
Glenmark Pharmaceuticals Nordic AB Sweden
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Slovakia (SK)
Czechia (CZ)
Asthmex
Denmark (DK)
Iceland (IS)
Salmex 50 míkróg/250 míkróg/skammt Innöndunarduft, afmældir skammtar
Norway (NO)
Salmex
Finland (FI)
许可日期
2017/11/29
最近更新日期
2024/06/25
药物ATC编码
R03AK06 salmeterol and fluticasone
申请类型
TypeLevel1:
Known Active Substance
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
PAR Summary
|
SE/H/1590/002_PAR Summary
Date of last change:2018/02/22
PAR
|
SE/H/1590/002_PAR
Date of last change:2018/02/22
Final PL
|
SE/H/1590/002_Final PL
Date of last change:2018/01/16
Final SPC
|
SE/H/1590/002_Final SPC
Date of last change:2018/01/16
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase