欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/2116/003
药品名称
Serefarm
活性成分
Fluticasone propionate 500.0 µg
Salmeterol xinafoate 50.0 µg
剂型
Inhalation powder, pre-dispensed
上市许可持有人
Orifarm Generics A/S, Denmark
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
Finland (FI)
许可日期
2022/04/27
最近更新日期
2024/12/02
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
Final PL
|
Final PL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210401000033
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210401000033_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase