欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
LT/H/0184/001
药品名称
APSEMID 5 mg
活性成分
Torasemide 5.0 mg
剂型
Tablet
上市许可持有人
Polfarmex S.A. Ul. Jozefow 9 Kutno Lodzkie 99-300 Poland
参考成员国 - 产品名称
Lithuania (LT)
-
互认成员国 - 产品名称
Poland (PL)
DIULAN
许可日期
2023/09/17
最近更新日期
2025/02/03
药物ATC编码
C03CA04 torasemide
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
common_5mg_pl_track
Date of last change:2025/02/03
Final SPC
|
common_5mg_smpc_track
Date of last change:2025/02/03
Final Labelling
|
LT_H_0184_001_003_DIULAN_outer_inter
Date of last change:2024/09/06
PubAR
|
LT_H_0184_PubAR_Scientific discussion
Date of last change:2024/09/06
PubAR
|
LT_H_0184_PubAR_Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase