欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0418/001
药品名称
Toralis
活性成分
Lisinopril dihydrate 11.0 mg
Torasemide 5.0 mg
剂型
Tablet
上市许可持有人
Aflofarm Farmacja Polska Sp. z o.o. ul. Partyzancka 133/151 95-200 Pabianice
参考成员国 - 产品名称
Poland (PL)
TORALIS
互认成员国 - 产品名称
Lithuania (LT)
Tolirasim 10 mg/ 5 mg tabletės
Czechia (CZ)
TOLIRASIM
Slovakia (SK)
Lisemid 10 mg/5 mg
许可日期
2017/09/28
最近更新日期
2024/12/16
药物ATC编码
C09BA03 lisinopril and diuretics
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PubAR
|
PL_H_0418_001_004_DC_Tolirasim_scientific discussion PAR
Date of last change:2024/09/06
PubAR Summary
|
PL_H_0418_001_004_DC_Tolirasim_summary of PAR
Date of last change:2024/09/06
Final Labelling
|
PL_H_0418_001_004_P_001_ Tolirasim_ Approval
Date of last change:2024/09/06
Final Labelling
|
Tolirasim ocena zmiany P_08_2018
Date of last change:2024/09/06
Final PL
|
Tolirasim_PL_0418_1_4_DC_Final_PIL
Date of last change:2024/09/06
Final SPC
|
Tolirasim_PL_0418_1_4_DC_Final_SmPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase