欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SI/H/0128/003
药品名称
Iruzid 20mg/25mg tablets
活性成分
Hydrochlorothiazide 25.0 mg
Lisinopril 20.0 mg
剂型
Tablet
上市许可持有人
Belupo d.o.o., Dvoržakova 6, 1000 Ljubljana, Slovenia.
参考成员国 - 产品名称
Slovenia (SI)
互认成员国 - 产品名称
Slovakia (SK)
许可日期
2011/10/13
最近更新日期
2024/11/08
药物ATC编码
C09BA03 lisinopril and diuretics
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
Acknowledgement of approval Lisinopril_hydrochlorothiazide IB 010
Date of last change:2024/09/06
Final PL
|
common_pl
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
Final Product Information
|
PLfD000338_5 IRUZID EN corr 09122014 final corr
Date of last change:2024/09/06
Final Product Information
|
PLfD000338_5 IRUZID EN corr 09122014 final corr clean
Date of last change:2024/09/06
Final Product Information
|
SmPCD000364_8 EN IRUZID clean _ 2 12 2014
Date of last change:2024/09/06
Final Product Information
|
SmPCD000364_8 EN IRUZID corr _ 2 12 2014
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase