欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0114/001
药品名称
Lozap 12,5 Zentiva
活性成分
Losartan 12.5 mg
剂型
Tablet
上市许可持有人
Zentiva a.s., Bratislava Einsteinova 24 851 01 Bratislava Slovak Republic
参考成员国 - 产品名称
Czechia (CZ)
互认成员国 - 产品名称
Slovakia (SK)
许可日期
2005/12/21
最近更新日期
2024/09/11
药物ATC编码
C09CA01 losartan
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other [Article 10.1.(a)(iii), last paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
CZ_H_0114_01_03_E_01_LAB_Lozap 12_5
Date of last change:2024/09/06
Final PL
|
CZ_H_0114_01_03_E_01_PIL_Lozap
Date of last change:2024/09/06
Final Product Information
|
LOSARTAN POTASSIUM_film_coated tablet_EN_CZ_H_0114_001_003_004_orig_221204cl
Date of last change:2024/09/06
Final SPC
|
Lozap SPC _ Day 90
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase