欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0314/002
药品名称
Lisinopril "Actavis"
活性成分
Lisinopril as lisinopril dihydrate 5.0 mg
剂型
Tablet
上市许可持有人
Actavis Nordic A/S Ørnegårdsvej 16 DK-2820 Gentofte Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Sweden (SE)
许可日期
2002/02/13
最近更新日期
2025/01/27
药物ATC编码
C09AA03 lisinopril
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
Lisinopril_DK_H_0314_002_004_ImP Bottle_25_02_19
Date of last change:2024/09/06
Final Labelling
|
Lisinopril_DK_H_0314_002_004_OuP_25_02_19
Date of last change:2024/09/06
Final PL
|
Lisinopril_DK_H_0314_002_004_PIL_13_04_23_tracked
Date of last change:2024/09/06
Final SPC
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Lisinopril_DK_H_0314_002_004_SPC_13_04_23_clean
Date of last change:2024/09/06
Final Product Information
|
PI lisinopril DK_H_314 V036 day 0 proposal_ CL 080212
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase