欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2738/001
药品名称
Enalapril/Lercanidipin DOC
活性成分
enalapril maleate 10.0 mg
lercanidipine hydrochloride 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Doc Generici S.R.L. Via Turati 40 20121 Milano Italy
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Italy (IT)
许可日期
2017/07/06
最近更新日期
2023/12/08
药物ATC编码
C09BB02 enalapril and lercanidipine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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 Labelling
|
Final common-labelling-Clean
Date of last change:2019/06/06
Final PL
|
Final common-pl-Clean
Date of last change:2019/06/06
Final SPC
|
Final common-spc-day20-Clean
Date of last change:2019/06/06
PAR Summary
|
sPAR Enalaprilmaleat_Lercanidipinhydrochlorid film-coated tablets_DK_H_2738
Date of last change:2018/02/07
PAR
|
PAR Enalaprilmaleat_Lercanidipinhydrochlorid film-coated tablets_DK_H_2738
Date of last change:2018/02/07
Final Product Information
|
PI-Enalapril Lercandipine-DK_H_2685,2738,2739_01.02-proposal day 195-230617-CL
Date of last change:2017/07/11
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase