欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IT/H/0125/001
药品名称
Delaman
活性成分
delapril hydrochloride 30.0 mg
manidipine dihydrochloride 10.0 mg
剂型
Tablet
上市许可持有人
Promedica Srl via Palermo 26A 43100 Parma Italy S.Donadoni@chiesi.com
参考成员国 - 产品名称
Italy (IT)
互认成员国 - 产品名称
Spain (ES)
许可日期
2005/12/21
最近更新日期
2024/01/04
药物ATC编码
C09 AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C09BB ACE inhibitors and calcium channel blockers
C CARDIOVASCULAR SYSTEM
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Fixed Combination [Article 10.1.(b)]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Package Leaflet _ V028
Date of last change:2024/01/04
Final Labelling
|
common_outer_2
Date of last change:2024/01/04
Final SPC
|
common_spc
Date of last change:2024/01/04
Final SPC
|
common-impack
Date of last change:2021/02/24
Final SPC
|
common-pl
Date of last change:2021/02/24
Final SPC
|
common-outer
Date of last change:2021/02/24
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase