欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/2628/002
药品名称
Delix 5 plus
活性成分
hydrochlorothiazide 25.0 mg
ramipril 5.0 mg
剂型
Tablet
上市许可持有人
Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 65926 Frankfurt am Main Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Belgium (BE)
Luxembourg (LU)
Austria (AT)
Italy (IT)
Greece (GR)
Poland (PL)
Tritace 5 comb
Estonia (EE)
Hungary (HU)
TRITACE HCT 5 mg/25 mg tabletta
Bulgaria (BG)
Tritace plus
Cyprus (CY)
Czechia (CZ)
Romania (RO)
Tritace 5 Plus
Slovakia (SK)
许可日期
2009/10/13
最近更新日期
2024/07/09
药物ATC编码
C09BA05 ramipril and diuretics
申请类型
TypeLevel1：
Known Active Substance
TypeLevel2：
Initial Application
TypeLevel3：
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Labelling
|
common_interp_h_2628_2629envarxxannotated15Dec2016
Date of last change:2024/09/06
Final Labelling
|
common_interp_h_2628_2629envarxxclean15Dec2016
Date of last change:2024/09/06
Final SPC
|
common_spc_h_2628_2457_enannotated
Date of last change:2024/09/06
Final PL
|
common_spc_h_2628_enannotated
Date of last change:2024/09/06
Final Product Information
|
final_common_spc_2628_047_Delix 2_5 5 plus
Date of last change:2024/09/06
Final Product Information
|
final_common_spc_2628_047_Delix plus HCT 10
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase