欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NL/H/1579/003
药品名称
Irbesartan/Hydrochloorthiazide Sandoz 150/12,5 mg, filmomhulde tabletten
活性成分
Hydrochlorothiazide 12.5 mg
Irbesartan 150.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Belgium (BE)
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Norway (NO)
Hungary (HU)
许可日期
2009/11/23
最近更新日期
2025/12/17
药物ATC编码
C09DA04 irbesartan and diuretics
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Generic
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final PL
|
common_pil_pdf_3
Date of last change:2025/03/17
Final SPC
|
common_spc__3
Date of last change:2025/03/17
Final Labelling
|
common_outer 1579_003
Date of last change:2024/09/06
Final Product Information
|
Irbesartan_1_3_1 spc_label_pl _ common_outer _ clean _ 150 mg 12_5
Date of last change:2024/09/06
Final Product Information
|
Irbesartan_1_3_1 spc_label_pl _ common_outer _ clean _ 300 mg 12_5 mg
Date of last change:2024/09/06
Final Product Information
|
Irbesartan_1_3_1 spc_label_pl _ common_outer _ clean _300 mg 25 mg
Date of last change:2024/09/06
Final Product Information
|
Irbesartan_1_3_1 spc_label_pl _ common_pl _ clean _ 150 mg 12_5
Date of last change:2024/09/06
Final Product Information
|
Irbesartan_1_3_1 spc_label_pl _ common_pl _ clean _ 300 mg 12_5
Date of last change:2024/09/06
Final Product Information
|
Irbesartan_1_3_1 spc_label_pl _ common_pl _ clean _ 300 mg 25 mg
Date of last change:2024/09/06
Final Product Information
|
Irbesartan_1_3_1 spc_label_pl _ common_spc _ clean _ 150 mg 12_5 mg
Date of last change:2024/09/06
Final Product Information
|
Irbesartan_1_3_1 spc_label_pl _ common_spc _ clean _ 300 mg 12_5 mg
Date of last change:2024/09/06
Final Product Information
|
Irbesartan_1_3_1 spc_label_pl _ common_spc _ clean _300 mg 25 mg
Date of last change:2024/09/06
PubAR
|
PAR_1579_DC_20 May 2010
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase