欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
NL/H/1581/002
药品名称
Irbesartan HEXAL comp 300/12,5 mg, filmomhulde tabletten
活性成分
Hydrochlorothiazide 12.5 mg
Irbesartan 300.0 mg
剂型
Film-coated tablet
上市许可持有人
HEXAL AG Industriestrasse 25, 83607 Holzkirchen Germany
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Germany (DE)
许可日期
2011/03/07
最近更新日期
2025/01/29
药物ATC编码
C09DA04 irbesartan and diuretics
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial 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
|
common_outer _ 300_12
Date of last change:2024/09/06
Final Labelling
|
common_outer _ 300_25
Date of last change:2024/09/06
Final Labelling
|
common_outer 150
Date of last change:2024/09/06
Final Product Information
|
Irbesartan Hexal_1_3_1 spc_label_pl _ common_outer _ clean _ 150 mg 12_5
Date of last change:2024/09/06
Final Product Information
|
Irbesartan Hexal_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 Hexal_1_3_1 spc_label_pl _ common_outer _ clean _ 300 mg 25 mg
Date of last change:2024/09/06
Final Product Information
|
Irbesartan Hexal_1_3_1 spc_label_pl _ common_pl _ clean _ 150 mg 12_5
Date of last change:2024/09/06
Final Product Information
|
Irbesartan Hexal_1_3_1 spc_label_pl _ common_pl _ clean _ 300 mg 12_5
Date of last change:2024/09/06
Final Product Information
|
Irbesartan Hexal_1_3_1 spc_label_pl _ common_pl _clean _ 300 mg 25 mg
Date of last change:2024/09/06
Final Product Information
|
Irbesartan Hexal_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 Hexal_1_3_1 spc_label_pl _ common_spc _ clean _ 300 mg 25 mg
Date of last change:2024/09/06
Final Product Information
|
Irbesartan Hexal_1_3_1 spc_label_pl _ common_spc _clean _ 300 mg 12_5 mg
Date of last change:2024/09/06
PubAR
|
PAR_1581_DC_20 May 2010
Date of last change:2024/09/06
Final PL
|
PIL_2
Date of last change:2024/09/06
Final SPC
|
Smpc_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase