欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0469/001
药品名称
Lisinopril/hydrochlorthiazid "Sandoz"
活性成分
hydrochlorothiazide dihydrate 13.0 mg
lisinopril dihydrate 10.0 mg
剂型
Tablet
上市许可持有人
Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl Austria
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
许可日期
2003/10/10
最近更新日期
2024/06/10
药物ATC编码
C03AA03 hydrochlorothiazide
C09AA03 lisinopril
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
1_3_1 spc_label_pl _ common_outer _ 3_827_clean
Date of last change:2024/09/06
Final PL
|
Common PIL Ciprofloxacin Pharmathen _ clean
Date of last change:2024/09/06
Final Product Information
|
common_pl _clean
Date of last change:2024/09/06
Final Product Information
|
common_spc_clean
Date of last change:2024/09/06
Final SPC
|
Lisinopril_Hydrochlorthiazid_SPC_common_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase