欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/1849/001
药品名称
Ipraalox 20mg
活性成分
pantoprazole sodium sesquihydrate 20.0 mg
剂型
Gastro-resistant tablet
上市许可持有人
sanofi-aventis Netherlands B.V.
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Belgium (BE)
France (FR)
Italy (IT)
Latvia (LV)
Ipraalox 20 mg zarnās šķīstošās tabletes
Lithuania (LT)
Ipraalox 20 mg skrandyje neirios tabletės
Estonia (EE)
IPRAALOX
Romania (RO)
DICARBOCALM CONTROL 20 mg comprimate gastrorezistente
许可日期
2010/11/17
最近更新日期
2024/05/03
药物ATC编码
A02BC02 pantoprazole
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:
Non Prescription (including OTC)
附件文件下载
Final PL
|
common PIL
Date of last change:2024/09/06
Final SPC
|
common SmPC
Date of last change:2024/09/06
Final Labelling
|
common_labelling
Date of last change:2024/09/06
Final Product Information
|
Ipraalox NLh1849 product information_common_pantoprazole_otc_nl_h_1849
Date of last change:2024/09/06
PubAR
|
PAR_1849_DC_pantoprazole_5 apr 2011
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase