欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/1304/001
药品名称
Esomeprazol Hospira
活性成分
esomeprazole sodium salt 40.0 mg
剂型
Powder for solution for infusion/injection
上市许可持有人
Hospira UK Limited United Kingdom
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Spain (ES)
Norway (NO)
Finland (FI)
Lithuania (LT)
Estonia (EE)
France (FR)
Slovakia (SK)
Denmark (DK)
Netherlands (NL)
Luxembourg (LU)
Germany (DE)
United Kingdom (Northern Ireland) (XI)
Belgium (BE)
Ireland (IE)
Iceland (IS)
Italy (IT)
Austria (AT)
Poland (PL)
Esomeprazole Hospira
Portugal (PT)
Hungary (HU)
Greece (GR)
Cyprus (CY)
ESOMEPRAZOLE HOSPIRA PWD FOR SOL FOR INJ/INF
Bulgaria (BG)
Romania (RO)
Slovenia (SI)
Malta (MT)
许可日期
2014/07/03
最近更新日期
2020/04/18
药物ATC编码
A02BC05 esomeprazole
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
PAR Summary
|
SE/H/1304/001_PAR Summary
Date of last change:2015/02/20
PAR
|
SE/H/1304/001_PAR
Date of last change:2015/02/10
Final PL
|
SE/H/1304/001_Final PL
Date of last change:2014/09/04
Final SPC
|
SE/H/1304/001_Final SPC
Date of last change:2014/09/04
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase