欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0211/004
药品名称
Nexium
活性成分
ESOMEPRAZOLE MAGNESIUM trihydrate 10.0 mg
剂型
Gastro-resistant granules for oral suspension
上市许可持有人
Grunenthal GmbH Germany
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Germany (DE)
Nexium 10 mg magensaftresistentes Granulat zur Herstellung einer Suspension zum Einnehmen
Denmark (DK)
Belgium (BE)
Netherlands (NL)
Nexium granules voor orale suspensie
Luxembourg (LU)
Iceland (IS)
Ireland (IE)
Austria (AT)
Nexium 10 mg magensaftresistentes Granulat zur Herstellung einer Suspension zum Einnehmen
France (FR)
Spain (ES)
Portugal (PT)
Nexium
Italy (IT)
Greece (GR)
Norway (NO)
Finland (FI)
Lithuania (LT)
Nexium 10 mg skrandyje neirios granulės geriamajai suspensijai
Cyprus (CY)
NEXIUM 10MG ORAL USE
Slovenia (SI)
许可日期
2008/04/17
最近更新日期
2024/04/17
药物ATC编码
A02BC05 esomeprazole
申请类型
TypeLevel1:
Line Extension
TypeLevel2:
Initial Application
TypeLevel3:
Full Dossier Art 8.3(i) Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
SE/H/0211/004_Final PL
Date of last change:2014/01/15
Final SPC
|
SE/H/0211/004_Final SPC
Date of last change:2014/01/15
PAR
|
SE/H/0211/004_PAR
Date of last change:2014/01/15
市场状态
Positive
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