欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1979/001
药品名称
Esomeprazole Orifarm
活性成分
esomeprazole magnesium salt 10.0 mg
剂型
Gastro-resistant granules
上市许可持有人
Orifarm Generics A/S, Denmark
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Norway (NO)
Esomeprazol Orifarm
Finland (FI)
Denmark (DK)
许可日期
2021/01/18
最近更新日期
2024/08/30
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
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20200131000038
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20200131000038_2
Date of last change:2024/09/06
Final PL
|
SE_H_1979_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1979_001_Final SPC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase