欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2302/001
药品名称
Nexizol
活性成分
esomeprazole 10.0 mg
剂型
Gastro-resistant granules for oral suspension in sachet
上市许可持有人
2care4 Generics ApS, denmark
参考成员国 - 产品名称
Sweden (SE)
Pralacid
互认成员国 - 产品名称
Denmark (DK)
Pralacid
Norway (NO)
许可日期
2023/06/21
最近更新日期
2024/01/11
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
Final PL
|
Final PL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20220728000104_nexizol_10_mg_granulat_till_oral_enterosuspension_i_dospase
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_20220728000104_nexizol_10_mg_granulat_till_oral_enterosuspension_i_dospase_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase