欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0482/002
药品名称
Nuclazol
活性成分
esomeprazole 40.0 mg
剂型
Gastro-resistant tablet
上市许可持有人
ICN Polfa Rzeszów S.A. 2 Przemuslowa Street, 35-959 Rzeszów Poland
参考成员国 - 产品名称
Poland (PL)
互认成员国 - 产品名称
Denmark (DK)
Nuclazol
许可日期
2011/09/22
最近更新日期
2017/02/28
药物ATC编码
A02BC05 esomeprazole
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final PL
|
DK_H_1969_002_IB_010_Nuclazol_Final_PIL_TC
Date of last change:2024/09/06
Final SPC
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DK_H_1969_002_IB_010_Nuclazol_Final_SmPC_CL
Date of last change:2024/09/06
PubAR Summary
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Module 5 Scientifc discussion Nuclazol DK_H_1969_001_002_DC
Date of last change:2024/09/06
Final Labelling
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Nuclazol_immediate_packaging_20 mg_final_clean_DK_H_1969_001_II_004
Date of last change:2024/09/06
Final Labelling
|
Nuclazol_immediate_packaging_40 mg_final_clean_DK_H_1969_002_II_004
Date of last change:2024/09/06
Final Labelling
|
Nuclazol_label_outer_20 mg_final_clean_DK_H_1969_001_II_004
Date of last change:2024/09/06
Final Labelling
|
Nuclazol_label_outer_40 mg_final_clean_DK_H_1969_002_II_004
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase