欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1366/001
药品名称
Nystimex
活性成分
Nystatin 100000.0 IU/ml
剂型
Oral suspension
上市许可持有人
RPH Pharmaceuticals AB Sweden
参考成员国 - 产品名称
Sweden (SE)
50386
互认成员国 - 产品名称
Netherlands (NL)
Nystatine RPH 100 000 IE/ml, suspensie voor oraal gebruik
Denmark (DK)
Iceland (IS)
Nystimex 100.000 a.e./ml mixtúra, dreifa
Norway (NO)
Nystimex
Finland (FI)
许可日期
2015/01/13
最近更新日期
2025/01/28
药物ATC编码
A07AA02 nystatin
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
SE_H_1366_001_Final Labelling
Date of last change:2024/09/06
Final PL
|
SE_H_1366_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1366_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1366_001_PAR
Date of last change:2024/09/06
PubAR Summary
|
SE_H_1366_001_PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase