欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/1016/001
药品名称
Taromentin
活性成分
Amoxicillin 400.0 mg
Clavulanic acid 57.0 mg
剂型
Powder for oral suspension
上市许可持有人
Tarchominskie Zakłady Farmaceutyczne "Polfa" S.A.
参考成员国 - 产品名称
Poland (PL)
Taromentin
互认成员国 - 产品名称
Iceland (IS)
许可日期
2024/11/12
最近更新日期
2024/11/12
药物ATC编码
J01CR02 amoxicillin and beta-lactamase inhibitor
申请类型
TypeLevel1:
Known Active Substance
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 Summary
|
Summary Public Assessment Report Taromentin
Date of last change:2025/01/14
Final PL
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PIL_ Taromentin proszek 400mg57mg5mlztw100524 EN220724 cl_RMS_comments clean_2
Date of last change:2024/11/12
Final SPC
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SmPC _Taromentin proszek 400mg57mg5mlzatw100524_EN220724 cl_RMS_comments clean_2
Date of last change:2024/11/12
Final Labelling
|
LBL_Taromentin proszek 400mg57mg5mlztw180822 RMS comments_230924 cl_2
Date of last change:2024/11/12
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase