欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
AT/H/1149/001
药品名称
Amclavu 875 mg/125 mg - Filmtabletten
活性成分
Amoxicillin trihydrate 875.0 mg
Clavulanic acid potassium salt 125.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz GmbH Biochemiestrasse 10 6250 Kundl
参考成员国 - 产品名称
Austria (AT)
互认成员国 - 产品名称
Italy (IT)
许可日期
2022/05/02
最近更新日期
2024/12/30
药物ATC编码
J01CR02 amoxicillin and beta-lactamase inhibitor
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 SPC
|
SPC_final_AT_H_1146_1149_001_IB_001_G_clean
Date of last change:2025/01/14
Final PL
|
PIL_final_AT_H_1146_1149_001_IB_001_G_clean
Date of last change:2025/01/14
Final Labelling
|
AT_H_1146_1149_001_DC_LAB_final
Date of last change:2024/09/06
PubAR
|
AT_H_1149_001_PAR_barrierefrei
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase