欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0113/003
药品名称
Amoclav forte Trockensaft
活性成分
amoxicillin trihydrate 287.0 mg
clavulanic acid potassium salt 75.0 mg
剂型
Powder for oral suspension
上市许可持有人
HEXAL AG Industriestr. 25 D-83607 Holzkirchen
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Belgium (BE)
Netherlands (NL)
Austria (AT)
Curam forte - Trockensaft
Portugal (PT)
许可日期
1997/09/04
最近更新日期
2024/04/29
药物ATC编码
J01CR02 amoxicillin and beta-lactamase inhibitor
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Article 4.8(a)(iii), first paragraph
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
common_final_spc_0113_002_003__V109G
Date of last change:2023/04/19
Final PL
|
common_final_pl_0113_002_003__V109G
Date of last change:2023/04/19
Final Labelling
|
common_final_labop_0113_002_003__V109G
Date of last change:2023/04/19
Final Product Information
|
final-common-spc-0113-097
Date of last change:2020/05/06
Final Product Information
|
final-common-outer-0113-097
Date of last change:2020/05/06
Final Product Information
|
final-common-pl-0113-097
Date of last change:2020/05/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase