欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DE/H/6644/003
药品名称
Ezetimib/Simva-AbZ 10 mg/40 mg Tabletten
活性成分
ezetimibe 10.0 mg
simvastatin 40.0 mg
剂型
Tablet
上市许可持有人
AbZ-Pharma GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Belgium (BE)
Ezetimibe-Simvastatine Teva 10 mg/40 mg tabletten
Netherlands (NL)
Austria (AT)
Ezetimib/Simvastatin ratiopharm GmbH 10 mg/40 mg Tabletten
Spain (ES)
Portugal (PT)
许可日期
2017/12/20
最近更新日期
2024/02/14
药物ATC编码
C10BA02 simvastatin and ezetimibe
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 Labelling
|
Ezetimibe_Simvastatin_DK_H_2731_001_004_ImP _Blister_
Date of last change:2024/09/06
Final Labelling
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Ezetimibe_Simvastatin_DK_H_2731_001_004_ImP _Bottle_
Date of last change:2024/09/06
Final Labelling
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Ezetimibe_Simvastatin_DK_H_2731_001_004_OuP _Blister_
Date of last change:2024/09/06
Final Labelling
|
Ezetimibe_Simvastatin_DK_H_2731_001_004_OuP _Bottle_
Date of last change:2024/09/06
PubAR
|
PAR ezetimib _ simvastatin 2731
Date of last change:2024/09/06
PubAR Summary
|
Summary PAR ezetimib _ simvastatin 2731
Date of last change:2024/09/06
Final Product Information
|
common_final_pl_6644_V007
Date of last change:2024/09/06
Final Product Information
|
common_final_spc_6644_V007
Date of last change:2024/09/06
Final PL
|
final_common_PL_DE_H_6644_001_004_IA_019
Date of last change:2024/09/06
Final SPC
|
final_common_SmPC_DE_H_6644_001_004_IA_019
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase