欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/2598/003
药品名称
Ezetimibe/Simvastatin "Krka"
活性成分
ezetimibe 10.0 mg
simvastatin 40.0 mg
剂型
Tablet
上市许可持有人
Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Iceland (IS)
Germany (DE)
Belgium (BE)
Ezetimibe/Simvastatine Krka 10 mg/40 mg tabletten
Netherlands (NL)
Ezetimibe/Simvastatine Krka 10mg/40mg tabletten
Ireland (IE)
Austria (AT)
Ezetimib/Simvastatin Krka 10 mg/40 mg Tabletten
France (FR)
Spain (ES)
Portugal (PT)
Italy (IT)
Greece (GR)
VASITIMB
Sweden (SE)
Norway (NO)
Ezetimib/Simvastatin Krka
Slovenia (SI)
Vasitimb 10 mg/40 mg tablete
Croatia (HR)
Vasitimb 10 mg/40 mg tablete
许可日期
2016/12/21
最近更新日期
2023/11/30
药物ATC编码
C10BA02 simvastatin and ezetimibe
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Multiple (Copy) 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
|
Common combined Ezetimib_simvastatin Krka _ clean
Date of last change:2024/09/06
Final Product Information
|
common_combined_clean
Date of last change:2024/09/06
Final Labelling
|
INVENTED NAME_Ezetimibe _ Simvastatin_tablets_clean
Date of last change:2024/09/06
Final Labelling
|
INVENTED NAME_Ezetimibe _ Simvastatin_tablets_tracked
Date of last change:2024/09/06
PubAR
|
PAR 2598
Date of last change:2024/09/06
PubAR Summary
|
sPAR 2598
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase