欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0468/004
药品名称
Ezehron Duo
活性成分
Ezetimibe 10.0 mg
Rosuvastatin 15.0 mg
剂型
Tablet
上市许可持有人
Adamed Pharma S.A. Mariana Adamkiewicza 6a street 05-152 Czosnow Poland
参考成员国 - 产品名称
Poland (PL)
Ezehron Duo
互认成员国 - 产品名称
Germany (DE)
Ezehron Duo 15mg/10mg Tabletten
Italy (IT)
Rosumibe
许可日期
2024/03/19
最近更新日期
2024/10/29
药物ATC编码
C10BA06 rosuvastatin and ezetimibe
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
TypeLevel3:
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
common_outer_track
Date of last change:2024/09/06
Final PL
|
common_pil trackchange
Date of last change:2024/09/06
Final SPC
|
common_spc trackchange_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase