欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0497/004
药品名称
Suvardio Plus
活性成分
Ezetimibe 10.0 mg
Rosuvastatin 40.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz GmbH Biochemiestrasse 10 6250 Kundl Austria
参考成员国 - 产品名称
Poland (PL)
Suvardio Plus
互认成员国 - 产品名称
Germany (DE)
Antilia 40 mg/10 mg Tabletten
许可日期
2022/09/07
最近更新日期
2024/11/04
药物ATC编码
C10BA06 rosuvastatin and ezetimibe
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
common labelling_2
Date of last change:2024/09/06
Final Product Information
|
common pl_4
Date of last change:2024/09/06
Final SPC
|
common spc_4
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase