欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0497/003
药品名称
Suvardio Plus
活性成分
Ezetimibe 10.0 mg
Rosuvastatin 20.0 mg
剂型
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)
RosuHEXAL plus Ezetimib 20 mg / 10 mg Filmtabletten
许可日期
2018/01/15
最近更新日期
2024/11/15
药物ATC编码
C10BA06 rosuvastatin and ezetimibe
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Multiple (Copy) Application
TypeLevel3:
Fixed combination Art 10b Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Labelling
|
1_3_1 spc_label_pl _ common_outer _ 6_166
Date of last change:2024/09/06
Final PL
|
1_3_1 spc_label_pl _ common_pl _ 12_804
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_label_pl _ common_spc _ 12_747
Date of last change:2024/09/06
Final Product Information
|
Ezehron_Duo_LAB_D210_clean
Date of last change:2024/09/06
Final Product Information
|
Ezehron_Duo_PIL_D210_clean
Date of last change:2024/09/06
Final Product Information
|
Ezehron_Duo_SPC_D210_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase