欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PL/H/0523/005
药品名称
Mibrex
活性成分
RIVAROXABAN 15.0 mg
RIVAROXABAN 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Zakłady Framaceutyczne Polpharma S.A.
参考成员国 - 产品名称
Poland (PL)
Mibrex
互认成员国 - 产品名称
Lithuania (LT)
Mibrex 15 mg plėvele dengtos tabletės. Mibrex 20 mg plėvele dengtos tabletės
许可日期
2019/12/12
最近更新日期
2024/08/14
药物ATC编码
B01AF01 rivaroxaban
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial 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
PAR
|
PAR_Scientific discussion PL_H_0523_001_005_DC
Date of last change:2024/03/05
PAR Summary
|
Summary PAR PL_H_0523_001_005_DC
Date of last change:2024/03/01
Final SPC
|
SmPC_Rivaro_20mg_p0523_2019_12EN clean
Date of last change:2020/05/28
Final SPC
|
SmPC_Rivaro_Initiat_15_20mg_p0523_2019_12EN clean
Date of last change:2020/05/28
Final SPC
|
SmPC_Rivaro_10mg_p0523_2019_12EN clean
Date of last change:2020/05/28
Final SPC
|
SmPC_Rivaro_2,5mg_p0523_2019_12EN clean
Date of last change:2020/05/28
Final SPC
|
SmPC_Rivaro_15mg_p0523_2019_12EN clean
Date of last change:2020/05/28
Final PL
|
PIL_Rivaro_15_20mg_p0523_2019_12EN clean
Date of last change:2020/05/28
Final PL
|
PIL_Rivaro_Initiat_15_20mg_p0523_2019_12EN clean
Date of last change:2020/05/28
Final PL
|
PIL_Rivaro_2,5mg_p0523_2019_12EN clean
Date of last change:2020/05/28
Final PL
|
PIL_Rivaro_10mg_p0523_2019_12EN clean
Date of last change:2020/05/28
Final Labelling
|
LB_Rivaro_Initiat_15 i 20mg_p0523_2019_10EN clean
Date of last change:2020/05/28
Final Labelling
|
LB_Rivaro_p0523_2019_10EN clean
Date of last change:2020/05/28
市场状态
Positive
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