欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0524/001
药品名称
Rivaroxaban Polpharma
活性成分
Rivaroxaban 2.5 mg
剂型
Film-coated tablet
上市许可持有人
Medana Pharma S.A.
参考成员国 - 产品名称
Poland (PL)
Rivaroxaban Medana
互认成员国 - 产品名称
Germany (DE)
Rivaroxaban Medana 2,5 mg Filmtabletten
United Kingdom (Northern Ireland) (XI)
France (FR)
Spain (ES)
Italy (IT)
Greece (GR)
Cyprus (CY)
Rivaroxaban Rafarm 2.5mg FCT
许可日期
2019/12/12
最近更新日期
2025/01/23
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
Final Labelling
|
LB_Rivaro_Initiat_15 i 20mg_p0524_2019_10EN clean
Date of last change:2024/09/06
Final Labelling
|
LB_Rivaro_p0524_2019_10EN clean
Date of last change:2024/09/06
PubAR
|
PAR_Scientific discussion PL_H_0524_001_005_DC
Date of last change:2024/09/06
Final PL
|
PIL_Rivaro_10mg_p0524_2019_12EN clean
Date of last change:2024/09/06
Final PL
|
PIL_Rivaro_15_20mg_p0524_2019_12EN clean
Date of last change:2024/09/06
Final PL
|
PIL_Rivaro_2_5mg_p0524_2018_12EN clean
Date of last change:2024/09/06
Final PL
|
PIL_Rivaro_Initiat_15_20mg_p0524_2019_12EN clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Rivaro_10mg_p0524_2019_12EN clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Rivaro_15mg_p0524_2019_12EN clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Rivaro_2_5mg_p0524_2019_12EN clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Rivaro_20mg_p0524_2019_12EN clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Rivaro_Initiat_15_20mg_p0524_2019_12EN clean
Date of last change:2024/09/06
PubAR Summary
|
Summary PAR PL_H_0524_001_005_DC
Date of last change:2024/09/06
市场状态
Positive
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