欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1770/004
药品名称
Rivaroxabano Aurobindo
活性成分
RIVAROXABAN 20.0 mg
RIVAROXABAN 15.0 mg
剂型
Film-coated tablet
上市许可持有人
GENERIS PHAR, UNIPESSOAL LDA
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Rivaroxaban PUREN Starterpackung 15 mg + 20 mg Filmtabletten
Netherlands (NL)
France (FR)
Poland (PL)
Rivaroxaban Aurovitas
许可日期
2018/07/11
最近更新日期
2023/12/21
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
PubAR
|
614702_614703_614704_614705_12122018_PAR_JMT
Date of last change:2024/09/06
PubAR Summary
|
614702_614703_614704_614705_20181212_PAR_JMT
Date of last change:2024/09/06
Final SPC
|
common _spc_15 mg _ 20 mg_initiation_pack
Date of last change:2024/09/06
Final PL
|
common_pl_15 mg _ 20 mg_initiation_pack
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase