欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
SE/H/2175/003
药品名称
Rivaroxaban ALIUD
活性成分
RIVAROXABAN 15.0 mg
RIVAROXABAN 20.0 mg
剂型
Capsule, hard
上市许可持有人
ALIUD PHARMA GmbH, Germany
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Hungary (HU)
Zafrix 15 mg + 20 mg kemény kapszula
Czechia (CZ)
Zafrix
Slovakia (SK)
Greece (GR)
Poland (PL)
Rivaroxaban STADA
许可日期
2022/11/24
最近更新日期
2024/06/04
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 SPC
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210731000079
Date of last change:2024/09/06
Final PL
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210731000079_2
Date of last change:2024/09/06
PubAR
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210731000079_3
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210731000079_4
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase