欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0837/001
药品名称
Rivoxan
活性成分
RIVAROXABAN 2.5 mg
剂型
Capsule, hard
上市许可持有人
Zentiva k.s., U Kabelovny 130, Prague 10, 102 37 Czech Republic
参考成员国 - 产品名称
Czechia (CZ)
Rivoxan
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Romania (RO)
许可日期
2020/03/22
最近更新日期
2023/12/11
药物ATC编码
B01AF01 rivaroxaban
申请类型
TypeLevel1:
Known Active Substance
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
|
CZ_0836_837_001_4_DC_PAR
Date of last change:2024/09/06
Final Product Information
|
Rivaroxaban 10 mg cps CZ_H_0837 EN text_PSUSA_EPAR_211105_cl
Date of last change:2024/09/06
Final Product Information
|
Rivaroxaban 15 mg cps CZ_H_0837 EN text_PSUSA_EPAR_220211_cl
Date of last change:2024/09/06
Final Product Information
|
Rivaroxaban 2_5 mg cps CZ_H_0837 EN text_PSUSA_EPAR_211214_cl
Date of last change:2024/09/06
Final Product Information
|
Rivaroxaban 20 mg cps CZ_H_0837 EN text_PSUSA_EPAR_220211_cl
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase