欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/5039/002
药品名称
Rivaroxaban Sandoz 10 mg
活性成分
Rivaroxaban 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz B.V. Veluwezoom 22 1301 AH Almere Netherlands
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Italy (IT)
许可日期
2020/11/25
最近更新日期
2025/01/20
药物ATC编码
B01AF01 rivaroxaban
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Additional Strength/Form
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
|
common_outer
Date of last change:2024/09/06
Final PL
|
common_pl_10mg_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_10mg_clean
Date of last change:2024/09/06
PubAR Summary
|
NL_H_5039_001_004_DC Rivaroxaban Sandoz sPAR EN
Date of last change:2024/09/06
PubAR
|
PAR_5039_Rivaroxaban Sandoz_25 mar 2021
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase