欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3427/004
药品名称
Rivaroxaban Medical Valley
活性成分
RIVAROXABAN 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Laboratorios Liconsa S.A.
参考成员国 - 产品名称
Denmark (DK)
Rivaroxaban "Medical Valley"
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
Poland (PL)
Germany (DE)
Rivaroxaban AXiromed 20 mg Filmtabletten
Netherlands (NL)
Iceland (IS)
许可日期
2024/07/05
最近更新日期
2024/10/15
药物ATC编码
B01AF01 rivaroxaban
申请类型
TypeLevel1:
Abridged
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 SPC
|
SPC_RIV_CC_DK_H_3427_004_IB_001_clean
Date of last change:2025/02/17
Final PL
|
PIL_RIV_CC_DK_H_3427_003_004_IB_001_clean
Date of last change:2025/02/17
Final Labelling
|
LAB_RIV_CC_DK_H_3427_004_IB_001_clean
Date of last change:2025/02/17
Final Product Information
|
SPC_RIV_DK_H_3427_004_cl
Date of last change:2024/10/15
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase