欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3268/002
药品名称
Arimas
活性成分
RIVAROXABAN 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Medochemie Ltd 1-10 Constantinoupoleos Street Limassol 3011 Cyprus
参考成员国 - 产品名称
Denmark (DK)
Arimas
互认成员国 - 产品名称
Romania (RO)
Arimas 20 mg comprimate filmate
Slovakia (SK)
Malta (MT)
Arimas 20 mg film-coated tablets
Spain (ES)
Portugal (PT)
Greece (GR)
Latvia (LV)
Lithuania (LT)
-
Estonia (EE)
Bulgaria (BG)
Arimas
Cyprus (CY)
Arimas 20mg film coated tablets
Czechia (CZ)
Arimas
许可日期
2023/01/17
最近更新日期
2024/08/05
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 PL
|
Common_PIL_DK_H_3268_001_002_IB_003_cl
Date of last change:2024/09/06
Final SPC
|
Common_SPC_DK_H_3268_001_002_IB_003_cl
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase