欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2153/004
药品名称
Rivaroxaban STADA
活性成分
RIVAROXABAN 20.0 mg
剂型
Film-coated tablet
上市许可持有人
STADA Arzneimittel AG, Germany
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Iceland (IS)
Ireland (IE)
Austria (AT)
France (FR)
Spain (ES)
Portugal (PT)
Greece (GR)
Hungary (HU)
Rivaroxaban STADA 20 mg filmtabletta
Germany (DE)
Rivaroxaban AL 20 mg Filmtabletten
Norway (NO)
Romania (RO)
Rivaroxaban STADA 20 mg comprimate filmate
Denmark (DK)
Finland (FI)
Belgium (BE)
Rivaroxaban EG 20 mg filmomhulde tabletten
Latvia (LV)
Netherlands (NL)
Rivaroxaban CF 20 mg, filmomhulde tabletten
Lithuania (LT)
Rivaroxaban STADA 20 mg plėvele dengtos tabletės
Luxembourg (LU)
Estonia (EE)
许可日期
2022/09/14
最近更新日期
2024/08/30
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
|
Final PL
Date of last change:2024/09/06
Final SPC
|
Final SPC
Date of last change:2024/09/06
PubAR
|
PAR
Date of last change:2024/09/06
PubAR Summary
|
PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase