欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2173/003
药品名称
Rivaroxaban STADA
活性成分
Rivaroxaban 15.0 mg
Rivaroxaban 20.0 mg
剂型
Capsule, hard
上市许可持有人
Stada Arzneimittel GmbH, Germany
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Ireland (IE)
Austria (AT)
France (FR)
Spain (ES)
Portugal (PT)
Norway (NO)
Germany (DE)
Rivaroxaban AL 15 mg/20mg Hartkapseln
Finland (FI)
Denmark (DK)
Rivaroxaban STADA
Latvia (LV)
Belgium (BE)
Lithuania (LT)
-
Netherlands (NL)
Estonia (EE)
Rivaroxaban Stada
Luxembourg (LU)
Romania (RO)
Rivaroxaban STADA 15 mg + 20 mg capsule
Iceland (IS)
许可日期
2022/11/24
最近更新日期
2025/04/25
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
Final SPC
|
Final SPC
PubAR
|
PAR
PubAR Summary
|
PAR Summary
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase