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
2024/07/24
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
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210730000155
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210730000155_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase