欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2173/001
药品名称
Rivaroxaban STADA
活性成分
RIVAROXABAN 15.0 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
Latvia (LV)
Ireland (IE)
Lithuania (LT)
-
Austria (AT)
Estonia (EE)
Rivaroxaban Stada
France (FR)
Romania (RO)
Rivaroxaban STADA 15 mg capsule
Germany (DE)
Rivaroxaban AL 15 mg Hartkapseln
Denmark (DK)
Rivaroxaban STADA
Spain (ES)
Belgium (BE)
Portugal (PT)
Netherlands (NL)
Norway (NO)
Luxembourg (LU)
Finland (FI)
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_20210730000131
Date of last change:2024/09/06
PubAR Summary
|
https___www_lakemedelsverket_se_sv_sok_lakemedelsfakta_lakemedel_id_20210730000131_2
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase