欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/3423/004
药品名称
ELMARDYA
活性成分
RIVAROXABAN 20.0 mg
剂型
Film-coated tablet
上市许可持有人
Pharmathen S.A. Dervenakion 6, Pallini Attiki, 153 51, Greece
参考成员国 - 产品名称
Denmark (DK)
Elmardya
互认成员国 - 产品名称
Germany (DE)
ELMARDYA 20 mg Filmtabletten
France (FR)
Spain (ES)
Greece (GR)
许可日期
2023/12/13
最近更新日期
2024/08/29
药物ATC编码
B01AF01 rivaroxaban
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
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
|
Rivaroxaban 15_20 mg_D196_common_PIL_clean
Date of last change:2024/09/06
Final SPC
|
Rivaroxaban 20 mg_D160_common_SPC_clean
Date of last change:2024/09/06
Final Labelling
|
Rivaroxaban 20 mg_D196_common_LBL_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase