欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2475/003
药品名称
Edoxaban Sandoz
活性成分
edoxaban tosylate hydrate 60.0 mg
剂型
Film-coated tablet
上市许可持有人
Sandoz A/S
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Norway (NO)
Finland (FI)
Hungary (HU)
Edoxaban Sandoz
Czechia (CZ)
Edoxaban Sandoz 60 mg potahované tablety
Germany (DE)
Edoxaban HEXAL 60 mg Filmtabletten
Slovakia (SK)
Denmark (DK)
Edoxaban ”Sandoz”
Belgium (BE)
Edoxaban Sandoz 60 mg filmomhulde tabletten
Netherlands (NL)
Edoxaban Sandoz 60 mg, filmomhulde tabletten
Iceland (IS)
Spain (ES)
Portugal (PT)
Italy (IT)
许可日期
2024/11/27
最近更新日期
2024/12/20
药物ATC编码
B01AF03 edoxaban
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 Labelling
|
Final labelling
Final PL
|
Final PL
Final SPC
|
Final SPC
市场状态
Positive
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