欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2475/002
药品名称
Edoxaban Sandoz
活性成分
edoxaban tosylate hydrate 30.0 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
Finland (FI)
Hungary (HU)
Edoxaban Sandoz
Germany (DE)
Edoxaban HEXAL 30 mg Filmtabletten
Czechia (CZ)
Edoxaban Sandoz 30 mg potahované tablety
Denmark (DK)
Edoxaban ”Sandoz”
Slovakia (SK)
Belgium (BE)
Edoxaban Sandoz 30 mg filmomhulde tabletten
Netherlands (NL)
Edoxaban Sandoz 30 mg, filmomhulde tabletten
Iceland (IS)
Ireland (IE)
Spain (ES)
Portugal (PT)
Italy (IT)
Norway (NO)
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
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Final labelling
Final PL
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Final PL
Final SPC
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Final SPC
市场状态
Positive
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