欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/2456/002
药品名称
Edoxaban Teva
活性成分
edoxaban tosilate monohydrate 30.0 mg
剂型
Film-coated tablet
上市许可持有人
Teva GmbH, Germany
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Norway (NO)
Germany (DE)
Edoxaban-ratiopharm 30 mg Filmtabletten
Finland (FI)
Denmark (DK)
Edoxaban Teva
Latvia (LV)
Belgium (BE)
Edoxaban Teva 30 mg filmomhulde tabletten
Lithuania (LT)
Edoxaban Teva 30 mg plėvele dengtos tabletės
Netherlands (NL)
Edoxaban Teva 30 mg, filmomhulde tabletten
Estonia (EE)
Luxembourg (LU)
Hungary (HU)
Iceland (IS)
Czechia (CZ)
Edoxaban Teva
Ireland (IE)
Romania (RO)
Edoxaban Teva 30 mg comprimate filmate
Austria (AT)
Slovakia (SK)
Spain (ES)
Portugal (PT)
Italy (IT)
许可日期
2025/01/22
最近更新日期
2025/09/10
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 PL
|
Final PL
Final SPC
|
Final SPC
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase