欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2792/002
药品名称
Elstabya
活性成分
febuxostat 120.0 mg
剂型
Film-coated tablet
上市许可持有人
Pharmathen 6, Dervenakion str. 153 51 Pallini Attikis Greece
参考成员国 - 产品名称
Denmark (DK)
Elstabya
互认成员国 - 产品名称
Germany (DE)
ELSTABYA 120 mg Filmtabletten
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
France (FR)
Spain (ES)
Italy (IT)
Greece (GR)
Hungary (HU)
许可日期
2018/08/15
最近更新日期
2023/03/22
药物ATC编码
M04 ANTIGOUT PREPARATIONS
M04AA Preparations inhibiting uric acid production
M MUSCULO-SKELETAL SYSTEM
M04AA03 febuxostat
申请类型
TypeLevel1:
Known Active Substance
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
|
Febuxostat 2792_IB011 var_ common_PIL_clean APR2022
Date of last change:2023/03/10
Final Labelling
|
common-lbl-80mg120mg-d205-clean-en
Date of last change:2019/01/11
市场状态
Positive
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