欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/3834/001
药品名称
Entecavir Helm 0,5 mg film-coated tablets
活性成分
entecavir monohydrate 0.5 mg
剂型
Film-coated tablet
上市许可持有人
Helm A.G.
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
许可日期
2017/04/20
最近更新日期
2022/05/12
药物ATC编码
J05AF10 entecavir
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) Application
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
|
common_pl_0009_20200721
Date of last change:2024/09/06
Final SPC
|
common_spc_0009_20200721
Date of last change:2024/09/06
PubAR
|
PAR_NL_H_3834_001_002_DC_EntecavirReddyPharma_11_01_2018
Date of last change:2024/09/06
PubAR Summary
|
summaryPAR_NL_H_3834_001_002_DC_EntecavirReddyPharma_11_01_2018_EN
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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