欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	NL/H/3856/001
药品名称	Entecavir 0.5 mg film coated tablets
活性成分	entecavir 0.5 mg
剂型	Film-coated tablet
上市许可持有人	Amarox Pharma B.V. Rouboslaan 32 2252 TR Voorschoten The Netherlands
参考成员国 - 产品名称	Netherlands (NL) Entecavir Amarox 0,5 mg filmomhulde tabletten
互认成员国 - 产品名称	Sweden (SE) Spain (ES) United Kingdom (Northern Ireland) (XI) Germany (DE) Entecavir Amarox 0,5 mg Filmtabletten
许可日期	2017/09/20
最近更新日期	2023/12/14
药物ATC编码	J05AF10 entecavir
申请类型	TypeLevel1：Abridged TypeLevel2：Initial 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 \| PILDate of last change:2023/10/03 Final SPC \| SPCDate of last change:2023/10/03 Final Product Information \| common-pl-cleanDate of last change:2020/02/10 Final Product Information \| common-spc-cleanDate of last change:2020/02/10 Final Product Information \| common-pl-trackedDate of last change:2020/02/10 Final Product Information \| common-spc-trackedDate of last change:2020/02/10 PAR \| PARDate of last change:2018/07/17 Final Labelling \| common-interpackDate of last change:2018/07/17 PAR Summary \| 180503 NL.H.3856.001-002.DC Entecavir Amarox summary ENDate of last change:2018/05/16
市场状态	Positive