欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/3828/002
药品名称
Entecavir Alvogen 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
Alvogen Malta operations
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
Hungary (HU)
ENTECAVIR ALVOGEN 1 mg filmtabletta
Bulgaria (BG)
Romania (RO)
ENTECAVIR ALVOGEN 1 mg comprimate filmate
许可日期
2017/04/13
最近更新日期
2024/06/07
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
PubAR
|
170918 NL_H_3828_001_002_DC Entecavir Alvogen PAR
Date of last change:2024/09/06
PubAR Summary
|
170918 NL_H_3828_001_002_DC Entecavir Alvogen summary EN
Date of last change:2024/09/06
Final PL
|
Common bijsluiter tekst clean
Date of last change:2024/09/06
Final Product Information
|
common_entecavir_PIL_cl
Date of last change:2024/09/06
Final Product Information
|
common_entecavir_SmPC_cl
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase