欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/1917/003
药品名称
Aciclovir Generis Phar
活性成分
Aciclovir 800.0 mg
剂型
Tablet
上市许可持有人
Generis Farmacêutica, S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Aciclovir PUREN 800 mg Tabletten
Belgium (BE)
Aciclovir AB 800 mg tabletten
Netherlands (NL)
Aciclovir Aurobindo 800 mg, tabletten
Poland (PL)
Aciclovir Aurovitas
许可日期
2019/02/28
最近更新日期
2024/10/17
药物ATC编码
J05AB01 aciclovir
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 SPC
|
common_spc_800mg
Date of last change:2024/10/17
PubAR Summary
|
625102_625103_625104_20190411_PAR_GBB
Date of last change:2024/09/06
Final Product Information
|
Labelling_clean
Date of last change:2024/09/06
Final Product Information
|
PIL_200mg_clean
Date of last change:2024/09/06
Final Product Information
|
PIL_400mg _clean
Date of last change:2024/09/06
Final Product Information
|
PIL_800mg _clean
Date of last change:2024/09/06
Final Product Information
|
SPC_200mg _clean
Date of last change:2024/09/06
Final Product Information
|
SPC_400mg _clean
Date of last change:2024/09/06
Final Product Information
|
SPC_800mg_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase