欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1917/001
药品名称
Aciclovir Generis Phar
活性成分
Aciclovir 200.0 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 200 mg Tabletten
Belgium (BE)
Aciclovir AB 200 mg tabletten
Netherlands (NL)
Aciclovir Aurobindo 200 mg, tabletten
France (FR)
Poland (PL)
Aciclovir Aurovitas
Romania (RO)
许可日期
2019/02/28
最近更新日期
2024/12/11
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_200mg
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