欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1182/001
药品名称
Valganciclovir Aurobindo
活性成分
valganciclovir hydrochloride 450.0 mg
剂型
Film-coated tablet
上市许可持有人
Aurobindo Pharma (Portugal), Unipessoal Limitada
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Denmark (DK)
Netherlands (NL)
Valganciclovir Aurobindo 450 mg
France (FR)
Spain (ES)
Sweden (SE)
Finland (FI)
Cyprus (CY)
VALGANCICLOVIR AUROBINDO FC TABS
Romania (RO)
Valganciclovir Aurobindo 450 mg comprimate filmate
Germany (DE)
Valganciclovir PUREN 450 mg Filmtabletten
Italy (IT)
许可日期
2014/10/08
最近更新日期
2023/05/10
药物ATC编码
J05AB14 valganciclovir
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 Product Information
|
Labelling
Date of last change:2018/02/12
Final Product Information
|
PIL
Date of last change:2018/02/12
Final Product Information
|
SPC
Date of last change:2018/02/12
Final PL
|
common-pl-annotated
Date of last change:2015/04/29
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase