欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/0877/002
药品名称
Donepezilo Orua
活性成分
donepezil hydrochloride 10.0 mg
剂型
Film-coated tablet
上市许可持有人
Aurobindo Pharma (Portugal), Unip Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Donepezil Aurobindo 10mg Filmtabletten
France (FR)
Italy (IT)
Malta (MT)
Donepezil hydrochloride 10mg film-coated tablets
Denmark (DK)
Spain (ES)
许可日期
2013/05/17
最近更新日期
2024/06/26
药物ATC编码
N06DA02 donepezil
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
Date of last change:2013/10/16
Final PL
|
common-pl
Date of last change:2013/10/16
Final Labelling
|
common-outer
Date of last change:2013/10/16
市场状态
Positive
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