欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0175/001
药品名称
YASNAL ORO TAB 5 MG
活性成分
Donepezil hydrochloride 5.0 mg
剂型
Orodispersible tablet
上市许可持有人
Krka d.d., Novo mesto, Slovenia
参考成员国 - 产品名称
Czechia (CZ)
sukls39171/2015
互认成员国 - 产品名称
Denmark (DK)
Portugal (PT)
Sweden (SE)
Donepezil Krka
Poland (PL)
Lithuania (LT)
YASNAL 5 mg burnoje disperguojamosios tabletės
Estonia (EE)
YASNAL Q-TAB
Slovakia (SK)
Slovenia (SI)
许可日期
2010/12/09
最近更新日期
2025/01/14
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 PL
|
common_combined texts
Date of last change:2024/09/06
Final Product Information
|
CZ_Comments_Day_20_common_combined_clean
Date of last change:2024/09/06
Final SPC
|
Donepezil orodispersible _D210_SPC
Date of last change:2024/09/06
Final Labelling
|
Donepezil orodispersible_D210_Labelling
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase