欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
CZ/H/0145/001
药品名称
Yasnal 5 mg
活性成分
Donepezil hydrochloride 5.0 mg
剂型
Film-coated tablet
上市许可持有人
KRKA d.d. Šmarješka cesta 6, 8501 Novo mesto Slovenia
参考成员国 - 产品名称
Czech Republic (CZ)
互认成员国 - 产品名称
Romania (RO)
Yasnal 5 mg comprimate filmate
Belgium (BE)
Austria (AT)
Donepezil Krka 5 mg Filmtabletten
Cyprus (CY)
DONEPEZIL KRKA 5mg FC TABS
Sweden (SE)
Italy (IT)
DONEPEZIL KRKA
Spain (ES)
France (FR)
Ireland (IE)
United Kingdom (Northern Ireland) (XI)
Denmark (DK)
Donepezeil "Krka"
Germany (DE)
Donepezil TAD 5 mg Filmtabletten
Bulgaria (BG)
Yasnal
Hungary (HU)
YASNAL 5 mg filmtabletta
Finland (FI)
Norway (NO)
Portugal (PT)
Slovak Republic (SK)
Donepezil KRKA 5 mg
许可日期
2007/10/03
最近更新日期
2025/04/22
药物ATC编码
N06DA02 donepezil
申请类型
TypeLevel1：
Abridged
TypeLevel2：
Initial Application
TypeLevel3：
Generic
TypeLevel4：
Chemical Substance
TypeLevel5：
Prescription Only
附件文件下载
Final Product Information
|
common_combined_clean
Date of last change:2024/09/06
Final SPC
|
CZ_H_145_01_02_E001_Yasnal_start_DMF_RUP1_confidential
Date of last change:2024/09/06
Final SPC
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CZ_H_145_01_02_E001_Yasnal_start_Quality_AR_confidential
Date of last change:2024/09/06
Final SPC
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CZ_H_145_01_02_E001_Yasnal_start_SPC_PL_Lab
Date of last change:2024/09/06
Final PL
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Yasnal_MRP_PIL_Day90
Date of last change:2024/09/06
Final SPC
|
Yasnal_MRP_SmPC_Day90
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase