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
Czechia (CZ)
互认成员国 - 产品名称
Portugal (PT)
Norway (NO)
Finland (FI)
Hungary (HU)
YASNAL 5 mg filmtabletta
Bulgaria (BG)
Yasnal
Romania (RO)
Yasnal 5 mg comprimate filmate
Germany (DE)
Donepezil TAD 5 mg Filmtabletten
Denmark (DK)
Donepezeil "Krka"
Belgium (BE)
United Kingdom (Northern Ireland) (XI)
Ireland (IE)
Austria (AT)
Donepezil Krka 5 mg Filmtabletten
France (FR)
Spain (ES)
Italy (IT)
DONEPEZIL KRKA
Greece (GR)
Sweden (SE)
Cyprus (CY)
DONEPEZIL KRKA 5mg FC TABS
Slovakia (SK)
Donepezil KRKA 5 mg
许可日期
2007/10/03
最近更新日期
2024/08/30
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 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
|
CZ_H_145_01_02_E001_Yasnal_start_Quality_AR_confidential
Date of last change:2024/09/06
Final SPC
|
CZ_H_145_01_02_E001_Yasnal_start_SPC_PL_Lab
Date of last change:2024/09/06
Final PL
|
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