欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
EE/H/0212/003
药品名称
ZYKALOR
活性成分
Aripiprazole 15.0 mg
剂型
Tablet
上市许可持有人
Medochemie Ltd. 1-10 Constantinoupoleos Street, 3011 Limassol Cyprus
参考成员国 - 产品名称
Estonia (EE)
ZYKALOR
互认成员国 - 产品名称
Greece (GR)
ZYKALOR
Latvia (LV)
Zykalor 15 mg tabletes
Lithuania (LT)
Zykalor 15 mg tabletės
Bulgaria (BG)
Zykalor
Cyprus (CY)
Spain (ES)
Czechia (CZ)
Zykalor 15 mg tablety
Portugal (PT)
Romania (RO)
Zykalor 15 mg comprimate
Slovenia (SI)
Malta (MT)
Croatia (HR)
Zykalor 15 mg tablete
许可日期
2015/08/19
最近更新日期
2025/01/24
药物ATC编码
N05AX12 aripiprazole
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PubAR
|
EE_212_PAR
Date of last change:2024/09/06
Final Labelling
|
final_labelling
Date of last change:2024/09/06
Final PL
|
PIL_ aripiprazole_May 2019_clean
Date of last change:2024/09/06
Final SPC
|
SPC_aripiprazole_May 2019_clean
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase