欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2441/003
药品名称
Arpoya
活性成分
aripiprazole 30.0 mg
剂型
Orodispersible tablet
上市许可持有人
Pharmathen S.A. 6, Dervenakion str., Pallini, Attiki 15351 Greece
参考成员国 - 产品名称
Denmark (DK)
Arpoya
互认成员国 - 产品名称
Spain (ES)
Greece (GR)
RIZARPIA (ex ARIPYA)
Cyprus (CY)
许可日期
2015/05/11
最近更新日期
2023/02/24
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
Final PL
|
2023_0130 Final common_pil_ib009_ clean
Date of last change:2024/09/06
Final Product Information
|
2023_0130 Final common_smpc_ib009_clean _H
Date of last change:2024/09/06
Final SPC
|
common_spc_clean
Date of last change:2024/09/06
PubAR
|
Final PAR Arpoya 10_ 15_ 30 mg orodispersible tablets DKH2441_001_003_DC
Date of last change:2024/09/06
PubAR Summary
|
Final sPAR Arpoya 10_ 15_ 30 mg orodispersible tablets DKH2441_001_003_DC
Date of last change:2024/09/06
Final Labelling
|
Final_labeling_ODT_CLEAN_v5 _ Arpoya _ DK_H_ 2441_01_03_IB_01
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase