欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
DK/H/2440/001
药品名称
Arpoya
活性成分
aripiprazole 5.0 mg
剂型
Tablet
上市许可持有人
Pharmathen International S.A. 4, 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
Germany (DE)
Arpoya 5 mg Tabletten
Italy (IT)
Greece (GR)
RIZARPIA (ex ARIPYA)
许可日期
2015/05/11
最近更新日期
2024/04/02
药物ATC编码
N05AX12 aripiprazole
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 Labelling
|
common_spc_ib015_clean
Date of last change:2022/06/02
Final Labelling
|
common_pl_ib015_clean
Date of last change:2022/06/02
Final Labelling
|
common_outer_ib015_clean
Date of last change:2022/06/02
Final SPC
|
common-form-spc-iain013-clean
Date of last change:2020/08/06
Final PL
|
common-form-pil-iain013-clean
Date of last change:2020/08/06
PAR Summary
|
Final sPAR Arpoya 5, 10, 15, 30 mg tablets DKH2440_001-004_DC
Date of last change:2016/09/26
PAR
|
Final PAR Arpoya 5, 10, 15, 30 mg tablets DKH2440_001-004_DC
Date of last change:2016/09/26
Final Product Information
|
common-labeling-tablets_clean_d196_v3
Date of last change:2015/05/11
Final Product Information
|
common-pil-tablets_clean_d196_v4
Date of last change:2015/05/11
Final Product Information
|
common-spc-tablets_clean_d196_v4
Date of last change:2015/05/11
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase