欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FI/H/1166/005
药品名称
Ketipinor
活性成分
quetiapine 400.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Orion Corporation Orionintie 1 02200 Espoo Finland
参考成员国 - 产品名称
Finland (FI)
互认成员国 - 产品名称
Denmark (DK)
Ketipinor
Lithuania (LT)
Ketipinor 400 mg pailginto atpalaidavimo tabletė
许可日期
2014/11/12
最近更新日期
2023/10/13
药物ATC编码
N05AH04 quetiapine
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final SPC
|
EU Ketipinor 50 150 200 300 400mg prolonged release tabl SPC 010721
Date of last change:2021/11/01
Final PL
|
EU Ketipinor 50 150 200 300 400mg prolonged release tabl PIL 010721
Date of last change:2021/11/01
Final Product Information
|
Ketipinor 50 150 200 300 400mg prolonged-release tabl DCP PIL 230718
Date of last change:2018/09/19
Final Product Information
|
Ketipinor 50 150 200 300 400mg prolonged-release tabl DCP SPC 230718
Date of last change:2018/09/19
Final Labelling
|
Ketipinor 50 150 200 300 400mg prolonged-release tabl DCP LABEL 210717
Date of last change:2017/10/19
PAR Summary
|
Final sPAR Ketipinor prolonged release tablets DKH2304_001-005_DC
Date of last change:2016/01/26
PAR
|
Final PAR Ketipinor prolonged release tablets DKH2304_001-005_DC
Date of last change:2016/01/26
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase