欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2788/001
药品名称
Atomoxetin Orion
活性成分
Atomoxetine 10.0 mg
剂型
Capsule, hard
上市许可持有人
Orion Corporation Orionintie 1, Espoo FI-02200 Finland
参考成员国 - 产品名称
Denmark (DK)
Atomoxetin Orion
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
Atomoxetin Orion
Finland (FI)
许可日期
2018/03/24
最近更新日期
2024/12/13
药物ATC编码
N06BA09 atomoxetine
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 PL
|
Atomoxetin_DK_H_2788_001_007_IA_008 _PIL_cl
Date of last change:2024/12/13
Final SPC
|
Atomoxetin_DK_H_2788_001_007_IA_008 _SmPC_cl
Date of last change:2024/12/13
Final Labelling
|
FINAL _ EU Atomoxetin Orion caps DCP LABEL
Date of last change:2024/09/06
PubAR
|
PAR _ Atomoxetin Orion_ DK_H_2788_001_007_DC
Date of last change:2024/09/06
PubAR Summary
|
Summary PAR _ Atomoxetin Orion _ DK_H_2788_001_007_DC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase