欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1556/004
药品名称
Aedon
活性成分
olanzapine 20.0 mg
剂型
Orodispersible tablet
上市许可持有人
G.L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
许可日期
2010/01/19
最近更新日期
2024/01/19
药物ATC编码
N05AH03 olanzapine
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 SPC
|
smpc_1556_olanzapine_2022_06_13_cl
Date of last change:2022/08/15
Final Product Information
|
pil-1556-olanzapine_2020-03-20_clean
Date of last change:2020/06/11
Final PL
|
pil-1556-olanzapine-final_clean
Date of last change:2018/05/16
Final Labelling
|
lab-1556-olanzapine-final_clean
Date of last change:2018/05/16
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase