欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1559/002
药品名称
Nykob
活性成分
olanzapine 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Pharmathen S.A., 6, Dervenakion street, 153 51 Pallini, Attiki, Greece
参考成员国 - 产品名称
Denmark (DK)
Nykob
互认成员国 - 产品名称
许可日期
2010/01/19
最近更新日期
2024/06/06
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 PL
|
common-odt-pl-ia016-clean
Date of last change:2020/05/11
Final PL
|
common-fct-pl-ia016-clean
Date of last change:2020/05/11
Final SPC
|
common-fct-spc-ia016-clean
Date of last change:2020/05/11
Final SPC
|
common-odt-spc-ia016-clean
Date of last change:2020/05/11
Final Labelling
|
common-label-fct-clean
Date of last change:2018/09/27
Final Labelling
|
common-label-odt-clean
Date of last change:2018/09/27
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase