欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/1553/005
药品名称
Zolathen
活性成分
olanzapine 15.0 mg
剂型
Film-coated tablet
上市许可持有人
IWA Consulting APS, Ølby Center 18-20, 4600 Køge Denmark
参考成员国 - 产品名称
Denmark (DK)
Zolathen
互认成员国 - 产品名称
Germany (DE)
许可日期
2010/01/19
最近更新日期
2012/01/27
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 Labelling
|
Final Labelling Zolathen film_coated tablets DKH_1553_001_006_DC
Date of last change:2024/09/06
Final PL
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Final PL Zolathen film_coated tablets DKH_1553_001_006_DC
Date of last change:2024/09/06
Final SPC
|
Final SPC Zolathen film_coated tablets DKH_1553_001_006_DC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase