欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
EE/H/0188/004
药品名称
Zalepin
活性成分
olanzapine 20.0 mg
剂型
Orodispersible tablet
上市许可持有人
Iasis Pharmaceuticals Hellas S.A.
参考成员国 - 产品名称
Estonia (EE)
ZALEPIN
互认成员国 - 产品名称
Greece (GR)
ZALEPIN® RAPID
Cyprus (CY)
ZALEPID RAPID OROD TABS
许可日期
2014/04/10
最近更新日期
2022/10/14
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
|
common_labelling_final
Date of last change:2024/09/06
Final PL
|
common_pl_final
Date of last change:2024/09/06
Final SPC
|
common_spc_final
Date of last change:2024/09/06
PubAR
|
Olanzapine_PAR_CTS
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase