欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0100/002
药品名称
Olanzapine +pharma
活性成分
Olanzapine 10.0 mg
剂型
Tablet
上市许可持有人
+pharma arzneimittel gmbh Hafnerstrasse 211 8054 Graz Austria
参考成员国 - 产品名称
Poland (PL)
互认成员国 - 产品名称
许可日期
2007/11/11
最近更新日期
2024/11/01
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 Product Information
|
lab_olanzapine_10_common_v026_response_TR
Date of last change:2024/09/06
Final Labelling
|
lab_olanzapine_5_common_v026_response_TR
Date of last change:2024/09/06
Final PL
|
pil_olanzapine_common_v031_tr OLD
Date of last change:2024/09/06
Final SPC
|
spc_olanzapine_common_v031_tr OLD
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase