欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NL/H/5158/001
药品名称
Olanzapin "Sandoz"
活性成分
Olanzapine 5.0 mg
剂型
Orodispersible tablet
上市许可持有人
Sandoz B.V. Hospitaaldreef 29 1315 RC Almere Nederland
参考成员国 - 产品名称
Netherlands (NL)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
许可日期
2011/07/25
最近更新日期
2025/07/01
药物ATC编码
N05AH03 olanzapine
申请类型
TypeLevel1:
TypeLevel2:
TypeLevel3:
TypeLevel4:
TypeLevel5:
附件文件下载
Final Labelling
|
1_3_1 spc_label_pl _ common_outer _ clean
Date of last change:2024/09/06
Final PL
|
1_3_1 spc_label_pl _ common_pl _ 10_773 _ clean
Date of last change:2024/09/06
Final SPC
|
1_3_1 spc_label_pl _ common_spc _ 10_214 _ clean
Date of last change:2024/09/06
PubAR
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Final PAR Scientific discussion Olanzapin Sandoz DKH1931_001_004_DC
Date of last change:2024/09/06
Final Product Information
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spc_label_pl___common_pl_dk_h_1931
Date of last change:2024/09/06
Final Product Information
|
spc_label_pl___common_spc_dk_h_1931
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase