欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/0866/002
药品名称
Olanzapine Accord
活性成分
Olanzapine 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Accord Healthcare B.V. The Netherlands
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Slovakia (SK)
Ireland (IE)
Austria (AT)
Olanzapin Accord 5 mg Filmtabletten
Italy (IT)
Cyprus (CY)
OLANZAPINE ACCORD FILM COATED TABLETS 5MG
Denmark (DK)
Netherlands (NL)
United Kingdom (Northern Ireland) (XI)
Norway (NO)
Finland (FI)
Latvia (LV)
Lithuania (LT)
Olanzapine Accord 5 mg plėvele dengtos tabletės
Estonia (EE)
OLANZAPINE ACCORD 5 MG
许可日期
2010/04/28
最近更新日期
2025/01/20
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
|
SE_H_0866_002_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_0866_002_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_0866_002_PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase