欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FI/H/0817/002
药品名称
Burana Comp 400 mg/60 mg
活性成分
codeine phosphate hemihydrate 60.0 mg
ibuprofen 400.0 mg
剂型
Film-coated tablet
上市许可持有人
Orion Corporation Orionintie 1 02200 ESPOO Finland
参考成员国 - 产品名称
Finland (FI)
互认成员国 - 产品名称
许可日期
2013/12/11
最近更新日期
2023/11/01
药物ATC编码
N02AA59 codeine, combinations excl. psycholeptics
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final SPC
|
Burana Comp 200_30 400_60 mg tabl DCP PIL 151013
Date of last change:2024/09/06
Final PL
|
Burana Comp 200_30 400_60 mg tabl DCP PIL 151013_2
Date of last change:2024/09/06
Final SPC
|
Burana Comp 200_30 mg_ 400_60 mg tabl SPC FI_H_817_01_02_DC
Date of last change:2024/09/06
Final SPC
|
Burana Comp PAR_Scientific Discussion
Date of last change:2024/09/06
PubAR
|
Burana Comp PAR_Scientific Discussion_2
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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European Union HMA Authorisation of Medicines DataBase