欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NO/H/0300/001
药品名称
Oxycodone SUBSTIPHARM
活性成分
oxycodone hydrochloride 10.0 mg/ml
剂型
Solution for injection/infusion
上市许可持有人
SUBSTIPHARM DEVELOPPEMENT
参考成员国 - 产品名称
Norway (NO)
互认成员国 - 产品名称
许可日期
2019/11/05
最近更新日期
2023/11/01
药物ATC编码
N02AA05 oxycodone
申请类型
TypeLevel1:
Known Active Substance
TypeLevel2:
Initial Application
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
|
Oxycodone Substipharm common_label_immediate_
Date of last change:2024/09/06
Final PL
|
Oxycodone Substipharm PIL_clean
Date of last change:2024/09/06
Final SPC
|
Oxycodone Substipharm SmPC_clean _002_
Date of last change:2024/09/06
Final Labelling
|
Oxycodone Susbstipharm common_label_outer _clean
Date of last change:2024/09/06
PubAR
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PAR
Date of last change:2024/09/06
PubAR Summary
|
Summary PAR
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Withdrawn(注:已撤市)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