欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1458/003
药品名称
Estaldem
活性成分
NALOXONE HYDROCHLORIDE 10.0 mg
oxycodone 20.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Acino AG Germany
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
许可日期
2016/01/21
最近更新日期
2022/02/01
药物ATC编码
N02AA55 oxycodone and naloxone
申请类型
TypeLevel1:
Abridged
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 PL
|
SE_H_1458_003_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1458_003_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1458_003_PAR
Date of last change:2024/09/06
PubAR Summary
|
SE_H_1458_003_PAR Summary
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Withdrawn(注:已撤市)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