欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
FI/H/1114/002
药品名称
Oxycodone Orifarm 10 mg/ml
活性成分
Oxycodone hydrochloride 10.0 mg/ml
剂型
Oral solution
上市许可持有人
Orifarm Generics A/S Energivej 15 5260 Odense S Denmark
参考成员国 - 产品名称
Finland (FI)
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
许可日期
2022/01/17
最近更新日期
2024/10/02
药物ATC编码
N02AA05 oxycodone
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
|
Oxycodone Orifarm _ FI_H_1114_01_02_DC _ Final PIL ENG
Date of last change:2024/09/06
Final SPC
|
Oxycodone Orifarm _ FI_H_1114_01_02_DC _ Final SPC ENG
Date of last change:2024/09/06
PubAR
|
Oxycodone Orifarm _ FI_H_1114_01_02_DC _ PAR
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase