欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SE/H/1917/001
药品名称
Methylphenidate Orion
活性成分
Methylphenidate hydrochloride 18.0 mg
剂型
Prolonged-release tablet
上市许可持有人
Orion Corporation, Finland
参考成员国 - 产品名称
Sweden (SE)
互认成员国 - 产品名称
Denmark (DK)
Methylphenidat "Orion"
Finland (FI)
许可日期
2020/04/20
最近更新日期
2024/09/12
药物ATC编码
N06BA04 methylphenidate
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_1917_001_Final PL
Date of last change:2024/09/06
Final SPC
|
SE_H_1917_001_Final SPC
Date of last change:2024/09/06
PubAR
|
SE_H_1917_001_PAR
Date of last change:2024/09/06
PubAR Summary
|
SE_H_1917_001_PAR Summary
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase