欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2991/001
药品名称
Levopidon
活性成分
Levomethadone hydrochloride 2.5 mg
剂型
Tablet
上市许可持有人
Dne Pharma AS Karihaugveien 22 1086 Oslo Norway
参考成员国 - 产品名称
Denmark (DK)
Levopidon
互认成员国 - 产品名称
Sweden (SE)
Norway (NO)
Levometadon G.L.
Finland (FI)
许可日期
2020/01/16
最近更新日期
2024/09/26
药物ATC编码
N07 OTHER NERVOUS SYSTEM DRUGS
N07B DRUGS USED IN ADDICTIVE DISORDERS
N07BC Drugs used in opioid dependence
N07BC05 levomethadone
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Common Levomethadone PIL_clean
Date of last change:2024/09/06
Final SPC
|
Common Levomethadone SmPC_clean
Date of last change:2024/09/06
Final Labelling
|
LAB_Levomethadone tablets_26_08_2020_clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase