欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
NO/H/0276/002
药品名称
Amitriptylin Orifarm
活性成分
amitriptyline 25.0 mg
剂型
Film-coated tablet
上市许可持有人
Orifarm Generics
参考成员国 - 产品名称
Norway (NO)
Amitriptylin Orifarm
互认成员国 - 产品名称
Sweden (SE)
许可日期
2018/02/16
最近更新日期
2023/10/16
药物ATC编码
N06AA09 amitriptyline
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
PAR Summary
|
Summary of Public Assessment Report
Date of last change:2020/02/19
PAR
|
Public Assessment Report w update
Date of last change:2020/02/19
Final PL
|
PIL ENG DAY 208_End of Procedure
Date of last change:2018/06/04
Final SPC
|
SPC ENG DAY 208_End of procedure
Date of last change:2018/06/04
Final Labelling
|
LAB ENG DAY 208_End of procedure
Date of last change:2018/06/04
市场状态
Positive
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