欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2760/004
药品名称
Saroten Retard
活性成分
amitriptyline 50.0 mg
剂型
Prolonged-release capsule, hard
上市许可持有人
H. Lundbeck A/S Ottiliavej 9 2500 Valby Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
许可日期
2017/06/28
最近更新日期
2018/05/01
药物ATC编码
N06AA09 amitriptyline
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final Product Information
|
EU Amitriptyline combined PI_REG_00075008 v11_0 film_coated tablets
Date of last change:2024/09/06
Final Product Information
|
EU Amitriptyline combined PI_REG_00075008 v11_0 prolonged release
Date of last change:2024/09/06
Final Labelling
|
labelling_ Saroten Retard 50mg_clean
Date of last change:2024/09/06
Final PL
|
PIL_Saroten Retard 50 mg prolonged_release capsules_ hard_clean
Date of last change:2024/09/06
Final SPC
|
SmPC_Saroten Retard 25 mg 50mg prolonged_release capsules_ hard_clean
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Withdrawn(注:已撤市)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