欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2485/002
药品名称
Coldamin
活性成分
benzydamine hydrochloride 1.5 mg/ml
剂型
Oromucosal spray
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
Denmark (DK)
Coldamin
互认成员国 - 产品名称
许可日期
2018/06/08
最近更新日期
2023/08/15
药物ATC编码
A01AD02 benzydamine
A01 STOMATOLOGICAL PREPARATIONS
A ALIMENTARY TRACT AND METABOLISM
A01AD Other agents for local oral treatment
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Other Generic application Art 10.3 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final Labelling
|
Coldamin 3 MG OMS 20180226 LAB ENG D106 respons PETKI
Date of last change:2024/09/06
Final PL
|
Coldamin 3 MG OMS 20180226 PIL ENG D106 respons PETKI
Date of last change:2024/09/06
Final SPC
|
Coldamin 3 MG OMS 20180615 SPC ENG PETKI
Date of last change:2024/09/06
市场状态
Withdrawn(注:已撤市)
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