欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2129/001
药品名称
Brimotimo
活性成分
brimonidine tartrate 2.0 mg/ml
timolol 5.0 mg/ml
剂型
Ear drops, solution
上市许可持有人
Teva Denmark A/S Denmark
参考成员国 - 产品名称
Denmark (DK)
Brimotimo
互认成员国 - 产品名称
许可日期
2012/08/13
最近更新日期
2019/06/27
药物ATC编码
S01ED51 timolol, combinations
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Multiple (Copy) 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 Product Information
|
DK2129 Day 200 Final Product Information
Date of last change:2024/09/06
Final Labelling
|
m1_3_1_label clean
Date of last change:2024/09/06
Final PL
|
m1_3_1_pl clean
Date of last change:2024/09/06
Final SPC
|
m1_3_1_spc clean
Date of last change:2024/09/06
PubAR
|
PAR_Module 5 Scientific discussion_2129
Date of last change:2024/09/06
PubAR
|
PAR_Module 6 Updated scientific discussion_2129
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase