欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2456/002
药品名称
Eyopto
活性成分
Timolol maleate 6.83 mg/mL
Timolol 5.0 mg/mL
剂型
Eye drops, solution
上市许可持有人
Pharmathen S.A. 6, Dervenakion str., Pallini, Attiki 153 51 Greece
参考成员国 - 产品名称
Denmark (DK)
Eyopto
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Austria (AT)
Eyopto 5 mg/ml Augentropfen, Lösung
Greece (GR)
EYOPTO (ex TIMOLOL PF MULTIDOSE PHARMATHEN)
许可日期
2016/06/02
最近更新日期
2025/02/14
药物ATC编码
S01ED01 timolol
申请类型
TypeLevel1:
Known Active Substance
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 Labelling
|
common_outer_r001_clean
Date of last change:2024/09/06
Final PL
|
common_pil_r001_clean
Date of last change:2024/09/06
Final SPC
|
common_spc_r001_clean
Date of last change:2024/09/06
PubAR
|
Final PAR Eyopto eye drops solution DH2456_001_DC
Date of last change:2024/09/06
PubAR Summary
|
Final_sPAR_Eyopto_eye_drops_solution_DH2456_001_DC
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase