欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/2715/001
药品名称
Lenigron
活性成分
Bimatoprost 0.3 mg/ml
Timolol maleate 6.83 mg/ml
剂型
Eye drops, solution
上市许可持有人
Pharmathen S.A. 6 Dervenakion Str. 15351 Pallini, Attiki Greece
参考成员国 - 产品名称
Denmark (DK)
Lenigron
互认成员国 - 产品名称
Greece (GR)
LENIGRON
Cyprus (CY)
LENIGRON EYE DROPS SOLUTION
许可日期
2017/11/08
最近更新日期
2024/11/21
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 Labelling
|
2715_common_outer_ib001_clean
Date of last change:2024/09/06
Final PL
|
Bimatoprost_Timolol PF 2715_IB004 D30 var_ common_PIL_clean
Date of last change:2024/09/06
Final SPC
|
Bimatoprost_Timolol PF 2715_IB004 D30 var_ common_SPC_clean
Date of last change:2024/09/06
PubAR
|
Final_PAR_DK_H_2715_001_DC_Lenigron
Date of last change:2024/09/06
PubAR Summary
|
Final_sPAR_DK_H_2715_001_DC_Lenigron
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase