欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PL/H/0212/001
药品名称
INALDIN Gardło
活性成分
Benzydamine hydrochloride 3.0 mg
剂型
Compressed lozenge
上市许可持有人
Bausch Health Ireland Limited Unit 3013 Dublin 24
参考成员国 - 产品名称
Poland (PL)
Septolux
互认成员国 - 产品名称
Slovakia (SK)
Garganta 3 mg
许可日期
2015/02/25
最近更新日期
2025/08/27
药物ATC编码
A01AD02 benzydamine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
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
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common_impack
Date of last change:2024/09/06
Final Labelling
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common_outer
Date of last change:2024/09/06
Final Product Information
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common_PIL_renewal_track
Date of last change:2024/09/06
Final PL
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common_pl
Date of last change:2024/09/06
Final Product Information
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common_SmPC_renewal_track
Date of last change:2024/09/06
Final SPC
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common_spc
Date of last change:2024/09/06
PubAR
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PAR Septolux_loz
Date of last change:2024/09/06
PubAR
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Summary PAR Septolux_loz
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase