欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
SK/H/0101/001
药品名称
MUCOSIN tablety
活性成分
ambroxol hydrochloride 30.0 mg
剂型
Tablet
上市许可持有人
Zentiva a.s., Einsteinova 24 851 01 Bratislava Slovak Republic
参考成员国 - 产品名称
Slovakia (SK)
MUCOSIN tablety
互认成员国 - 产品名称
Romania (RO)
Mucosin comprimate 30 mg
Bulgaria (BG)
许可日期
2007/12/16
最近更新日期
2020/05/14
药物ATC编码
R05CB06 ambroxol
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Non Prescription (including OTC)
附件文件下载
Final Product Information
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Common text_clean
Date of last change:2024/09/06
Final Product Information
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Common text_track
Date of last change:2024/09/06
Final Labelling
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Labelling_MUCOSIN
Date of last change:2024/09/06
Final PL
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Package leaflet_MUCOSIN
Date of last change:2024/09/06
Final SPC
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Summary of product characteristics_MUCOSIN
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase