欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）

MR编号	DE/H/3590/001
药品名称	Flavamed Hustensaft 15 mg/5 ml Lösung zum Einnehmen
活性成分	ambroxol 3.0 mg
剂型	Oral solution
上市许可持有人	Berlin-Chemie AG Glienicker Weg 125 D-12489 Berlin Germany
参考成员国 - 产品名称	Germany (DE) Ambroxolhydrochlorid Fontane 15 mg/5ml Lösung zum Einnehmen
互认成员国 - 产品名称	Poland (PL) Ambroxoli hydrochloridum Fontane Latvia (LV) Flavamed bērniem 15 mg/5 ml šķīdums iekšķīgai lietošanai Lithuania (LT) Ambroxol Fontane 15 mg/5 ml geriamasis tirpalas Estonia (EE) FLAVAMED VAARIKAS Bulgaria (BG) Flavamed for children Slovenia (SI) Flavamed 3 mg/ml peroralna raztopina
许可日期	2013/05/15
最近更新日期	2023/01/10
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 Labelling \| common-final-labip-3590-V008Date of last change:2019/01/11 Final SPC \| common-final-spc-3590-V008Date of last change:2019/01/11 Final PL \| common-final-pl-3590-V008Date of last change:2019/01/11 Final Labelling \| common-final-labop-3590-V008Date of last change:2019/01/11 Final Product Information \| common-final-PL-3590-V006Date of last change:2017/03/17 Final Product Information \| common-final-labip-3590-V006Date of last change:2017/03/17 Final Product Information \| common-final-labop-3590-V006Date of last change:2017/03/17 Final Product Information \| common-final-SmPC-3590-V006Date of last change:2017/03/17 PAR \| PAREN-DE3590_AmbroxolDate of last change:2014/04/11
市场状态	Positive