欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DE/H/0849/001
药品名称
Flavamed Hustentabletten
活性成分
ambroxol hydrochloride 30.0 mg
剂型
Tablet
上市许可持有人
Berlin-Chemie AG Glienicker Weg 125 12489 Berlin Gemany
参考成员国 - 产品名称
Germany (DE)
互认成员国 - 产品名称
Finland (FI)
Poland (PL)
Flavamed
Latvia (LV)
Lithuania (LT)
Flavamed 30 mg tabletės
Estonia (EE)
FLAVAMED 30 MG
Bulgaria (BG)
Flavamed
Slovakia (SK)
Slovenia (SI)
许可日期
2007/08/29
最近更新日期
2023/04/26
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 SPC
|
common_final_spc_0849_V020_plus_antitussivs_clean
Date of last change:2023/04/26
Final PL
|
common_final_pl_0849_V020_plus_antitussivs_clean
Date of last change:2023/04/26
Final Product Information
|
common-final-labop-0849-V016
Date of last change:2020/12/10
Final Product Information
|
common-final-pl-0849-V016
Date of last change:2020/12/10
Final Product Information
|
common-final-spc-0849-V016
Date of last change:2020/12/10
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase