欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/2469/001
药品名称
Broxivan
活性成分
ambroxol 3.0 mg/ml
剂型
Oral solution
上市许可持有人
Medochemie Iberia, SA
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Lithuania (LT)
BROXIVAN 3 mg/ml geriamasis tirpalas
Bulgaria (BG)
Broxivan
Cyprus (CY)
Broxivan 15mg/5ml oral solution
Romania (RO)
Broxivan, 15mg/5ml soluție orală
Slovakia (SK)
Malta (MT)
许可日期
2021/08/05
最近更新日期
2023/09/29
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：
Prescription Only
附件文件下载
PAR
|
653728_653729_20220622_PAR_MSP
Date of last change:2024/02/19
Final Product Information
|
common-combined-label-6mgaug2021cl[1]
Date of last change:2021/09/22
Final Product Information
|
common-combined-label-3mgaug2021cl[1]
Date of last change:2021/09/22
Final Product Information
|
common-combined-pil-6mgaug2021cl[1]
Date of last change:2021/09/22
Final Product Information
|
common-combined-pil-3mgaug2021cl[1]
Date of last change:2021/09/22
Final Product Information
|
common-combined-spc-6mgjuly2021cl[1]
Date of last change:2021/09/22
Final Product Information
|
common-combined-spc-3mgjuly2021cl[1]
Date of last change:2021/09/22
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase