欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1212/002
药品名称
Ebastine Qualitec
活性成分
ebastine 20.0 mg
剂型
Orodispersible tablet
上市许可持有人
QualitecFarma, S.L.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
许可日期
2014/12/03
最近更新日期
2023/12/11
药物ATC编码
R06AX22 ebastine
申请类型
TypeLevel1:
Known Active Substance
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
Final Product Information
|
common-spc-ebastine-20mg-odt-day160
Date of last change:2015/02/24
Final Product Information
|
common-interpack-ebastine-10mg-odt
Date of last change:2015/02/24
Final Product Information
|
common-interpack-ebastine-20mg-odt
Date of last change:2015/02/24
Final Product Information
|
common-pl-ebastine-10mg-odt-day105
Date of last change:2015/02/24
Final Product Information
|
common-pl-ebastine-20mg-odt-day105
Date of last change:2015/02/24
Final Product Information
|
common-spc-ebastine-10mg-odt-day160
Date of last change:2015/02/24
PAR Summary
|
582241_582242_20150210_PAR_GBB
Date of last change:2015/02/24
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase