欧盟HMA药品数据库（European Union HMA Authorisation of Medicines DataBase）
MR编号
PT/H/1468/002
药品名称
Hidroxizina Alvogen
活性成分
hydroxyzine chloride 25.0 mg
剂型
Film-coated tablet
上市许可持有人
Generic Speciality Pharma Limited
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Poland (PL)
Hydroxyzinum Alvogen
许可日期
2016/11/23
最近更新日期
2021/06/02
药物ATC编码
N05BB01 hydroxyzine
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
Final Product Information
|
combined_pl_hydroxyzine-10 mg_25 mg_fct_tracked changes0005
Date of last change:2017/10/20
Final Product Information
|
combined_pl_hydroxyzine-10 mg_25 mg_fct_clean0005
Date of last change:2017/10/20
Final Product Information
|
common-10mg-25mg -hydroxyzine label-clean0005
Date of last change:2017/10/20
Final Product Information
|
common-10mg-25mg -hydroxyzine label-tracked changes0005
Date of last change:2017/10/20
Final Product Information
|
SmPC Combined Hydroxyzine 10_25 FCT_trackedchanges_0005
Date of last change:2017/10/20
Final Product Information
|
SmPC Combined Hydroxyzine 10_25 FCT_clean_0005
Date of last change:2017/10/20
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase