欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IS/H/0432/001
药品名称
Hydroxyzine Medical Valley
活性成分
Hydroxyzine hydrochloride 10.0 mg
剂型
Film-coated tablet
上市许可持有人
参考成员国 - 产品名称
Iceland (IS)
互认成员国 - 产品名称
Denmark (DK)
Sweden (SE)
Norway (NO)
Hydroxyzine Medical Valley
许可日期
2021/06/16
最近更新日期
2025/12/12
药物ATC编码
N05BB01 hydroxyzine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final Product Information
|
IS_H_0432_001_002_DC_D197_PI_Hydroxyzine_Medical_Valley_11_06_2021
Date of last change:2024/09/06
PubAR
|
IS_H_0432_001_002_DC_PAR_Hydroxyzine Medical Valley
Date of last change:2024/09/06
PubAR Summary
|
IS_H_0432_001_002_DC_PAR_Summary_Hydroxyzine Medical Valley
Date of last change:2024/09/06
Final PL
|
IS_H_0432_IB_005_G_PIL_Hydroxyzine_Medical_Valley_14_11_2023
Date of last change:2024/09/06
Final SPC
|
IS_H_0432_IB_005_G_SmPC_Hydroxyzine_Medical_Valley_14_11_2023
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase