欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
DK/H/0587/001
药品名称
Alnok
活性成分
cetirizine dihydrochloride 1.0 mg/ml
剂型
Oral solution
上市许可持有人
Sandoz A/S Edvard Thomsens Vej 14 2300 København S Denmark
参考成员国 - 产品名称
Denmark (DK)
互认成员国 - 产品名称
Belgium (BE)
Cetirizine Sandoz 1 mg-ml oral solution
许可日期
2005/03/17
最近更新日期
2023/11/16
药物ATC编码
R06AE07 cetirizine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Initial Application
TypeLevel3:
Generic [Article 10.1.(a)(iii), first paragraph]
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
Final PL
|
Final PIL _ clean
Date of last change:2022/06/02
Final SPC
|
Final SmPC _ clean
Date of last change:2022/06/02
Final Product Information
|
1.3.1 spc-label-pl - common-pl - 9,565_clean
Date of last change:2019/02/22
Final Product Information
|
1.3.1 spc-label-pl - common-spc - 9,044_clean
Date of last change:2019/02/22
Final Product Information
|
1.3.1 spc-label-pl - common-outer - 4,773_clean
Date of last change:2019/02/22
Final Labelling
|
label common-outer DKH0587001P001 Alnok - Clean
Date of last change:2018/08/27
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase