欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1779/001
药品名称
Rupatadine Aurobindo
活性成分
Rupatadine 10.0 mg
剂型
Tablet
上市许可持有人
Aurobindo Pharma (Portugal), Unipessoal, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Spain (ES)
Italy (IT)
Poland (PL)
Rupurix
许可日期
2018/02/14
最近更新日期
2024/10/07
药物ATC编码
R06AX28 rupatadine
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
PubAR
|
617863_20180404_PAR_GBB
Date of last change:2024/09/06
Final Product Information
|
common_pl_Clean
Date of last change:2024/09/06
Final SPC
|
common_spc
Date of last change:2024/09/06
Final Product Information
|
common_spc_Clean
Date of last change:2024/09/06
Final Product Information
|
Labelling_Clean
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase