欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1326/001
药品名称
Rupatadina Mylan
活性成分
Rupatadine fumarate 10.0 mg
剂型
Tablet
上市许可持有人
Mylan, Lda.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Italy (IT)
Slovakia (SK)
Veratine 10 mg tablety
许可日期
2016/01/20
最近更新日期
2025/01/27
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
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5889655_20160415_PAR_GBB
Date of last change:2024/09/06
PubAR
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588966_20160415_PAR_GBB
Date of last change:2024/09/06
PubAR
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599482_20160415_PAR_GBB
Date of last change:2024/09/06
PubAR
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599484_20160415_PAR_GBB
Date of last change:2024/09/06
PubAR
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600235_20160415_PAR_GBB
Date of last change:2024/09/06
Final Product Information
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common_impack
Date of last change:2024/09/06
Final Product Information
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common_outer_clean205
Date of last change:2024/09/06
Final Product Information
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common_pl_cleand205
Date of last change:2024/09/06
Final Product Information
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common_spc_cleand205
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase