欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1680/001
药品名称
Rupatadina Bluefish
活性成分
rupatadine fumarate 12.79 mg
剂型
Tablet
上市许可持有人
Bluefish Pharmaceuticals AB
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Rupatadin Bluefish 10 mg Tabletten
Spain (ES)
Poland (PL)
Rupatadine Bluefish
许可日期
2017/05/31
最近更新日期
2024/08/05
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
Final SPC
|
1_3_1 Common_spc_clean_2_
Date of last change:2024/09/06
PubAR
|
609179_20170803_PAR_GBB
Date of last change:2024/09/06
Final Product Information
|
Rupatadine Bluefish _ PL_Clean
Date of last change:2024/09/06
Final Product Information
|
Rupatadine Bluefish _ SmPC_ Clean
Date of last change:2024/09/06
Final Product Information
|
Rupatadine Labelling _ Clean
Date of last change:2024/09/06
市场状态
Positive
©2006-2025
Drugfuture
->
European Union HMA Authorisation of Medicines DataBase