欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/1707/001
药品名称
Desloratadina Aurobindo
活性成分
desloratadine 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Aurobindo
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
Germany (DE)
Desloratadin PUREN 5 mg Filmtabletten
Belgium (BE)
Desloratadine AB 5 mg filmomhulde tabletten
Netherlands (NL)
Desloratadine Aurobindo 5 mg, filmomhulde tabletten
Spain (ES)
Italy (IT)
Poland (PL)
Desloratadine Aurovitas
Czechia (CZ)
Desloratadin Aurovitas 5 mg potahované tablety
Romania (RO)
DESLORATADINĂ AUROBINDO 5 mg comprimate filmate
许可日期
2017/07/19
最近更新日期
2024/06/07
药物ATC编码
R06AX27 desloratadine
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 Product Information
|
Rupatadine Bluefish - PL-Clean
Date of last change:2018/02/15
Final Product Information
|
Rupatadine Labelling - Clean
Date of last change:2018/02/15
Final Product Information
|
Rupatadine Bluefish - SmPC- Clean
Date of last change:2018/02/15
PAR
|
608942_20170807_PAR_GBB
Date of last change:2018/02/15
PAR Summary
|
PT_1707_Desloratadina_Aurobindo_AR_D210_Q
Date of last change:2017/08/28
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase