欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
ES/H/0946/001
药品名称
Ebastin Aristo
活性成分
Ebastine 10.0 mg
剂型
Orodispersible tablet
上市许可持有人
Aristo Pharma GmbH Wallenroder Strasse 8-10 13435 Berlin Germany
参考成员国 - 产品名称
Spain (ES)
互认成员国 - 产品名称
Denmark (DK)
Ebastine Aristo
Germany (DE)
Ebastine Aristo 10 mg Schmelztabletten
Italy (IT)
许可日期
2013/06/27
最近更新日期
2024/11/14
药物ATC编码
R06AX22 ebastine
申请类型
TypeLevel1:
[not specified]
TypeLevel2:
[not specified]
TypeLevel3:
[not specified]
TypeLevel4:
[not specified]
TypeLevel5:
[not specified]
附件文件下载
Final PL
|
Common PIL _ Ebastin clean
Date of last change:2024/09/06
Final SPC
|
Common SPC _ Ebastin clean
Date of last change:2024/09/06
PubAR
|
DK_H_2266_001_PAR
Date of last change:2024/09/06
Final Labelling
|
Final Labelling 10mg clean
Date of last change:2024/09/06
PubAR
|
PAR_Module 6 Updated scientific discussion
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase