欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
ES/H/0946/002
药品名称
Ebastin Aristo
活性成分
ebastine 20.0 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
Germany (DE)
Ebastine Aristo 20 mg orodispersible Tabletten
Italy (IT)
Denmark (DK)
Ebastine Aristo
许可日期
2013/06/27
最近更新日期
2023/11/15
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 SPC
|
Common SPC _ Ebastin clean
Date of last change:2023/03/09
Final PL
|
Common PIL _ Ebastin clean
Date of last change:2023/03/09
PAR
|
DK_H_2266_001_PAR
Date of last change:2018/01/11
PAR
|
PAR_Module 6 Updated scientific discussion
Date of last change:2018/01/11
Final Labelling
|
common_impack_10mg_clean
Date of last change:2013/09/09
Final Labelling
|
common_impack_20mg_clean
Date of last change:2013/09/09
Final Labelling
|
common_outer_10mg_clean
Date of last change:2013/09/09
Final Labelling
|
common_outer_20mg_clean
Date of last change:2013/09/09
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase