欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
CZ/H/0277/001
药品名称
ELICEA 5mg
活性成分
Escitalopram oxalate 5.0 mg
剂型
Film-coated tablet
上市许可持有人
Krka, d.d, Novo mesto, Slovenia
参考成员国 - 产品名称
Czechia (CZ)
sukls173108/2013
互认成员国 - 产品名称
Austria (AT)
Escitalopram Krka 5 mg Filmtabletten
Poland (PL)
Elicea
Lithuania (LT)
Elicea 5 mg plėvele dengtos tabletės
Estonia (EE)
ELICEA 5 MG
Hungary (HU)
ELICEA 5 mg filmtabletta
Bulgaria (BG)
Elicea
Slovakia (SK)
Elicea 5 mg
Slovenia (SI)
许可日期
2009/07/08
最近更新日期
2024/12/17
药物ATC编码
N06AB10 escitalopram
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:
Non Prescription (including OTC)
附件文件下载
Final Product Information
|
common_combined_fct_cl_doc
Date of last change:2024/12/18
Final PL
|
Elicea common texts
Date of last change:2024/09/06
Final Labelling
|
Elicea_LAB_final
Date of last change:2024/09/06
Final SPC
|
Elicea_SPC_final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase