欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
EE/H/0351/002
药品名称
Esketex
活性成分
esketamine hydrochloride 25.0 mg/ml
剂型
Solution for injection/infusion
上市许可持有人
AS KALCEKS Krustpils Iela 71E, Riga, LV-1057, Latvia
参考成员国 - 产品名称
Estonia (EE)
互认成员国 - 产品名称
Germany (DE)
Esketamin Baltijos Bite 25 mg/ml Injektions-/Infusionslösung
Austria (AT)
许可日期
2022/06/15
最近更新日期
2024/06/03
药物ATC编码
N01AX14 esketamine
申请类型
TypeLevel1:
Abridged
TypeLevel2:
Additional Strength/Form
TypeLevel3:
Generic Art 10.1 and 10.2 Dir 2001/83/EC
TypeLevel4:
Chemical Substance
TypeLevel5:
Prescription Only
附件文件下载
PAR
|
Public AR_EE_H_0351_DC
Date of last change:2024/04/29
Final Labelling
|
LAB_Esketex_common_Day106_20220209_clean
Date of last change:2022/06/15
Final PL
|
PIL_Esketex_common_Day160_20220414_clean
Date of last change:2022/06/15
Final SPC
|
SmPC_Esketex_common_Day160_20220414_clean
Date of last change:2022/06/15
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase