欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
IS/H/0435/001
药品名称
ESLICARBAZEPIN DOC
活性成分
ESLICARBAZEPINE ACETATE 200.0 mg
ESLICARBAZEPINE ACETATE 800.0 mg
剂型
Tablet
上市许可持有人
DOC Generici Srl Via Turati 40, Milan 20121 Italy
参考成员国 - 产品名称
Iceland (IS)
ESLICARBAZEPIN DOC
互认成员国 - 产品名称
Italy (IT)
许可日期
2021/02/25
最近更新日期
2023/01/20
药物ATC编码
N03AF04 eslicarbazepine
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
|
IS_H_0435_001_002_DC_D201_PI_Eslicarbacepine Coripharma_final
Date of last change:2024/09/06
PubAR
|
IS_H_0435_Eslicarbazepin Doc_PAR
Date of last change:2024/09/06
PubAR Summary
|
IS_H_0435_Eslicarbazepin Doc_PAR_summary
Date of last change:2024/09/06
Final PL
|
IS_H_0435_IA_01_PIL_Eslicarbazepin_Doc_3_6_2022
Date of last change:2024/09/06
Final SPC
|
IS_H_0435_IB_002_SmPC_Eslicarbazepin_Doc_20_1_2023
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase