欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
EE/H/0381/001
药品名称
Kanilad
活性成分
Lacosamide 10.0 mg/ml
剂型
Oral solution
上市许可持有人
Medochemie Limited 1-10 Constantinoupoleos Limassol 3011 Cyprus
参考成员国 - 产品名称
Estonia (EE)
互认成员国 - 产品名称
Greece (GR)
Cyprus (CY)
Kanilad OS 10 mg/ml oral solution
Malta (MT)
Kanilad OS 10 mg/ml oral solution
许可日期
2024/11/06
最近更新日期
2024/11/06
药物ATC编码
N03AX18 lacosamide
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 Labelling
|
EE_H_381_Labelling
Date of last change:2025/01/13
Final PL
|
EE_H_381_PIL
Date of last change:2025/01/13
Final SPC
|
EE_H_381_SmPC
Date of last change:2025/01/13
PubAR
|
EE_H_381_PAR
Date of last change:2025/01/10
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase