欧盟HMA药品数据库(European Union HMA Authorisation of Medicines DataBase)
MR编号
PT/H/2774/001
药品名称
Lacosamida Hikma
活性成分
LACOSAMIDE 10.0 mg/ml
剂型
Solution for infusion
上市许可持有人
Hikma Farmacêutica (Portugal), S.A.
参考成员国 - 产品名称
Portugal (PT)
互认成员国 - 产品名称
United Kingdom (Northern Ireland) (XI)
Germany (DE)
Lacosamid Hikma 10 mg/ml Infusionslösung
Belgium (BE)
Netherlands (NL)
Austria (AT)
France (FR)
Spain (ES)
Italy (IT)
许可日期
2023/01/13
最近更新日期
2024/07/08
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 PL
|
common_pl_lacosamide_dcp_var001 _clean__updated
Date of last change:2024/09/06
Final SPC
|
common_spc_lacosamide_dcp_var001 _clean__BDCF_updated COM 6_3
Date of last change:2024/09/06
PubAR
|
PT_2774_PAR_Final
Date of last change:2024/09/06
市场状态
Positive
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European Union HMA Authorisation of Medicines DataBase