欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Lacosamide Adroiq
适用类别Human
治疗领域Epilepsy
通用名/非专利名称lacosamide
活性成分lacosamide
产品号EMEA/H/C/006047
患者安全信息no
授权状态Authorised
ATC编码N03AX18
是否额外监管no
是否仿制药yes
是否生物类似药no
是否附条件批准no
是否特殊情形no
是否加速审评no
是否罕用药no
批准上市日期2023/05/31
上市许可持有人/公司名称Extrovis EU Ltd.
人用药物治疗分组Antiepileptics,
审评意见发布日期2023/03/30
决定日期2023/10/09
修订号2
适应症Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.Lacosamide Adroiq is indicated as adjunctive therapyin the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.
首次发布日期2023/03/27
修订日期2023/10/13
产品信息https://www.ema.europa.eu/en/documents/product-information/lacosamide-adroiq-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/lacosamide-adroiq
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