欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Lyrica
适用类别Human
治疗领域Epilepsy;Anxiety Disorders;Neuralgia
通用名/非专利名称pregabalin
活性成分pregabalin
产品号EMEA/H/C/000546
患者安全信息No
许可状态Authorised
ATC编码N02BF02
是否额外监管No
是否仿制药或hybrid药物No
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
上市许可日期2004/07/05
上市许可开发者/申请人/持有人Upjohn EESV
人用药物治疗学分组Analgesics;Other analgesics and antipyretics
兽用药物治疗学分组
欧盟委员会决定日期2025/09/15
修订号71
治疗适应症Neuropathic pain Lyrica is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Lyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Lyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
适用物种
兽用药物ATC编码
首次发布日期2017/11/16
最后更新日期2025/09/18
产品说明书https://www.ema.europa.eu/en/documents/product-information/lyrica-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/lyrica
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