欧盟EMA药品数据库(European Medicines Agency Authorisation of Medicines DataBase)
商品名称Levetiracetam Hospira
适用类别Human
治疗领域Epilepsy
通用名/非专利名称levetiracetam
活性成分levetiracetam
产品号EMEA/H/C/002783
患者安全信息No
许可状态Authorised
ATC编码N03AX14
是否额外监管No
是否仿制药或hybrid药物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
上市许可日期2014/01/07
上市许可开发者/申请人/持有人Pfizer Europe MA EEIG
人用药物治疗学分组Antiepileptics
兽用药物治疗学分组
审评意见日期2013/10/23
欧盟委员会决定日期2025/05/12
修订号25
治疗适应症Levetiracetam Hospira is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam Hospira is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy. in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy. Levetiracetam Hospira concentrate is an alternative for patients when oral administration is temporarily not feasible.
适用物种
兽用药物ATC编码
首次发布日期2017/11/01
最后更新日期2025/05/12
产品说明书https://www.ema.europa.eu/en/documents/product-information/levetiracetam-hospira-epar-product-information_en.pdf
公共评估报告https://www.ema.europa.eu/en/medicines/human/EPAR/levetiracetam-hospira
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