Product Name 产品名称 | Levetiracetam Sciecure 100mg/ml concertrate solution for infusion 左乙拉西坦注射用浓溶液 |
Strength 规格 | 500mg/5ml |
Product License | PL 43801/0042 - 0001 |
Indications 适应症 | • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. • partial onset seizures with or without generalisation in adults, adolescents and children from 4 years of age. • myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy. • primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsy. •在成人和16岁以下新诊断为癫痫的青少年中单独治疗某种形式的癫痫。 •成人、青少年和4岁以上儿童的部分发作性癫痫，伴有或不伴有全身性发作 •12岁以下患有青少年肌阵挛性癫痫的成人和青少年的肌阵挛性癫痫发作。 •12岁以下患有特发性全身性癫痫的成人和青少年的原发性全身强直阵挛发作。 |
Approved Date 批准日期 | 15/02/2017 |
Market Authorization Holder 持有人 | SCIECURE PHARMA LIMITED |
Manufacture 生产商 | Beijing Sciecure Pharmaceutical Co., Ltd. 北京世桥生物制药有限公司 |