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普洛药业(000739.SZ):左乙拉西坦片获得药品注册批件
格隆汇 09-10 19:21

格隆汇9月10日丨普洛药业(000739.SZ)公布,近日,公司之全资子公司浙江普洛康裕制药有限公司收到国家药品监督管理局核准签发的《药品注册批件》。

药品名称:左乙拉西坦片;剂型:片剂;规格:0.25g、0.5g;申请事项:国产药品注册;注册分类:化学药品第4类;药品标准编号:YBH01922019;批件号:2019S00516、2019S00517;药品批准文号:国药准字H20193256、国药准字H20193257;审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品注册的有关要求,批准注册,发给药品批准文号。

左乙拉西坦是由比利时UCB Pharma公司研制的一种新型抗癫痫药物,1999年在欧洲和美国上市,上市不久即凭借确切的抗癫痫疗效和很好的耐受性在临床中获得广泛肯定,销售额一路上升。我国于2009年批准UCB Pharma公司的左乙拉西坦片进口注册申请,商品名为开浦兰。米内数据库显示,其在国内的销售额达到了10亿元以上,呈现出较快的增长趋势。

公司于 2017年完成该项目的BE试验后,于2018年2月向国家药监局递交药品注册申请并获得受理。截至目前,该项目前期已投入费用约为510万元人民币。

左乙拉西坦片是公司首个通过仿制药一致性评价的品种(视同),该项目以新注册分类4类的获批上市,丰富了公司产品品种,扩大了公司产品的领域分布,对公司长期经营有一定积极作用。

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