山大华特(000915.SZ)口服补液盐散(Ⅲ)获得药品注册批件
格隆汇8月13日丨山大华特(000915.SZ)公布,近日,公司子公司山东达因海洋生物制药股份有限公司(达因药业)收到国家药品监督管理局核准签发的“药品注册批件”。药品名称为口服补液盐散(Ⅲ);剂型:散剂;规格:每包5.125g;药品有效期:24个月。
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,该品符合药品注册的有关要求,批准注册,发给药品批准文号。
同意该品按照国务院办公厅《关于印发药品上市许可持有人制度试点方案的通知》(国办发【2016】41号)和原食品药品监管总局《关于推进药品上市许可持有人制度试点工作有关事项的通知》(食药监药化管【2017】68号)的相关规定作为药品上市许可持有人制度试点品种。同意“山东达因海洋生物制药股份有限公司”作为本品上市许可持有人并自行生产本品。“山东达因海洋生物制药股份有限公司”应当按照《药品上市许可持有人制度试点方案》的有关规定履行持有人的相关义务与责任。
口服补液盐散(Ⅲ)是世界卫生组织(WHO)推荐的低渗型ORS配方,与口服补液盐(Ⅱ)相比,减少了钠和葡萄糖的含量,从而降低了渗透压,更适合婴幼儿预防和治疗腹泻引起的轻中度脱水,并可用于补充钠、钾、氯。该药物也是WHO要求各国用于治疗腹泻的首选药物。
该药物的获批丰富了达因药业儿科药品产品线,有利于提升竞争实力。该药品在进行商业化生产前,尚需取得散剂GMP认证。
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