山东新华制药股份(00719)获得盐酸左沙丁胺醇雾化吸入溶液《药品补充申请批准通知书》

智通财经
20 Jan

智通财经APP讯,山东新华制药股份(00719)发布公告,近日,公司收到国家药品监督管理局核准签发的盐酸左沙丁胺醇雾化吸入溶液《药品补充申请批准通知书》,该产品上市许可持有人转让申请获得批准。

盐酸左沙丁胺醇雾化吸入溶液用于治疗或预防成人及6岁以上儿童可逆性气道阻塞性疾病引起的支气管痉挛。左沙丁胺醇是一种肾上腺素β受体激动剂,为沙丁胺醇的左旋体,能够产生舒张支气管平滑肌的作用。根据有关数据显示,近年来左沙丁胺醇吸入制剂的销售额快速增长,2023年中国公立医疗机构销售额达人民币8.04亿元。

盐酸左沙丁胺醇雾化吸入溶液于2025年1月通过国家药品监督管理局审批,新华制药成为本品的上市许可持有人。该产品的上市,有利于丰富公司呼吸系统药物产品线,提升公司综合竞争优势。

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