山东新华制药股份(00719)氨茶碱片通过药监局仿制药质量和疗效一致性评价

金吾财讯2025-04-14

金吾财讯 | 山东新华制药股份(00719)公布，公司收到国家药品监督管理局核准签发的氨茶碱片(《药品补充申请批准通知书》，该产品通过仿制药质量和疗效一致性评价。本品对呼吸道平滑肌有直接松弛作用，适用于支气管哮喘、喘息型支气管炎、阻塞性肺气肿等缓解喘息症状；也可用于心源性肺水肿引起的哮喘。氨茶碱片属于《国家基本药物目录》与《国家基本医疗保险、工伤保险和生育保险药品目录(2023年)》甲类品种，根据有关统计数据显示，2023年中国公立医疗机构氨茶碱销售额约为人民币6.51亿元。

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