上海医药：盐酸索他洛尔片通过仿制药一致性评价

南方财经网2025-12-15

上海医药公告，常州制药厂有限公司收到国家药监局颁发的《药品补充申请批准通知书》，盐酸索他洛尔片通过仿制药质量和疗效一致性评价。该药品主要用于转复和预防室上性心动过速、心房扑动、心房颤动、各种室性心律失常以及急性心肌梗死并发严重心律失常。2024年11月，常州制药厂就该药品的一致性评价向国家药监局提出补充申请并获受理，截至目前已投入研发费用约460万元。目前中国境内主要生产厂家包括济南恒基制药...

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