赛诺菲(SNY.US)抗过敏药“非索非那定”新适应症在华申报上市

智通财经2025-02-25

智通财经APP获悉，2月25日，中国国家药监局药品审评中心（CDE）官网最新公示，赛诺菲(SNY.US)申报的盐酸非索非那定口服混悬液新适应症上市申请获得受理。此前非索非那定片已经在中国获批，用于治疗过敏性鼻炎及慢性特发性荨麻疹。本次申报上市的为口服混悬液剂型，同时这也是口服混悬液剂型在中国的第二项上市申请。根据赛诺菲此前新闻稿，美国FDA此前已批准盐酸非索非那定口服混悬液用于治疗2~11岁儿童...

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