新华制药葡萄糖酸钙注射液通过一致性评价

财中社
05 Nov 2024

新华制药(000756/00719)发布关于葡萄糖酸钙注射液通过仿制药一致性评价的公告。近日,公司收到国家药品监督管理局核准签发的《药品补充申请批准通知书》,确认该产品(10ml:1g)已通过仿制药质量和疗效一致性评价。该药品属于处方药,注册为化学药品,相关申请于2023年7月递交并获受理,最终于2024年11月获得审批结论。葡萄糖酸钙注射液临床用于治疗钙缺乏、急性血钙过低等多种症状,并已被列入《...

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