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尼莫地平片《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。
2025年7月，新华制药向国家药品监督管理局药品审评中心(CDE)递交尼莫地平片一致性评价申报资料并获受理，2026年10月获得《药品补充申请批准通知书》，审评结论为：经审查，本品通过仿制药质量和疗效一致性评价。
本品作为尼莫地平注射液预先使用后的继续治疗，可预防和治疗由于动脉瘤性蛛网膜下腔出血后脑血管痉挛引起的缺血性神经损伤。本品还可以用于治疗老年性脑功能障碍，例如：记忆力减退，定向力和注意力障碍和情绪波动。治疗前，应确定这些症状不是由需要特殊治疗的潜在疾病引起的。
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