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山东新华制药股份(00719.HK)头孢拉定胶囊(0.25g)首家通过仿制药一致性评价
格隆汇 09-17 16:35

格隆汇9月17日丨山东新华制药股份(00719.HK)发布公告,公司于近日收到国家药品监督管理局核准签发的头孢拉定胶囊0.25g规格的《药品补充申请批件》,该产品通过仿制药质量和疗效一致性评价。公司成为国内首家通过头孢拉定胶囊(0.25g)仿制药一致性评价的企业。

根据国家相关政策规定,对于通过仿制药一致性评价的药品品种,在医保支付方面予以适当支持,医疗机构应优先采购并在临床中优先选用。同品种药品通过仿制药一致性评价的生产企业达到3家以上的,在药品集中采购等方面不再选用未通过仿制药一致性评价的品种。新华制药的头孢拉定胶囊通过仿制药一致性评价,有利于提升该产品的市场竞争力,同时为后续仿制药一致性评价产品的研发工作积累了宝贵的经验。

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