白云山(00874):注射用青霉素钠通过仿制药一致性评价

智通财经
Feb 11

智通财经APP讯,白云山(00874)发布公告,近日,公司控股子公司广州白云山天心制药股份有限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》,注射用青霉素钠0.96g(160万单位)已通过仿制药质量和疗效一致性评价。

注射用青霉素钠适用于敏感菌所致的各类感染,如脓肿、菌血症、肺炎和心内膜炎。其中青霉素为以下感染的首选药物:溶血性链球菌感染;肺炎链球菌感染;不产青霉素酶葡萄球菌感染;炭疽;破伤风、气性坏疽等梭状芽孢杆菌感染;梅毒(包括先天性梅毒);钩端螺旋体病;回归热;白喉;青霉素与氨基糖苷类药物联合用于治疗草绿色链球菌心内膜炎。

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