华森制药公告,公司近日收到国家药监局核准签发的《药物临床试验批准通知书》,主要内容为:药物名称CX001缓释片,剂型为缓释片剂,申请事项为临床试验申请,注册分类为化学药品2.2类,申请人为重庆华森制药股份有限公司。根据《中华人民共和国药品管理法》及有关规定,经审查,同意本品开展“用于治疗带状疱疹后神经痛”适应症的临床试验。CX001缓释片为公司自研产品,将速释制剂改良为缓释制剂(胃滞留缓释片),该缓释制剂可降低给药频率、增加患者顺应性、提高睡眠质量。
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