财经快讯|科兴制药:注射用紫杉醇(白蛋白结合型)通过欧盟GMP认证
科兴制药5月5日公告,该公司注射用紫杉醇(白蛋白结合型)(5mg/ml)产品于近日收到挪威药品管理局依据欧洲药品管理局相关法规颁发的《药品GMP证书》。注射用紫杉醇(白蛋白结合型)是欧洲医学肿瘤学会指南推荐治疗转移性胰腺癌和非小细胞肺癌的主流一线用药。本次通过GMP认证表明该公司注射用紫杉醇(白蛋白结合型)产品具备欧盟市场准入资格,注射用紫杉醇(白蛋白结合型)于欧盟上市前尚需获得欧盟上市许可申请(MAA)批准。
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