中生製藥(01177.HK)腫瘤治療輔助用藥獲中國藥品註冊證書
中生製藥(01177.HK)公布,集團開發的腫瘤治療輔助用藥「阿瑞匹坦膠囊」(商品名:善依)(獲批規格為:80mg、125mg)已獲中國國家藥品監督管理局頒發藥品註冊證書。
該產品按照化藥新4類申報,視同通過仿製藥質量和療效一致性評價,是該品種第二家過評。該產品批准的適應症為:與其他止吐藥物聯合給藥,適用於預防高度致吐性抗腫瘤化療的初次和重複治療過程中出現的急性和遲發性噁心和嘔吐(CINV)。
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