九典制藥(300705.SZ):獲得依巴斯汀片的藥品註冊證書
格隆匯7月5日丨九典制藥(300705.SZ)公佈,公司於近日收到國家藥品監督管理局下發的《藥品註冊證書》,藥品名稱為依巴斯汀片。
依巴斯汀是一種強效、高選擇性、特異性的H1受體阻斷藥,並能抑制中性粒細胞移行和5-脂氧合酶,具有抗炎作用,適用於伴有或不伴有過敏性結膜炎的過敏性鼻炎(季節性和常年性),慢性特發性蕁麻疹的對症治療。
依巴斯汀最早由西班牙Almirall-Prodesfarma(現為Almirall)開發,1989年12月在西班牙批准上市,商品名:Ebastel®,片劑,10 mg,20 mg,其中依巴斯汀片10mg於2014年在國內進口上市,目前本品已在50多個國家上市銷售。
截至公吿日,依巴斯汀片國內共有4家(含公司和原研)企業取得了藥品註冊證書,公司該品種按照新註冊分類4申報,為國內第2家通過或視同通過仿製藥質量和療效一致性評價的企業。該藥品註冊證書的取得進一步豐富了公司製劑產品品種,對進一步優化公司產品結構有着積極意義。
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