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華森製藥(002907.SZ)成為威地美(鋁碳酸鎂咀嚼片)國內首家通過一致性評價
格隆匯 08-22 17:42

格隆匯8月22日丨華森製藥(002907.SZ)公佈,公司於2019年8月22日收到國家藥品監督管理局核准簽發的關於“威地美(鋁碳酸鎂咀嚼片)”的《藥品補充申請批件》(批件號:2019B03627),華森製藥成為國內鋁碳酸鎂咀嚼片按照仿製藥一致性評價補充申請申報第一家通過的企業。

威地美(鋁碳酸鎂咀嚼片)消化系統一線用藥具有抗酸、抗膽汁、保護粘的功效,三效合一整體治療上消化道疾病。該產品適用於廣泛治療多種胃部疾病:1.急、慢性胃炎2.胃、十二指腸潰瘍3.反流性食管炎4.與胃酸有關的胃部不適症狀,如胃痛、胃灼熱、酸性噯氣、飽脹等5.預防非甾體類藥物的胃黏膜損傷可廣泛用於消化科、急診科、耳鼻喉科、神經內科等科室主藥鋁碳酸鎂為不溶於水的結晶性粉末,呈層狀網絡結構,口服之後不被胃腸道吸收安全性高此外,公司為國內第一家通過美國FDADMF備案鋁碳酸鎂原料企業,具有出口資質並實現原料製劑一體化,品質優良、保障供應

威地美(鋁碳酸鎂咀嚼片)《中國慢性胃炎共識意見》《消化性潰瘍中西醫結合診療共識意見》推薦用藥,被列入《國家基本藥物目錄(2018年版)國家基本醫療保險、工傷保險和生育保險藥品目錄(2019年版)

威地美(鋁碳酸鎂咀嚼片)通過一致性評價,質量和療效等同原研產品,市場競爭力提高,可以使更多患者獲益的同時,也有利於擴大產品的市場銷售,對公司的經營業績產生積極影響,併為其他產品開展仿製藥一致性評價工作積累了寶貴經驗。

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