海辰藥業(300584.SZ):注射用艾司奧美拉唑鈉通過一致性評價
格隆匯1月7日丨海辰藥業(300584.SZ)公佈,近日,公司收到國家藥監局核准簽發的公司產品注射用艾司奧美拉唑鈉的《藥品補充申請批件通知書》,該產品通過仿製藥質量和療效一致性評價。
注射用艾司奧美拉唑鈉為新一代的質子泵抑制劑,主要適用於:消化性潰瘍出血、吻合口潰瘍出血;應激狀態時併發的急性胃黏膜損害、非甾體類抗炎藥引起的急性胃黏膜損傷;預防重症疾病(如腦出血、嚴重創傷等)應激狀態及胃手術後引起的上消化道出血等;作為當口服療法不適用時,胃食管反流病(GERD)的替代療法;口服療法不適用的急性胃或十二指腸潰瘍出血的低危患者(胃鏡下Forrest分級Ⅱc-Ⅲ)。
該產品2000年首次在德國、英國、瑞典、丹麥等國家上市,2001年美國FDA批准上市,之後又陸續在加拿大、意大利、澳大利亞、日本等眾多國家上市。2007年,進口的注射用艾司奧美拉唑鈉在我國上市,目前國內有多家企業通過(或視同通過)一致性評價。根據米內網數據顯示,2020年注射用奧美拉唑鈉在全國公立醫療機構終端的銷售額為50億元。
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