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白雲山(00874.HK)子公司藥品“磷酸氯喹片”獲藥品補充申請批件
格隆匯 02-17 22:03

格隆匯2月17日丨白雲山(00874.HK)發佈公告,2020年2月17日,公司控股子公司廣州白雲山光華製藥股份有限公司(“光華藥業”)收到廣東省藥品監督管理局核准簽發的磷酸氯喹片《藥品補充申請批件》。

該藥品補充申請批件藥物為片劑“磷酸氯喹片”,該批件僅在疫情期間內有效。該品經廣東省藥檢所檢驗一批產品合格後,方可依據該批件上市生產。

根據披露,磷酸氯喹片主要用於治療對氯喹敏感的惡性瘧、間日瘧及三日瘧。並可用於瘧疾症狀的抑制性預防。也可用於治療腸外阿米巴並結締組織並光敏感性疾病(如日曬紅斑)等。

在國家藥品監督管理局網站查詢,磷酸氯喹片共有30個批准文號。根據米內網數據顯示,2018年,磷酸氯喹片在中國城市公立醫院、縣級公立醫院的銷售總額約為人民幣170萬元。除此之外,公司無法從公開渠道獲悉其他生產企業此藥品的生產或銷售數據。

光華藥業於1977年獲得廣東省衞生廳批准的磷酸氯喹片的註冊證書和生產批件,於2015年獲得再註冊批件;於2002年獲得國家藥品轉證批准文號,但自2002年至今沒有生產銷售,現按有關法規要求申請恢復生產並獲得《藥品補充申請批件》。光華藥業獲得《藥品補充申請批件》後,將迅速恢復磷酸氯喹片生產,並經廣東省藥檢所檢驗合格後上市。

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