九典制藥(300705.SZ):取得枸櫞酸氫鉀鈉顆粒的藥品註冊證書
格隆匯 10 月 16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,藥品通用名稱為枸櫞酸氫鉀鈉顆粒。
枸櫞酸氫鉀鈉顆粒,適應症為溶解尿酸結石,預防尿酸結石的復發。
枸櫞酸氫鉀鈉顆粒是由德國馬博士大藥廠原研生產,於1965年首先在德國上市,後在瑞士、澳大利亞、意大利、奧地利、比利時、以色列、保加利亞、格魯吉亞、阿曼、泰國、羅馬尼亞等國上市,2001年進口至中國上市。
鹼化尿液是治療尿酸結石的主要方法,目前已成為歐美治療尿酸結石的“金標準”。與同類產品碳酸氫鈉相比,枸櫞酸氫鉀鈉顆粒有更符合人體的生理離子配比,安全性高,不會引起電解質紊亂;人性化的設計,可根據pH值調整用藥量,服用更科學;生物利用度高、藥效穩定。經過多個國家、幾十年臨牀驗證:安全、快速、無毒副作用、可長期服用。
截至目前,國內共有2家(含公司)企業取得了枸櫞酸氫鉀鈉顆粒的藥品注冊批文,公司該品種是國內首家按照新註冊分類4申報的品種,視同通過一致性評價,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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