華仁藥業(300110.SZ):子公司取得左氧氟沙星注射液藥品註冊證書
格隆匯4月20日丨 華仁藥業(300110.SZ)公佈,近日,公司子公司安徽恆星製藥有限公司(“安徽恆星製藥”)收到國家藥品監督管理局核准簽發的“左氧氟沙星注射液20ml:0.5g規格”的《藥品註冊證書》。
左氧氟沙星注射液主要用於治療成年人(≥18歲)由下列細菌的敏感菌株所引起的下列輕、中、重度感染。包括如下感染:醫院獲得性肺炎、社區獲得性肺炎、急性細菌性鼻竇炎、慢性支氣管炎的急性細菌性發作、複雜性皮膚及皮膚結構感染、非複雜性皮膚及皮膚軟組織感染、慢性細菌性前列腺炎、複雜性尿路感染、急性腎盂腎炎、非複雜性尿路感染及吸入性炭疽(暴露後)等。
左氧氟沙星注射液原研廠家為日本第一三共株式會社,安徽恆星製藥是國內第2家以藥品註冊分類3類申請獲批(視同通過一致性評價)的企業。根據國家藥監局《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第100號)相關規定,本品視同通過仿製藥質量和療效一致性評價。本次左氧氟沙星注射液取得藥品註冊批件,將進一步豐富公司的產品線,推動產品力建設升級,對公司未來發展具有積極的影響。
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