普利製藥(300630.SZ):注射用鹽酸萬古黴素獲得加拿大上市許可
格隆匯 7 月 28日丨普利製藥(300630.SZ)公佈,公司於近日收到了加拿大衞生部簽發的注射用鹽酸萬古黴素的上市許可。
藥品名稱:注射用鹽酸萬古黴素;適應症:鹽酸萬古黴素用於治療由耐甲氧西林(β-內酰胺)葡萄球菌敏感菌株引起的嚴重感染。它適用於青黴素過敏患者、不能接受或對其他藥物(包括青黴素或頭孢菌素)沒有反應的患者,以及萬古黴素敏感生物引起的對其他抗菌藥物有抵抗力的感染。對葡萄球菌性心內膜炎、以及葡萄球菌所致的其他感染包括敗血症、骨髓炎、下呼吸道感染、皮膚和皮膚組織感染等有效。劑型:注射劑;規格:500mg和1g。
化合物萬古黴素首先由禮來公司從土壤中分離出來並完成研製,禮來公司該品種在1958年獲得FDA的批准上市,商標是Vancocin®。萬古黴素在世界衞生組織基本藥物標準清單中有收載。目前注射用鹽酸萬古黴素已經在全球廣泛上市銷售。
普利製藥的注射用鹽酸萬古黴素成功研發後,分別遞交美國和加拿大的仿製藥註冊申請。並於2019年6月獲得美國食品藥品監督管理局簽發的批准通知,於近日收到了加拿大衞生部簽發的上市許可。
公司近日取得加拿大的上市許可,標誌着普利製藥具備了在加拿大銷售注射用鹽酸萬古黴素的資格,將對公司拓展市場帶來積極的影響。
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