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李氏大藥廠(00950.HK)附屬嬰兒(酉每)缺乏症藥物獲註冊證書並完成首次發貨
阿思達克 05-21 12:04
李氏大藥廠(00950.HK)公布,公司全資附屬兆科廣州開發並生產的苯丁酸鈉顆粒(規格:150g/瓶,每1g含苯丁酸鈉0.94g)獲中國國家藥監局的藥品註冊證書,並已於本公布日期完成首次發貨。

苯丁酸鈉作為輔助治療藥物,用於氨基甲(酉先)磷酸合成(酉每)缺乏症、鳥氨酸氨甲(酉先)基轉移(酉每)缺乏症或精氨基琥珀酸合成(酉每)缺乏症引起的尿素循環異常患者的長期治療,適用於所有新生兒期(出生28天內)出現完全(酉每)缺乏症的患者,也適用於有高血氨性腦病病史的遲發型(部分(酉每)缺乏症,發生於出生1個月後)患者。兆科廣州開發並生產的苯丁酸鈉顆粒為國內首仿藥物,因用於治療罕見病且為兒童用藥品,被國家藥監局藥品審評中心納入優先審評審批品種名單。

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