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天壇生物(600161.SH):下屬企業獲得藥品補充申請批準通知書
格隆匯 07-08 17:18

格隆匯7月8日丨天壇生物(600161.SH)公佈,公司下屬成都蓉生藥業有限責任公司(簡稱“成都蓉生”)於近日收到國家藥品監督管理局簽發的《藥品補充申請批準通知書》,成都蓉生研製的2.5g/瓶(10%,25ml)規格的“靜注人免疫球蛋白(pH4)”符合藥品註冊的相關要求。

適應症:1.治療原發性免疫球蛋白G缺乏症,如X聯鎖低免疫球蛋白G血癥,常見變異性免疫缺陷病,免疫球蛋白G亞類缺陷病等。2.治療繼發性免疫球蛋白G缺陷病,如重症感染,新生兒敗血癥等。3.治療自身免疫性疾病,如原發免疫性血小板減少症,川崎病等。

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