苑東生物(688513.SH):水合氯醛灌腸劑獲得藥品註冊證書
格隆匯5月21日丨苑東生物(688513.SH)公佈,全資子公司成都碩德藥業有限公司於近日收到國家藥品監督管理局覈準簽發的《藥品註冊證書》,水合氯醛灌腸劑主要成份爲水合氯醛,適應症:兒童檢查、操作前的鎮靜、催眠。監護條件下抗驚厥。
公司水合氯醛灌腸劑按化學藥品3類註冊申報,獲批後視同通過一致性評價。該藥品獲批,標誌着該產品符合藥品註冊的有關要求,進一步豐富了公司麻醉鎮痛領域產品管線,提升公司在麻醉鎮痛領域的核心競爭力,對公司經營發展具有一定的積極作用。
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