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健康元(600380.SH):鹽酸左沙丁胺醇霧化吸入溶液新增規格獲批
格隆匯 04-18 17:58

格隆匯4月18日丨健康元(600380.SH)公佈,近日,公司收到國家藥監局核准簽發的關於鹽酸左沙丁胺醇霧化吸入溶液(3ml:1.25mg)的《藥品補充申請批准通知書》。經審查,該藥品此次申請事項符合藥品註冊的有關要求,同意該藥品增加3ml:1.25mg規格。

該產品活性成分鹽酸左沙丁胺醇為短效β2受體激動劑,其能產生舒張支氣管平滑肌的作用,主要用於治療或預防成人及6歲以上兒童可逆性氣道阻塞性疾病引起的支氣管痙攣。

產品是在公司已獲批的鹽酸左沙丁胺醇霧化吸入溶液(規格:3ml:0.63mg、3ml:0.31mg,批准文號:國藥準字H20193279、H20205016)基礎上,申請新增規格3ml:1.25mg。首次提交該藥品註冊申請的受理時間為2021年8月25日(受理號:CYHB2101735)。

截至該公吿日,鹽酸左沙丁胺醇霧化吸入溶液累計投入的研發費用約為人民幣3950.16萬元。

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