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恩華藥業(002262.SZ):咪達唑侖注射液首家通過一致性評價
格隆匯 12-17 15:38

格隆匯 12 月 17日丨恩華藥業(002262.SZ)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於“咪達唑侖注射液”的《藥品補充申請批准通知書》,批准該藥品首家通過仿製藥質量和療效一致性評價(“一致性評價”)。

咪達唑侖注射液適應症:1、肌內或靜脈注射用於術前鎮靜/抗焦慮/記憶缺失。2、靜脈注射用於診斷、治療、內窺鏡手術(如支氣管鏡檢查、胃鏡檢查、膀胱鏡檢查、冠狀動脈造影、心臟導管插入術、腫瘤手術、放射過程、縫合撕裂傷和其它單獨用藥或與其他中樞神經系統抑制劑聯合用藥的過程)之前或操作過程中的鎮靜/抗焦慮/記憶缺失。3、靜脈注射用於其他麻醉劑給藥之前的全麻誘導。在使用麻醉性前驅用藥的情況下,能在相對狹窄的劑量範圍和短時間內實現麻醉誘導。靜脈注射咪達唑侖也可作為氧化亞氮和氧的靜脈補充(複合麻醉)。4、持續靜脈滴注咪達唑侖作為麻醉劑用於氣管插管及機械通氣患者的鎮靜,或是用於病危護理治療中的鎮靜。

截至目前,公司的咪達唑侖注射液為國內首家通過一致性評價的產品,公司在一致性評價項目上已投入研發費用約361萬元人民幣。

根據國家相關政策規定,對於通過仿製藥一致性評價的藥品品種,在醫保支付方面予以適當支持,醫療機構應優先採購併在臨牀中優先選用。同品種藥品通過仿製藥一致性評價的生產企業達到3家以上的,在藥品集中採購等方面不再選用未通過仿製藥一致性評價的品種。因此公司咪達唑侖注射液通過一致性評價,有利於提高市場競爭力,對公司未來的經營業績產生積極的影響。

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