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康芝藥業(300086.SZ):布洛芬顆粒通過仿製藥一致性評價
格隆匯 04-08 19:22

格隆匯4月8日丨康芝藥業(300086.SZ)公佈,公司全資子公司河北康芝製藥有限公司(“河北康芝”)近日收到國家藥品監督管理局下發的布洛芬顆粒《藥品補充申請批件》,河北康芝布洛芬顆粒通過仿製藥質量和療效一致性評價(“仿製藥一致性評價”)。

布洛芬顆粒作為常用的解熱鎮痛藥品,已列入《國家基本醫療保險、工傷保險和生育保險藥品目錄》(2019年版),是醫保甲類藥品。河北康芝的布洛芬顆粒由於其方便的劑型與良好的口感,主要適用於兒童普通感冒或流行性感冒引起的發熱,也可用於成人。同時也可緩解兒童和成人輕至中度疼痛如頭痛、關節痛、偏頭痛、牙痛、肌肉痛、神經痛、痛經。

截至公告披露日,通過國家藥品監督管理局一致性評價的布洛芬顆粒(0.2g)廠家有河北康芝、石藥集團歐意藥業有限公司及浙江康恩貝製藥股份有限公司三家企業。

根據國家相關政策規定,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,河北康芝的布洛芬顆粒(0.2g)通過仿製藥一致性評價後,本品市場競爭力將進一步增強,有利於擴大該藥品的市場份額,提升市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。

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