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華北製藥(600812.SH)獲得布洛芬緩釋膠囊(0.3g)《藥品註冊批件》
格隆匯 12-26 23:21

格隆匯12月26日丨華北製藥(600812.SH)公佈,近日,公司收到國家藥品監督管理局(“國家藥監局”)核准簽發的布洛芬緩釋膠囊(0.3g)《藥品註冊批件》。

1968年,布洛芬口服制劑(商品名為Brufen)首次由英國布茨公司申請在英國上市,獲批之後在臨牀上廣泛用於輕至中度疼痛和發熱的治療,到目前為止已有50餘年安全使用的歷史。布洛芬為非甾體類抗炎鎮痛藥物,具有鎮痛、抗炎、解熱作用。其作用機制通過對環氧酶的抑制而減少前列腺素的合成,由此可減輕因前列腺素引起的組織充血、腫脹、降低周圍神經痛覺的敏感性。它通過下丘腦體温調節中心而起到解熱的作用。

適應症:用於緩解輕至中度疼痛,如頭痛、關節痛、偏頭痛、牙痛、肌肉痛、神經痛、痛經。也用於普通感冒或流行性感冒引起的發熱。

該藥品首次提交註冊申請獲得受理的時間:2017年11月23日。

截至目前,該藥品累計研發支出共計887.57萬元。

藥物後續進展:批准生產。

該品藥品註冊分類為化學藥品4類。根據國家藥監局《關於仿製藥質量和療效一致性評價工作有關事項的公告》(2017年第100號)文件相關規定,該品視為通過仿製藥質量和療效一致性評價。公司為該藥品第三家通過一致性評價的企業。

此次公司獲得布洛芬緩釋膠囊(0.3g)的《藥品註冊批件》,是對公司產品及產品規格的進一步補充,豐富了公司產品線。製劑產品銷售業務易受到國內醫藥行業政策變動、招標採購、市場環境變化等因素影響,存在不確定性,敬請廣大投資者理性投資,注意投資風險。

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