江蘇吳中(600200.SH):美索巴莫注射液通過仿製藥一致性評價
格隆匯11月16日丨江蘇吳中(600200.SH)公佈,近日,公司全資子公司江蘇吳中醫藥集團有限公司下屬分支機構江蘇吳中醫藥集團有限公司蘇州製藥廠(“蘇州製藥廠”)收到了國家藥品監督管理局(“國家藥監局”)核准簽發的關於“美索巴莫注射液”的《藥品補充申請批准通知書》(通知書編號:2021B04074),該藥品通過仿製藥質量和療效一致性評價。
審批結論:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44號)、《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第100號)和《國家藥監局關於開展化學藥品注射劑仿製藥質量和療效一致性評價工作的公吿》(2020年第62號)的規定,經審查,本品通過仿製藥質量和療效一致性評價。同時同意以下變更:1、變更藥品處方及生產工藝;2、變更藥品質量標準;3、增加6 支/盒的包裝規格。
美索巴莫為一種新型中樞性肌肉鬆弛藥物,主要作用部位在脊髓前角運動神經元,機制為抑制脊髓的多突觸反射,臨牀上用於治療關節肌肉扭傷、腰肌勞損、坐骨神經痛等症,也可用於增生性脊柱炎、風濕性關節炎、類風濕性關節炎的治療,也可用於美容手術術後對疼痛的控制、嚴重的神經障礙和骨骼肌痙攣患者。也為促進骨骼肌疼痛患者恢復提供一種用藥選擇。
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