廣濟藥業(000952.SZ):維生素B6片通過一致性評價
格隆匯3月9日丨廣濟藥業(000952.SZ)公佈,公司於近日收到國家藥品監督管理局核准簽發的化學藥品“維生素B6片”的《藥品補充申請批件》,該藥品通過仿製藥質量和療效一致性評價。
受理號:CYHB1850426;藥品名稱:維生素 B6片;劑型:片劑;註冊分類:化學藥品;規格:10mg;申請內容:一致性評價申請;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)和《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)的規定,經審查,本品視同通過仿製藥質量和療效一致性評價。同意變更本品的處方工藝。質量標準、説明書和標籤照所附執行,有效期為12個月。1、基於申報的生產線與生產設備,本品的生產批量為800萬片。今後的商業化生產如需放大批量,請注意開展相應的放大研究及驗證,必要時應針對生產規模放大提出補充申請。2、本品有效期為12個月,後續積累的穩定性研究數據支持延長本品有效期時,請按相關程序申請。
維生素B6片由公司開發,劑型:片劑。用於預防和治療維生素B6缺乏症,如脂溢性皮炎、脣乾裂。也可用於減輕妊娠嘔吐。
公司維生素B6片通過一致性評價,有利於提升該藥品市場競爭力,對公司的經營業績產生積極的影響,同時為公司後續其他產品開展仿製藥一致性評價工作積累經驗。
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