廣濟藥業(000952.SZ):收到化學藥品替硝唑片的藥品補充申請批准通知書
格隆匯 1 月 7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(“國家藥監局”)核准簽發的化學藥品“替硝唑片”的《藥品補充申請批准通知書》,該藥品通過仿製藥質量和療效一致性評價。
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吿》(2017年第100號)的規定,經審查,本品通過仿製藥質量和療效一致性評價,同意本品的處方工藝、質量標準及包裝規格的變更。質量標準、説明書按所附執行。有效期為24個月。注:基於申報的生產線與生產設備,本品的工藝驗證批量為15萬片/批。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。
替硝唑片由公司開發,劑型:片劑。用於預防由厭氧菌引起的術後感染,如結腸、胃腸道和泌尿生殖系統手術後感染;用於治療滴蟲病、賈第鞭毛蟲病、阿米巴病、細菌性陰道炎、與抗生素和抗酸藥聯合應用用於根治幽門螺旋桿菌相關的十二指腸潰瘍、厭氧菌感染。
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