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華邦健康(002004.SZ):吡嗪酰胺片通過仿製藥一致性評價
格隆匯 08-17 16:41

格隆匯 8 月 17日丨華邦健康(002004.SZ)公佈,公司全資子公司重慶華邦製藥有限公司(“華邦製藥”)於近日收到國家藥品監督管理局核准簽發的關於吡嗪酰胺片的《藥品補充申請批件》,該藥品通過國家仿製藥質量和療效一致性評價。

藥品名稱:吡嗪酰胺片;劑型:片劑;規格:0.25g;註冊分類:化學藥品;受理號:CYHB1850483;批件號:2020B04326;審批結論:經審查,本品通過仿製藥質量和療效一致性評價。

吡嗪酰胺片為抗結核藥物,可與其他抗結核藥(如鏈黴素、異煙肼、利福平及乙胺丁醇)聯合用於結核病治療。

吡嗪酰胺片為國家基本藥物、《國家基本醫療保險、工傷保險和生育保險目錄(2020版)》甲類藥品、世界衞生組織(WHO)推薦的一線抗結核藥、抗結核治療標準療法中的基礎藥物,根據2010年WHO結核病防治司出台的《結核病治療指南》第4版,新患者的標準治療方案是2HRZE/4HR(H:異煙肼;R:利福平;Z:吡嗪酰胺;E:乙胺丁醇)。

根據《國務院辦公廳關於開展仿製藥質量和療效一致性評價的意見》(國辦發〔2016〕8號)的規定,對於通過仿製藥一致性評價的藥品品種,在醫保支付方面予以適當支持,醫療機構應優先採購併在臨牀中優先選用,同品種藥品通過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一致性評價的品種。此次公司全資子公司華邦製藥的藥品吡嗪酰胺片通過一致性評價,將增加公司產品市場競爭機會,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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