華森製藥(002907.SZ):鹽酸特拉唑嗪膠囊通過一致性評價
格隆匯3月21日丨華森製藥(002907.SZ)公佈,公司於2022年3月18日收到國家藥監局核准簽發的關於“鹽酸特拉唑嗪膠囊(歐得曼)”的《藥品補充申請批准通知書》(通知書編號:2022B01082)。
經審查,該藥品通過仿製藥質量和療效一致性評價。同時同意該藥品變更處方工藝的質量標準。質量標準、説明書按所附執行,有效期為24個月。該藥品工藝驗證批量為60萬粒/批,今後的商業化生產如進行批量變更,需注意開展相應的研究及驗證。
鹽酸特拉唑嗪膠囊(歐得曼)用於治療良性前列腺增生症。鹽酸特拉唑嗪也可用於治療高血壓,可單獨使用或與其它抗高血壓藥物如利尿劑或β-腎上腺素能阻滯劑合用。鹽酸特拉唑嗪膠囊(歐得曼)是《良性前列腺增生中西醫結合診療指南(2017)》推薦用藥,被列入《國家基本藥物目錄》(2018年版)及《國家基本醫療保險、工傷保險和生育保險藥品目錄》(2004-2021年版)。
截止目前國內已經通過或視同通過一致性評價鹽酸特拉唑嗪膠囊企業有3家。
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