華潤雙鶴(600062.SH):甲硝唑片通過仿製藥質量和療效一致性評價
格隆匯5月11日丨華潤雙鶴(600062.SH)公佈,近日,公司全資子公司華潤雙鶴利民藥業(濟南)有限公司(“雙鶴利民”)收到了國家藥品監督管理局(“國家藥監局”)頒發的甲硝唑片《藥品補充申請批准通知書》(通知書編號:2022B01849)。
甲硝唑為硝基咪唑衍生物,用於治療和預防鑑定為或懷疑是由厭氧菌導致的感染。本品對多種病原微生物有抑制活性,特別是擬桿菌屬、梭桿菌門、梭菌屬、真細菌類、消化球菌屬、消化鏈球菌屬、厭氧球菌和陰道加德納氏菌,也對滴蟲、溶組織內阿米巴、賈第鞭毛蟲、結腸小袋纖毛蟲和麥地那龍線蟲等有治療作用。
此次該藥品通過一致性評價將進一步提升公司該藥品的質量,有利於未來的市場銷售和市場競爭,併為後續開展一致性評價積累了寶貴的經驗。
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