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華北製藥(600812.SH):阿莫西林膠囊及鹽酸二甲雙胍片通過仿製藥一致性評價
格隆匯 01-15 17:29

格隆匯1月15日丨華北製藥(600812.SH)公佈,近日,公司收到國家藥品監督管理局核准簽發的阿莫西林膠囊(0.5g、0.25g)和鹽酸二甲雙胍片(0.5g)的《藥品補充申請批件》,上述藥品通過仿製藥質量和療效一致性評價。

阿莫西林屬於青黴素類廣譜β-內酰胺類抗生素,對大多數致病的革蘭氏陽性菌及革蘭氏陰性菌均有強大的抑菌和殺菌作用,臨牀廣泛用於治療敏感菌所致上呼吸道感染、泌尿生殖道感染、皮膚軟組織感染、下呼吸道感染以及與其他藥物聯用根除幽門螺桿菌,且輕中度腎病患者無需調整劑量。開展一致性評價工作以來,該藥品兩個規格累計研發投入1038.76萬元人民幣(未經審計)。

鹽酸二甲雙胍片首選用於單純飲食控制及體育鍛煉控制血糖無效的2型糖尿病。對於成人,可用於單藥治療,也可以與磺脲類藥物或胰島素聯合治療。對於10歲及以上的兒童和青少年,可用於單藥治療或與胰島素聯合治療。本品由Merck研發,1957年在法國上市,商品名為Glucophage;1995年03月03日獲美國FDA批准在美國上市。開展一致性評價工作以來,該藥品研發投入約828萬元人民幣(未經審計)。

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