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北大醫藥(000788.SZ):注射用頭孢曲松鈉通過仿製藥質量和療效一致性評價
格隆匯 05-06 17:11

格隆匯 5 月 6日丨北大醫藥(000788.SZ)公佈,公司於近日獲得國家藥品監督管理局核准簽發的化學藥品“注射用頭孢曲松鈉”《藥品補充申請批准通知書》司注射用頭孢曲松鈉通過仿製藥質量和療效一致性評價。

該藥品為半合成的第三代頭孢菌素,對大多數革蘭陽性菌和陰性菌都有強大抗菌活性,抗菌譜包括綠膿桿菌、大腸桿菌、肺炎桿菌、流感嗜血桿菌、產氣腸細菌、變形桿菌屬、雙球菌屬及金葡菌等。該藥品對β內酰胺酶穩定。自上市以來,全球超過兩億病人使用,充分證明頭孢曲松是安全可靠的抗菌藥物,並由此長年來保持暢銷藥地位。臨牀主要用於敏感菌感染的腦膜炎、肺炎、皮膚軟組織感染、腹膜炎、泌尿系統感染、淋病、肝膽感染、外科創傷,敗血症及生殖器感染等。已作為治療淋病的第一線藥物。

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