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特一藥業(002728.SZ):藥品鹽酸多西環素片通過一致性評價
格隆匯 02-27 15:41

格隆匯2月27日丨特一藥業(002728.SZ)公佈,公司於近日獲得國家藥品監督管理局覈準簽發的“鹽酸多西環素片”的《藥品補充申請批準通知書》,經審查,上述藥品通過化學仿製藥質量和療效一致性評價。

本次通過一致性評價的鹽酸多西環素片共有2個規格,分別爲0.05g、0.1g(其中0.05g規格爲首家通過一致性評價,0.1g規格爲第二家通過一致性評價)。鹽酸多西環素片主要用於敏感的革蘭陽性球菌和革蘭陰性桿菌所致的上呼吸道感染、扁桃體炎、膽道感染、淋巴結炎、蜂窩織炎、老年慢性支氣管炎等,也用於斑疹傷寒、恙蟲病、支原體肺炎等。尚可用於治療霍亂,也可用於預防惡性瘧疾和鉤端螺旋體感染。

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