金陵藥業(000919.SZ):分公司收到琥珀酸亞鐵片一致評價受理通知書
格隆匯 3 月 22日丨金陵藥業(000919.SZ)公佈,公司於近日收到分公司金陵藥業股份有限公司南京金陵製藥廠(“金陵製藥廠”)的通知,金陵製藥廠收到國家藥品監督管理局下發的琥珀酸亞鐵片一致性評價受理通知書(CYHB2150172國)。
琥珀酸亞鐵片(速力菲),有多年的臨牀歷史,並得到臨牀醫生、專家廣泛認可。是用於預防及治療缺鐵性貧血常用且安全有效的藥物。金陵製藥廠2002年首次取得該品種《藥品註冊批件》,劑型為片劑,批准文號為:國藥準字H10930005(0.1g),並於2020年5月完成了再註冊,有效期至2025年5月。
琥珀酸亞鐵片(速力菲)被國家藥品監督管理局受理,標誌着該品種一致性評價工作進入了審評階段,公司將積極推進後續相關工作,如順利通過一致性評價將增加其市場競爭力,對公司的經營業績產生積極的影響。
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