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常山藥業(300255.SZ):獲得肝素鈉注射液補充申請批准通知書
格隆匯 11-23 17:21

格隆匯 11 月 23日丨常山藥業(300255.SZ)公佈,公司近日收到國家藥品監督管理局核准簽發的藥品補充申請批准通知書藥品名稱為肝素鈉注射液。

依據《中華人民共和國藥品管理法》及有關規定,經審查,本品符合藥品註冊的有關要求,批准本品增加5ml50單位5ml500單位規格的補充申請,核發藥品批准文號。

肝素鈉注射液功能主治:用於防治血栓形成或栓塞性疾病(如心肌梗塞、血栓性靜脈炎、肺栓塞等);各種原因引起的瀰漫性血管內凝血(DIC);也用於血液透析、體外循環、導管術、微血管手術等操作中及某些血液標本或器械的抗凝處理。

2004年,公司肝素鈉注射液首次獲得國家藥監局頒發的《藥品註冊批件》。次公司獲得肝素鈉注射液補充申請批准通知書增加了公司產品規格,可以更好滿足臨牀不同用藥量需求,有利於該產品未來的銷售工作開展。

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