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海思科(002653.SZ):獲得精氨酸穀氨酸注射液的受理通知書
格隆匯 04-06 15:22

格隆匯 4 月 6日丨海思科(002653.SZ)公佈,公司全資子公遼寧海思科製藥有限公司於近日收到國家藥品監督管理局下發的受理通知書根據《中華人民共和國行政許可法》第三十二條的規定,經審查,決定予以受理。

藥品名稱:精氨酸穀氨酸注射液;規格:200ml:20g;申請事項:仿製藥一致性評價;註冊分類:化學藥品3.1類;適應症:高氨血癥。

精氨酸穀氨酸鹽注射液是一種有效的降低血氨的藥物。精氨酸谷氨酸鹽注射液在體內離解為精氨酸和穀氨酸。精氨酸是合成鳥氨酸的前體,通過促進鳥氨酸循環,加速肝對血氨的降解,使血氨生成尿素,通過尿液排出體外,從而維持體內氮平衡,逆轉大腦障礙,治療肝昏迷。精氨酸作為注射液輸入體內,可增加肝臟的精氨酸酶活性,促使血氨轉化為尿素排出。谷氨酸能與血中過多的氨結合而成為無害的谷氨酰胺,由尿排出,可防止肝昏迷。

精氨酸穀氨酸鹽注射液在國內無廠家生產,也無進口。公司開精氨酸穀氨酸鹽注射液,開創國內高血氨治療的新藥物本品為射液臨牀直接輸注,無需配製,應用方便。本品療效顯著,無重大安全性隱患,安全性好為臨牀醫生和患者增加新的有效的選擇,緩解患者病痛,減輕患者的用藥負擔

產品20155月取得國家藥品監督管理局藥品註冊批件(件號:2015S00385藥品批准文號:國藥準字H20150032)。

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