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莎普愛思(603168.SH)獲得左氧氟沙星片《藥品註冊證書》
格隆匯 11-06 16:38

格隆匯 11 月 6日丨莎普愛思(603168.SH)公佈,近日,公司收到國家藥品監督管理局核發的左氧氟沙星片的《藥品註冊證書》。

藥品名稱:左氧氟沙星片;劑型:片劑;註冊分類:化學藥品4類;規格:0.5g(按C18H20FN3O4計);申請事項:藥品註冊(境內生產);藥品批准文號:國藥準字H20203540;審批結論:根據《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,批准註冊,發給藥品註冊證書。生產工藝、註冊標準、説明書與標籤照所附執行。

左氧氟沙星片適用於敏感細菌所引起的呼吸系統感染、泌尿系統感染、生殖系統感染、皮膚軟組織感染、腸道感染等多種細菌感染。截至目前,公司左氧氟沙星片項目累計研發投入約為 490.23萬元人民幣。

公司此次獲得左氧氟沙星片的《藥品註冊證書》,將進一步豐富公司產品的品類,有利於優化公司產品佈局,但不會對公司當期經營業績產生重大影響。

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