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甘李藥業(603087.SH):歐洲子公司門冬胰島素注射液上市許可申請獲得歐洲EMA正式受理
格隆匯 10-09 16:40

格隆匯10月9日丨甘李藥業(603087.SH)公佈,公司全資子公司甘李藥業歐洲有限責任公司(Gan & Lee Pharmaceuticals Europe GmbH,以下簡稱“甘李歐洲”)此前向歐洲藥品管理局(European Medicines Agency,以下簡稱“EMA”)遞交了門冬胰島素注射液生物類似藥的上市許可申請(MarketingAuthorisation Application,以下簡稱“MAA”),並於近日收到 EMA 的正式受理通知,進入審查階段。

門冬胰島素注射液是一種速效胰島素類似物,皮下注射後 10~20 分鐘內起效,最大作用時間為注射後 1~3 小時,作用持續時間為 3~5 小時,可以有效地控制餐後血糖。門冬胰島素一般緊鄰餐前注射,必要時可在餐後立即給藥。門冬胰島素具有起效快,作用持續時間較短,夜間低血糖風險較低的特點,並通常與長效胰島素聯合使用以實現患者的基礎與餐後血糖控制。

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