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翰宇藥業(300199.SZ):醋酸阿託西班注射液6.75mg獲得德國藥品上市許可
格隆匯 05-06 11:54

格隆匯5月6日丨翰宇藥業(300199.SZ)公佈,公司的醋酸阿託西班注射液6.75mg近日收到了德國聯邦藥品和醫療器械研究所的上市許可。

醋酸阿託西班注射液適用於有下列情況的妊娠婦女,以推遲即將來臨的早產:1、每次至少30秒的規律子宮收縮,每30分鐘內≥4次;2、宮頸擴張1~3cm(初產婦0~3cm)和子宮軟化度/變薄≥50%;3、妊娠24至33足周;4、年齡≥18;5、胎心率正常。

阿託西班是子宮內及蜕膜、胎膜上受體的催產素競爭性拮抗劑。使用該藥品後可劑量相關性地抑制宮縮,並使催產素介導的前列腺素分泌減少,達到保胎的目的。醋酸阿託西班注射液的原研企業為Ferring Pharmaceuticals(輝凌製藥),2000年1月20日在歐洲獲批上市,商品名Tractocile(中文名:依保),目前已在歐洲、中國、俄羅斯等地上市銷售。

阿託西班作為目前歐洲藥物總署批准用於治療早產的唯一具有子宮特異性的宮縮抑制劑,優點是保胎效果好,對母體及胎兒安全性高,早於2007年歐洲早產指南就建議阿託西班用於抗早產一線用藥。

公司表示,此次公司醋酸阿託西班注射液6.75mg/0.9ml規格產品收到德國聯邦藥品和醫療器械研究所的上市許可,標誌着公司該規格產品具備了在德國上市的資格,對公司產品在德國市場的推廣具有積極影響。公司該藥品37.5mg/5ml規格產品的上市許可也已在德國國家階段的批件審核發放階段。

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