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康恩貝(600572.SH):萘敏維滴眼液獲得藥品補充申請批准通知書
格隆匯 08-07 16:10

格隆匯 8 月 7日丨康恩貝(600572.SH)公佈,近日,公司控股子公司江西珍視明藥業有限公司(“珍視明藥業公司”)收到國家藥品監督管理局核准簽發萘敏維滴眼液《藥補充申請批准通知書

萘敏維滴眼液屬感覺系統藥物眼科用藥,適用於緩解眼睛疲勞、結膜充血以及眼睛發癢等症狀,是珍視明藥業公司2004年自主研發的產品,於200711月獲得《藥品註冊批件》(批件號2007S00693),原規格為10ml:鹽酸萘甲唑啉0.2mg、馬來酸氯苯那敏2mg、維生素B121mg;組分為鹽酸萘甲唑啉、馬來酸氯苯那敏、維生素B12硼酸、硼砂、依地酸二鈉和苯扎氯銨;貯藏條件為密封保存。珍視明藥業公司於20183月遞交了萘敏維滴眼液的補充申請,申請事項為變更藥品規格、變更藥品處方中已有藥用要求的輔料、修改藥品註冊標準以及變更直接接觸藥品的包裝材料或者容器,並於近日獲得國家藥品監督管理局核准簽發的萘敏維滴眼液批准通知書,具體變更內容詳見批准通知書審批結論。

截至目前,珍視明藥業公司對0.4ml規格單劑量萘敏維滴眼液已投入研發費用人民幣約230萬元。

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