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長春高新(000661.SZ):子公司注射用醋酸西曲瑞克獲批
格隆匯 12-08 16:33

格隆匯12月8日丨長春高新(000661.SZ)公佈,近日,公司控股子公司長春金賽藥業有限責任公司(簡稱“金賽藥業”)收到國家藥監局核准簽發的《藥品註冊證書》。

經審查,注射用醋酸西曲瑞克(規格:0.25mg,以西曲瑞克計)符合藥品註冊的有關要求,批准註冊,發給藥品註冊證書。該批件系國家藥監局批准金賽藥業注射用醋酸西曲瑞克(規格:0.25mg,以西曲瑞克計)註冊上市。該產品適應症為:輔助生育技術中,對控制性卵巢刺激的患者,該藥品可防止提前排卵。

藥品符合金賽藥業在婦科生殖領域的發展戰略,上市後可進一步豐富公司婦科生殖領域的產品線。產品獲批後,公司將嚴格按照相關國家法律、法規和規章等及時組織開展藥品生產質量管理規範檢查,並積極開展該產品的生產及市場推廣工作。

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