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華潤醫藥(03320.HK)兩款藥品分別獲得藥品補充申請批准通知書及藥品註冊證書並通過一致性評價
阿思達克 02-26 12:30
華潤醫藥(03320.HK)公布,集團旗下海南雙鶴)獲得國家藥監局頒發的注射用更昔洛韋《藥品補充申請批准通知書》(證書編號:2024B00699、2024B00700),並通過一致性評價;華潤賽科獲得國家藥監局頒發的左乙拉西坦緩釋片《藥品註冊證書》(證書編號:2024S00242、2024S00243)。 注射用更昔洛韋是核(甘)類抗病毒藥,臨床用於治療危及生命或視覺的免疫缺陷患者的巨細胞病毒感染以及預防器官移植病人的巨細胞病毒感染,商品名為「Cymevene」。根據國家藥監局信息顯示,中國境內已批准上市的注射用更昔洛韋共有87間企業,其中通過一致性評價的生產企業為8間。 左乙拉西坦緩釋片適用於12歲及以上的癲癇患者部分性發作的加用治療。中國大陸境內已批准上市的左乙拉西坦緩釋片生產廠家有5間。
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