恩華藥業(002262.SZ):注射用鹽酸瑞芬太尼新增適應症獲批臨牀
格隆匯12月30日丨恩華藥業(002262.SZ)公佈,公司於近日收到國家藥監局核准簽發的有關注射用鹽酸瑞芬太尼的《藥物臨牀試驗批准通知書》。
注射用鹽酸瑞芬太尼用於全麻誘導和全麻中維持鎮痛,是國家管制類麻醉藥品。恩華藥業於2014年取得注射用鹽酸瑞芬太尼產品的生產批件,當年即生產上市,2021年6月該藥品通過仿製藥質量和療效一致性評價。
2021年10月,公司根據國內外同品種藥品説明書的適應症,申請增加註射用鹽酸瑞芬太尼麻醉監護室或重症監護室患者的術後早期鎮痛(在麻醉醫師的監護下)和作為鎮痛劑的組成成分用於調節成人患者的麻醉護理的適應症,並獲得受理。
根據該次獲得的《藥物臨牀試驗批准通知書》,國家藥監局同意本品按照化藥3類要求開展麻醉監護室或重症監護室患者的術後早期鎮痛(在麻醉醫師的監護下)和作為鎮痛劑的組成成分用於調節成人患者的麻醉護理的驗證性臨牀試驗。
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