仙琚製藥(002332.SZ):鹽酸羅哌卡因注射液一致性評價申請獲受理
格隆匯6月30日丨仙琚製藥(002332.SZ)宣佈,公司於近日收到國家藥品監督管理局下發的鹽酸羅哌卡因注射液一致性評價受理通知書。該藥物在臨牀上適用於外科手術麻醉和急性疼痛控制。
鹽酸羅哌卡因注射液是第一個純左旋體長效酰胺類局麻藥,有麻醉和鎮痛雙重效應,大劑量可產生外科麻醉,小劑量時則產生感覺阻滯(鎮痛)僅伴有侷限的非進行性運動阻滯。鹽酸羅哌卡因注射液通過阻斷鈉離子流入神經纖維細胞膜內對沿神經纖維的衝動傳導產生可逆性的阻滯。
公司鹽酸羅哌卡因注射液(規格10ml:20mg、10ml:75mg)首次於2016年7月12日獲得藥品註冊批件(批准文號分別為:國藥準字H20163207、國藥準字H20163208),目前產品執行標準為《中國藥典》2015年版二部。
公司表示,鹽酸羅哌卡因注射液被國家藥品監督管理局藥品審評中心受理,標誌着該品種一致性評價工作進入了審評階段,公司將積極推進後續相關工作,如順利通過一致性評價將增加其市場競爭力。
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