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恩華藥業(002262.SZ):利培酮分散片首家通過一致性評價
格隆匯 11-19 16:54

格隆匯11月19日丨恩華藥業(002262.SZ)宣佈,公司於近日收到國家藥監局核准簽發的化學藥品“利培酮分散片”的《藥品補充申請批件》,該藥品視同通過仿製藥質量和療效一致性評價。該藥品通用名稱為利培酮分散片,商品名稱泰維思;劑型片劑;規格1mg。

該藥品適應症為:

1、用於治療急性和慢性精神分裂症以及其它各種精神病性狀態的明顯的陽性症狀(如幻覺、幻想、思維紊亂、敵視、懷疑)和明顯的陰性症狀(如反應遲鈍、情緒淡漠及社交淡漠、少語)。也可減輕與精神分裂症有關的情感症狀(如抑鬱、負罪感、焦慮)。對於急性期治療有效的患者,在維持期治療中,該藥品可繼續發揮其臨牀療效。

2、可用於治療雙相情感障礙的躁狂發作,其表現為情緒高漲、誇大或易激惹、自我評價過高、睡眠要求減少、語速加快、思維奔逸、注意力分散或判斷力低下(包括紊亂或過激行為)。

截至目前,公司在利培酮分散片一致性評價項目上已投入研發費用約758萬元人民幣。

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