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太極集團(600129.SH):鹽酸嗎啡緩釋片(24h滲透泵型)獲得臨牀試驗通知書
格隆匯 04-01 18:13

格隆匯4月1日丨太極集團(600129.SH)公佈,公司控股子公司西南藥業股份有限公司(西南藥業)近日收到國家藥品監督管理局核准簽發的鹽酸嗎啡緩釋片(24h滲透泵型)的《臨牀試驗通知書》。

藥品名稱:鹽酸嗎啡緩釋片(24h滲透泵型);劑型:片劑;規格:60mg;註冊分類:化學藥品2.2類;審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2019年12月27日受理的鹽酸嗎啡緩釋片(24h滲透泵型)符合藥品註冊的有關要求,同意本品開展臨牀試驗。

鹽酸嗎啡緩釋片(24h滲透泵型)主要適用於其他鎮痛藥無效的,需要每天、連續不斷、長期阿片類鎮痛治療的疼痛。

西南藥業於2019年12月27日獲得鹽酸嗎啡緩釋片(24h滲透泵型)臨牀註冊申請受理,截至目前,已累計投入研發費用約637萬元人民幣(未經審計)。根據我國藥品註冊相關的法律法規要求,西南藥業在收到上述藥物臨牀試驗通知書後,將着手啟動藥物的臨牀研究相關工作,待完成臨牀研究後,將向國家藥品監督管理局遞交臨牀試驗數據及相關資料,申報生產上市。

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