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以嶺藥業(002603.SZ):“蘇夏解鬱除煩膠囊”新藥註冊申請已獲正式受理
格隆匯 03-17 20:00

格隆匯 3 月 17日丨以嶺藥業(002603.SZ)公佈,近日,公司收到國家藥品監督管理局下發的《受理通知書》,由公司提交的“蘇夏解鬱除煩膠囊”新藥註冊申請已獲正式受理。

蘇夏解鬱除煩膠囊是公司自主研製的中藥新藥,其功能主治為:清熱除煩,解鬱化痰。適用於輕、中度抑鬱症屬氣鬱痰阻、鬱火內擾者,症見精神抑鬱、心煩不寧、焦慮不安、緊張恐懼、咽部不適、胸腹痞滿、易歎氣、失眠多夢、頭暈耳鳴、食慾不振、口苦咽乾、大便祕結等。

根據國家藥品註冊相關的法律法規要求,上述藥品在獲國家藥品監督管理局註冊申請受理後將轉入國家藥品監督管理局藥品審評中心接受技術審評、現場核查、抽樣檢驗等一系列環節,完成時間、審批結果均具有一定的不確定性,因此上述產品獲得註冊受理對公司近期業績不會產生影響。

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