方盛製藥(603998.SH):小兒荊杏止咳顆粒獲得藥物臨牀試驗補充申請批准通知書
格隆匯3月25日丨方盛製藥(603998.SH)公佈,公司近日收到國家藥品監督管理局核准簽發的小兒荊杏止咳顆粒的《藥物臨牀試驗補充申請批准通知書》。
國家藥品監管部門審批的補充申請事項:變更適用人羣範圍。
小兒荊杏止咳顆粒為公司自主研發的中藥創新藥,於2019年批准上市。該藥品處方源於小兒外感咳嗽的臨牀經驗方,現行説明書【功能主治】為“疏風散寒,宣肺清熱,祛痰止咳。用於小兒外感風寒化熱的輕度急性支氣管炎引起的咳嗽,咯痰、痰黃,咽部紅腫等症”,用於3-14歲兒童人羣。
前次申請未提交該藥品既往用於成人急性氣管-支氣管炎的人用經驗數據,現擬開展用於成人急性氣管-支氣管炎(風寒化熱證)的探索性臨牀試驗,需進一步明確擬納入人羣,尤其需與急性上呼吸道感染人羣進行鑑別,以確保受試人羣的準確性。
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