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華森製藥(002907.SZ):獲得富馬酸伏諾拉生片藥品補充申請批准通知書
格隆匯 12-10 18:03

格隆匯12月10日丨華森製藥(002907.SZ)公佈,公司近日收到國家藥品監督管理局(以下簡稱"國家藥監局")核准簽發的關於公司產品富馬酸伏諾拉生片(10mg和20mg)(以下簡稱"該藥品")的《藥品補充申請批准通知書》(證書編號分別為:2024B05799、2024B05800),將變更富馬酸伏諾拉生片(10mg和20mg)藥品説明書中適應症和用法用量的內容。

適應症項由"反流性食管炎"修訂為"反流性食管炎。與適當的抗生素聯用以根除幽門螺桿菌。";用法用量項修訂為:"口服。反流性食管炎成人每日1次,每次20mg。大部分患者通常4周可獲益,如果療效不佳,療程最多可延長至8周。用於反覆發作的反流性食管炎患者的維持治療時,每次10mg,每日一次;如果療效不佳,可增加至每次20mg,每日一次。與適當的抗生素聯用以根除幽門螺桿菌伏諾拉生20mg,每日兩次,通常與阿莫西林1g、克拉黴素0.5g和枸櫞酸鉍鉀0.6g(相當於鉍0.22g)每日兩次聯合服用14天。

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