放一年療效剩8成未達標!杏輝6藥品下架.. - 股票
By Doris
at 2020-09-13T16:26
at 2020-09-13T16:26
Table of Contents
標題:放一年療效剩8成未達標!杏輝6藥品下架...「喜癒痔軟膏」也在內
1.原文連結:
https://reurl.cc/ygM2o8
2.原文內容:
記者嚴云岑/台北報導
國內知名的杏輝藥廠,因安定性測試不合格,遭食藥署勒令下架6款藥品,國人愛用的「
喜癒痔軟膏」也在內,所有產品須在10月27日前完成回收,若未依規定下架,可依《藥事
法》處20萬至500萬元罰鍰。
食藥署風險監測管理組簡任技正陳映樺表示,為了確保藥品品質,食藥署會針對出廠藥品
,每3、6、9、12個月各進行一次安定性測試,確保藥效不可低於原成分含量9成以上。
食藥署7月底啟動PICS/GMP查廠,針對藥廠效期剩不到一年的藥品進行安定性測試,杏輝
有6款藥品,藥效均剩下原成分含量8成左右,因此要求廠商在釐清原因前先行下架。
依據食藥署公告,回收藥品包括2款處方藥「杏輝布咳樂液0.8毫克/毫升」1批及「若蘭仙
施面皰凝膠10毫克/公克」29批;另有4款指示藥「杏輝欣吉視點眼液」11批、「杏輝咳定
舒糖漿」2批、「杏輝胃邁寧錠」11批、「杏輝喜癒痔軟膏」64批。
陳映樺提到,目前回收藥品中,國人使用量較大的兩項產品分別為「杏輝喜癒痔軟膏」以
及「若蘭仙施面皰凝膠10毫克/公克」,市面上約流通數十萬支,但具體回收量還是要看
產商提交的計畫書而定。雖然產品已陸續回收,但市面上都有同成份替代藥品,民眾不用
過於擔心。
3.心得/評論:
對欲站穩腳步,急欲想反彈的生技股來說,無疑是個滿重的打擊
星期一電梯向?
--
1.原文連結:
https://reurl.cc/ygM2o8
2.原文內容:
記者嚴云岑/台北報導
國內知名的杏輝藥廠,因安定性測試不合格,遭食藥署勒令下架6款藥品,國人愛用的「
喜癒痔軟膏」也在內,所有產品須在10月27日前完成回收,若未依規定下架,可依《藥事
法》處20萬至500萬元罰鍰。
食藥署風險監測管理組簡任技正陳映樺表示,為了確保藥品品質,食藥署會針對出廠藥品
,每3、6、9、12個月各進行一次安定性測試,確保藥效不可低於原成分含量9成以上。
食藥署7月底啟動PICS/GMP查廠,針對藥廠效期剩不到一年的藥品進行安定性測試,杏輝
有6款藥品,藥效均剩下原成分含量8成左右,因此要求廠商在釐清原因前先行下架。
依據食藥署公告,回收藥品包括2款處方藥「杏輝布咳樂液0.8毫克/毫升」1批及「若蘭仙
施面皰凝膠10毫克/公克」29批;另有4款指示藥「杏輝欣吉視點眼液」11批、「杏輝咳定
舒糖漿」2批、「杏輝胃邁寧錠」11批、「杏輝喜癒痔軟膏」64批。
陳映樺提到,目前回收藥品中,國人使用量較大的兩項產品分別為「杏輝喜癒痔軟膏」以
及「若蘭仙施面皰凝膠10毫克/公克」,市面上約流通數十萬支,但具體回收量還是要看
產商提交的計畫書而定。雖然產品已陸續回收,但市面上都有同成份替代藥品,民眾不用
過於擔心。
3.心得/評論:
對欲站穩腳步,急欲想反彈的生技股來說,無疑是個滿重的打擊
星期一電梯向?
--
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