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總局關于修訂含可待因藥品說明書的公告(2016年第199號)

發布時間:2017-03-10 09:20:48 發布人:湖南楚濟堂

根據藥品不良反應評估結果,為進一步保障公眾用藥安全,國家食品藥品監督管理總局決定對含可待因藥品說明書【不良反應】、【禁忌】、【兒童用藥】、【孕婦及哺乳期婦女用藥】等項進行修訂。現將有關事項公告如下:

  一、所有含可待因藥品生產企業均應依據《藥品注冊管理辦法》等有關規定,按照含可待因藥品說明書修訂要求(見附件),提出修訂說明書的補充申請,于2017228日前報省級食品藥品監管部門備案。
  修訂內容涉及藥品標簽的,應當一并進行修訂;說明書及標簽其他內容應當與原批準內容一致。在補充申請備案后6個月內對已出廠的藥品說明書及標簽予以更換。
  各含可待因藥品生產企業應當對新增不良反應發生機制開展深入研究,采取有效措施做好使用和安全性問題的宣傳培訓,指導醫師合理用藥。

  二、臨床醫師應當仔細閱讀含可待因藥品說明書的修訂內容,在選擇用藥時,應當根據新修訂說明書進行充分的效益/風險分析。

  三、含可待因藥品為處方藥,患者應嚴格遵醫囑用藥,用藥前應當仔細閱讀說明書。

  特此公告。

  附件:含可待因藥品說明書修訂要求


食品藥品監管總局
2016年12月28

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