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總局關于修訂匹多莫德制劑說明書的公告(2018年第30號)

瀏覽次數: 日期:2018年3月14日 17:28
 
 
總局關于修訂匹多莫德制劑說明書的公告(2018年第30號)
 
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2018年03月09日 發布
 

  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匹多莫德制劑(包括匹多莫德片、匹多莫德散、匹多莫德分散片、匹多莫德口服溶液、匹多莫德口服液、匹多莫德膠囊、匹多莫德顆粒)說明書進行修訂。現將有關事項公告如下:

  一、所有匹多莫德制劑生產企業均應依據《藥品注冊管理辦法》等有關規定,按照匹多莫德制劑說明書模板(見附件),提出修訂說明書的補充申請,于2018年4月30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個月內對所有已出廠的藥品說明書及標簽予以更換。
  各匹多莫德制劑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匹多莫德制劑說明書的修訂內容,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、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:匹多莫德制劑說明書模板


食品藥品監管總局
2018年3月2日

2018年第30號公告附件.doc

 

 
 
 
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