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台灣:食藥署公布至2019年9月24日已完成檢驗得恢復供應、銷售之含ranitidine成分藥品清單 (Chinese only)
 
有關胃藥成分中ranitidine原料藥含有不純物「N-亞硝基二甲胺 (NDMA)」,衛生福利部食品藥物管理署(以下簡稱食藥署)已主動針對台灣ranitidine藥品中健保用量較大的製劑及原料藥優先抽樣,並要求業者啟動調查及針對市售效期內所有ranitidine成分原料藥及製劑進行檢驗。為保障民眾用藥安全,食藥署已要求業者應於2019年9月23日前完成含ranitidine成分藥品之預防性下架作業,經檢驗確認合格者,始得恢復供應、銷售。目前食藥署已確認市售效期內含ranitidine成分藥品2項,共12批,經檢驗合格,即日起得恢復供應、銷售。

食藥署將持續於本署網站公布得恢復供應、銷售含ranitidine成分藥品之清單,並持續與國際合作,以快速取得最新資訊,對於受影響的藥品,將即時公布資訊,以保障民眾用藥權益。

詳情請按以下連結: http://www.fda.gov.tw/../newsContent.aspx?cid=4&id=t549083

在香港,有67種註冊藥劑製品含有雷尼替丁。這些產品包括口服製劑和注射劑型,分別屬於非處方藥物和醫生處方藥物。至今,衞生署未接獲任何涉及雷尼替丁的藥物不良反應個案。

歐洲藥物監管局、美國食物及藥物管理局、加拿大衞生局、新加坡衞生科學局、澳洲藥物管理局和台灣衛生福利部食品藥物管理署早前已公布有關在雷尼替丁產品中檢測到N-亞硝基二甲胺(NDMA)的消息,而相關資訊已從2019年9月16日起刊登於藥物辦公室的網頁,最新的更新亦已於2019年9月25日刊登。衞生署已在2019年9月18日發信通知本地醫護專業人員。衞生署已聯絡有關海外藥物監管局以獲取在雷尼替丁產品中檢測到NDMA的進一步資料,並繼續對有關監管局公布的最新調查結果保持警惕。

有關台灣衛生福利部食品藥物管理署公布暫停銷售雷尼替丁產品,有6個品牌的產品在香港註冊,當中2個品牌已暫停銷售,另外2個品牌的產品現時並無在港銷售。至於新加坡衞生科學局公布回收8個雷尼替丁品牌,有5個品牌在香港註冊,當中1個品牌已暫停銷售,另外2個品牌的產品現時並無在港銷售。

於二零一九年九月二十四日,衞生署同意持牌藥物批發商葛蘭素史克有限公司採取預防措施,從市面回收所有善胃得(雷尼替丁)產品,因產品含有雜質NDMA。於二零一九年九月二十五日,衞生署同意另外2個持牌藥物批發商顯榮行有限公司和五豐藥業有限公司採取預防措施,分別從市面回收所有愛胃妥藥片和Zantidon 150毫克藥片產品,因產品可能含有雜質NDMA。善胃得和愛胃妥亦與台灣衛生福利部食品藥物管理署和新加坡衞生科學局的公告有關。

衞生署一直聯絡所有註冊雷尼替丁產品的註冊證書持有人以跟進這事件的本地影響,並要求所有註冊證書持有人提供產品內NDMA的含量低於可接受的水平的証據。衞生署會繼續對事件的發展和海外藥物監管局就此藥物發出的安全更新保持警惕,以考慮任何必要的行動。

正在服用含有雷尼替丁產品的病人不應自行停止服用藥物,他們應盡快向其醫護人員諮詢意見,以作適當安排,例如使用有類似用途的替代藥物。


2019年9月26日 (星期四)
香港時間16時正
 
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