國際藥品

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有關Pro Doc Ltd.;Sivem Pharmaceuticals ULC;Mint Pharmaceuticals;Sun Pharma Canada Inc.;Pharmascience Inc. Inc.;Auro Pharma Inc.;Teva Canada Ltd.;Sandoz Canada Inc.;Sanis H公司主動回收藥品「(1) Irbesartan;(2)losartan;(3) valsartan drugs」(批號:詳如內文),國內並未輸入該等回收批號產品。 2021/06/01

事件過程:

  Health Canada1100530日發布藥品回收訊息,說明Pro Doc Ltd.Sivem Pharmaceuticals ULCMint PharmaceuticalsSun Pharma Canada Inc.;Pharmascience Inc. Inc. ;Auro Pharma Inc.Teva Canada Ltd. Sandoz Canada Inc.Sanis H主動回收藥品「(1) Irbesartan (2)losartan (3) valsartan drugs」,回收原因係產品含有azido不純物,故啟動回收作業。經查,案內警訊產品並未輸入國內,請民眾放心。

  經查,衛生福利部核准「羅莎答膜衣錠50毫克Losartan Tevapharm Film Coated Tablets 50mg (衛部藥輸字第026391)」藥品,申請廠商為香港商艾維斯有限公司台灣分公司,製造廠為TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY,主成分為LOSARTAN POTASSIUM。核准適應症為「高血壓、治療第II型糖尿病腎病變」。該藥品為處方藥,須經醫師診斷並開立處方後,方能使用。

  為確保藥物安全與醫療效能,衛生福利部已建置藥物安全監測,即時監視國內、外藥物安全訊息,除設有藥物不良反應通報系統及藥物不良品通報中心之外,並對於藥物之安全性與療效亦隨時進行再評估,如醫療人員或病患疑似因使用(服用)藥品導致不良反應之發生,請立即通報衛生福利部所建置之全國藥物不良反應通報中心,藥物不良反應通報專線02-2396-0100,網站:https://adr.fda.gov.tw。如發現藥物不良品時,請立即通報衛生福利部所建置之全國藥物不良品通報中心,藥物不良品通報專線02-6625-1166分機6401,網站: https://qms.fda.gov.tw

  案內警訊相關藥品批號如下:

一、             Irbesartan

(一)  IRBESARTAN 150 mg TABLETS:617491618112624632624633630546

(二)  IRBESARTAN 300 mg TABLETS:615929617091617264620694624189624190624191624192

(三)  IRBESARTAN 75 mg TABLETS:616518619960622192622193

(四)  IRBESARTAN HCT/TABLET/150/12.5 mg:JV2163JY7867KT2519KT2520JP2979JP2980JU8206JU8207

(五)  IRBESARTAN HCT/TABLET/300/25 mg:JX8881JX8882JB0216

(六)  IRBESARTAN/TABLET/150 mg:KC7215

(七)  IRBESARTAN/TABLET/300 mg:KF8325

(八)  IRBESARTAN-HCTZ 150/12.5 mg TABLETS:JN4976JU3231JY1913HW0586HW0587JR7823JR7824JU7506

(九)  IRBESARTAN-HCTZ 300/25 mg TABLETS:JS0731

(十)  MINT- IRBESARTAN /HCTZ 150/12.5 mg TABLETS:1805011398

(十一)          MINT- IRBESARTAN /HCTZ 300/12.5 mg TABLETS:1805011402

(十二)          MINT- IRBESARTAN /HCTZ 300/25.0 mg TABLETS: 1805011576

(十三)          pms-IRBESARTAN 150 mg TABLETS:617492624634630661

(十四)          pms-IRBESARTAN 75 mg TABLETS:61746661746761746862027622195624738

(十五)          pms-IRBESARTAN-HCTZ 300/12.5 mg TABLETS:621822621823625318625902 629920631052632583624235

(十六)          RAN-IRBESARTAN Tablets 150 mg:AB47146AB47147AB47148AB57691AB57688AB57689AB588273990655

(十七)          RAN-IRBESARTAN Tablets 300 mg:AB47144AB47145AB58305AB58304AB58312AB58314AB58828AB57696AB70496AB70498AB7049939913583991360

(十八)          RAN-IRBESARTAN Tablets 75 mg:AB47143AB58473AB588293994101

(十九)          Sandoz IRBESARTAN 150 mg TABLETS:KC7216

(二十)          Sandoz IRBESARTAN 300 mg TABLETS: KF8326

(二十一)  Sandoz IRBESARTAN HCT 150/12.5 mg TABLETS:JF5840JN4197JN4971JU3217JV2167JF8892JN4191JA4033HY7383JA4034JE2529JK7459JK7460JM3516JM3517JR7821JU7500JU7501JU7502JU7503JY0147JE2529JM4631JZ2686

(二十二)  Sandoz IRBESARTAN HCT 300/25 mg TABLETS:JB0221JB0222JC4402JC4404JH2487JR7112JR7833JU3181JW9512JW9513KC1750JE1833JR8726

二、Losartan

(一)  AURO-LOSARTAN 100 mg TABLETS:WB1019001-AWB1019001-B

(二)  AURO-LOSARTAN 25 mg TABLETS:WB2519001-A      

(三)  AURO-LOSARTAN 50 mg TABLETS:WB5019001-AWB5019001-B   

(四)  LOSARTAN /TABLET/100 mg:2151119

(五)  LOSARTAN /TABLET/25 mg:00806200090620

(六)  LOSARTAN/TABLET/100 mg:21010182020219203021920402192090619210091921109192120919213091920504202060420207081720402182140919

(七)  LOSARTAN/TABLET/25 mg:0050919006091900709190080919 0080919A01010190101019A00301200040120

(八)  LOSARTAN/TABLET/50 mg:112101811310181130819114081911508191160819118091910702201080220109022011002201110220106022011709191120620

(九)  TEVA-LOSARTAN 100 mg TABLETS: 20102192010420202021920204202030420  20402192060419208061920809182091018210101821611192171119001021900204190030419003101800401200040919005062000509190060620007062000101200020120

(十)  TEVA-LOSARTAN 50 mg TABLETS: 104012010301201040419105041910604191070419108091810908191090918110081911010181110819111101811210181130819118091910101201030218108041911208191141018 

(十一)          TEVA-LOSARTAN 25 mg TABLETS: 001021900204190030419003101800401200040919005062000509190060620007062000101200020120

三、Valsartan

(一)  Sandoz Valsartan 160 mg TABLETS:KT9598

(二)  Sandoz Valsartan 320 mg TABLETS:KT8923

(三)  Sandoz Valsartan 320 mg TABLETS:KV6185

(四)  Sandoz Valsartan 80 mg TABLETS:KT7180

(五)  Sandoz Valsartan 80 mg TABLETS:KT9515    
(六)VALSARTAN 160 mg TABLETS:KT9597



處置建議:
為維護消費者健康與權益,衛生福利部呼籲 : 我國並未輸入案內疑慮批號,消費者勿自行由國外、網路或其他通路商購買該藥品使用。