國際藥品

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有關HMS Wholesale Limited未能保證運輸之藥品儲存條件一案,國內並未輸入該等警示批號產品。 2020/03/20

事件過程:

  MHRA1090319發布藥品警訊,說明HMS Wholesale Limited運輸之藥品曾遭盜竊,隨後於1085月至8月間重新導入供應鏈中,惟案內藥品曾離開物流運輸供應鏈,無法確保藥品運輸和儲存條件符合規定,受影響藥品37項,分別為(1) Plegridy 125 micrograms solution for injection in pre-filled pen(2) Avonex 30 micrograms/0.5ml solution for injection in pre-filled pen(3) Eliquis 2.5 mg film-coated tablets(4) Eliquis 5 mg film-coated tablets(5) Privigen 20g/200ml solution for infusion vials(6) Ambisome 50mg Powder for solution for infusion(7) Celsentri 300 mg film-coated tablets(8) Stelara 130mg Concentrate for solution for infusion(9) Stelara 90mg solution for injection prefilled Syringe(10) Stelara 45mg/0.5ml solution for injection in pre-filled syringe(11) Lemtrada 12mg concentrate for solution for infusion(12) Mimpara 90mg, 28 film-coated tablets(13) Mimpara 60mg, 28 film-coated tablets(14) Humira 40 Mg Solution for Injection Pre-filled Syringe(15) Ferinject 50mg iron/mL solution for injection/infusion(16) Tysabri 300mg Concentrate for solution for infusion(17) Roactemra 20 mg/mL concentrate for solution for infusion(18) Avodart 0.5mg soft capsules(19) Betmiga 25mg Tablets(20) Budenofalk 3mg gastro-resistant capsules(21) Duaklir Genuair 340 micrograms /12 micrograms inhalation powder(22) Entresto® 24 mg/26 mg film-coated tablets(23) Entresto® 49 mg/51 mg film-coated tablets(24) Entresto® 97 mg/103 mg film-coated tablets(25) Octasa 800 mg Modified Release Tablets(26) Prograf 1 mg hard capsules(27) Spiolto Respimat 2.5 microgram/2.5 microgram, inhalation solution(28) Symbicort® Turbohaler® 200 micrograms/6 micrograms/inhalation, inhalation powder(29)Symbicort® Turbohaler® 400 micrograms/12 micrograms/inhalation, inhalation powder(30) Tresiba 100 u/ml sol for injection flextouch 3ml(31) Ultibro breezehaler 0.085/0.043mg(32) Xarelto tablets 10mg(33) Xarelto tablets 15mg<14>(34) Xarelto tablets 15mg <28>(35) Xarelto tablets 15mg <42>(36) Xarelto tablets 20mg <28>(37) Zomig Nasal Spray 5mg 2x3 (批號:(1)14241571423890(2) 14239931424275(3) ABA8983ABA8984ABA9471ABA4740ABA9473ABA5177(4) ABA8800ABA9710ABB0771ABA8136ABA3176ABB1037ABA7810ABB0358ABA9709ABB0768ABB1020ABB0769ABB2389ABB2387ABB3282ABB3193ABB3194ABB3278ABB3285ABB4034(5) 428560001043856000124285600014(6) GAD140DGAD137D(7) AG7174(8) IIS1I00(9) IJS4IMCIJS4KMA(10) IIS0XMQ(11) 8HV1780(12) 11020391095112(13) 1095112109093810938131088757(14) 93453XH06(15) 7291112AVA(16) 1424525(17) B3016H11B3026H02(18) BF5A4T2J7H7P9M4M(19) 17L01/2617L02/2617L03/3817L04/2618C03/2618C04/2618F04/2718J01/2617G01/2817G02/2717G21/2617J12/2617L07/2617L14/2617L15/2617L16/2618A05/2618A07/2618C09/2618C10/2618C21/2718F12/2618F13/2618F24/2618G07/2618G08/2618H06/2718H12/2617G08/26(20) 18D11946L18D11947L(21) 312N504N(22) TL215TM727TN204TP169TP762TU784TR812(23) TL179TP273TP745TR729TP687TT981TU274TR253TT409(24) TP637TW186TR305TR852TU050TU051TR304TU701(25) 81833814158194181944817298183883207832098183481840832088194381624912123(26) 1E3426C1E3426C1E3426C(27) 807918807918A808101804929806467807599A806847807999805271801796806212(28) SHKXSKCTSKCZSKDASKDDSKECSKEDSKEKSKFVSKGESKGUSHWWSHXA(29) PFUTPFWKPFWRPFPXPFPWPFREPFPFPFTUPFPKPFRZ(30) JZFB148HZF9822HZF8977HZF9367HZF9821(31) BFR65(32) ITA37ZCITA3ERVITA3CK3(33) BXJ0EK1(34) BXJ49C1BXJ49C2BXJ49C3BXJ49D1BXJ2753BXJ49C1BXJ2752BXJ2551BXHV612(35) BXJ2761(36) BXJ06F1BXJ4BE1BXJ4BE2BXJ4BE3BXJ4BF2BXJ4BF3BXJ4BF4BXJ4BF5BXJ6G61BXJ6G62BXJ6G63BXJ6G64BXJ6V62BXHTAK2BXHZB44BXJ0UD1BXJ2PH2BXJ1E51BXJ0UD2BXJ39T2BXJ1E52BXJ0UD4BXJ1E53BXJ1E54BXJ0UD3(37) PB896PG657PG659PJ254PC366)

  經查,我國核有相關藥品許可證共26張,經確認案內批號藥品均未輸入我國。另,本署核定專案進口共10件,申請商已確認該等批號藥品未輸入我國。綜上,經評估該則警訊暫不影響我國,請民眾放心。

  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



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。