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dennylvny銀蟲 (小有名氣)
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[求助]
米庫氯銨是否在美國(guó)退市了?
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| 近期聽說米庫氯銨在美國(guó)退市了,不知是真是假,想了解退市原因,請(qǐng)各位神通廣大的蟲友幫幫忙查一下米庫氯銨的退市原因,謝謝。 |
鐵桿木蟲 (小有名氣)
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http://www.fda.gov/Safety/SafetyofSpecificProducts/ucm180603.htm http://www.fda.gov/Safety/MedWat ... ation/ucm233345.htm http://www.fda.gov/ohrms/dockets/dockets/06p0445/06p0445.htm 這三個(gè)網(wǎng)頁可說明,這個(gè)藥在美國(guó)撤市主要原因是因?yàn)椴涣挤磻?yīng)。 Mivacron (mivacurium chloride) Injection7 *Severe anaphylactic reactions X X 嚴(yán)重過敏性反應(yīng) |
銀蟲 (小有名氣)
銀蟲 (小有名氣)
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第二個(gè)網(wǎng)頁內(nèi)容大致是 總結(jié)觀點(diǎn)包括藥物產(chǎn)品安全標(biāo)簽改變包裝盒上的警告,警告、預(yù)防、禁忌、不良反應(yīng)、病人或包裝說明書/用藥指導(dǎo)部分。這一快速viewa下表提供藥物名稱和部分修改。點(diǎn)擊藥物名稱去詳細(xì)的見解。詳細(xì)的觀點(diǎn)包括部分的內(nèi)容和范圍的修改,新的或修改描述安全信息在包裝盒上的警告、禁忌癥、或警告部分,和一個(gè)鏈接,鏈接到修訂的處方信息。 標(biāo)簽:關(guān)鍵部分縮略語 BW =包裝盒上的警告,C =禁忌癥、W =警告,P =預(yù)防措施,AR =不良反應(yīng)、PPI /毫克=病人用藥指導(dǎo)包裝說明書/ 打XX的兩個(gè)是在W和P那,是警告和預(yù)防措施,應(yīng)該是關(guān)于更改標(biāo)簽的吧 |
鐵桿木蟲 (小有名氣)
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http://www.accessdata.fda.gov/sc ... ovalHistory#apphist Letter (PDF) 仿制藥批準(zhǔn)信息 We noted that the reference listed drug product (RLD) upon whichyou have based this application, Mivacron (Mivacurium Chloride)Injection, 2 mg (base)/mL, of Abbott Laboratories, is no longerbeing marketed in the United States. Thus, Abbott’s Mivacron(Mivacurium Chloride) Injection, 2 mg (base)/mL, was moved fromthe Active to the Discontinued section of the agency’spublication titled Approved Drug Products with TherapeuticEquivalence Evaluations, the “Orange Book”. Subsequently, in aFederal Register Notice dated August 8, 2007 (Volume 72, No.152), the agency announced its determination that Abbott’sMivacron (Mivacurium Chloride) Injection, 2 mg (base)/mL, wasnot withdrawn from sale for reasons of safety or effectiveness.This determination allows the agency to approve ANDAs for thediscontinued drug product. 其實(shí)自2006年開始2mg/ml的已經(jīng)不在美國(guó)上市了。 |
銀蟲 (小有名氣)
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