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[미국] 바이오의약품 허가제품 정보: 「Amtagvi」

[미국] 바이오의약품 허가제품 정보: 「Amtagvi」 : 작성자, 작성일, 조회수, 출처,원문, 첨부파일 정보 제공
작성자	관리자
작성일	2024-02-22	조회수	210
국가정보	북 아메리카>미국
출처	한국바이오의약품협회
원문	https://www.kobia.kr/bbs/board.php?tbl=data05&mode=VIEW&num=598&category=&findEx=&findType=&findWord=&sort1=&sort2=&it_id=&shop_flag=&mobile_flag=&page=1
첨부파일	[미국] 바이오의약품 허가제품 정보_AMTAGVI.pdf(224.89KB)내려받기

※ 자료를 인용하실 경우, "한국바이오의약품협회" 제공 정보임을 밝혀주시기 바랍니다.

[출처]

① FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma (FDA, 2024.02.16.)

② Package Insert - AMTAGVI

③ Approval letter - AMTAGVI

④ ClinicalTrials.gov(C-144-01(NCT02360579))

이전글 [미국] 바이오의약품 허가제품 정보: 「Xolair」
다음글 단일 세포 분석 기법에 대한 개요 및 이를 활용한 질병의 이해 및 신약개발 사례

<p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);">※ 자료를 인용하실 경우, "한국바이오의약품협회" 제공 정보임을 밝혀주시기 바랍니다.     
<p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"> 
<p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(37,="" 37,="" style="box-sizing: inherit; text-size-adjust: none; color: rgb(37, 37, 37); font-family: 나눔고딕, NanumGothic; font-size: 10pt;">[출처<span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(37,="" 37,="" style="box-sizing: inherit; text-size-adjust: none; color: rgb(37, 37, 37); font-family: 나눔고딕, NanumGothic; font-size: 10pt;">]
<p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(0,="" 0,="" style="box-sizing: inherit; text-size-adjust: none; color: rgb(70, 70, 70); font-family: 나눔고딕, NanumGothic; font-size: 9pt;">① <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-unresectable-or-metastatic-melanoma" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px; font-size: 9pt; letter-spacing: -0.6pt; text-indent: -13.5pt; font-family: 돋움, Dotum, Helvetica, sans-serif;">FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma </a>(FDA, 2024.02.16.)
<p class="0" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255); line-height: 16.9px; word-break: keep-all;">② <a href="https://www.fda.gov/media/176417/download?attachment" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">Package Insert - AMTAGVI</a>
<p class="0" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255); line-height: 16.9px; word-break: keep-all;">③ <a href="https://www.fda.gov/media/176418/download?attachment" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">Approval letter - AMTAGVI</a>
<p class="0" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); line-height: 15.6px; word-break: keep-all; font-size: 9pt;">④ ClinicalTrials.gov(<a href="https://clinicaltrials.gov/study/NCT02360579" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">C-144-01(NCT02360579)</a>)

<p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);">※ 자료를 인용하실 경우, "한국바이오의약품협회" 제공 정보임을 밝혀주시기 바랍니다. <p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"> <p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(37,="" 37,="" style="box-sizing: inherit; text-size-adjust: none; color: rgb(37, 37, 37); font-family: 나눔고딕, NanumGothic; font-size: 10pt;">[출처<span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(37,="" 37,="" style="box-sizing: inherit; text-size-adjust: none; color: rgb(37, 37, 37); font-family: 나눔고딕, NanumGothic; font-size: 10pt;">] <p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255);"><span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(0,="" 0,="" style="box-sizing: inherit; text-size-adjust: none; color: rgb(70, 70, 70); font-family: 나눔고딕, NanumGothic; font-size: 9pt;">① <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-unresectable-or-metastatic-melanoma" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px; font-size: 9pt; letter-spacing: -0.6pt; text-indent: -13.5pt; font-family: 돋움, Dotum, Helvetica, sans-serif;">FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma </a>(FDA, 2024.02.16.) <p class="0" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255); line-height: 16.9px; word-break: keep-all;">② <a href="https://www.fda.gov/media/176417/download?attachment" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">Package Insert - AMTAGVI</a> <p class="0" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255); line-height: 16.9px; word-break: keep-all;">③ <a href="https://www.fda.gov/media/176418/download?attachment" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">Approval letter - AMTAGVI</a> <p class="0" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); line-height: 15.6px; word-break: keep-all; font-size: 9pt;">④ ClinicalTrials.gov(<a href="https://clinicaltrials.gov/study/NCT02360579" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">C-144-01(NCT02360579)</a>)
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[미국] 바이오의약품 허가제품 정보: 「Amtagvi」

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