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[미국] 바이오의약품 허가제품 정보: 「Xolair」

[미국] 바이오의약품 허가제품 정보: 「Xolair」 : 작성자, 작성일, 조회수, 출처,원문, 첨부파일 정보 제공
작성자	관리자
작성일	2024-02-22	조회수	203
국가정보	북 아메리카>미국
출처	한국바이오의약품협회
원문	https://www.kobia.kr/bbs/board.php?tbl=data05&mode=VIEW&num=597&category=&findEx=&findType=&findWord=&sort1=&sort2=&it_id=&shop_flag=&mobile_flag=&page=1
첨부파일	[미국] 바이오의약품 허가제품 정보_XOLAIR.pdf(230.75KB)내려받기

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

[출처]

① FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure (FDA,

2024.02.16.)

② Package Insert – XOLAIR

③ Approval Letter - XOLAIR

④ ClinicalTrials.gov(NCT03881696)

이전글 [유럽] 바이오의약품 허가제품 정보: 「Casgevy」
다음글 [미국] 바이오의약품 허가제품 정보: 「Amtagvi」

<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;">※ 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:="" margin-left:="" 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 <span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure <span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; text-indent: -13.5pt; font-size: 9pt; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70);">(FDA,       
<p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" margin-left:="" 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;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; text-indent: -13.5pt; font-size: 9pt; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70);">    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;"><span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">② <a href="https://clinicaltrials.gov/study/NCT04208529" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;"><span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">Package Insert <span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">– <span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">XOLAIR</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;"><span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">③ <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103976s5245lbl.pdf" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;"><span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">Approval Letter - XOLAIR</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;"><span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">④ <span lang="EN-US" 맑은="" letter-spacing:="" -0.1pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">ClinicalTrials.gov(<a href="https://clinicaltrials.gov/study/NCT03881696" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;"><span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-style:="" italic;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">NCT03881696</a><span lang="EN-US" 맑은="" letter-spacing:="" -0.1pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">)

<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;">※ 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:="" margin-left:="" 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 <span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure <span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; text-indent: -13.5pt; font-size: 9pt; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70);">(FDA, <p class="0" nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" 16.9px;="" word-break:="" margin-left:="" 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;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; text-indent: -13.5pt; font-size: 9pt; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70);"> 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;"><span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">② <a href="https://clinicaltrials.gov/study/NCT04208529" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;"><span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">Package Insert <span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">– <span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">XOLAIR</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;"><span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">③ <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103976s5245lbl.pdf" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;"><span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">Approval Letter - XOLAIR</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;"><span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">④ <span lang="EN-US" 맑은="" letter-spacing:="" -0.1pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">ClinicalTrials.gov(<a href="https://clinicaltrials.gov/study/NCT03881696" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;"><span lang="EN-US" 맑은="" letter-spacing:="" 0pt;="" font-style:="" italic;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">NCT03881696</a><span lang="EN-US" 맑은="" letter-spacing:="" -0.1pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; color: rgb(70, 70, 70); font-size: 9pt;">)
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[미국] 바이오의약품 허가제품 정보: 「Xolair」

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