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[미국] 바이오의약품 허가제품 정보: 「Roctavian」

[미국] 바이오의약품 허가제품 정보: 「Roctavian」 : 작성자, 작성일, 조회수, 출처,원문, 정보 제공
작성자	관리자
작성일	2023-07-13	조회수	469
국가정보	북 아메리카>미국
출처	한국바이오의약품협회
원문	https://www.kobia.kr/bbs/board.php?tbl=data05&mode=VIEW&num=518&category=&findEx=&findType=&findWord=&sort1=&sort2=&page=1&mobile_flag=

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

[출처]

① FDA Approves First Gene Therapy for Adults with Severe Hemophilia A (FDA, 2023.06.29.)

② Package Insert - ROCTAVIAN

③ Approval Letter - ROCTAVIAN

④ ClinicalTrials.gov(BMN 270-301, BMN 270-302, BMN 270-303)

이전글 [미국] 바이오의약품 허가제품 정보: 「Beyfortus」
다음글 [미국] 바이오의약품 허가제품 정보: 「Lantidra」

<p 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 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" 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;">[출처]
<p class="0" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 13.5pt; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255); line-height: 16.9px; text-indent: -13.5pt; word-break: keep-all;">① <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-adults-severe-hemophilia" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">FDA Approves First Gene Therapy for Adults with Severe Hemophilia A</a> (FDA, 2023.06.29.)
<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/169937/download" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">Package Insert - ROCTAVIAN</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/169963/download" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">Approval Letter - ROCTAVIAN</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;">④ ClinicalTrials.gov(<a href="https://classic.clinicaltrials.gov/ct2/show/NCT03370913" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">BMN 270-301</a>, <a href="https://www.clinicaltrials.gov/study/NCT03392974" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">BMN 270-302</a>, <a href="https://www.clinicaltrials.gov/study/NCT04323098" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">BMN 270-303</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: 0.5; word-break: keep-all;"> 
<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;"><img src="https://www.kobia.kr/smart_editor/upload/202307131333462105609642.jpg" title="%255B%25EB%25AF%25B8%25EA%25B5%25AD%255D%2B%25EB%25B0%2594%25EC%259D%25B4%25EC%2598%25A4%25EC%259D%2598%25EC%2595%25BD%25ED%2592%2588%2B%25ED%2597%2588%25EA%25B0%2580%25EC%25A0%259C%25ED%2592%2588%2B%25EC%25A0%2595%25EB%25B3%25B4_Roctavian_1.jpg" style="box-sizing: inherit; text-size-adjust: none; border: 0px; vertical-align: top; max-width: 100%; height: auto;" alt=""> 
<img src="https://www.kobia.kr/smart_editor/upload/202307131333531842867011.jpg" title="%255B%25EB%25AF%25B8%25EA%25B5%25AD%255D%2B%25EB%25B0%2594%25EC%259D%25B4%25EC%2598%25A4%25EC%259D%2598%25EC%2595%25BD%25ED%2592%2588%2B%25ED%2597%2588%25EA%25B0%2580%25EC%25A0%259C%25ED%2592%2588%2B%25EC%25A0%2595%25EB%25B3%25B4_Roctavian_2.jpg" style="box-sizing: inherit; text-size-adjust: none; border: 0px; vertical-align: top; max-width: 100%; height: auto;" alt="">

<p 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 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" 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;">[출처] <p class="0" style="box-sizing: inherit; text-size-adjust: none; margin-right: 0px; margin-left: 13.5pt; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; font-size: 13px; background-color: rgb(255, 255, 255); line-height: 16.9px; text-indent: -13.5pt; word-break: keep-all;">① <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-adults-severe-hemophilia" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">FDA Approves First Gene Therapy for Adults with Severe Hemophilia A</a> (FDA, 2023.06.29.) <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/169937/download" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">Package Insert - ROCTAVIAN</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/169963/download" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">Approval Letter - ROCTAVIAN</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;">④ ClinicalTrials.gov(<a href="https://classic.clinicaltrials.gov/ct2/show/NCT03370913" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">BMN 270-301</a>, <a href="https://www.clinicaltrials.gov/study/NCT03392974" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">BMN 270-302</a>, <a href="https://www.clinicaltrials.gov/study/NCT04323098" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px;">BMN 270-303</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: 0.5; word-break: keep-all;"> <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;"><img src="https://www.kobia.kr/smart_editor/upload/202307131333462105609642.jpg" title="%255B%25EB%25AF%25B8%25EA%25B5%25AD%255D%2B%25EB%25B0%2594%25EC%259D%25B4%25EC%2598%25A4%25EC%259D%2598%25EC%2595%25BD%25ED%2592%2588%2B%25ED%2597%2588%25EA%25B0%2580%25EC%25A0%259C%25ED%2592%2588%2B%25EC%25A0%2595%25EB%25B3%25B4_Roctavian_1.jpg" style="box-sizing: inherit; text-size-adjust: none; border: 0px; vertical-align: top; max-width: 100%; height: auto;" alt=""> <img src="https://www.kobia.kr/smart_editor/upload/202307131333531842867011.jpg" title="%255B%25EB%25AF%25B8%25EA%25B5%25AD%255D%2B%25EB%25B0%2594%25EC%259D%25B4%25EC%2598%25A4%25EC%259D%2598%25EC%2595%25BD%25ED%2592%2588%2B%25ED%2597%2588%25EA%25B0%2580%25EC%25A0%259C%25ED%2592%2588%2B%25EC%25A0%2595%25EB%25B3%25B4_Roctavian_2.jpg" style="box-sizing: inherit; text-size-adjust: none; border: 0px; vertical-align: top; max-width: 100%; height: auto;" alt="">
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[미국] 바이오의약품 허가제품 정보: 「Roctavian」

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