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의약품 인허가 개요

[유럽] 바이오의약품 허가제품 정보: 「Casgevy」

[유럽] 바이오의약품 허가제품 정보: 「Casgevy」 : 작성자, 작성일, 조회수, 출처,원문, 첨부파일 정보 제공
작성자	관리자
작성일	2024-02-22	조회수	306
국가정보	유럽>모든국가
출처	한국바이오의약품협회
원문	https://www.kobia.kr/bbs/board.php?tbl=data05&mode=VIEW&num=596&category=&findEx=&findType=&findWord=&sort1=&sort2=&it_id=&shop_flag=&mobile_flag=&page=1
첨부파일	[유럽] 바이오의약품 허가제품 정보_Casgevy.pdf(230.84KB)내려받기

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

[출처]

① First gene editing therapy to treat beta thalassemia and severe sickle cell disease (EMA, 2023.12.15.)

② Product information – Casgevy (EC, 2024.02.09.)

③ ClinicalTrials.gov(Study 111(NCT03655678), Study 121(NCT03745287), Study 131(NCT04208529))

④ Redman M, King A, Watson C, King D. What is CRISPR/Cas9?. Arch Dis Child Educ Pract Ed. 2016;101(4):213-215. doi:10.1136/archdischild-2016-310459

이전글 미국 FDA, 고형암 대상 세포치료제 최초 허가
다음글 [미국] 바이오의약품 허가제품 정보: 「Xolair」

<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);">※ 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);"> 
<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);"><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);"><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.ema.europa.eu/en/news/first-gene-editing-therapy-treat-beta-thalassemia-and-severe-sickle-cell-disease" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px; font-size: 9pt; text-indent: -13.5pt; font-family: 돋움, Dotum, Helvetica, sans-serif;"><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; font-size: 9pt; color: rgb(70, 70, 70);">First gene editing therapy to treat beta thalassemia and severe sickle cell disease (EMA, 2023.12.15.)</a>
<span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">② <a href="https://ec.europa.eu/health/documents/community-register/html/h1787.htm" 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; font-size: 9pt; color: rgb(70, 70, 70);">Product information <span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">– <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; font-size: 9pt; color: rgb(70, 70, 70);">Casgevy (EC, 2024.02.09.)</a>
<span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">③ <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; font-size: 9pt; color: rgb(70, 70, 70);">ClinicalTrials.gov(<a href="https://clinicaltrials.gov/study/NCT03655678" 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; font-size: 9pt; color: rgb(70, 70, 70);">Study 111(NCT03655678),</a> <a href="https://clinicaltrials.gov/study/NCT03745287" 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; font-size: 9pt; color: rgb(70, 70, 70);">Study 121(NCT03745287),</a> <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-style:="" italic;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">Study 131(NCT04208529)</a><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; font-size: 9pt; color: rgb(70, 70, 70);">)
<span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">④ <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4975809/" 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:="" -0.1pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">Redman M, King A, Watson C, King D. What is CRISPR/Cas9?. Arch Dis Child Educ Pract Ed. 2016;101(4):213-215. doi:10.1136/archdischild-2016-310459</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);">※ 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);"> <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);"><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);"><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.ema.europa.eu/en/news/first-gene-editing-therapy-treat-beta-thalassemia-and-severe-sickle-cell-disease" style="box-sizing: inherit; text-size-adjust: none; color: rgb(125, 125, 125); text-decoration-line: none; border: 0px; font-size: 9pt; text-indent: -13.5pt; font-family: 돋움, Dotum, Helvetica, sans-serif;"><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; font-size: 9pt; color: rgb(70, 70, 70);">First gene editing therapy to treat beta thalassemia and severe sickle cell disease (EMA, 2023.12.15.)</a> <span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">② <a href="https://ec.europa.eu/health/documents/community-register/html/h1787.htm" 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; font-size: 9pt; color: rgb(70, 70, 70);">Product information <span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">– <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; font-size: 9pt; color: rgb(70, 70, 70);">Casgevy (EC, 2024.02.09.)</a> <span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">③ <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; font-size: 9pt; color: rgb(70, 70, 70);">ClinicalTrials.gov(<a href="https://clinicaltrials.gov/study/NCT03655678" 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; font-size: 9pt; color: rgb(70, 70, 70);">Study 111(NCT03655678),</a> <a href="https://clinicaltrials.gov/study/NCT03745287" 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; font-size: 9pt; color: rgb(70, 70, 70);">Study 121(NCT03745287),</a> <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-style:="" italic;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">Study 131(NCT04208529)</a><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; font-size: 9pt; color: rgb(70, 70, 70);">) <span 맑은="" letter-spacing:="" 0pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">④ <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4975809/" 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:="" -0.1pt;="" font-size:="" 9pt;="" color:="" rgb(70,="" 70,="" style="box-sizing: inherit; text-size-adjust: none; font-family: 나눔고딕, NanumGothic; font-size: 9pt; color: rgb(70, 70, 70);">Redman M, King A, Watson C, King D. What is CRISPR/Cas9?. Arch Dis Child Educ Pract Ed. 2016;101(4):213-215. doi:10.1136/archdischild-2016-310459</a> 
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[유럽] 바이오의약품 허가제품 정보: 「Casgevy」

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