<p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 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 style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 12pt;"><strong style="box-sizing: inherit; text-size-adjust: none;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 14pt;"><br class="Apple-interchange-newline"> <식품의약품안전처</span></strong></span><strong style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 16px;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 14pt;"> </span></strong><span style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 12pt;"><strong style="box-sizing: inherit; text-size-adjust: none;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 14pt;"><span style="box-sizing: inherit; text-size-adjust: none;"><knibrt < span="" style="box-sizing: inherit; text-size-adjust: none;"><span style="box-sizing: inherit; text-size-adjust: none; color: rgb(81, 143, 187);">의약품 품목 허가사항 변경명령 사전예고 알림(아테졸리주맙)</span></knibrt <></span></span></strong></span><strong style="box-sizing: inherit; text-size-adjust: none; font-family: tahoma; font-size: 12pt;"><span style="box-sizing: inherit; text-size-adjust: none; font-size: 14pt;">></span></strong></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 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 style="box-sizing: inherit; text-size-adjust: none; color: rgb(0, 0, 0); font-family: 나눔고딕, NanumGothic; font-size: 11pt; letter-spacing: -0.6pt;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></p> <p nanum="" font-size:="" 13px;="" background-color:="" rgb(255,="" 255,="" 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 style="box-sizing: inherit; text-size-adjust: none; color: rgb(0, 0, 0); font-family: 나눔고딕, NanumGothic; font-size: 11pt; letter-spacing: -0.6pt;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></p> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 10pt; font-weight: inherit;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; color: rgb(0, 0, 0); text-align: justify; text-indent: -24.9333px; overflow-wrap: break-word; border: 0px;">식품의약품안전처 바이오의약품품질관리과에서는 '키트루다주(펨브롤리주맙)'에 대한 시판 후 중대한 이상사례 보고자료를 분석·평가, 중앙약사심의위원회 자문 결과 등을 토대로 허가사항 변경명령(안)을 마련하여 의견조회를 실시한 바 있습니다.</span></span></div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 10pt; font-weight: inherit;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: tahoma; font-size: 10pt; font-weight: inherit; color: rgb(0, 0, 0); text-align: justify; text-indent: -24.9333px; overflow-wrap: break-word; border: 0px;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></span></div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 나눔고딕, NanumGothic, sans-serif; font-size: 10pt; font-weight: inherit;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; color: rgb(0, 0, 0); text-align: justify; text-indent: -24.9333px; overflow-wrap: break-word; border: 0px;">동 성분 함유 품목은 사용상의 주의사항에 대한 변경이 필요하다고 판단되어 허가사항 변경 명령을 할 예정이며, 이에 앞서 변경명령 내용을 다음과 같이 사전예고 하오니 관련 업무에 참고하시기 바랍니다.</span></span></div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"></div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><b style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" text-align:="" justify;="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; overflow-wrap: break-word; border: 0px; color: rgb(0, 0, 0);"> <span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-size: 11pt; font-weight: inherit;"> ○ 사전예고기간 : '22. 10. 20. ~ '22. 11. 3.</span></span></span></b></div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><b style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" text-align:="" justify;="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; overflow-wrap: break-word; border: 0px; color: rgb(0, 0, 0);"><b style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-size: 11pt; font-weight: inherit; overflow-wrap: break-word; border: 0px;">  ○ </span></span></b>허가사항</span><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; overflow-wrap: break-word; border: 0px; color: rgb(0, 0, 0);">변경명령예정일 : '</span></span><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" text-align:="" justify;="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; overflow-wrap: break-word; border: 0px; color: rgb(0, 0, 0);">22. 11. 4.</span></span></b> </div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" text-align:="" justify;="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움체; font-size: inherit; font-weight: inherit; overflow-wrap: break-word; border: 0px;"> </span></span></div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" text-align:="" justify;="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움체; font-size: inherit; font-weight: inherit; overflow-wrap: break-word; border: 0px;"></span></span></div> <p noto="" sans="" background-color:="" rgb(255,="" 255,="" 255);="" overflow-wrap:="" break-word;="" border:="" 0px;="" color:="" rgb(98,="" 98,="" 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);"><br style="box-sizing: inherit; text-size-adjust: none;"></p> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" text-align:="" justify;="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움체; font-size: inherit; font-weight: inherit; overflow-wrap: break-word; border: 0px;"></span></span></div> <p nanum="" box-sizing:="" inherit;="" text-size-adjust:="" none;="" color:="" rgb(125,="" 125,="" 125);="" background-color:="" rgb(255,="" 255,="" 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 style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; color: rgb(0, 0, 0);">※ </span><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: inherit; font-size: inherit; font-weight: inherit;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; color: rgb(0, 0, 0);">붙임자료는 의약품 안전나라 홈페이지> 고시/공고/알림>의약품허가승인>변경명령 </span></span><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: inherit; font-size: inherit; font-weight: inherit;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; color: rgb(0, 0, 0);">에서 </span></span><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; color: rgb(0, 0, 0);">내려받으실 수 있습니다. </span></p> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" text-align:="" justify;="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움체; font-size: inherit; font-weight: inherit; overflow-wrap: break-word; border: 0px;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></span></div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" text-align:="" justify;="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움체; font-size: inherit; font-weight: inherit; overflow-wrap: break-word; border: 0px;"><br style="box-sizing: inherit; text-size-adjust: none;"></span></span></div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span noto="" sans="" font-size:="" 12pt;="" font-weight:="" inherit;="" color:="" rgb(98,="" 98,="" 98);="" text-align:="" justify;="" overflow-wrap:="" break-word;="" border:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px;"><span style="box-sizing: inherit; text-size-adjust: none; margin: 0px; padding: 0px; font-family: 돋움, Dotum; font-size: 11pt; font-weight: inherit; overflow-wrap: break-word; border: 0px; color: rgb(0, 0, 0);">붙임 1. 허가사항 변경명령 내용(변경대비표 포함)</span></span></div> <div noto="" sans="" sans-serif;="" color:="" rgb(51,="" 51,="" 51);="" background-color:="" rgb(255,="" 255,="" 255);="" line-height:="" style="box-sizing: inherit; text-size-adjust: none; margin: 0px 0px 0px 40px; padding: 0px; color: rgb(125, 125, 125); font-family: 'Nanum Gothic'; background-color: rgb(255, 255, 255); font-size: 14px;"><span style="box-sizing: inherit; text-size-adjust: none; font-family: 돋움, Dotum; font-size: 11pt; color: rgb(0, 0, 0);">2. 펨브롤리주맙 품목 및 업체현황.  끝.</span></div>
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