<![CDATA[
<div><p class="cafe-editor-text"><br></p></div><p><a href="http://www.kukinews.com/news/article.html?no=719749"><span style="font-size: 18pt;">http://www.kukinews.com/news/article.html?no=719749</span></a></p><p><br></p><p><br></p><p><span style="font-size: 18pt;">16일 식품의약품안전처에 따르면, 경인지방식품의약품안전청<span style="font-size: 18pt;">은</span></span></p><p><span style="font-size: 18pt;">지난 8일 다림바이오텍의 ‘디카맥스디정’, ‘디카맥스디플러스정’</span></p><p><span style="font-size: 18pt;">에 대해 회수‧폐기 명령을 내리고 해당 내용을 홈페이지에 </span></p><p><span style="font-size: 18pt;">게시했다. </span></p><p><span style="font-size: 18pt;"><br></span></p><p><span style="font-size: 18pt;">칼슘제로 분류되는 이들 제품은 탄산칼슘과립과 농축콜레칼시페롤과립이 복합된 비타민D 제제로 일반의약품에 속한다. </span></p><p><span style="font-size: 18pt;">임신‧수유기, 발육기, 노년기에 비타민 D를 보급하고, </span></p><p><span style="font-size: 18pt;">구루병 예방 등의 효능과 효과를 가진 이 제품의 용법‧용량은 </span></p><p><span style="font-size: 18pt;">만8세 어린이 이상 1일 1회 1정 복용이다. </span></p><p><span style="font-size: 18pt;"><br></span></p><p><span style="font-size: 18pt;">경인식약청은 회수사유를 ‘국민보건에 위해를 주었거나 줄 </span></p><p><span style="font-size: 18pt;">염려가 있는 의약품’으로 기재했는데, ‘품질부적합’이 아닌 경우</span></p><p><span style="font-size: 18pt;">임에도 불구하고 회수 명령이 떨어진 것은 이례적인 일이라는 </span></p><p><span style="font-size: 18pt;">것이 식약처 측 설명이다. </span><span style="font-size: 18pt;" name="inspace_pos"> </span></p><p><span style="font-size: 18pt;"><br></span></p><p><span style="color: rgb(0, 0, 0); font-size: 18pt; background-color: rgb(255, 255, 255);">내용은 이렇다. <strong><span style="color: rgb(9, 0, 255);">의약품 안전성이나 유효성 면을 보장하기 </span></strong></span></p><p><span style="color: rgb(0, 0, 0); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="color: rgb(9, 0, 255);">위해 <span style="color: rgb(0, 0, 0); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="color: rgb(9, 0, 255);">의약품 제조소는 의약품 등의 제조나 품질관리에 관한 </span></strong></span></span></strong></span></p><p><span style="color: rgb(0, 0, 0); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="color: rgb(9, 0, 255);"><span style="color: rgb(0, 0, 0); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="color: rgb(9, 0, 255);">규칙<span style="font-size: 18pt;"><strong><span style="color: rgb(9, 0, 255); background-color: rgb(255, 255, 255);">(GMP)</span><span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(255, 255, 255);">승인을 받아야 한다. </span></strong></span></span></strong></span></span></strong></span></p><p><span style="font-size: 18pt;"><strong><span style="color: rgb(9, 0, 255); background-color: rgb(255, 255, 255);">그런데 다림바이오텍이 GMP 승인을 받지</span><span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(255, 255, 255);">않은 신(新)공장에서 </span></strong></span></p><p><span style="font-size: 18pt;"><strong><span style="color: rgb(9, 0, 255); background-color: rgb(255, 255, 255);">일부 제품을 생산했기 때문에 </span><span style="font-size: 18pt;"><span style="color: rgb(9, 0, 255); background-color: rgb(255, 255, 255);">그 제품에 </span><span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(255, 255, 255);">대해서만 회수 조치된 </span></span></strong></span></p><p><span style="color: rgb(0, 0, 0); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="color: rgb(9, 0, 255);">것이다.</span></strong><span style="color: rgb(9, 0, 255);"> </span></span></p><p><span style="font-size: 18pt;"><br></span></p><p><span style="font-size: 18pt;">이에 따라 디카맥스디정은 9월 4일, 16일, 17일에 제조한 </span></p><p><span style="font-size: 18pt;">제조번호 B19037, B19038, B19039, B19040, B19041, </span></p><p><span style="font-size: 18pt;">B19042, B19043, B19044, B19045, B19046 등이, </span></p><p><span style="font-size: 18pt;">디카맥스디플러스정은 9월 6일 제조된 제조번호 B19009, </span></p><p><span style="font-size: 18pt;">B19010, B19011, B19012, B19013, B19014 등이 회수되고 </span></p><p><span style="font-size: 18pt;">있다. </span></p><p><span style="font-size: 18pt;"><br></span></p><p><span style="font-size: 18pt;">문제는 이러한 내용이 고지가 되지 않아 약을 복용하고 있는 </span></p><p><span style="font-size: 18pt;">환자들의 불안감이 커지고 있다는 점이다. </span><span style="font-size: 18pt;" name="inspace_pos"> </span></p><p><p><span style="font-size: 18pt;"><br></span></p><p><span style="font-size: 18pt;">식약처 관계자는 </span></p><p><span style="font-size: 18pt;"><strong><span style="color: rgb(9, 0, 255);"><br></span></strong></span></p><p><span style="font-size: 18pt;"><strong><span style="color: rgb(9, 0, 255);">"</span><span style="color: rgb(9, 0, 255); font-size: 24pt;">GMP 승인을 </span><span style="font-size: 24pt;">받지</span><span style="color: rgb(9, 0, 255); font-size: 24pt; background-color: rgb(255, 255, 255);">않은 제조소에서 </span><span style="color: rgb(9, 0, 255); font-size: 24pt; background-color: rgb(255, 255, 255);">생산됐기 </span></strong></span></p><p><span style="font-size: 18pt;"><strong><span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(102, 0, 255);"><span style="color: rgb(9, 0, 255); font-size: 24pt; background-color: rgb(255, 255, 255);">때문에 그에 대한</span><span style="color: rgb(9, 0, 255); font-size: 24pt; background-color: rgb(255, 255, 255);"> <span style="font-size: 18pt;"><strong><span style="color: rgb(9, 0, 255); font-size: 24pt; background-color: rgb(255, 255, 255);">회수명령을 내린 것이다. </span></strong></span></span></span></strong></span></p><p><span style="font-size: 18pt;"><strong><span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(102, 0, 255);"><span style="color: rgb(9, 0, 255); font-size: 24pt; background-color: rgb(255, 255, 255);"><span style="font-size: 18pt;"><strong><span style="font-size: 18pt;"><span style="color: rgb(9, 0, 255); font-size: 24pt; background-color: rgb(255, 255, 255);">의약품에 문제가 있는 것은 아니다”</span></span></strong></span></span></span></strong></span></p><p><span style="font-size: 18pt;">라면서</span> </p><p><br></p><p><span style="font-size: 18pt;"><br></span></p><p><span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="font-size: 24pt;">“GMP 인증을 받지 않은 제조소에서 생산된 </span></strong></span></p><p><span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="font-size: 24pt;">일부 제품에 <span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="font-size: 24pt;">대해서만 조치가 내려졌고, 그 외 </span></strong></span></span></strong></span></p><p><span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="font-size: 24pt;"><span style="color: rgb(9, 0, 255); font-size: 18pt; background-color: rgb(255, 255, 255);"><strong><span style="font-size: 24pt;">다른 제품들은 대상이 아니다”</span></strong></span></span></strong></span></p><p><span style="font-size: 18pt;"><br></span></p><p><span style="font-size: 18pt;">라고 <span style="font-size: 18pt;">밝혔다. </span></span></p><p><span style="font-size: 18pt;"><br></span></p><p><span style="font-size: 18pt;"><br></span></p><p><span style="font-size: 18pt;">유수인 기자 suin92710@kukinews.com</span><span style="font-size: 18pt;" name="inspace_pos"> </span></p><p><br></p><div class="btn_allarticle"><br></div><p><br><br><!-- 20180125 cs10227 바이라인 하단 광고 -->
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디카맥스 회수 이유는 GMP승인을 받지 않은 신(新)공장에서 제조되었기 때문이다
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19.11.16 11:05
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