乌龟刻苦 发表于 2024-7-20 16:32:17

提醒!这一药品暂停进口、销售和使用!

<!----><style type="text/css">html{font-size:375%}</style><link href="https://pics.app.cnyw.net/static/publish/css/style.css?v=20240712" rel="stylesheet" position="1" data-qf-origin="/static/publish/css/style.css?v=20240712"><!--    付费贴-->    <div class="preview_article ">            <!---->    <p class="empty_paragraph" style="margin-bottom: 0px; text-wrap: wrap; outline: 0px; font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; background-color: #ffffff; visibility: visible;">&nbsp;</p><p class="empty_paragraph" style="margin-bottom: 0px; text-wrap: wrap; outline: 0px; font-family: system-ui, -apple-system, BlinkMacSystemFont, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; letter-spacing: 0.544px; background-color: #ffffff; text-align: center; visibility: visible;">&nbsp;</p><p style="margin-bottom: 0px; outline: 0px; letter-spacing: 0.544px; background-color: #ffffff; visibility: visible; font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif;"><img class="rich_pages wxw-img" style="vertical-align: baseline; outline: 0px; color: #000000; font-size: 16px; letter-spacing: 0.54px; text-align: left; font-family: mp-quote, -apple-system-font, BlinkMacSystemFont, Arial, sans-serif; width: 676.969px !important; visibility: visible !important; display: block; margin-left: auto; margin-right: auto;" title="金属质感分割线" src="https://pics.app.cnyw.net/Fp_h4100VyxoZitkSWWx91oQ-HDO" width="640" /></p><section style="margin-bottom: 0px; letter-spacing: 0.578px; text-wrap: wrap; outline: 0px; background-color: #ffffff; visibility: visible;"><section style="outline: 0px; visibility: visible;"><section style="outline: 0px; visibility: visible;"><section style="outline: 0px; visibility: visible;"><section style="margin-bottom: 0px; outline: 0px; font-size: 16px; text-wrap: wrap; letter-spacing: 0.544px; background-color: #ffffff; font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif;"><p style="outline: 0px; letter-spacing: 0.544px; font-family: system-ui, -apple-system, system-ui, 'Helvetica Neue', 'PingFang SC', 'Hiragino Sans GB', 'Microsoft YaHei UI', 'Microsoft YaHei', Arial, sans-serif; background-color: #ffffff; line-height: 1.75em; visibility: visible;">&nbsp;</p><p style="outline: 0px; letter-spacing: 0.544px; text-wrap: wrap; font-family: system-ui, -apple-system, system-ui, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; background-color: #ffffff; line-height: 1.75em; visibility: visible; text-indent: 2em;"><span style="outline: 0px; visibility: visible; font-size: 16px;">近日,DAEWOONG BIO INC. (韩国大熊制药)<strong style="outline: 0px; visibility: visible;">未按要求接受</strong>国家药监局对于国家组织集采中选药品注射用头孢地嗪钠的<strong style="outline: 0px; visibility: visible;">境外现场动态检查</strong>,国家药监局将该检查判定为<strong style="outline: 0px; visibility: visible;">&ldquo;不符合要求&rdquo;</strong>,<strong style="outline: 0px; visibility: visible;">并对该产品采取暂停进口、销售和使用措施</strong>,并发布公告。公告内容如下:</span></p><p style="outline: 0px; letter-spacing: 0.544px; text-wrap: wrap; font-family: system-ui, -apple-system, system-ui, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; background-color: #ffffff; line-height: 1.75em; visibility: visible; text-indent: 2em;"><span style="outline: 0px; visibility: visible; font-size: 16px;">&nbsp;</span></p><p style="outline: 0px; letter-spacing: 0.544px; text-wrap: wrap; font-family: system-ui, -apple-system, system-ui, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; background-color: #ffffff; line-height: 1.75em; visibility: visible; text-indent: 2em;"><span style="outline: 0px; visibility: visible; font-size: 16px;">第八批国家组织药品集中采购中选结果已于2023年7月在各地落地实施。DAEWOONG BIO INC.未按照要求接受国家药监局对于中选药品注射用头孢地嗪钠的境外现场动态检查,违反《中华人民共和国药品管理法》《药品医疗器械境外检查管理规定》,国家药监局将该检查判定为&ldquo;不符合要求&rdquo;。<strong style="outline: 0px; visibility: visible;">2024年7月18日,国家药品监督管理局发布公告,暂停进口、销售和使用该产品。</strong></span></p><p style="outline: 0px; letter-spacing: 0.544px; text-wrap: wrap; font-family: system-ui, -apple-system, system-ui, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; background-color: #ffffff; line-height: 1.75em; visibility: visible; text-indent: 2em;"><span style="outline: 0px; visibility: visible; font-size: 16px;"><strong style="outline: 0px; visibility: visible;">&nbsp;</strong></span></p><p style="outline: 0px; letter-spacing: 0.544px; text-wrap: wrap; font-family: system-ui, -apple-system, system-ui, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; background-color: #ffffff; line-height: 1.75em; visibility: visible; text-indent: 2em;"><span style="outline: 0px; visibility: visible; font-size: 16px;">按照《国务院办公厅关于推动药品集中带量采购工作常态化制度化开展的意见》(国办发〔2021〕2号)精神,经国家组织药品联合采购办公室相关成员单位集体审议,该企业违背在申报材料中作出的承诺,违反《全国药品集中采购文件(GY-YD2023-1)》有关条款,联合采购办公室决定取消DAEWOONG BIO INC.的注射用头孢地嗪钠中选资格,同时将该企业列入&ldquo;违规名单&rdquo;,<strong style="outline: 0px; visibility: visible;">暂停该企业自2024年7月18日至2026年1月17日参与国家组织药品集中采购活动的申报资格</strong>。</span></p><p style="outline: 0px; letter-spacing: 0.544px; text-wrap: wrap; font-family: system-ui, -apple-system, system-ui, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; background-color: #ffffff; line-height: 1.75em; visibility: visible; text-indent: 2em;"><span style="outline: 0px; visibility: visible; font-size: 16px;">&nbsp;</span></p><p style="outline: 0px; letter-spacing: 0.544px; text-wrap: wrap; font-family: system-ui, -apple-system, system-ui, Helvetica Neue, PingFang SC, Hiragino Sans GB, Microsoft YaHei UI, Microsoft YaHei, Arial, sans-serif; background-color: #ffffff; line-height: 1.75em; visibility: visible; text-indent: 2em;"><span style="outline: 0px; visibility: visible; font-size: 16px;">由DAEWOONG BIO INC.作为注射用头孢地嗪钠主供企业的省份,应按照《全国药品集中采购文件(GY-YD2023-1)》相关条款启动替补程序,由备供企业替补成为主供企业,并按其中选价格供应;当备供企业不能满足供应需求时,由所在省份启动增补备供企业供应流程。</span></p></section></section></section></section></section><section style="margin-bottom: 0px; text-wrap: wrap; font-family: system-ui, -apple-system, BlinkMacSystemFont, Arial, sans-serif; letter-spacing: 0.544px; outline: 0px; background-color: #ffffff; caret-color: rgba(0, 0, 0, 0); text-align: center; visibility: visible;"><section style="outline: 0px; visibility: visible;"><section style="outline: 0px;"><section style="outline: 0px; font-size: 16px; letter-spacing: 0.578px; text-align: left;"><span style="outline: 0px; letter-spacing: 0.54px; color: #888888; font-size: 12px; text-align: center; visibility: visible; font-family: -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">来源&nbsp;|</span><span style="outline: 0px; color: #888888; font-size: 12px; letter-spacing: 0.54px; text-align: center; font-family: -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">&nbsp;</span><span style="outline: 0px; letter-spacing: 0.54px; color: #888888; font-size: 12px; text-align: center; visibility: visible; font-family: -apple-system-font, BlinkMacSystemFont, Arial, sans-serif;">央视新闻客户端</span></section></section></section></section><p style="display: none;">&nbsp;</p>    <!----></div>            
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