{"id":9251,"date":"2018-10-05T12:27:09","date_gmt":"2018-10-05T12:27:09","guid":{"rendered":"http:\/\/fefac.cat\/empresarial\/?p=9251"},"modified":"2018-10-05T12:27:09","modified_gmt":"2018-10-05T12:27:09","slug":"comunicat-de-salut-sobre-la-nova-retirada-de-medic","status":"publish","type":"post","link":"https:\/\/fefac.cat\/empresarial\/comunicat-de-salut-sobre-la-nova-retirada-de-medic\/","title":{"rendered":"Comunicat de Salut sobre la nova retirada de medicaments que contenen valsart\u00e1n"},"content":{"rendered":"<p>Els lots s&#39;han retirar pel risc que poguessin estar contaminats amb principi actiu provinent de Zhejiang Huahai Pharmaceutical Co. La informaci&oacute; sobre els lots retirats pot consultar-se a la<strong>&nbsp;<a href=\"https:\/\/www.aemps.gob.es\/informa\/alertas\/medicamentosUsoHumano\/home.htm\" target=\"_blank\">secci&oacute; d&rsquo;Alertes de medicaments d&rsquo;&uacute;s hum&agrave;&nbsp;<\/a><\/strong>de la web de l&rsquo;Aemps<strong>, <a href=\"https:\/\/www.aemps.gob.es\/informa\/alertas\/medicamentosUsoHumano\/2018\/calidad_34_2018_Valsartan-lab-Stada.htm\" target=\"_blank\">Alerta farmac&egrave;utica R 34\/2018<\/a><\/strong>. Les recomanacions per a la substituci&oacute; dels medicaments es mantenen, podent dirigir-se els pacients a la farm&agrave;cia amb l&rsquo;env&agrave;s afectat per al seu reempla&ccedil;ament.<\/p>\n<p><strong>El passat 5 de juliol, l&rsquo;Aemps va informar de la detecci&oacute; d&rsquo;una impuresa probablement carcin&ograve;gena en el principi actiu valsart&aacute;n <\/strong>fabricat per Zhejiang Huahai Pharmaceutical Co. (Xina). Com a conseq&uuml;&egrave;ncia d&rsquo;aquesta detecci&oacute;, van retirar-se els lots de medicaments afectats i va iniciar-se a escala europea un procediment d&rsquo;arbitratge i revisi&oacute; de tots els medicaments que contenien aquest principi, en el marc de la Directiva 2001\/83\/CE.<\/p>\n<p><strong>Inspecci&oacute; a les instal&middot;lacions de Zhejiang Huahai Pharmaceutical Co. <\/strong><\/p>\n<p>L&rsquo;Aemps, juntament amb inspectors d&rsquo;altres autoritats de la UE, ha participat en una inspecci&oacute; realitzada a les instal&middot;lacions de la companyia, a Xina, el passat mes de setembre. Com a resultat d&rsquo;aquesta inspecci&oacute; s&rsquo;ha publicat una declaraci&oacute; d&rsquo;incompliment en normes de correcta fabricaci&oacute; de valsart&aacute;n per aquesta empresa,<strong> prohibint la fabricaci&oacute; d&rsquo;aquest principi actiu per a medicaments europeus.<\/strong><\/p>\n<p>Aquesta planta de fabricaci&oacute; ha estat inspeccionada recentment per la Food and Drug Administration, FDA.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Els lots s&#39;han retirar pel risc que poguessin estar contaminats amb principi actiu provinent de Zhejiang Huahai Pharmaceutical Co. La informaci&oacute; sobre els lots retirats pot consultar-se a la&nbsp;secci&oacute; d&rsquo;Alertes [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[18,11,12,13,14,15,101],"tags":[136,188,1748,1760,1830],"class_list":["post-9251","post","type-post","status-publish","format-standard","hentry","category-general","category-fefac","category-afb","category-afet","category-afell","category-agfe","category-sanitaria","tag-medicaments","tag-aemps","tag-farmacs","tag-valsartan","tag-alertes"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Comunicat de Salut sobre la nova retirada de medicaments que contenen valsart\u00e1n - FEFAC<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fefac.cat\/empresarial\/comunicat-de-salut-sobre-la-nova-retirada-de-medic\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Comunicat de Salut sobre la nova retirada de medicaments que contenen valsart\u00e1n - FEFAC\" \/>\n<meta property=\"og:description\" content=\"Els lots s&#039;han retirar pel risc que poguessin estar contaminats amb principi actiu provinent de Zhejiang Huahai Pharmaceutical Co. 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