{"id":9459,"date":"2019-01-18T12:30:24","date_gmt":"2019-01-18T12:30:24","guid":{"rendered":"http:\/\/fefac.cat\/empresarial\/?p=9459"},"modified":"2019-01-18T12:30:24","modified_gmt":"2019-01-18T12:30:24","slug":"retirada-de-lots-dirbesartn","status":"publish","type":"post","link":"https:\/\/fefac.cat\/empresarial\/retirada-de-lots-dirbesartn\/","title":{"rendered":"Retirada de lots d&#8217;Irbesart\u00e1n"},"content":{"rendered":"<p>En el marc dels controls addicionals posats en marxa per a tots els medicaments del grup denominat dels &quot;sartans&quot;, s&#39;ha detectat la pres&egrave;ncia de&nbsp;N-nitrosaminas en determinats lots del principi actiu irbesart&aacute;n fabricat per&nbsp;Zhejiang Huahai Pharmaceutical Co. (Xina), utilitzats en la fabricaci&oacute; de medicaments comercialitzats a la Uni&oacute; Europea.<\/p>\n<p>L&#39;Ag&egrave;ncia Espanyola de Medicaments i Productes Sanitaris (AEMPS) ha ordenat la retirada del mercat de lots de medicaments de dos titulars d&#39;autoritzaci&oacute; de comercialitzaci&oacute;. La informaci&oacute; sobre els lots retirats es pot consultar a la secci&oacute; d&#39;Alertes de medicaments d&#39;&uacute;s hum&agrave; 3 de<a href=\"https:\/\/www.aemps.gob.es\/informa\/alertas\/medicamentosUsoHumano\/home.htm\" target=\"_blank\"> la web de l&#39;AEMPS.<\/a><\/p>\n<p>Les recomanacions per a la substituci&oacute; dels medicaments acordades al juliol de l&#39;any passat, s&oacute;n aplicables per a aquest nou principi actiu afectat, podent acudir els pacients a la farm&agrave;cia amb l&#39;env&agrave;s afectat per al seu reempla&ccedil;ament (v<a href=\"https:\/\/www.aemps.gob.es\/informa\/notasInformativas\/medicamentosUsoHumano\/calidad\/2019\/docs\/protocolo-MSCBS-CGCOF-NI-ICM-CONT-01-2019-irbesartan.pdf\" target=\"_blank\">eure protocol de gesti&oacute; del Ministeri de Sanitat, Consum Benestar Social per a la retirada de lots de irbesart&aacute;n<\/a>).&nbsp;<\/p>\n<p>L&#39;Ag&egrave;ncia Europea de Medicaments (EMA) i les autoritats nacionals continuen treballant en la recerca dels fets i s&#39;informar&agrave; de les novetats sobre aquest tema.<\/p>\n<div style=\"background:#eee;border:1px solid #ccc;padding:5px 10px;\"><strong style=\"font-family: Verdana, Arial, Helvetica, sans-serif; font-size: 12px;\">No has rebut aquesta not&iacute;cia per e-mail?&nbsp;<a href=\"https:\/\/fefac.us13.list-manage.com\/subscribe?u=1311ec6dc48b0ce978cd11b98&amp;id=e86c9f9c9d\" target=\"_blank\">Subscriu-te a la newsletter di&agrave;ria de FEFAC<\/a><\/strong><\/div>\n","protected":false},"excerpt":{"rendered":"<p>En el marc dels controls addicionals posats en marxa per a tots els medicaments del grup denominat dels &quot;sartans&quot;, s&#39;ha detectat la pres&egrave;ncia de&nbsp;N-nitrosaminas en determinats lots del principi actiu [&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":[136,188,1127,1704,2003,2004,2005,2006,2007],"class_list":["post-9459","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-farmacia","tag-pacient","tag-ibersartan","tag-sartans","tag-retirada","tag-lots","tag-envas"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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