{"id":17056,"date":"2019-06-06T13:48:15","date_gmt":"2019-06-06T13:48:15","guid":{"rendered":"https:\/\/celonpharma.com\/?p=17056"},"modified":"2019-06-06T13:48:15","modified_gmt":"2019-06-06T13:48:15","slug":"valzek-drug-status-update","status":"publish","type":"post","link":"https:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/","title":{"rendered":"Valzek \u2013 drug status update"},"content":{"rendered":"<p style=\"text-align: justify;\"><span lang=\"EN-GB\">By way of decisions of the Chief Pharmaceutical Inspectorate of 6\/06\/2019, the following drug batches mentioned therein \u2013 Valzek 80mg and Valzek 160mg \u2013 were <strong>re-approved for marketing<\/strong>, as a result of confirming their compliance with quality requirements for the applicable substance valsartan, determined by the regulators. Based on these decisions, batches of Valzek marked with numbers listed in the aforementioned decisions can be administered to patients and sold by pharmacies in line with the current market availability.<\/span><\/p>\n<p><span lang=\"EN-GB\">Decisions on re-approving the listed product batches for marketing:<\/span><\/p>\n<p><span lang=\"EN-GB\"><a href=\"http:\/\/celon.group\/wp-content\/uploads\/2019\/06\/Decyzja_z_dn__06_06_2019r__Valzek_80mg_uchylenie.pdf\">Decision of the Chief Pharmaceutical Inspectorate_Valzek 80<br \/>\n<\/a><a href=\"https:\/\/celonpharma.com\/decyzja_z_dn__06_06_2019r__valzek_160mg_uchylenie-1\/\">Decision of the Chief Pharmaceutical Inspectorate Valzek 160<\/a><\/span><\/p>\n<p style=\"text-align: justify;\"><span lang=\"EN-GB\">By way of separate decisions of the Chief Pharmaceutical Inspectorate of 6\/06\/2019, the following drug batches mentioned therein \u2013 Valzek 80 mg and Valzek 160 mg \u2013 <strong>were withdrawn from the market<\/strong> for slightly exceeding the level of NDMA (nitrosodimethylamine) impurities determined by the regulators with regard to valsartan. This situation in no way puts the patients\u2019 health and lives at risk. Patients in possession of Valzek marked with the numbers listed in the aforementioned decisions may return the drug to the pharmacy where it was purchased. The pharmacies will provide the patients with all information on the procedure of returning a drug belonging to a batch covered by the decision of the Chief Pharmaceutical Inspectorate.<\/span><\/p>\n<p><span lang=\"EN-GB\">Decisions on withdrawing the listed product batches from the market:<\/span><\/p>\n<p><span lang=\"EN-GB\"><a href=\"http:\/\/celon.group\/wp-content\/uploads\/2019\/06\/24_WC_2019_Valzek_80mg_wycofanie.pdf\">Decision of the Chief Pharmaceutical Inspectorate Valzek 80 &#8211; withdrawn batches<\/a><br \/>\n<a href=\"http:\/\/celon.group\/wp-content\/uploads\/2019\/06\/25_WC_2019_Valzek_160mg_wycofanie.pdf\">Decision of the Chief Pharmaceutical Inspectorate Valzek 160 &#8211; withdrawn batches<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>By way of decisions of the Chief Pharmaceutical Inspectorate of 6\/06\/2019, the following drug batches mentioned therein \u2013 Valzek 80mg and Valzek 160mg \u2013 were re-approved for marketing, as a result of confirming their compliance with quality requirements for the applicable substance valsartan, determined by the regulators. Based on these decisions, batches of Valzek marked<a class=\"excerpt-read-more float-right\" href=\"https:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/\" title=\"ReadValzek \u2013 drug status update\">Read more &raquo;<\/a><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[26],"tags":[],"class_list":["post-17056","post","type-post","status-publish","format-standard","hentry","category-general-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.8.1 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Valzek \u2013 drug status update - CelonGROUP<\/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:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Valzek \u2013 drug status update - CelonGROUP\" \/>\n<meta property=\"og:description\" content=\"By way of decisions of the Chief Pharmaceutical Inspectorate of 6\/06\/2019, the following drug batches mentioned therein \u2013 Valzek 80mg and Valzek 160mg \u2013 were re-approved for marketing, as a result of confirming their compliance with quality requirements for the applicable substance valsartan, determined by the regulators. Based on these decisions, batches of Valzek markedRead more &raquo;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/\" \/>\n<meta property=\"og:site_name\" content=\"CelonGROUP\" \/>\n<meta property=\"article:published_time\" content=\"2019-06-06T13:48:15+00:00\" \/>\n<meta name=\"author\" content=\"Ma\u0142gorzata Siewierska\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ma\u0142gorzata Siewierska\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/\",\"url\":\"https:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/\",\"name\":\"Valzek \u2013 drug status update - CelonGROUP\",\"isPartOf\":{\"@id\":\"https:\/\/celon.group\/en\/#website\"},\"datePublished\":\"2019-06-06T13:48:15+00:00\",\"author\":{\"@id\":\"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf\"},\"breadcrumb\":{\"@id\":\"https:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/celon.group\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Valzek \u2013 drug status update\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/celon.group\/en\/#website\",\"url\":\"https:\/\/celon.group\/en\/\",\"name\":\"CelonGROUP\",\"description\":\"\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/celon.group\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/celon.group\/en\/#\/schema\/person\/e0ffc863fc928f3fd9bd67757492badf\",\"name\":\"Ma\u0142gorzata Siewierska\",\"url\":\"https:\/\/celon.group\/en\/author\/malgorzata-siewierska\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Valzek \u2013 drug status update - CelonGROUP","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/celon.group\/en\/2019\/06\/06\/valzek-drug-status-update\/","og_locale":"en_US","og_type":"article","og_title":"Valzek \u2013 drug status update - CelonGROUP","og_description":"By way of decisions of the Chief Pharmaceutical Inspectorate of 6\/06\/2019, the following drug batches mentioned therein \u2013 Valzek 80mg and Valzek 160mg \u2013 were re-approved for marketing, as a result of confirming their compliance with quality requirements for the applicable substance valsartan, determined by the regulators. 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