{"id":16561,"date":"2013-04-27T01:30:00","date_gmt":"2013-04-26T23:30:00","guid":{"rendered":"http:\/\/www.fedaiisf.it\/medicinali-sottoposti-a-monitoraggio-addizionale-pubblicata-la-prima-lista\/"},"modified":"2013-04-27T01:30:00","modified_gmt":"2013-04-26T23:30:00","slug":"medicinali-sottoposti-a-monitoraggio-addizionale-pubblicata-la-prima-lista","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/medicinali-sottoposti-a-monitoraggio-addizionale-pubblicata-la-prima-lista\/","title":{"rendered":"Medicines subject to additional monitoring: first list published"},"content":{"rendered":"

The first was published on the European Medicines Agency website <\/font>list of medicines subject to additional monitoring<\/font><\/span><\/a>. This is an important step in applying the <\/font>new pharmacovigilance legislation<\/font><\/span><\/a> which provides for further surveillance activity for some types of medicinal products for which limited safety data are available, with a view to transparency and greater involvement of patients and healthcare professionals in reporting adverse reactions.<\/p>\n

<\/font><\/span><\/p>\n

The provision, which provides for the inclusion of a black symbol - an inverted equilateral triangle - on package leaflets and Summaries of Product Characteristics starting next autumn, applies to the following types of medicines:<\/p>\n

<\/font><\/span><\/p>\n

\u00b7       <\/span><\/span><\/span>products containing new active substances authorized in Europe after 1 January 2011;<\/p>\n

<\/font><\/span><\/p>\n

\u00b7       <\/span><\/span><\/span>biological medicinal products (such as vaccines and plasma derivatives) and biosimilars for which post-marketing experience data are limited;<\/p>\n

<\/font><\/span><\/p>\n

\u00b7       <\/span><\/span><\/span>E’ stata pubblicata sul sito dell’Agenzia Europea dei Medicinali la prima lista dei medicinali sottoposti a monitoraggio addizionale. Si tratta di un passaggio importante nell’applicazione della nuova legislazione di farmacovigilanza che prevede un’ulteriore attività di sorveglianza per alcune tipologie di medicinali per i quali sono disponibili dati di sicurezza limitati, nell’ottica della trasparenza e del …<\/p>","protected":false},"author":1,"featured_media":9846,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[90],"tags":[],"class_list":["post-16561","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fedaiisf-archivio-storico"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/16561","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=16561"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/16561\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/9846"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=16561"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=16561"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=16561"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}