{"id":38363,"date":"2024-12-20T08:23:17","date_gmt":"2024-12-20T08:23:17","guid":{"rendered":"https:\/\/radioorahovica.hr\/?p=38363"},"modified":"2024-12-20T08:23:17","modified_gmt":"2024-12-20T08:23:17","slug":"povlaci-se-lijek-s-trzista-eu-a-javio-se-i-halmed","status":"publish","type":"post","link":"https:\/\/radioorahovica.hr\/?p=38363","title":{"rendered":"Povla\u010di se lijek s tr\u017ei\u0161ta EU-a, javio se i HALMED"},"content":{"rendered":"<p><a href=\"https:\/\/radioorahovica.hr\/wp-content\/uploads\/2024\/09\/Dizajn-bez-naslova-2.png\"><img fetchpriority=\"high\" decoding=\"async\" class=\"aligncenter size-full wp-image-34558\" src=\"https:\/\/radioorahovica.hr\/wp-content\/uploads\/2024\/09\/Dizajn-bez-naslova-2.png\" alt=\"\" width=\"940\" height=\"788\" srcset=\"https:\/\/radioorahovica.hr\/wp-content\/uploads\/2024\/09\/Dizajn-bez-naslova-2.png 940w, https:\/\/radioorahovica.hr\/wp-content\/uploads\/2024\/09\/Dizajn-bez-naslova-2-300x251.png 300w, https:\/\/radioorahovica.hr\/wp-content\/uploads\/2024\/09\/Dizajn-bez-naslova-2-768x644.png 768w\" sizes=\"(max-width: 940px) 100vw, 940px\" \/><\/a><\/p>\n<div class=\"single__lead\">\n<p>Lijek Alofisel (darvadstrocel) se povla\u010di s tr\u017ei\u0161ta Europske unije. Hrvatska agencija za lijekove i medicinske proizvode (HALMED) objavila je da se lijek povla\u010di uslijed toga \u0161to vi\u0161e ne pokazuje klini\u010dku korist koja bi opravdala daljnju primjenu..<\/p>\n<\/div>\n<div class=\"single__content article__content\">\n<p>Sveobuhvatni podaci o lijeku relevantni za odobrenje za stavljanje lijeka u promet u EU-u, uklju\u010duju\u0107i rezultate ispitivanja ADMIRE-CD II, pokazuju da klini\u010dka korist lijeka Alofisel vi\u0161e nije dokazana da bi opravdala daljnju primjenu u zemljama EU-a, odnosno korist lijeka vi\u0161e ne nadma\u0161uje rizike povezane s njegovom primjenom.<\/p>\n<p>U randomiziranom, placebom kontroliranom klini\u010dkom ispitivanju ADMIRE-CD II koje istra\u017euje jednokratnu primjenu lijeka Alofisel u lije\u010denju kompleksnih perianalnih fistula u 568 bolesnika s Crohnovom bole\u0161\u0107u, nije postignuta primarna mjera ishoda kombinirane remisije u 24. tjednu, niti bilo koja od sekundarnih mjera ishoda.<\/p>\n<p>Navedeno ispitivanje je bilo obvezna mjera koja se morala provesti nakon davanja odobrenja, a koja je bila prethodno usugla\u0161ena s Europskom agencijom za lijekove (EMA) kod davanja odobrenja za stavljanje lijeka u promet, kako bi se potvrdila klini\u010dka korist lijeka, priop\u0107io je\u00a0<a href=\"https:\/\/www.halmed.hr\/Novosti-i-edukacije\/Novosti\/2024\/Pismo-zdravstvenim-radnicima-o-povlacenju-lijeka-Alofisel-darvastrocel-s-trzista-Europske-unije-uslijed-toga-sto-vise-ne-pokazuje-klinicku-korist-koja-bi-opravdala-daljnju-primjenu\/3438\" target=\"_blank\" rel=\"noreferrer noopener\">HALMED<\/a>.<\/p>\n<p>Nakon 13. prosinca 2024, na podru\u010dju EU\/EEA novi bolesnici ne smiju se lije\u010diti lijekom Alofisel.<\/p>\n<\/div>\n<p>(poslovni.hr \/ Foto: Canva)<\/p>\n<div class=\"single__content article__content\">\n<p>&nbsp;<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Lijek Alofisel (darvadstrocel) se povla\u010di s tr\u017ei\u0161ta Europske unije. Hrvatska agencija za lijekove i medicinske proizvode (HALMED) objavila<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-38363","post","type-post","status-publish","format-standard","hentry","category-vijesti"],"featured_image_urls":{"full":"","thumbnail":"","medium":"","medium_large":"","large":"","1536x1536":"","2048x2048":"","morenews-featured":"","morenews-large":"","morenews-medium":""},"author_info":{"display_name":"radio orahovica","author_link":"https:\/\/radioorahovica.hr\/?author=2"},"category_info":"<a href=\"https:\/\/radioorahovica.hr\/?cat=5\" rel=\"category\">Vijesti<\/a>","tag_info":"Vijesti","comment_count":"0","_links":{"self":[{"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=\/wp\/v2\/posts\/38363","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=38363"}],"version-history":[{"count":1,"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=\/wp\/v2\/posts\/38363\/revisions"}],"predecessor-version":[{"id":38364,"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=\/wp\/v2\/posts\/38363\/revisions\/38364"}],"wp:attachment":[{"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=38363"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=38363"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/radioorahovica.hr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=38363"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}