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{"id":6790,"date":"2021-10-26T12:59:00","date_gmt":"2021-10-26T09:59:00","guid":{"rendered":"https:\/\/inews24.eu\/?p=6790"},"modified":"2021-10-28T13:01:00","modified_gmt":"2021-10-28T10:01:00","slug":"covid-19-eiropas-zalu-agentura-uzsak-molnupiravira-paatrinato-vertesanu","status":"publish","type":"post","link":"https:\/\/inews24.eu\/covid-19-eiropas-zalu-agentura-uzsak-molnupiravira-paatrinato-vertesanu\/","title":{"rendered":"Covid-19: Eiropas Z\u0101\u013cu a\u0123ent\u016bra uzs\u0101k molnupirav\u012bra pa\u0101trin\u0101to v\u0113rt\u0113\u0161anu"},"content":{"rendered":"\n<p>Z\u0101\u013cu valsts a\u0123ent\u016bra inform\u0113, ka&nbsp;Eiropas Z\u0101\u013cu a\u0123ent\u016bras (EZA)&nbsp;Cilv\u0113kiem paredz\u0113to z\u0101\u013cu komiteja (CHMP) ir uzs\u0101kusi pa\u0101trin\u0101to v\u0113rt\u0113\u0161anu peror\u0101laj\u0101m pretv\u012brusu z\u0101l\u0113m&nbsp;molnupirav\u012bram&nbsp;(zin\u0101ms ar\u012b k\u0101 MK-4482 vai&nbsp;Lagevrio), ko Covid-19 \u0101rst\u0113\u0161anai pieaugu\u0161ajiem izstr\u0101d\u0101jis uz\u0146\u0113mums&nbsp;<em>Merck Sharp &amp;&nbsp;<\/em><em>Dohme<\/em>&nbsp;sadarb\u012bb\u0101 ar&nbsp;<em>Ridgeback<\/em><em>&nbsp;<\/em><em>Biotherapeutics<\/em>.<\/p>\n\n\n\n<p>CHMP l\u0113mums uzs\u0101kt pa\u0101trin\u0101to v\u0113rt\u0113\u0161anu ir balst\u012bts uz s\u0101kotn\u0113jiem rezult\u0101tiem no laboratoriskajiem p\u0113t\u012bjumiem (nekl\u012bniskajiem datiem) un kl\u012bniskajiem p\u0113t\u012bjumiem. \u0160ie p\u0113t\u012bjumi liecina, ka \u0161\u012bs z\u0101les var samazin\u0101t SARS-CoV-2 (v\u012bruss, kas izraisa Covid-19) sp\u0113ju vairoties organism\u0101, t\u0101d\u0113j\u0101di nov\u0113r\u0161ot Covid-19 pacientu hospitaliz\u0101ciju un n\u0101vi.<\/p>\n\n\n\n<p>EZA izv\u0113rt\u0113s pla\u0161\u0101kus datus par \u0161o z\u0101\u013cu kvalit\u0101ti, dro\u0161umu un efektivit\u0101ti. Pa\u0101trin\u0101t\u0101 v\u0113rt\u0113\u0161ana tiks turpin\u0101ta, l\u012bdz uz\u0146\u0113mumam b\u016bs pieejams pietiekams pier\u0101d\u012bjumu daudzums, lai iesniegtu ofici\u0101lu re\u0123istr\u0101cijas pieteikumu.<\/p>\n\n\n\n<p>EZA izv\u0113rt\u0113s&nbsp;molnupirav\u012bra&nbsp;atbilst\u012bbu parastajiem ES efektivit\u0101tes, dro\u0161uma un kvalit\u0101tes standartiem. Lai gan EZA nevar paredz\u0113t kop\u0113jo proced\u016bras ilgumu, iesp\u0113jam\u0101 re\u0123istr\u0101cijas pieteikuma izv\u0113rt\u0113\u0161anai vajadz\u0113tu aiz\u0146emt maz\u0101k laika k\u0101 parasti, pateicoties pa\u0101trin\u0101t\u0101s v\u0113rt\u0113\u0161anas laik\u0101 paveiktajam darbam.<\/p>\n\n\n\n<p>EZA sniegs t\u0101l\u0101ku inform\u0101ciju, kad tiks iesniegts pieteikums \u0161o z\u0101\u013cu re\u0123istr\u0101cijai.<\/p>\n\n\n\n<p>EZA komitej\u0101s un darba grup\u0101s piedal\u0101s ar\u012b Latvijas Z\u0101\u013cu valsts a\u0123ent\u016bras eksperti.<\/p>\n\n\n\n<p><strong>K\u0101da ir \u0161o z\u0101\u013cu sagaid\u0101m\u0101 iedarb\u012bba?<\/strong><\/p>\n\n\n\n<p>\u0160\u012bs z\u0101les ir pretv\u012brusu l\u012bdzeklis, kuru var lietot iek\u0161\u0137\u012bgi (or\u0101li lietojamas).&nbsp;Tas&nbsp;ir \u201cv\u012brusa RNS&nbsp;polimer\u0101zes&nbsp;inhibitors\u201d \u2013 z\u0101les, kuras&nbsp;trauc\u0113&nbsp;v\u012brusa \u0123en\u0113tisk\u0101 materi\u0101la (RNS) veido\u0161anu. Sagaid\u0101ms, ka,&nbsp;trauc\u0113jot&nbsp;SARS-CoV-2 RNS veido\u0161anu,&nbsp;molnupirav\u012brs&nbsp;nov\u0113rs\u012bs v\u012brusa vairo\u0161anos.<\/p>\n\n\n\n<p><strong>Kas ir pa\u0101trin\u0101t\u0101 v\u0113rt\u0113\u0161ana?<\/strong><\/p>\n\n\n\n<p>Pa\u0101trin\u0101t\u0101 v\u0113rt\u0113\u0161ana ir viens no&nbsp;regulatorajiem&nbsp;r\u012bkiem, ko EZA izmanto, lai pa\u0101trin\u0101tu&nbsp;daudzsolo\u0161u&nbsp;z\u0101\u013cu vai vakc\u012bnu v\u0113rt\u0113\u0161anu sabiedr\u012bbas vesel\u012bbas \u0101rk\u0101rtas situ\u0101cij\u0101. Parasti ofici\u0101la re\u0123istr\u0101cijas pieteikuma gad\u012bjum\u0101 visi dati par z\u0101\u013cu efektivit\u0101ti, dro\u0161umu un kvalit\u0101ti, k\u0101 ar\u012b visi nepiecie\u0161amie dokumenti ir j\u0101iesniedz v\u0113rt\u0113\u0161anas s\u0101kum\u0101.<\/p>\n\n\n\n<p>Pa\u0101trin\u0101t\u0101s v\u0113rt\u0113\u0161anas gad\u012bjum\u0101 EZA&nbsp;Cilv\u0113kiem paredz\u0113to z\u0101\u013cu komiteja&nbsp;(CHMP) izv\u0113rt\u0113 datus pirms ofici\u0101la pieteikuma iesnieg\u0161anas, tikl\u012bdz dati k\u013c\u016bst pieejami no norito\u0161ajiem p\u0113t\u012bjumiem. Kad CHMP pie\u0146em l\u0113mumu, ka pieejamie dati ir pietiekami, uz\u0146\u0113mumam ir j\u0101iesniedz ofici\u0101ls pieteikums. Izv\u0113rt\u0113jot datus, tikl\u012bdz tie k\u013c\u016bst pieejami, CHMP var \u0101tr\u0101k pie\u0146emt l\u0113mumu, vai attiec\u012bg\u0101s z\u0101les vai vakc\u012bna ir re\u0123istr\u0113jama.<\/p>\n\n\n\n<p>Pa\u0101trin\u0101t\u0101 v\u0113rt\u0113\u0161an\u0101 un pand\u0113mijas laik\u0101 EZA un t\u0101s zin\u0101tnisk\u0101s komitejas atbalsta EZA COVID-19 pand\u0113mijas darba grupa (COVID-ETF). \u0160aj\u0101 grup\u0101 darbojas eksperti no visa Eiropas za\u013cu jomas regulator\u0101 t\u012bkla, lai sniegtu padomu par Covid-19 vakc\u012bnu un z\u0101\u013cu izstr\u0101di, re\u0123istr\u0113\u0161anu un dro\u0161uma uzraudz\u012bbu un lai veicin\u0101tu \u0101tru un koordin\u0113tu regulatoru r\u012bc\u012bbu.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Z\u0101\u013cu valsts a\u0123ent\u016bra inform\u0113, ka&nbsp;Eiropas Z\u0101\u013cu a\u0123ent\u016bras (EZA)&nbsp;Cilv\u0113kiem paredz\u0113to z\u0101\u013cu komiteja (CHMP) ir uzs\u0101kusi pa\u0101trin\u0101to v\u0113rt\u0113\u0161anu peror\u0101laj\u0101m pretv\u012brusu z\u0101l\u0113m&nbsp;molnupirav\u012bram&nbsp;(zin\u0101ms ar\u012b k\u0101 MK-4482 vai&nbsp;Lagevrio), ko Covid-19 \u0101rst\u0113\u0161anai pieaugu\u0161ajiem izstr\u0101d\u0101jis uz\u0146\u0113mums&nbsp;Merck Sharp &amp;&nbsp;Dohme&nbsp;sadarb\u012bb\u0101 ar&nbsp;Ridgeback&nbsp;Biotherapeutics. CHMP l\u0113mums uzs\u0101kt pa\u0101trin\u0101to v\u0113rt\u0113\u0161anu ir balst\u012bts uz s\u0101kotn\u0113jiem rezult\u0101tiem no laboratoriskajiem p\u0113t\u012bjumiem (nekl\u012bniskajiem datiem) un kl\u012bniskajiem p\u0113t\u012bjumiem. \u0160ie p\u0113t\u012bjumi liecina, ka \u0161\u012bs [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6791,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_jetpack_memberships_contains_paid_content":false,"jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false}}},"categories":[38],"tags":[],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/inews24.eu\/wp-content\/uploads\/2021\/10\/21B5417A-1F93-4DCE-A431-251CE143A036.jpeg?fit=829%2C553&ssl=1","jetpack_sharing_enabled":true,"jetpack-related-posts":[],"_links":{"self":[{"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/posts\/6790"}],"collection":[{"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/comments?post=6790"}],"version-history":[{"count":0,"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/posts\/6790\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/media\/6791"}],"wp:attachment":[{"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/media?parent=6790"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/categories?post=6790"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/inews24.eu\/wp-json\/wp\/v2\/tags?post=6790"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}