{"id":39474,"date":"2020-12-09T07:40:22","date_gmt":"2020-12-09T07:40:22","guid":{"rendered":"https:\/\/i-base.info\/htb\/?p=39474"},"modified":"2020-12-10T15:16:31","modified_gmt":"2020-12-10T15:16:31","slug":"eu-approves-dolutegravir-5-mg-dispersible-for-children-older-than-four-weeks","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/39474","title":{"rendered":"EU approves dolutegravir 5 mg dispersible for children older than four weeks"},"content":{"rendered":"<div><\/div>\n<div>\n<p class=\"HTBsubhead3authorcredit\"><strong><span lang=\"EN-US\">Polly Clayden, HIV i-Base<\/span><\/strong><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><b><span lang=\"EN-US\">On 12 November, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion recommending marketing authorisation for dolutegravir 5 mg dispersible tablets for young children with HIV. <\/span><\/b><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">This formulation can be used as part of an ART combination to treating children aged at least four weeks and weighing at least 3 kg. <\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">CHMP\u2019s opinion follows the\u00a0US Food and Drug Administration (FDA) paediatric approval\u00a0earlier this year. <\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The positive opinion also supports the updated dosing recommendations for dolutegravir film-coated tablets for children aged 6 years and above and weighing at least 14 kg, including the adult 50 mg tablet for children weighing at least 20 kg.<\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Full EMA approval is expected in January 2021. <\/span><\/p>\n<\/div>\n<div>\n<p class=\"HTBreference-noindent\"><span lang=\"EN-US\">Reference<br \/>\n<\/span>European Medicines Agency (EMA). Summary of opinion: Tivicay (dolutegravir). 12 November 2020.<br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/summaries-opinion\/tivicay\">https:\/\/www.ema.europa.eu\/en\/medicines\/human\/summaries-opinion\/tivicay<\/a><\/p>\n<\/div>\n<p><em>This report was first posted on 1 December 2020.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Polly Clayden, HIV i-Base On 12 November, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion recommending marketing authorisation for dolutegravir 5 mg dispersible tablets for young children with HIV. &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3,32],"tags":[],"class_list":["post-39474","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals","category-paediatric-care"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39474","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=39474"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/39474\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=39474"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=39474"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=39474"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}