{"id":5353,"date":"2016-01-18T14:53:46","date_gmt":"2016-01-18T11:53:46","guid":{"rendered":"http:\/\/btv.md\/?p=5353"},"modified":"2016-01-18T14:53:46","modified_gmt":"2016-01-18T11:53:46","slug":"preparat-vandut-in-moldova-si-interzis-in-ue","status":"publish","type":"post","link":"https:\/\/www.btv.md\/ro\/preparat-vandut-in-moldova-si-interzis-in-ue\/","title":{"rendered":"Preparat  v\u00e2ndut  \u00een  Moldova  \u0219i  interzis  \u00een  UE"},"content":{"rendered":"<p><strong>Agen\u0163ia European\u0103 pentru Medicamente (EMA) a decis la 21 mai 2015 suspendarea v\u00e2nz\u0103rilor mai multor medicamente din cauza suspiciunii efectu\u0103rii studiilor clinice de bioechivalen\u0163\u0103 defectuoase. \u00cen lista preparatelor cu probleme se reg\u0103se\u0219te \u0219i \u201eDesloratadina Alvogen 5 mg\u201d, medicament \u00eenregistrat \u015fi \u00een Republica Moldova. Produsul continu\u0103 s\u0103 fie v\u00e2ndut \u00een farmaciile noastre, iar Agen\u021bia Medicamentului \u0219i Dispozitivelor Medicale (AMED) explic\u0103 motivul, scrie <a href=\"http:\/\/www.ziarulnational.md\/de-ce-se-vinde-in-r-moldova-un-medicament-interzis-in-ue-explicatia-agentiei-medicamentului\/\" target=\"_blank\">Ziarul Na\u021bional<\/a>.<\/strong><\/p>\n<p>Potrivit AMED, Comisia European\u0103 a recomandat autorit\u0103\u0163ilor competente din UE am\u00e2narea punerii \u00een aplicare a deciziei de suspendare a medicamentului pe o perioada de cel mult 24 de luni, \u00een cazul \u00een care medicamentul este de importan\u0163\u0103 critic\u0103 la nivel na\u0163ional. Ca m\u0103sur\u0103 de redresare a situa\u0163iei \u00een aceste state, Comisia European\u0103 a propus solicitarea studiului de bioechivalen\u0163\u0103, \u00een termen de 12 luni de la de\u021bin\u0103torii Certificatului de \u00eenregistrare a medicamentului.<br \/>\nReprezentan\u021bii AMED sus\u021bin c\u0103 s-au autosesizat la acest anun\u0163 \u015fi subiectul a fost discutat \u00een cadrul Comisiei Medicamentului din 4 iunie 2015. <\/p>\n<p>\u00cen urma examin\u0103rii datelor privind importul medicamentelor cu denumirea comun\u0103 interna\u0163ional\u0103 \u201eDesloratadin\u0103\u201d, s-a constatat c\u0103 la moment cantit\u0103\u0163ile acestui preparat nu erau suficiente pentu acoperirea necesit\u0103\u0163ilor la nivel na\u021bional. <\/p>\n<p>Astfel, s-a luat decizia de a urma recomandarea Comisiei Europene \u015fi de a solicita de\u0163in\u0103torului certificatului de \u00eenregistrare a acestui medicament, companiei \u201eAlvogen IPCoS\u201d din Luxemburg, prezentarea studiilor de bioechivalen\u0163\u0103 \u00een termen de 12 luni, adic\u0103 p\u00e2n\u0103 la 21 mai 2016. <\/p>\n<p>Dac\u0103 p\u00e2n\u0103 atunci cerin\u021ba nu va fi executat\u0103, AMED va suspenda certificatul de \u00eenregistrare a medicamentului \u201eDesloratadina Alvogen 5 mg\u201d, cu retragerea ulterioar\u0103 a acestuia din farmacii. <\/p>\n<p>Institu\u021bia d\u0103 asigur\u0103ri c\u0103, din data \u00eenregistr\u0103rii medicamentului respectiv, pe teritoriul Republicii Moldova nu au fost raportate reac\u0163ii adverse la preparat. <\/p>\n","protected":false},"excerpt":{"rendered":"<p>Agen\u0163ia European\u0103 pentru Medicamente (EMA) a decis la 21 mai 2015 suspendarea v\u00e2nz\u0103rilor mai multor medicamente din cauza suspiciunii efectu\u0103rii studiilor clinice de bioechivalen\u0163\u0103 defectuoase. \u00cen lista preparatelor cu probleme se reg\u0103se\u0219te \u0219i \u201eDesloratadina Alvogen 5 mg\u201d, medicament \u00eenregistrat \u015fi \u00een Republica Moldova. Produsul continu\u0103 s\u0103 fie v\u00e2ndut \u00een farmaciile noastre, iar Agen\u021bia Medicamentului \u0219i [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":5354,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[8],"tags":[],"class_list":["post-5353","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-obshestvo"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Preparat v\u00e2ndut \u00een Moldova \u0219i interzis \u00een UE - BTV<\/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:\/\/www.btv.md\/ro\/preparat-vandut-in-moldova-si-interzis-in-ue\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Preparat v\u00e2ndut \u00een Moldova \u0219i interzis \u00een UE - BTV\" \/>\n<meta property=\"og:description\" content=\"Agen\u0163ia European\u0103 pentru Medicamente (EMA) a decis la 21 mai 2015 suspendarea v\u00e2nz\u0103rilor mai multor medicamente din cauza suspiciunii efectu\u0103rii studiilor clinice de bioechivalen\u0163\u0103 defectuoase. \u00cen lista preparatelor cu probleme se reg\u0103se\u0219te \u0219i \u201eDesloratadina Alvogen 5 mg\u201d, medicament \u00eenregistrat \u015fi \u00een Republica Moldova. 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