\nZentiva a anun\u0163at c\u0103 Distonocalm, unul dintre cele mai utilizate medicamente din Rom\u00e2nia, nu va fi disponibil pe pia\u0163\u0103 \u00een perioada urm\u0103toare. Potrivit unui comunicat de pres\u0103, Distonocalm se afl\u0103 \u00een proces de autorizare la ANMDM \u00eentr-o nou\u0103 formul\u0103, din combina\u0163ia c\u0103reia a fost exclus derivatul de ergot. Dosarul pentru noua formul\u0103 a fost depus spre evaluare \u00een decembrie 2013.<\/p>\n
\nDecizia companiei Zentiva Rom\u00e2nia de a \u00eenregistra o nou\u0103 formul\u0103 Distonocalm vine dup\u0103 ce \u00een 2013 Comitetul pentru medicamente de uz uman (CHMP) al Agen\u0163iei Europene pentru Medicamente (EMA) a recomandat restric\u0163ionarea utiliz\u0103rii medicamentelor care con\u0163in deriva\u0163i de ergot pentru anumite indica\u0163ii terapeutice, nu \u015fi pentru cele ale medicamentului Distonocalm. Recomandarea CHMP a condus la dificult\u0103\u0163i de aprovizionare cu derivat de ergot \u015fi, \u00een final, la epuizarea stocurilor de materie prim\u0103, ceea ce face imposibil\u0103 continuarea produc\u0163iei \u00een formula actual\u0103.<\/p>\n
\n\u201cRegret\u0103m nepl\u0103cerile provocate pacien\u0163ilor \u015fi comunit\u0103\u0163ii de profesioni\u015fti \u00een s\u0103n\u0103tate \u015fi sper\u0103m c\u0103 reluarea produc\u0163iei \u00een noua formul\u0103 se va face c\u00e2t mai cur\u00e2nd, dup\u0103 ob\u0163inerea autoriz\u0103rii ANMDM\u201d, a declarat Simona Coco\u015f, Director General Zentiva Rom\u00e2nia.<\/p>\n","protected":false},"excerpt":{"rendered":"
Zentiva a anun\u0163at c\u0103 Distonocalm, unul dintre cele mai utilizate medicamente din Rom\u00e2nia, nu va fi disponibil pe pia\u0163\u0103 \u00een perioada urm\u0103toare. Potrivit unui comunicat de pres\u0103, Distonocalm se afl\u0103 \u00een proces de autorizare la ANMDM \u00eentr-o nou\u0103 formul\u0103, din combina\u0163ia c\u0103reia a fost exclus derivatul de ergot. Dosarul pentru noua formul\u0103 a fost depus […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[510],"tags":[33019,10356,13077,323,60,259,80,98,8769],"class_list":["post-131971","post","type-post","status-publish","format-standard","hentry","category-actualitate","tag-autorizare","tag-cautare","tag-disparitie","tag-medicamente","tag-piata","tag-productie","tag-refuz","tag-romania","tag-zentiva"],"_links":{"self":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts\/131971","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=131971"}],"version-history":[{"count":0,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts\/131971\/revisions"}],"wp:attachment":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=131971"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=131971"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=131971"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}