{"id":16956,"date":"2025-05-12T22:48:08","date_gmt":"2025-05-12T22:48:08","guid":{"rendered":"https:\/\/kamucalisanlari.net\/?p=16956"},"modified":"2025-05-12T22:48:08","modified_gmt":"2025-05-12T22:48:08","slug":"turk-ilaca-m-cicegi-acil-kullanim-onayi","status":"publish","type":"post","link":"https:\/\/kamucalisanlari.net\/index.php\/2025\/05\/12\/turk-ilaca-m-cicegi-acil-kullanim-onayi\/","title":{"rendered":"Turk \u0130la\u00e7&#8217;a M-\u00e7i\u00e7e\u011fi acil kullan\u0131m onay\u0131"},"content":{"rendered":"<div>\n<p>T\u00fcrk \u0130la\u00e7 ve Serum Sanayi A.\u015e&#8217;nin Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu&#8217;na TPOXX 200 Mg kaps\u00fcl ilac\u0131n ruhsatland\u0131rma s\u00fcrecinin ba\u015flat\u0131lmas\u0131 i\u00e7in yapt\u0131\u011f\u0131 &#8221;acil kullan\u0131m onay\u0131&#8221; ba\u015fvurusu onayland\u0131.<\/p>\n<p>Kamuyu Ayd\u0131nlatma Platformuna (KAP) yap\u0131lan a\u00e7\u0131klama ise \u015f\u00f6yle:<\/p>\n<p>D\u00fcnya Sa\u011fl\u0131k Te\u015fkilat\u0131 Acil Durum Komitesi taraf\u0131ndan Uluslararas\u0131 \u00d6neme Sahip bir \u2018Halk Sa\u011fl\u0131\u011f\u0131 Acil Durumu&#8217; olarak ilan edilen Maymun \u00c7i\u00e7e\u011fi Vir\u00fcs\u00fc&#8217;n\u00fcn tedavisinde EMA (Avrupa \u0130la\u00e7 Ajans\u0131) taraf\u0131ndan onayl\u0131 olarak kabul edilen tek m\u00fcstahzar olan Tecovirimat (Ticari ismi ile Tpoxx) i\u00e7in Turk \u0130la\u00e7 ve Serum Sanayi A\u015e ile Siga Pharmaceuticals Inc. (ABD) aras\u0131nda T\u00fcrkiye M\u00fcnhas\u0131ran Tek Yetkili Distrib\u00fct\u00f6rl\u00fck S\u00f6zle\u015fmesi 19. 09.2024 tarihinde imza alt\u0131na al\u0131nm\u0131\u015ft\u0131r.<\/p>\n<\/div>\n<div>\n<p>Bu anla\u015fmaya istinaden T.C. Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu\u2019na TPOXX 200 Mg Kaps\u00fcl ilac\u0131n ruhsatland\u0131rma s\u00fcrecinin ba\u015flat\u0131lmas\u0131 i\u00e7in 23.09.2024 Tarihinde Acil Kullan\u0131m Onay\u0131 ba\u015fvurusunda bulunulmu\u015ftur.<\/p>\n<p>T.C. Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu taraf\u0131ndan ba\u015fvurumuzun de\u011ferlendirilmesi sonucunda Be\u015feri T\u0131bbi \u00dcr\u00fcnler \u00d6ncelik De\u011ferlendirme Kurulu \u00c7al\u0131\u015fma Usul ve Esaslar\u0131na \u0130li\u015fkin K\u0131lavuz do\u011frultusunda \u201cBe\u015feri t\u0131bbi \u00fcr\u00fcnler i\u00e7in ko\u015fullu ruhsatland\u0131rma (Acil Kullan\u0131m Onay\u0131) ihtiyac\u0131na y\u00f6nelik \u00f6zel durum tespiti ba\u015fvurusu\u201d kapsam\u0131nda yapt\u0131\u011f\u0131m\u0131z ba\u015fvuru \u201cBe\u015feri t\u0131bbi \u00fcr\u00fcnler i\u00e7in istisnai ruhsatland\u0131rma ihtiyac\u0131na y\u00f6nelik \u00f6zel durum tespiti ba\u015fvurusu\u201d t\u00fcr\u00fcne aktar\u0131larak istisnai ruhsat ba\u015fvurusu yap\u0131lmas\u0131na onay verilmi\u015ftir.<\/p>\n<p>07.11.2024 Tarihinde T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu taraf\u0131ndan \u015firketimize iletilen \u201c\u00d6ncelik De\u011ferlendirme Kurulu Karar\u0131\u201d\u2019 onay yaz\u0131s\u0131na istinaden TPOXX isimli Maymun \u00c7i\u00e7e\u011fi Vir\u00fcs\u00fc ilac\u0131 ile ilgili istisnai ruhsat ba\u015fvurusu ile ilgili t\u00fcm i\u015flemler firmam\u0131zca tamamlanacakt\u0131r.<\/p>\n<\/div>\n<\/p>\n<p><\/p>\n<p>Kaynak :\u00a0<span style=\"background-color: rgb(255, 249, 236); color: rgb(55, 58, 60); font-size: 14px;\">https:\/\/www.bloomberght.com\/turk-ilac-ve-serum-sanayi-as-nin-maymun-cicegi-basvurusu-onaylandi-3734106<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Turk \u0130la\u00e7 ve Serum Sanayi A.\u015e&#8217;nin Sa\u011fl\u0131k Bakanl\u0131\u011f\u0131 T\u00fcrkiye \u0130la\u00e7 ve T\u0131bbi Cihaz Kurumu&#8217;na TPOXX 200 Mg kaps\u00fcl ilac\u0131n ruhsatland\u0131rma s\u00fcrecinin ba\u015flat\u0131lmas\u0131 i\u00e7in yapt\u0131\u011f\u0131 acil kullan\u0131m onay\u0131 ba\u015fvurusu onayland\u0131.<\/p>\n","protected":false},"author":1,"featured_media":16957,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[2269,177,2268,2267,156],"manset":[],"class_list":["post-16956","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ekonomi","tag-basvurusu","tag-onay","tag-ruhsat","tag-tibbi","tag-turk"],"_links":{"self":[{"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/posts\/16956","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/comments?post=16956"}],"version-history":[{"count":1,"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/posts\/16956\/revisions"}],"predecessor-version":[{"id":16958,"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/posts\/16956\/revisions\/16958"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/media\/16957"}],"wp:attachment":[{"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/media?parent=16956"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/categories?post=16956"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/tags?post=16956"},{"taxonomy":"manset","embeddable":true,"href":"https:\/\/kamucalisanlari.net\/index.php\/wp-json\/wp\/v2\/manset?post=16956"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}