Катрен Стиль
В Германии отзывают из оборота ранитидин из индийской субстанции
Федеральный институт лекарств и медицинских изделий Германии (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) объявляет об изъятии из обращения всех лекарственных препаратов, содержащих ранитидин, произведенных из субстанции индийского производителя. Сообщение об этом опубликовано 17 сентября на сайте немецкого регулятора.
Отзыву подлежат все препараты, изготовленные из субстанции ранитидин индийской компании Saraca Laboratories Limited. Причины для отзыва — возможное наличие канцерогенных примесей N-нитрозодиметиламин (NDMA) в веществе. Ранее об обнаружении таких примесей в ранитидине различных производителей сообщило Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (FDA).
Немецкий регулятор отмечает, что на данный момент следы примесей обнаружены не во всех препаратах ранитидина, поэтому отзыв носит превентивный характер. При дальнейшем изучении опасности обнаруженных примесей и их количества в других препаратах, меры по контролю могут быть изменены.
По информации из Государственного реестра лекарственных средств, в России зарегистрировано 12 наименований лекарственных препаратов, которые изготавливаются из фармацевтической субстанции ранитидин производства компании Saraca Laboratories Limited.
В прошлом году широкий общественный резонанс вызвало обнаружение подобных примесей N-нитрозодиметиламина (NDMA) в препаратах, содержащих валсартан. Примеси были обнаружены в субстанции, изготовленной на индийских и китайских фармацевтических предприятиях. Из-за этого в России было отозвано свыше 600 серий ЛС.
23 сентября 2019
Фото: depositphotos.com
Выпуск: №188, сентябрь 20193021 просмотров
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