Катрен СтильОпубликован подробный список ЛС с опасным валсартаном, подлежащих отзыву (скачать)
Росздравнадзор опубликовал обобщенную информацию о сериях лекарственных препаратов, отзываемых из обращения по причине использования при их производстве фармацевтической субстанции валсартан с содержанием опасной канцерогенной примеси. Полный список серий отозванных препаратов опубликован 25 декабря.
Росздравнадзор публикует полный список (по состоянию на декабрь 2018 года) серий лекарственных препаратов, в производстве которых использовалась субстанция компаний «Чжэцзян Хуахай Фармасьютикал Ко. Лтд» и «Майлен Лабораториз Лимитед». Все эти серии ЛС подлежат отзыву из обращения в России.
В список вошли торговые наименования «Валз», «Валз Н», «Нортиван», «Валсартан-СЗ», «Валсартан», «Валсартан МС», «Валсартан Зентива», «Амлодипин-Валсартан-Рихтер», «Валсартан-Гидрохлоротиазид-Акрихин».
Подробную таблицу с указаниями всех 612 серий препаратов можно найти в приложении к информационному письму.
Напомним, что в июле этого года в субстанции валсартан, изготовленной на китайском предприятии «Чжэцзян Хуахай Фармасьютикал Ко. Лтд» были обнаружены примеси N-нитрозодиметиламина. В результате в Европе были изъяты все изготовленные из нее препараты.
В декабре Европейским директоратом по качеству лекарственных средств и здравоохранения (EDQM) было установлено, что индийская компания «Майлен Лабораториз Лимитед» в регистрационных документах указывала вышеупомянутое китайское предприятие как одну из промежуточных площадок изготовления субстанции валсартана. После публикации этой информации производители начали отзывать из обращения ЛС, изготовленные из индийской субстанции.
26 декабря 2018
7976 просмотров
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