Катрен Стиль26 декабря 2018
7536 просмотров
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Опубликован 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.
7536 просмотров
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