Катрен Стиль
Возобновлено применение препарата для лечения почечной недостаточности
Министерство здравоохранения сообщает о решении разрешить применение препарата «Кетоаминол» после приостановки с марта 2020 года. Приказ об этом опубликован 24 августа в Государственном реестре лекарственных средств.
Речь идет о лекарственном средстве «Кетоаминол» (МНН: кетоаналоги аминокислот) в лекарственной форме таблетки, покрытые пленочной оболочкой, производства ЗАО «ФармФирма Сотекс» и «Наньцзин Байцзинюй Фарсмасьютикалз Ко., Лтд», Китай. Номер регистрационного удостоверения ЛП-002756 от 15.12.2014.
Применение этого ЛС было приостановлено в марте 2020 года на основании письма из Минпромторга, в котором были представлены сведения «о несоответствии производителя требованиям правил надлежащей производственной практики и/или о нарушении лицензионных требований».
Сейчас министерство опубликовало новое письмо о том, что все нарушения и несоответствия устранены. На основании его Минздрав вновь разрешил применение «Кетоаминола».
Напомним, что в середине августа в России было приостановлено применение двух индийских и одного американского препарата.
«Катрен-Стиль» ежемесячно публикует обзоры информационных писем Росздравнадзора, посвященных отзыву и изъятию ЛС, а также последним изменениям в ГРЛС. В том числе и лекарственным препаратам, применение которых приостановлено по решению Минздрава. Большое количество данных в таких статьях организовано в виде таблиц — по ним удобно проверять свой ассортимент на наличие «карантинных» или лишившихся регистрации препаратов. Последний обзор с перечнем таких ЛС читайте по этой ссылке.
25 августа 2020
Фото: depositphotos.com
Выпуск: №199, август 20202036 просмотров
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