Катрен Стиль
Отменена регистрация импортного муколитика
Министерство здравоохранения сообщает об отмене государственной регистрации препарата «Амброксол-Рихтер». Соответствующий приказ опубликован в Государственном реестре лекарственных средств 27 апреля.
Из реестра исключен препарат «Амброксол-Рихтер» (амброксол) в лекарственной форме «сироп 6 мг/мл» производства компании «Гедеон Рихтер Румыния А. О.», Румыния. Номер регистрационного удостоверения: ЛСР-002666/08 от 10.04.2008.
Решение об отмене регистрации принято на основании подачи заявления компании «Гедеон Рихтер», которая является держателем регистрационного удостоверения на препарат.
Напомним, что реализация ЛС после отмены их государственной регистрации является административным нарушением и расценивается как «Продажа или ввоз на территорию Российской Федерации недоброкачественных лекарственных средств, либо реализация или ввоз недоброкачественных медицинских изделий, либо незаконные производство, продажа или ввоз незарегистрированных лекарственных средств» (ч. 2 статьи 6.33 КоАП РФ). Наказанием за это нарушение служит крупный штраф.
Ранее была отменена государственная регистрация препаратов «Алестамин», «Цисотер» и «Тэдаллис».
«Катрен-Стиль» ежемесячно публикует обзоры информационных писем Росздравнадзора, посвященных отзыву и изъятию ЛС, а также последним изменениям в ГРЛС. 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.
28 апреля 2020
Фото: depositphotos.com
Выпуск: №195, апрель 20204250 просмотров
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