Импортный муколитик лишился государственной регистрации
28 октября 2020
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№201, октябрь 2020
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Импортный муколитик лишился государственной регистрации
Министерство здравоохранения сообщает о принятом решении отменить государственную регистрацию лекарственного препарата «Лазонгин» (амброксол). Приказ об этом опубликован 27 октября в Государственном реестре лекарственных средств.
Речь идет о препарате «Лазонгин» в лекарственной форме «таблетки для рассасывания мятные, 20 мг», производства компании «Дельфарм Реймс», Франция. Номер регистрационного удостоверения: ЛП-000523 от 01.03.2011 г.
Регистрация этого ЛС отменена после подачи соответствующего заявления от владельца регистрационного удостоверения АО «Санофи Россия».
Ранее из государственного реестра был исключен гепатопротектор «Тиоктовая кислота» производства компании «Эском». В апреле этого года Минздрав также отменил регистрацию другого препарата с амброксолом в лекарственной форме сиропа.
Напоминаем, 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.
«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.
Катрен Стиль
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