Катрен Стиль
Производитель приостановил оборот серии препарата от недержания
Компания ООО «Эббот Лабораториз» приняла решение приостановить обращение одной серии лекарственного средства «Дриптан» (оксибутинин). Информационное письмо об этом опубликовано 27 июля на сайте Росздравнадзора.
Речь идёт о серии 30811 препарата «Дриптан, таблетки, 5 мг 15 шт., блистеры (2), пачки картонные» производства компании «Ресифарм Фонтэн» (Франция). Приостановление обращения связано с необходимостью провести дополнительные испытания указанной серии лекарственного средства на соответствие требованиям нормативной документации по показателю «Родственные примеси».
Всем субъектам обращения ЛС — аптекам, медицинским организациями и оптовым поставщикам — необходимо провести проверку наличия этой серии в ассортименте и при обнаружении поместить её в зону карантинного хранения, а также сообщить об этом в территориальный орган Росздравнадзора. Региональным отделениям ведомства поручено обеспечить изъятие указанной серии из оборота.
Оксибутинин — препарат, снижающий тонус гладкой мускулатуры мочевыводящих путей. Показанием к его применению являются недержание мочи, обусловленное нестабильностью функции мочевого пузыря нейрогенного характера (например, при рассеянном склерозе) либо идиопатической природы, а также ночной энурез у детей старше пяти лет.
Ранее по решению Росздравнадзора был прекращён гражданский оборот серии лекарственного препарата «Парацетамол Велфарм».
Напомним, что мы ежемесячно составляем перечень лекарственных средств, оборот которых был прекращён Росздравнадзором, а также препаратов, которые были отозваны производителями или лишились государственной регистрации. Последний обзор информационных писем регулятора со списком таких ЛС за июнь читайте по этой ссылке.
27 июля 2022
Фото: © kalinovsky / Фотобанк Фотодженика
Выпуск: №223, июль 20221163 просмотров
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1163 просмотров
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