Официально: все серии «Эреспала» изымают из обращения
15 февраля 2019
Фото: depositphotos.com
Выпуск:
№181, февраль 2019
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Официально: все серии «Эреспала» изымают из обращения
Росздравнадзор объявил об отзыве регистрационных удостоверений и изъятии из обращения всех серий лекарственного препарата «Эреспал» (МНН: фенспирид) в лекарственных формах «таблетки, покрытые пленочной оболочкой, 80 мг» и «сироп 2 мг/мл». Такое решение было принято после обращения производителя препарата компании АО «Лаборатории Сервье».
Причина отзыва лекарственного средства — неблагоприятное соотношение польза/риск при применении препарата.
Клинические исследования, проведенные в 2018 году Комитетом по оценке рисков в сфере фармаконадзора (PRAC) Европейского агентства по лекарственным средствам (ЕМА), выявили потенциальную возможность удлинения интервала QT при применении фенспирида. В связи с обнаружением такого побочного действия препарата, который применяется для лечения не угрожающих жизни симптомов, компания «Сервье» приняла решение отозвать «Эреспал» с рынка Франции, а также с рынков других стран, включая Российскую Федерацию.
Фенспирид включен в Перечень жизненно необходимых и важнейших лекарственных препаратов на 2019 год. Согласно Государственному реестру лекарственных средств, в настоящий момент в России зарегистрировано 12 торговых наименований с действующим веществом фенспирид. Решение о дальнейшей судьбе этих препаратов будет принято Минздравом по результатам фармаконадзора или после обращения в министерство держателей регистрационных удостоверений.
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