Катрен Стиль
Производитель отзывает пять серий шампуня от псориаза
Компания ООО «Галдерма» приняла решение отозвать из обращения несколько серий лекарственного средства «Этривекс» из‑за несоответствия информации о фармацевтической субстанции, из которой изготовлена партия этого ЛС. Информационное письмо об этом опубликовано на сайте Росздравнадзора 17 июня.
Речь идёт о препарате «Этривекс, шампунь 0,05 %, 60 мл, флаконы (1), пачки картонные» серий 1114257, 1114255, 1114239, 0114303, 9114279 производства «Лаборатории Галдерма» (Франция). При изготовлении данных серий была использована субстанция «клобетазол» производства «Симбиотек Фармалаб Прайвит Лимитед» (Индия), сведения о которой отсутствуют в регистрационном досье на данный препарат. По этой причине производитель решил отозвать эти серии из гражданского оборота.
При обнаружении указанных серий «Этривекса» в своём ассортименте аптекам необходимо предоставить в территориальный орган Росздравнадзора сведения, подтверждающие возврат ЛС поставщикам или производителю.
Ранее по аналогичной причине из обращения были отозваны восемь серий препарата «Эффезел» компании «Галдерма».
На прошлой неделе из гражданского оборота по решению производителя «Тюменский химико-фармацевтический завод» была отозвана серия препарата «Тетрациклин-ЛекТ» из‑за нехватки одной из таблеток в запакованном блистере.
«Катрен-Стиль» регулярно публикует обзоры информационных писем Росздравнадзора, посвящённых отзыву и изъятию ЛС, а также списки препаратов, лишившихся регистрации в течение месяца. Большое количество данных в таких статьях организовано в виде таблиц — по ним удобно проверять свой ассортимент на наличие таких ЛС. Последний обзор с перечнем таких ЛС читайте по этой ссылке.
20 июня 2022
Фото: © tiverylucky / Фотобанк Фотодженика
Выпуск: №222, июнь 20221058 просмотров
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