Катрен Стиль18 октября 2021
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Выпуск: №214, октябрь 20211014 просмотров
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У индийского лозартана калия приостановлен сертификат пригодности
Специальный комитет Европейского директората по качеству медицинской продукции (EDQM) 22 сентября приостановил сертификат пригодности на субстанцию «Лозартан калия» компании «Микро Лабс Лимитед» (Индия). Росздравнадзор сообщает об этом в официальном письме от 15 октября.
Речь идёт о приостановлении сертификата пригодности СЕР 2019–317. Причина такого решения в письме Росздравнадзора не указана, однако на официальном сайте EDQM она сформулирована следующим образом: «Suspended by EDQM Failure to CEP procedure» («Приостановлен из‑за ошибки в процедуре сертификации»).
Лозартан калия — это антигипертензивное средство из группы антагонистов рецепторов ангиотензина II (АТ1‑подтип).
Ранее фармацевтическая субстанция «Лозартан калия» уже попадала под ограничительные меры Европейского директората по качеству медицинской продукции. В феврале 2019 года стало известно о приостановке сертификата пригодности аналогичной субстанции производства другой индийской компании — «Хетеро Лабс Лимитед». Тогда решение регулятора было связано с наличием в пробах недопустимого уровня примеси N-нитpo-N-метиламиномасляной кислоты (NMBA).
«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.
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