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Вниманию производителей: в фармсубстанции фенотерола обнаружены посторонние примеси
Вниманию производителей: в фармсубстанции фенотерола обнаружены посторонние примеси
Федеральная служба по надзору в сфере здравоохранения приняла решение прекратить оборот серии фармацевтической субстанции «Фенотерола гидробромид» из‑за обнаружения в ней посторонних примесей. Информационное письмо об этом опубликовано 5 апреля на сайте ведомства.
Речь идёт о серии FNO 220 лекарственного средства «Фенотерола гидробромид, субстанция-порошок» производства компании «Люсокимика С. п. А.» (Италия). Проверка, проведённая экспертным учреждением екатеринбургского филиала Росздравнадзора, обнаружила в ней несоответствие нормативной документации по показателю «Посторонние примеси».
Производителям необходимо сообщить в Росздравнадзор обо всех сериях лекарственных препаратов, в изготовлении которых была использована эта серия субстанции, чтобы в дальнейшем изъять их из оборота.
Согласно Государственному реестру лекарственных средств, в России зарегистрировано 18 торговых наименований с действующим веществом фенотерол (в том числе комбинированных ЛС). Субстанция «Фенотерола гидробромид» компании «Люсокимика С. п. А.» используется при производстве восьми из них.
Напомним, что ранее Минздрав отменил государственную регистрацию двух фармацевтических субстанций — «Акарбоза» и «Азтреонам с L-аргинином».
6 апреля 2021
Фото: depositphotos.com
Выпуск: №207, апрель 20211580 просмотров
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