Катрен Стиль
Препараты для лечения COVID-19 получили долгосрочную регистрацию
Лекарственные средства с фавипиравиром «Коронавир» и «Арепливир», предназначенные для лечения коронавирусной инфекции, получили постоянную регистрацию в России. Об этом 29 октября пишет ТАСС со ссылкой на заявление заместителя министра здравоохранения Виктора Фисенко.
Напомним, что эти ЛС были зарегистрированы по «ускоренной процедуре», которая предусмотрена для лекарственных препаратов, предназначенных для применения в условиях чрезвычайной ситуации или профилактики и лечения заболеваний, представляющих опасность для окружающих. Регистрация ЛС по такой схеме занимает гораздо меньшее время. Также производителю не нужно проводить углубленные клинические исследования препарата.
Регистрационные удостоверения, выданные по ускоренной схеме, действуют до 1 января 2021 года. Предполагается, что после этой даты производитель должен пройти процедуру перерегистрации, проведя ее по всем правилам.
Теперь, согласно информации из Государственного реестра лекарственных средств, срок действия регистрационных удостоверений «Коронавира» и «Арепливира» продлен до сентября 2025 года. Отметим, что третий российский препарат с действующим веществом фавипиравир — «Афиравир» — по‑прежнему имеет регистрацию до 1 января 2021 года.
Ранее все лекарственные препараты с фавипиравиром были включены в перечень ЖНВЛП. После этого Минздрав официально утвердил предельные отпускные цены на них — в 2 раза ниже, чем стоимость, объявленная ранее производителями.
30 октября 2020
Фото: depositphotos.com
Выпуск: №201, октябрь 20202274 просмотров
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