Антимикробный препарат отзывают из обращения из‑за отмены регистрации
ЗАО «ФармФирма «Сотекс» сообщает об отзыве из обращения 64 серий препарата «Палин» (МНН: пипемидовая кислота) из‑за прекращения государственной регистрации ЛС. Соответствующее информационное письмо опубликовано 23 августа на сайте Росздравнадзора.
Речь идет о препарате «Палин», капсулы 200 мг 10 шт., упаковки ячейковые контурные, пачки картонные производства «Лек д. д.» (Словения) / упаковано: ЗАО «ФармФирма «Сотекс» (Россия). Отзыву подлежат серии:
010515, 020515, 031215, 010116, 020116, 030216, 040216, 050216, 060216, 070316, 080416, 090416, 100416, 110416, 120416, 130416, 140916, 150916, 160916, 170916, 180916, 190916, 201116, 211116, 221116, 010217, 020217, 030217, 040217, 050217, 060217, 070217, 080217, 090217, 100917, 110917, 120917, 130917, 140917, 150917, 010118, 020118, 030118, 040118, 050118, 060118, 070318, 080318, 090318, 100318, 110318, 120318, 131018, 141018, 151118, 161118, 010119, 020119, 030219, 040219, 050419, 060419, 070519, 080519.
От всех субъектов обращения лекарственных средств требуется сообщить в территориальный орган Росздравнадзора о том, что они сделали, чтобы исключить попадание этих серий в оборот. В частности, упаковки «Палина» указанных серий следует поместить в карантин и впоследствии вернуть поставщику.
«Палин» относится к антимикробным препаратам хинолонового ряда. Государственная регистрация этого ЛС прекращена 16 июля. Напомним, что реализация лекарств, исключенных из государственного реестра, является административным правонарушением, максимальный штраф за которое может достигать 5 миллионов рублей. Например, в мае Росздравнадзор оштрафовал аптеку на 500 тысяч рублей за отпуск препарата, регистрация которого была прекращена за месяц до момента проверки.
Также ранее по причине отмены государственной регистрации производитель отозвал из обращения препарат от гиперплазии «Тулозин».
26 августа 2019
Фото: depositphotos.com
Выпуск: №187, август 201925018 просмотров
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