Катрен Стиль
Приостановлены сертификаты пригодности на иностранную субстанцию ирбесартан
Федеральная служба здравоохранения сообщает о приостановлении в Европе действия сертификатов пригодности на фармацевтическую субстанцию ирбесартан производства турецкой и китайской компаний. Информационные письма об этом опубликованы 13 февраля на сайте ведомства.
Решение приостановить действие сертификатов было принято Специальным комитетом Европейского директората по качеству медицинской продукции (EDQM) из‑за того, что производители не смогли предоставить необходимые документы для прохождения процедуры сертификации. Речь идет о следующих сертификатах:
№ R0 СЕР 2014–029 на субстанцию «ирбесартан» производства компании «Чжэцзян Кинглюань Фармасьютикал Ко. Лтд.» (Zhejiang Kinglyuan Pharmaceutical Со., Ltd.) (No. 3, Weijiu Road, Hangzhou Bay Industrial Area China-312 369 Shangyu, Zhejiang Province).
№ R0 СЕР 2012–156 на субстанцию «ирбесартан» производства компании «Улькар Кимья Санайи Be Тикарет Аноним Сиркети» (Ulkar Kimya Sanayii Ve Ticaret Anonim Sirketi) (Saray Mahallesi Dr. Adnan Buyukdeniz Cad. No. 14 Turkey-34768 Umraniye, Istanbul).
Производители лекарственных препаратов, выпускающие ЛС с использованием указанной субстанции, до 25 февраля должны сообщить в Росздравнадзор по адресу [email protected] информацию о принятых решениях в отношении субстанции и лекарственных препаратов, произведенных из нее.
Напомним, что в январе прошлого года EDQM приостановил действие сертификата пригодности на ирбесартан еще одного китайского производителя, компании «Чжэцзян Хуахай Фармасьютикал Ко. Лтд». Тогда причиной для этого стало наличие в субстанции примесей N-нитрозодиэтиламина.
14 февраля 2020
Фото: depositphotos.com
Выпуск: №193, февраль 20202090 просмотров
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