Отечественный производитель приостанавливает реализацию «Ранитидина» после сообщений из Европы
13 ноября 2019
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№190, ноябрь 2019
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Отечественный производитель приостанавливает реализацию «Ранитидина» после сообщений из Европы
12 ноября Росздравнадзор сообщил о решении ОАО «Тюменский химико-фармацевтический завод» приостановить реализацию лекарственного препарата «Ранитидин-ЛекТ». Это связано с решением Специального комитета Европейского директората по качеству медицинской продукции (EDQM) о приостановлении сертификата пригодности на субстанцию «ранитидина гидрохлорид» производства SMS Pharmaceuticals Limited (Индия).
Речь идет о препарате «Ранитидин-ЛекТ» в лекарственной форме «таблетки, покрытые пленочной оболочкой, 150 мг 10 шт., упаковки ячейковые контурные, пачки картонные».
Выводу из реализации подлежат серии: 010119, 020119, 030119, 040219, 050419, 060419, 070419, 080419, 090519, 100519, 110719, 120719, 130719, 140719 и 150719.
В производстве этих серий была использована субстанция «ранитидина гидрохлорид» производства индийской компании SMS Pharmaceuticals Limited.
Росздравнадзор предлагает субъектам обращения лекарственных средств и медицинским организациям провести проверку наличия указанных серий лекарственного препарата, о результатах которой информировать территориальный орган ведомства. Также указанные ЛС следует поместить в карантинную зону.
Ранее, 15 октября 2019 года Специальный комитет Европейского директората по качеству медицинской продукции (EDQM) приостановил сертификат пригодности на фармацевтическую субстанцию «ранитидина гидрохлорид» производства компании SMS Pharmaceuticals Limited. Такое решение было принято в связи с выявлением в указанной субстанции примеси потенциально канцерогенного вещества — N-нитрозодиметиламина (NDMA).
Также 9 октября ОАО «Ирбитский химико-фармацевтический завод» сообщило о решении отозвать из оборота серию препарата «Ранитидин» из‑за приостановки действия сертификата пригодности на субстанцию, из которой изготовлен препарат. Тогда речь шла о субстанции другого индийского производителя — компании «Сарака Лабораториз Лимитед».
Катрен Стиль
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