Индийский валсартан снова признан безопасным
8 ноября 2019
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№190, ноябрь 2019
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Индийский валсартан снова признан безопасным
Специальный комитет Европейского директората по качеству медицинской продукции (EDQM) 25 октября 2019 года восстановил сертификат пригодности СЕР 2016–069 на субстанцию «валсартан» производства компании «Хетеро Лабс Лимитед» (Индия). Об этом 6 ноября сообщил Росздравнадзор в своем официальном письме.
Речь идет о фармацевтической субстанции «валсартан», производимой на заводе Gaddapotharam (Индия). Теперь это вещество снова можно использовать для производства лекарственных препаратов.
Ранее, 18 июня 2019 года, Комитет Европейского директората по качеству медицинской продукции (ЕDQМ) также восстановил сертификаты пригодности для субстанций валсартан производства китайских компаний «Майлен Лабораториз Лимитед» и «Чжэцзян Танья Фармасьютикал Ко. Лтд».
Напомним, что в 2018 году в препаратах, изготовленных из фармацевтической субстанции ряда китайских и индийских производителей, были обнаружены канцерогенные примеси N-нитрозодиметиламина. В Европе были изъяты из обращения все препараты, изготовленные из таких субстанций, и отозваны сертификаты пригодности. Также регуляторы Евросоюза запретили дальнейшее использование такого валсартана при производстве ЛС. В России в прошлом году из обращения было отозвано 612 серий препаратов, изготовленных из потенциально опасной субстанции.
Катрен Стиль
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