Уже во втором индийском ранитидине нашли потенциально опасные примеси
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. Об этом сообщил Росздравнадзор в своем официальном письме от 21 октября.
По данным ведомства, такое решение было принято в связи с выявлением в указанной субстанции примеси N-нитрозодиметиламина (NDMA).
Речь идет о субстанции от индийской компании SMS Pharmaceuticals Limited, произведенной по адресу: Unit-VII Poosapatirega Mandal. Vizianagaram District India-535 204 Kandivalasa Village, Andhra Pradesh.
Росздравнадзор предписывает производителям лекарственных средств, выпускающим лекарственные препараты с использованием указанной фармацевтической субстанции, а также организациям-импортерам лекарственных препаратов, выпущенных с ее использованием, в срок до 25 октября 2019 года предоставить информацию о принятых решениях в отношении этой субстанции и произведенных из нее ЛС.
Напомним, что ранее подобные меры были приняты в отношении фармсубстанции «ранитидин» производства компании Saraca Laboratories Limited (Индия). Вслед за этим сразу несколько производителей объявили об отзыве своих ЛС, изготовленных с использованием указанной субстанции.
22 октября 2019
Фото: depositphotos.com
Выпуск: №189, октябрь 20192325 просмотров
Array ( [0] => Array ( [ID] => 16466 [~ID] => 16466 [NAME] => apteka.ru/search/?q=%D1%81%D1%82%D0%B5%D0%BB%D0%BB%D0%B0%D0%BD%D0%B8%D0%BD&order=products%2Cmaterials&vendor= [~NAME] => apteka.ru/search/?q=%D1%81%D1%82%D0%B5%D0%BB%D0%BB%D0%B0%D0%BD%D0%B8%D0%BD&order=products%2Cmaterials&vendor= [DATE_ACTIVE_FROM] => 01.09.2019 11:17:00 [~DATE_ACTIVE_FROM] => 01.09.2019 11:17:00 [IBLOCK_ID] => 12 [~IBLOCK_ID] => 12 [PREVIEW_PICTURE] => 8171 [~PREVIEW_PICTURE] => 8171 ) [PROPERTIES] => Array ( [SWF] => Array ( [ID] => 99 [TIMESTAMP_X] => 2018-08-19 19:34:17 [IBLOCK_ID] => 12 [NAME] => Ссылка во флеше (link1) [ACTIVE] => Y [SORT] => 500 [CODE] => SWF [DEFAULT_VALUE] => [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 50 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Ссылка во флеше (link1) [~DEFAULT_VALUE] => ) [LINK] => Array ( [ID] => 100 [TIMESTAMP_X] => 2018-08-19 19:34:17 [IBLOCK_ID] => 12 [NAME] => Ссылка (без протокола) [ACTIVE] => Y [SORT] => 500 [CODE] => LINK [DEFAULT_VALUE] => [PROPERTY_TYPE] => S [ROW_COUNT] => 1 [COL_COUNT] => 50 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => 320465417 [VALUE] => apteka.ru/search/?q=%D0%B1%D0%B5%D1%80%D0%B5%D1%88&order=products%2Cmaterials&vendor=0 [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => apteka.ru/search/?q=%D0%B1%D0%B5%D1%80%D0%B5%D1%88&order=products%2Cmaterials&vendor=0 [~DESCRIPTION] => [~NAME] => Ссылка (без протокола) [~DEFAULT_VALUE] => ) [WEBINARS] => Array ( [ID] => 102 [TIMESTAMP_X] => 2020-11-05 08:23:57 [IBLOCK_ID] => 12 [NAME] => Вебинары [ACTIVE] => Y [SORT] => 500 [CODE] => WEBINARS [DEFAULT_VALUE] => [PROPERTY_TYPE] => E [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => Y [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 5 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => Y [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => EList [USER_TYPE_SETTINGS] => Array ( [size] => 20 [width] => 0 [group] => Y [multiple] => Y ) [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Вебинары [~DEFAULT_VALUE] => ) [TYPES] => Array ( [ID] => 103 [TIMESTAMP_X] => 2018-08-20 03:08:52 [IBLOCK_ID] => 12 [NAME] => Где показывать [ACTIVE] => Y [SORT] => 500 [CODE] => TYPES [DEFAULT_VALUE] => [PROPERTY_TYPE] => L [ROW_COUNT] => 20 [COL_COUNT] => 30 [LIST_TYPE] => C [MULTIPLE] => Y [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => Y [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => Array ( [0] => 320482201 ) [VALUE] => Array ( [0] => Страница статьи (273px) ) [DESCRIPTION] => Array ( [0] => ) [VALUE_ENUM] => Array ( [0] => Страница статьи (273px) ) [VALUE_XML_ID] => Array ( [0] => ade3837e8e0b9a67adab1fec2bc57639 ) [VALUE_SORT] => Array ( [0] => 500 ) [VALUE_ENUM_ID] => Array ( [0] => 458 ) [~VALUE] => Array ( [0] => Страница статьи (273px) ) [~DESCRIPTION] => Array ( [0] => ) [~NAME] => Где показывать [~DEFAULT_VALUE] => ) [RUBRICS] => Array ( [ID] => 104 [TIMESTAMP_X] => 2018-08-20 03:09:12 [IBLOCK_ID] => 12 [NAME] => Рубрики [ACTIVE] => Y [SORT] => 500 [CODE] => RUBRICS [DEFAULT_VALUE] => [PROPERTY_TYPE] => G [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => Y [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 20 [TMP_ID] => [LINK_IBLOCK_ID] => 2 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => Y [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Рубрики [~DEFAULT_VALUE] => ) [VIEWS] => Array ( [ID] => 105 [TIMESTAMP_X] => 2018-08-19 23:38:24 [IBLOCK_ID] => 12 [NAME] => Показы [ACTIVE] => Y [SORT] => 500 [CODE] => VIEWS [DEFAULT_VALUE] => [PROPERTY_TYPE] => N [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Показы [~DEFAULT_VALUE] => ) [CLICKS] => Array ( [ID] => 106 [TIMESTAMP_X] => 2018-08-19 23:38:24 [IBLOCK_ID] => 12 [NAME] => Клики [ACTIVE] => Y [SORT] => 500 [CODE] => CLICKS [DEFAULT_VALUE] => [PROPERTY_TYPE] => N [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 0 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => [USER_TYPE_SETTINGS] => [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Клики [~DEFAULT_VALUE] => ) [ARTICLE] => Array ( [ID] => 116 [TIMESTAMP_X] => 2019-05-17 13:18:54 [IBLOCK_ID] => 12 [NAME] => Статьи [ACTIVE] => Y [SORT] => 500 [CODE] => ARTICLE [DEFAULT_VALUE] => [PROPERTY_TYPE] => E [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => Y [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 2 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => EList [USER_TYPE_SETTINGS] => Array ( [size] => 20 [width] => 0 [group] => N [multiple] => Y ) [HINT] => [PROPERTY_VALUE_ID] => Array ( [0] => 320482202 ) [VALUE] => Array ( [0] => 32724 ) [DESCRIPTION] => Array ( [0] => ) [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => Array ( [0] => 32724 ) [~DESCRIPTION] => Array ( [0] => ) [~NAME] => Статьи [~DEFAULT_VALUE] => ) [CRIB] => Array ( [ID] => 117 [TIMESTAMP_X] => 2019-05-30 07:53:16 [IBLOCK_ID] => 12 [NAME] => Шпаргалки [ACTIVE] => Y [SORT] => 500 [CODE] => CRIB [DEFAULT_VALUE] => [PROPERTY_TYPE] => E [ROW_COUNT] => 1 [COL_COUNT] => 30 [LIST_TYPE] => L [MULTIPLE] => N [XML_ID] => [FILE_TYPE] => [MULTIPLE_CNT] => 5 [TMP_ID] => [LINK_IBLOCK_ID] => 3 [WITH_DESCRIPTION] => N [SEARCHABLE] => N [FILTRABLE] => N [IS_REQUIRED] => N [VERSION] => 1 [USER_TYPE] => EList [USER_TYPE_SETTINGS] => Array ( [size] => 20 [width] => 0 [group] => N [multiple] => N ) [HINT] => [PROPERTY_VALUE_ID] => [VALUE] => [DESCRIPTION] => [VALUE_ENUM] => [VALUE_XML_ID] => [VALUE_SORT] => [~VALUE] => [~DESCRIPTION] => [~NAME] => Шпаргалки [~DEFAULT_VALUE] => ) ) [1] => Array ( [ID] => 15705 [~ID] => 15705 [NAME] => Стелланин апрель [~NAME] => Стелланин апрель [DATE_ACTIVE_FROM] => 01.04.2019 13:37:00 [~DATE_ACTIVE_FROM] => 01.04.2019 13:37:00 [IBLOCK_ID] => 12 [~IBLOCK_ID] => 12 [PREVIEW_PICTURE] => 7449 [~PREVIEW_PICTURE] => 7449 ) [2] => Array ( [ID] => 32741 [~ID] => 32741 [NAME] => Береш Май Обзор писем РЗН [~NAME] => Береш Май Обзор писем РЗН [DATE_ACTIVE_FROM] => 28.05.2020 08:53:00 [~DATE_ACTIVE_FROM] => 28.05.2020 08:53:00 [IBLOCK_ID] => 12 [~IBLOCK_ID] => 12 [PREVIEW_PICTURE] => 10191 [~PREVIEW_PICTURE] => 10191 ) )
2325 просмотров
Поделиться ссылкой с друзьями ВКонтакте Одноклассники
Нашли ошибку? Выделите текст и нажмите Ctrl+Enter.
зарегистрированным пользователям