РОСЗДРАВНАДЗОР Информационное письмо № 04И-638/12 от 19.07.2012


ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ В СФЕРЕ ЗДРАВООХРАНЕНИЯ (РОСЗДРАВНАДЗОР)

109012, Москва, Славянская пл. 4, стр. 1, Телефон: 8(495)698-45-38; 8(495)698-15-74 https://roszdravnadzor.gov.ru

Информационное письмо № 04И-638/12 от 19.07.2012

О новых данных по безопасности лекарственного препарата Зофран

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Министерство здравоохранения Российской Федерации
ФЕДЕРАЛЬНАЯ СЛУЖБА ПО НАДЗОРУ Zz |
В СФЕРЕ ЗДРАВООХРАНЕНИЯ (РОСЗДРАВНАДЗОР) Субъектам обращения лекарственных средств Славянская пл. 4, стр. |, Москва, 109074 Телефон: (495) 698 45 38; 698 46 11 Медицинским организациям
LG OF BLO! № OY Lf -CBS ИХ Федеральному центру
На № от OT мониторинга безопасности лекарственных средств ФГБУ О новых данных по безопасности «Научный центр экспертизы лекарственного препарата Зофран средств медицинского
применения» Росздравнадзора
Федеральная служба по надзору в сфере здравоохранения направляет специалистам в области здравоохранения письмо ЗАО «ГлаксоСмитКляйн Трейдинг», Россия, в связи с выявленным риском удлинения интервала ОТ на фоне применения лекарственного препарата Зофран (международное непатентованное название — ондансетрон), раствор для внутривенного и внутримышечного введения 2 мг/мл, производства ГлаксоСмитКляйн Мэньюфэкчуринг С.п.А., Италия (регистрационное удостоверение - II М№015077/01 от 05.02.2009, владелец регистрапионного удостоверения ЗАО «ГлаксоСмитКляйн Трейлинг». Россия}.

Приложение: на 4 л. в 1 экз.

Врио руководителя Е.А, Тельнова
К,В. Горелов (499) 578-02-73

Скачать документ: Письмо 04И-638/12 от 19.07.2012

Информационные письма Росздравнадзора по контролю качества: Лекарственные средства

Информационные письма Росздравнадзора по контролю качества: Медицинские изделия

   

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