新 聞 及 資 訊
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| FDA has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir IV (English only) |
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FDA has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. Given there are limited safety data on peramivir, mandatory reporting requirements are important to defining the safety profile of this unapproved drug. As part of the conditions of the EUA, health care providers (or designee) must report adverse events and all medication errors associated with peramivir to FDA’s MedWatch program. The relevant link for the news is:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187814.htm
Situation in Hong Kong: The above product is not registered in Hong Kong.
Ends/Tuesday, October 27, 2009
Issued at HKT 15:00 |
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