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rotacaps pre-qualified by who

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    WHO Prequalification Programme adds the below new Influenza product to its prequalified list

    IN008: Zanamivir - 5mg/dose - Inhalation powder - GlaxoSmithKline Ltd - UK

    The prequalification of this product (Relenza Rotacaps) is based on the authorization by the Medical Products Agency (MPA). As quoted from the MPA's regulatory approval letter (15 July 2009):

    The temporary authorisation for distribution of Relenza Rotacap/Rotahalar is valid, unless the Medical Products Agency decides otherwise, during the time the influenza A(H1N1) is classified as phase 4, 5 or 6 by WHO. The temporary authorisation will expire when the influence pandemic is downgraded to phase 3."

    In line with the temporary MPA authorization, the prequalification of IN008 will also be temporary.

    Related Link: WHO List of Prequalified Medicinal Products

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