Qualifying Notice - Veklury (English, HTML)

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Publisher-reported update

2023-11-01

This Notice of Compliance with Conditions Qualifying Notice (NOC/c-QN), issued in accordance with the Health Canada Guidance Document: Notice of Compliance with Conditions (NOC/c), is to advise you that information submitted in support of the New Drug Submission for Veklury (remdesivir), Control Number 240551, for the indication of "treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia requiring supplemental oxygen", qualifies to be considered for authorization in accordance with the NOC/c Guidance. In light of the public health emergency caused by the COVID-19 pandemic and because there are no currently approved therapeutic options, Health Canada is prepared to grant, on exceptional basis, flexibility in the application of the NOC/c Guidance and allow conditions for both the safety and quality profile of VEKLURY.

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