Qualifying notice for Tepmetko (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 Tepmetko (tepotinib), Control Number 242300, for the indication of the treatment of adult patients with locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) tyrosine kinase receptor exon 14 skipping alterations, qualifies to be considered for authorization in accordance with the NOC/c Guidance

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