Qualifying notice: Truseltiq

Description

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 Truseltiq (infigratinib phosphate), control number 246904, for the indication of treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement, qualifies to be considered for authorization in accordance with the NOC/c Guidance.

Resources

Name Format Description Link
Qualifying notice: Truseltiq HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions/qualifying-notice-truseltiq-246904.html
Qualifying notice: Truseltiq HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/avis-conformite/conditions/avis-admissibilite-truseltiq-246904.html

Tags

Topics

Categories