Qualifying notice: Truseltiq

Qualifying notice: Truseltiq 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. 2023-11-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyqualifying noticeTruseltiqnotice-of-compliance with conditions-qualifying noticeNOC/c-QN Qualifying notice: TruseltiqHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions/qualifying-notice-truseltiq-246904.html Qualifying notice: TruseltiqHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/avis-conformite/conditions/avis-admissibilite-truseltiq-246904.html

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.

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