Qualifying notice: Pemazyre

Qualifying notice: Pemazyre 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 Pemazyre (pemigatinib), control number 242569, indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) 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 noticePemazyrenotice-of-compliance with conditions-qualifying noticeNOC/c-QN Qualifying notice: PemazyreHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions/qualifying-notice-pemazyre-242569.html Qualifying notice: PemazyreHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/avis-conformite/conditions/avis-admissibilite-pemazyre-242569.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 Pemazyre (pemigatinib), control number 242569, indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement, qualifies to be considered for authorization in accordance with the NOC/c Guidance.

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