Qualifying notice: Pemazyre (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 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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