Pays: Canada
Langue: anglais
Source: Health Canada
PEMIGATINIB
INCYTE CORPORATION
L01EN02
PEMIGATINIB
4.5MG
TABLET
PEMIGATINIB 4.5MG
ORAL
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0163133001; AHFS:
APPROVED
2021-09-17
_PEMAZYRE™ Product Monograph _ _1 of 37_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PEMAZYRE™ Pemigatinib tablets Tablets, 4.5 mg, 9 mg, and 13.5 mg, Oral Protein Kinase Inhibitor (L01EX20) PEMAZYRE™ is 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. PEMAZYRE™ has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of authorization. For further information for PEMAZYRE™, please refer to Health Canada’s Notice of Compliance with conditions - drug products web site: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/notice-compliance/conditions.html Incyte Corporation 1801 Augustine Cut-Off Wilmington, DE 19803 USA www.incyte.com Imported by: Innomar Strategies Oakville, ON L6L 0C4 Date of Initial Authorization: September 8, 2021 Submission Control No: 242569 _ _ _PEMAZYRE™ Product Monograph _ _Page 2 of 37_ WHAT IS A NOTICE OF COMPLIANCE WITH CONDITIONS (NOC/C)? _An NOC/c is a form of market approval granted to a product on the basis of promising _ _evidence of clinical effectiveness following review of the submission by Health Canada. _ _Products authorized under Health Canada’s NOC/c policy are intended for the treatment, _ _prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have _ _demonstrated promising benefit, are of high quality and possess an acceptable safety profile _ _based on a benefit/risk assessment. In addition, they either respond to a serious unmet medical _ _need in Canada or have demonstrated a significant improvement in the benefit/risk profile over _ _existing therapies. Health Canada has provided access to this product on the condition that _ _sponsors carry out additional clinical trials to verify the anticipated benefit with Lire le document complet