PEMAZYRE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PEMIGATINIB

Available from:

INCYTE CORPORATION

ATC code:

L01EN02

INN (International Name):

PEMIGATINIB

Dosage:

13.5MG

Pharmaceutical form:

TABLET

Composition:

PEMIGATINIB 13.5MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0163133003; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-09-17

Summary of Product characteristics

_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