Страна: Канада
мова: англійська
Джерело: Health Canada
ELRANATAMAB
PFIZER CANADA ULC
L01FX
OTHER MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
76MG
SOLUTION
ELRANATAMAB 76MG
SUBCUTANEOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0165382001; AHFS:
APPROVED
2023-12-06
_Pr_ _ELREXFIO_ _TM_ _ (elranatamab injection) _ _Page 1 of 34_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr ELREXFIO TM elranatamab injection 44 mg/1.1 mL (40 mg/mL) solution for subcutaneous injection 76 mg/1.9 mL (40 mg/mL) solution for subcutaneous injection Professional Standard Antineoplastic, monoclonal antibody ATC code: L01FXXX “Elrexfio (elranatamab solution for injection), indicated for: - the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy 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 the authorization. For further information for Elrexfio 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” Pfizer Canada ULC 17,300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Initial Authorization: DEC 6, 2023 Submission Control Number: 273519 TM Pfizer Inc. Pfizer Canada licensee _ _ _Pr_ _ELREXFIO_ _TM_ _ (elranatamab injection) _ _Page 2 of 34_ 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 Прочитайте повний документ