Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
TECLISTAMAB
JANSSEN INC
L01FX24
TECLISTAMAB
30MG
SOLUTION
TECLISTAMAB 30MG
SUBCUTANEOUS
15G/50G
Prescription
Active ingredient group (AIG) number: 0164822001; AHFS:
APPROVED
2023-07-26
_Non-Ann PM TEC NDS 269369 06282023 _ _EDMS-RIM-849146 v21.0 _ _TECVAYLI (teclistamab injection) _ _Page 1 of 41_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr TECVAYLI TM Teclistamab injection Solution for subcutaneous injection 153 mg/ 1.7 mL (90 mg/mL) and 30 mg / 3 mL (10 mg/mL) Professed Standard Antineoplastic, monoclonal antibody ATC code: L01FX24 Tecvayli, indicated for: • the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three 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 Tecvayli 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 Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.janssen.com/canada Date of Initial Authorization: July 26, 2023 Submission Control Number: 269369 © 2023 Janssen Inc. All trademarks used under license _Non-Ann PM TEC NDS 269369 06282023 _ _EDMS-RIM-849146 v21.0 _ _TECVAYLI (teclistamab injection) _ _Page 2 of 41_ 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 eith Baca dokumen lengkap