देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
ERDAFITINIB
JANSSEN INC
L01EN01
ERDAFITINIB
4MG
TABLET
ERDAFITINIB 4MG
ORAL
100
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0161931002; AHFS:
APPROVED
2019-10-25
_Approved Product Monograph 1.docx_ _ _ _ _ _EDMS-RIM-869219 v6.0 _ _Page 1 of 36 _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BALVERSA ® Erdafitinib tablets tablet, 3 mg, 4 mg and 5 mg, oral Protein Kinase Inhibitor, (ATC code: L01EN01) BALVERSA ® (erdafitinib), indicated for: • the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC), whose tumors have susceptible fibroblast growth factor receptor (FGFR)2 or FGFR3 genetic alterations and who have disease progression during or following at least one line of prior chemotherapy, including within 12 months of neoadjuvant or adjuvant chemotherapy has been issued marketing 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 BALVERSA ® please refer to Health Canada’s Notice of Compliance with conditions - drug products web site: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices- avis/conditions/index-eng.php Janssen Inc. 19 Green Belt Drive Toronto, Ontario M3C 1L9 www.janssen.com/canada © 2023 Janssen Inc. All trademarks used under license. Date of Initial Authorization: October 25, 2019 Date of Revision: April 05, 2023 Submission Control Number: 269952 _Approved Product Monograph 1.docx_ _ _ _ _ _EDMS-RIM-869219 v6.0 _ _Page 2 of 36 _ _ _ NOTICE OF COMPLIANCE WITH CONDITIONS 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 _ _ser पूरा दस्तावेज़ पढ़ें