BALVERSA TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ERDAFITINIB

Disponible depuis:

JANSSEN INC

Code ATC:

L01EN01

DCI (Dénomination commune internationale):

ERDAFITINIB

Dosage:

4MG

forme pharmaceutique:

TABLET

Composition:

ERDAFITINIB 4MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0161931002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2019-10-25

Résumé des caractéristiques du produit

_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