BALVERSA TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ERDAFITINIB

Dostępny od:

JANSSEN INC

Kod ATC:

L01EN01

INN (International Nazwa):

ERDAFITINIB

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

ERDAFITINIB 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTINEOPLASTIC AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0161931003; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2019-10-25

Charakterystyka produktu

_Approved Product Monograph 1.docx_
_ _
_ _
_EDMS-RIM-1068395 v13.0 _
_Page 1 of 38 _
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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:
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
© 2024 Janssen Inc.
All trademarks used under license.
Date of Initial Authorization:
OCT 25, 2019
Date of Revision:
FEB 06, 2024
Submission Control Number: 278912
_Approved Product Monograph 1.docx_
_ _
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_EDMS-RIM-1068395 v13.0 _
_Page 2 of 38 _
_ _
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 addit