BALVERSA TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

ERDAFITINIB

Доступна с:

JANSSEN INC

код АТС:

L01EN01

ИНН (Международная Имя):

ERDAFITINIB

дозировка:

4MG

Фармацевтическая форма:

TABLET

состав:

ERDAFITINIB 4MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

ANTINEOPLASTIC AGENTS

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2019-10-25

Характеристики продукта

_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