BALVERSA TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ERDAFITINIB

제공처:

JANSSEN INC

ATC 코드:

L01EN01

INN (국제 이름):

ERDAFITINIB

복용량:

4MG

약제 형태:

TABLET

구성:

ERDAFITINIB 4MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

ANTINEOPLASTIC AGENTS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2019-10-25

제품 특성 요약

_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