TECVAYLI SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TECLISTAMAB

Available from:

JANSSEN INC

ATC code:

L01FX24

INN (International Name):

TECLISTAMAB

Dosage:

153MG

Pharmaceutical form:

SOLUTION

Composition:

TECLISTAMAB 153MG

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0164822002; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-07-26

Summary of Product characteristics

_Non-Ann PM TEC NDS 269369 06282023 _
_EDMS-RIM-849146 v21.0 _
_TECVAYLI (teclistamab injection) _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TECVAYLI
TM
Teclistamab injection
Solution for subcutaneous injection
153 mg/ 1.7 mL (90 mg/mL) and 30 mg / 3 mL (10 mg/mL)
Professed Standard
Antineoplastic, monoclonal antibody
ATC code: L01FX24
Tecvayli, indicated for:
•
the treatment of adult patients with relapsed or refractory multiple
myeloma who have
received at least three prior lines of therapy, including a proteasome
inhibitor, an
immunomodulatory agent and an anti-CD38 monoclonal antibody, and who
have
demonstrated disease progression on the last therapy,
has been issued market 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 Tecvayli 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
Date of Initial Authorization:
July 26, 2023
Submission Control Number: 269369
© 2023 Janssen Inc.
All trademarks used under license
_Non-Ann PM TEC NDS 269369 06282023 _
_EDMS-RIM-849146 v21.0 _
_TECVAYLI (teclistamab injection) _
_Page 2 of 41_
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 eith