Country: Canada
Language: English
Source: Health Canada
ATEZOLIZUMAB
HOFFMANN-LA ROCHE LIMITED
L01FF05
ATEZOLIZUMAB
840MG
SOLUTION
ATEZOLIZUMAB 840MG
INTRAVENOUS
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0158930001; AHFS:
APPROVED
2019-09-19
_Pr_ _Tecentriq_ _®_ _ (atezolizumab for injection) _ _Page 1 of 110_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TECENTRIQ® atezolizumab for injection Concentrate for solution for infusion, 60 mg/mL 1200 mg/20 mL and 840 mg/14 mL single use vials For intravenous infusion Professed Standard ATC Code: L01FF05 Antineoplastic agent, monoclonal antibody Hoffmann-La Roche Limited 7070 Mississauga Road Mississauga, Ontario, Canada L5N 5M8 www.rochecanada.com Date of Initial Authorization: Apr 12, 2017 Date of Revision: Mar 13, 2024 Submission Control Number: 273807 TECENTRIQ® is a registered trademark of F. Hoffmann-La Roche AG, used under license © Copyright 2023, Hoffmann-La Roche Limited _ _ _Pr_ _Tecentriq_ _®_ _ (atezolizumab for injection) _ _Page 2 of 110_ RECENT MAJOR LABEL CHANGES 1 Indications 12/2022 4 Dosage and Administration 03/2024 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 03/2024 4 Dosage and Administration, 4.3 Reconstitution 03/2024 7 Warnings and Precautions 03/2024 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ......................................................................................................... 2 TABLE OF CONTENTS ........................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................................. 4 1 INDICATIONS .......................................................................................................................... 4 1.1 Pediatrics .........................................................................................................................5 1.2 Geriatrics .........................................................................................................................5 2 CONTRAINDICATIONS ................................................... Read the complete document