Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
OSIMERTINIB (OSIMERTINIB MESYLATE)
ASTRAZENECA CANADA INC
L01EB04
OSIMERTINIB
80MG
TABLET
OSIMERTINIB (OSIMERTINIB MESYLATE) 80MG
ORAL
30
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0158250002; AHFS:
APPROVED
2016-07-05
_ _ _TAGRISSO_ _®_ _ (osimertinib) Product Monograph. _ _Page 1 of 62_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION TAGRISSO® osimertinib tablets Tablets, 40 mg and 80 mg osimertinib (as osimertinib mesylate), Oral Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor, L01XE35 AstraZeneca Canada Inc. 1004 Middlegate Road, Suite 5000 Mississauga, Ontario Canada, L4Y 1M4 www.astrazeneca.ca Date of Initial Authorization: JUL 05, 2016 Date of Revision: JAN 02, 2024 Submission Control Number: 277035 TAGRISSO® is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc. ©AstraZeneca Canada Inc. 2023 _ _ _TAGRISSO_ _®_ _ (osimertinib) Product Monograph. _ _Page 2 of 62_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS 01/2021 1 INDICATIONS, 1.2 Geriatrics 01/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 01/2021 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 03/2023 7 WARNINGS AND PRECAUTIONS 01/2024 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 01/2021 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 ...........................................................................................................................4 1.2 Geriatrics ............................................................................................................................4 2 CONTRAINDICATIONS .......................................... Կարդացեք ամբողջական փաստաթուղթը