Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
LENVATINIB (LENVATINIB MESYLATE)
EISAI LIMITED
L01EX08
LENVATINIB
24MG
CAPSULE
LENVATINIB (LENVATINIB MESYLATE) 24MG
ORAL
90 (60 X 10MG, 30 X 4MG)
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0157671001; AHFS:
APPROVED
2015-12-22
_Product Monograph _ _Template Date: September 2020 _ _LENVIMA_ _®_ _ lenvatinib capsules _ _Page 1 of 110_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr LENVIMA® Lenvatinib capsules 4 mg and 10 mg Lenvatinib (as lenvatinib mesylate) Multiple Receptor Tyrosine Kinase Inhibitor Antineoplastic Agent, ATC code: L01EX08 Eisai Limited 6925 Century Avenue, Suite 701 Mississauga, Ontario L5N 7K2 Date of Initial Authorization: DEC 22, 2015 Date of Revision: JUL 19, 2023 Submission Control Number: 267356 _LENVIMA_ _®_ _ lenvatinib capsules _ _Page 2 of 110_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS [07/2023] 1 INDICATIONS, 1.2 Geriatrics [07/2023] 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment [05/2022] 7 WARNINGS AND PRECAUTIONS [07/2023] 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 (<18 years of age) .................................................................................... 4 1.2 Geriatrics (≥ 65 years of age) ................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION ................................................................................ 6 4.1 Dosing Considerations ................................................................. Aqra d-dokument sħiħ