Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
IMATINIB (IMATINIB MESYLATE)
ACCORD HEALTHCARE INC
L01EA01
IMATINIB
400MG
TABLET
IMATINIB (IMATINIB MESYLATE) 400MG
ORAL
15G/50G
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0145503003; AHFS:
APPROVED
2019-07-29
_ACH-IMATINIB (imatinib mesylate tablets) _ _Page 1 of 78 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ACH-IMATINIB Imatinib Mesylate Tablets Tablets, 100 mg and 400 mg imatinib (as imatinib mesylate), Oral Protein kinase inhibitor (ATC code: L01EA01) Accord Healthcare Inc. 3535 boul. St. Charles, Suite 704 Kirkland, QC, H9H 5B9 Canada Date of Initial Authorization: July 29, 2019 Date of Revision: November 22, 2023 Submission Control Number: 278120 _ACH-IMATINIB (imatinib mesylate tablets) _ _Page 2 of 78 _ RECENT MAJOR LABEL CHANGES Section 7 Warnings and Precautions, Musculoskeletal 12/2022 Section 1 INDICATIONS 11/2023 Section 1 INDICATIONS, 1.2 Geriatrics 11/2023 Section 3 SERIOUS WARNINGS AND PRECAUTIONS BOX 11/2023 Section 4.2 Recommended Dose and Dosage Adjustment 11/2023 Section 7 WARNINGS AND PRECAUTIONS, Hemorrhage 11/2023 Section 7 WARNINGS AND PRECAUTIONS, Hepatic/biliary/Pancreatic 11/2023 Section 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 11/2023 Section 8.2 Clinical Trial Adverse Reactions 11/2023 Section 8.4 Abnormal laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data 11/2023 Section 10.1 Mechanism of Action 11/2023 Section 14 CLINICAL TRIALS, 14.1 Clinical Trials by Indication 11/2023 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 .................................................................................................................5 1.2 Geriatrics ....................... Aqra d-dokument sħiħ