Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
IMATINIB (IMATINIB MESYLATE)
TEVA CANADA LIMITED
L01EA01
IMATINIB
100MG
TABLET
IMATINIB (IMATINIB MESYLATE) 100MG
ORAL
100/120/500
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0145503002; AHFS:
APPROVED
2013-04-02
TEVA-IMATINIB (imatinib mesylate tablets) Page 1 of 95 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr TEVA-IMATINIB Imatinib Mesylate Tablets Tablets, 100 mg and 400 mg imatinib (as imatinib mesylate), Oral Protein kinase inhibitor (ATC code: L01EA01) Teva Canada Limited. 30 Novopharm Court Toronto, ON M1B 2K9 Canada www.tevacanada.com Submission Control Number: 279590 Date of Initial Authorization: April 02, 2013 Date of Revis_i_on: February 28, 2024 _TEVA-IMATINIB (imatinib mesylate tablets) _ _ _ _Page 2 of 95_ RECENT MAJOR LABEL CHANGES Section 7 Warnings and Precautions, Musculoskeletal 02/2023 Section 1 Indications 02/2024 Section 14 Clinical Trials 02/2024 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 ................................................................................................... 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................... 6 4 DOSAGE AND ADMINISTRATION ............................................................................... 6 4.1 DOSING CONSIDERATIONS .............................................................................................. 6 4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT ....................... Soma hati kamili