MINT-IMATINIB TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMATINIB (IMATINIB MESYLATE)

Available from:

MINT PHARMACEUTICALS INC

ATC code:

L01EA01

INN (International Name):

IMATINIB

Dosage:

400MG

Pharmaceutical form:

TABLET

Composition:

IMATINIB (IMATINIB MESYLATE) 400MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0145503003; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-09-18

Summary of Product characteristics

_MINT-IMATINIB(Imatinib Mesylate Tablets) _
_Page 1 of 74_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-IMATINIB
Imatinib Mesylate Tablets
Tablets, 100 mg and 400 mg imatinib (as imatinib mesylate), Oral
Protein Kinase Inhibitor
ATC Code: L01EA01
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
SEP 18, 2019
Date of Revision:
NOV 14, 2023
Submission Control Number:
277157
_MINT-IMATINIB(Imatinib Mesylate Tablets) _
_Page 2 of 74_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Musculoskeletal
11/2022
1 Indications
11/2023
4 Dosage and Administration
11/2023
7 Warnings and Precautions, General
11/2023
7 Warnings and Precautions, Hepatic/Biliary/Pancreatic
11/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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1.2
Geriatrics
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2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4
DOSAGE AND ADMINISTRATION
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