MINT-IMATINIB TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IMATINIB (IMATINIB MESYLATE)

Saatavilla:

MINT PHARMACEUTICALS INC

ATC-koodi:

L01EA01

INN (Kansainvälinen yleisnimi):

IMATINIB

Annos:

400MG

Lääkemuoto:

TABLET

Koostumus:

IMATINIB (IMATINIB MESYLATE) 400MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2019-09-18

Valmisteyhteenveto

_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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