ACH-IMATINIB TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IMATINIB (IMATINIB MESYLATE)

Saatavilla:

ACCORD HEALTHCARE INC

ATC-koodi:

L01EA01

INN (Kansainvälinen yleisnimi):

IMATINIB

Annos:

100MG

Lääkemuoto:

TABLET

Koostumus:

IMATINIB (IMATINIB MESYLATE) 100MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0145503002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2019-07-29

Valmisteyhteenveto

_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
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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
................................................................................................................
4
1.1
Pediatrics
.................................................................................................................5
1.2
Geriatrics
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