TARO-IMATINIB TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IMATINIB (IMATINIB MESYLATE)

Saatavilla:

SUN PHARMA CANADA INC

ATC-koodi:

L01EA01

INN (Kansainvälinen yleisnimi):

IMATINIB

Annos:

100MG

Lääkemuoto:

TABLET

Koostumus:

IMATINIB (IMATINIB MESYLATE) 100MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2023-04-24

Valmisteyhteenveto

_TARO-IMATINIB (Imatinib Mesylate Tablets)_
Page 1 of 76_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-IMATINIB
Imatinib Mesylate Tablets
Tablets, 100 mg and 400 mg
imatinib (as imatinib mesylate), Oral
Protein kinase inhibitor
Sun Pharma Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Initial Authorization:
July 16, 2014
Date of Revision:
January 6, 2023
SUBMISSION CONTROL NUMBER: 269656
_TARO-IMATINIB (Imatinib Mesylate Tablets)_
Page 2 of 76_ _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
09/2022
1 INDICATIONS, 1.2 Geriatrics
09/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
09/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
09/2022
7 WARNINGS AND PRECAUTIONS
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
09/2022
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
.....................................................................
5
1 INDICATIONS
......................................................................................................................
5
1.1 Pediatrics
................................................................................................................................
5
1.2 Geriatrics
................................................................................................................................
6
2 CONTRAINDICATIONS
.........................................................................................................
6
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
.....................................................................
6
4 DOSAGE AND ADMINISTRATION
.........................................................................................