TARO-IMATINIB TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

IMATINIB (IMATINIB MESYLATE)

Dostupno od:

SUN PHARMA CANADA INC

ATC koda:

L01EA01

INN (International ime):

IMATINIB

Doziranje:

100MG

Farmaceutski oblik:

TABLET

Sastav:

IMATINIB (IMATINIB MESYLATE) 100MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

ANTINEOPLASTIC AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2023-04-24

Svojstava lijeka

_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
.........................................................................................