GLEEVEC TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

IMATINIB (IMATINIB MESYLATE)

Disponibbli minn:

NOVARTIS PHARMACEUTICALS CANADA INC

Kodiċi ATC:

L01EA01

INN (Isem Internazzjonali):

IMATINIB

Dożaġġ:

100MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

IMATINIB (IMATINIB MESYLATE) 100MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

120

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ANTINEOPLASTIC AGENTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2004-06-02

Karatteristiċi tal-prodott

_GLEEVEC_
_®_
_ (imatinib) Product Monograph _
_Page 1 of 70 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GLEEVEC®
Imatinib Mesylate
Tablets, 100 mg and 400 mg, Oral
Protein kinase inhibitor
(ATC code:
L01EA01)
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.,
Dorval, Quebec
H9S 1A9
www.novartis.ca
Date of Initial Authorization:
September 19, 2001
Submission Control Number: 264052
Date of Revision:
August 31, 2022
GLEEVEC is a registered trademark
_GLEEVEC_
_®_
_ (imatinib) Product Monograph _
_Page 2 of 70_
RECENT MAJOR LABEL CHANGES
Section 7 Warnings and Precautions, Musculoskeletal
08/2022
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
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
5
2
CONTRAINDICATIONS
................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 6
4