NAT-IMATINIB TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IMATINIB (IMATINIB MESYLATE)

Saatavilla:

NATCO PHARMA (CANADA) INC

ATC-koodi:

L01EA01

INN (Kansainvälinen yleisnimi):

IMATINIB

Annos:

100MG

Lääkemuoto:

TABLET

Koostumus:

IMATINIB (IMATINIB MESYLATE) 100MG

Antoreitti:

ORAL

Kpl paketissa:

30

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2017-02-16

Valmisteyhteenveto

_NAT-IMATINIB (imatinib) Product Monograph _
_Page 1 of 68_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAT-IMATINIB
Imatinib Mesylate Tablets
Tablets, 100 mg and 400 mg imatinib (as imatinib mesylate), Oral
Protein kinase inhibitor
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, ON Canada L5N 1P7
Date of Initial Authorization:
February 16, 2017
Date of Revision:
December 14 2022
Submission Control Number: 266004
_ _
_NAT-IMATINIB (imatinib) Product Monograph _
_Page 2 of 68_
RECENT MAJOR LABEL CHANGES
Section 7 Warnings and Precautions, Musculoskeletal
12/2022
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...........................................................................................................
4
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
4.5
Missed Dose
.................