TEVA-IMATINIB TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

IMATINIB (IMATINIB MESYLATE)

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

L01EA01

INN (Kansainvälinen yleisnimi):

IMATINIB

Annos:

100MG

Lääkemuoto:

TABLET

Koostumus:

IMATINIB (IMATINIB MESYLATE) 100MG

Antoreitti:

ORAL

Kpl paketissa:

100/120/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANTINEOPLASTIC AGENTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2013-04-02

Valmisteyhteenveto

TEVA-IMATINIB (imatinib mesylate tablets)
Page 1 of 95
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-IMATINIB
Imatinib Mesylate Tablets
Tablets, 100 mg and 400 mg
imatinib (as imatinib mesylate), Oral
Protein kinase inhibitor
(ATC code: L01EA01)
Teva Canada Limited.
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Submission Control Number:
279590
Date of Initial Authorization:
April 02, 2013
Date of Revis_i_on:
February 28, 2024
_TEVA-IMATINIB (imatinib mesylate tablets) _
_ _
_Page 2 of 95_
RECENT MAJOR LABEL CHANGES
Section 7 Warnings and Precautions, Musculoskeletal
02/2023
Section 1 Indications
02/2024
Section 14 Clinical Trials
02/2024
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
..................................................................................................................
5
1.2
GERIATRICS
...................................................................................................................
5
2
CONTRAINDICATIONS
...................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..................................................... 6
4
DOSAGE AND ADMINISTRATION
...............................................................................
6
4.1
DOSING CONSIDERATIONS
..............................................................................................
6
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
.......................