TEVA-IMATINIB TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

IMATINIB (IMATINIB MESYLATE)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

L01EA01

INN (International Adı):

IMATINIB

Doz:

400MG

Farmasötik formu:

TABLET

Kompozisyon:

IMATINIB (IMATINIB MESYLATE) 400MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100/500

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0145503003; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2013-04-02

Ürün özellikleri

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
.......................