APO-IMATINIB TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

IMATINIB (IMATINIB MESYLATE)

Предлага се от:

APOTEX INC

АТС код:

L01EA01

INN (Международно Name):

IMATINIB

дозиране:

100MG

Лекарствена форма:

TABLET

Композиция:

IMATINIB (IMATINIB MESYLATE) 100MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2013-04-02

Данни за продукта

_APO-IMATINIB (Imatinib Mesylate) _
_Page 1 of 89_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
APO-IMATINIB
Imatinib Mesylate Tablets
Tablets, 100 mg and 400 mg imatinib (as imatinib mesylate), Oral
Protein Kinase Inhibitor
(ATC code: L01EA01)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Initial Authorization:
APR 02, 2013
Date of Revision:
APR 18, 2023
Submission Control Number: 270347
_APO-IMATINIB (Imatinib Mesylate) _
_Page 2 of 89_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Musculoskeletal
04/2023
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
.......................................................................................
7
4.1
Dosing Considerations
..................................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
.............................................................. 7
4.5
Missed Dose
.....