IMJUDO SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

TREMELIMUMAB

Предлага се от:

ASTRAZENECA CANADA INC

АТС код:

L01

INN (Международно Name):

ANTINEOPLASTIC AGENTS

дозиране:

20MG

Лекарствена форма:

SOLUTION

Композиция:

TREMELIMUMAB 20MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Каталог на резюме:

Active ingredient group (AIG) number: 0164941001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2023-08-31

Данни за продукта

_ _
IMJUDO
®
Product Monograph._ _
_Page 1 of 36_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
IMJUDO
®
tremelimumab for injection
Concentrate for solution for infusion, 20 mg / mL, Intravenous
Antineoplastic
(Anatomical Therapeutic Code: L01FX20)
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
AUG 31, 2023
Date of Revision:
JAN 26, 2024
Submission Control Number: 279086
IMJUDO
®
and IMFINZI
®
are trademarks of AstraZeneca AB, used under license by AstraZeneca
Canada Inc.
©
AstraZeneca Canada Inc. 2023
_ _
IMJUDO
®
Product Monograph._ _
_Page 2 of 36_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended
Dose and Dosage Adjustment
09/2023
7 WARNINGS AND PRECAUTIONS
09/2023
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
.................................................................. 4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 4
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...........