BYDUREON BCISE SUSPENSION (EXTENDED-RELEASE)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

EXENATIDE

Доступна з:

ASTRAZENECA CANADA INC

Код атс:

A10BJ01

ІПН (Міжнародна Ім'я):

EXENATIDE

Дозування:

2MG

Фармацевтична форма:

SUSPENSION (EXTENDED-RELEASE)

Склад:

EXENATIDE 2MG

Адміністрація маршрут:

SUBCUTANEOUS

Одиниць в упаковці:

4 AUTOINJECTORS

Тип рецепту:

Prescription

Терапевтична области:

INCRETIN MIMETICS

Огляд продуктів:

Active ingredient group (AIG) number: 0152872002; AHFS:

Статус Авторизація:

CANCELLED PRE MARKET

Дата Авторизація:

2022-05-30

Характеристики продукта

_ _
BYDUREON
®
BCise
TM
(exenatide) COPY RIGHT 2015-2022 ASTRAZENECA CANA DA INC._ _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
BYDUREON
®
BCise
TM
Exenatide prolonged-release injectable suspension
Prolonged-release injectable suspension, 2 mg/dose, subcutaneous use
Glucagon-like peptide-1 (GLP-1) analogues
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
NOV 26, 2018
Date of Revision:
MAR 02, 2022
Submission Control Number: 257624
BYDUREON
®
is a registered trademark of Amylin Pharmaceuticals LLC used under
license by
AstraZeneca Canada.
BCise™ is a trademark of AstraZeneca Pharmaceuticals LP, used with
permission by
AstraZeneca Canada Inc.
_ _
BYDUREON
®
BCise
TM
(exenatide) COPY RIGHT 2015-2022 ASTRAZENECA CANA DA INC._ _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
03/2022
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
...............................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................... 5
4
DOSAGE AND ADMINISTRATION
....................................