ACH-QUETIAPINE FUMARATE XR TABLET (EXTENDED-RELEASE)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

QUETIAPINE (QUETIAPINE FUMARATE)

Доступна з:

ACCORD HEALTHCARE INC

Код атс:

N05AH04

ІПН (Міжнародна Ім'я):

QUETIAPINE

Дозування:

50MG

Фармацевтична форма:

TABLET (EXTENDED-RELEASE)

Склад:

QUETIAPINE (QUETIAPINE FUMARATE) 50MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

60/100/1000

Тип рецепту:

Prescription

Терапевтична области:

ATYPICAL ANTIPSYCHOTICS

Огляд продуктів:

Active ingredient group (AIG) number: 0131858006; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2016-03-29

Характеристики продукта

_ACH-Quetiapine Fumarate XR (Quetiapine Fumarate Extended-Release
Tablets) _
_Page 1 of 85 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-QUETIAPINE FUMARATE XR
Quetiapine Fumarate Extended-Release Tablets
Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg
quetiapine
(as quetiapine fumarate), Oral Use
House Standard
Antipsychotic / Antidepressant Agent
Accord Healthcare Inc.
Date of Initial Authorization:
3535 boul. St. Charles, Suite 704
March 29, 2016
Kirkland, QC, H9H 5B9
Canada
Date of Revision:
February 9, 2022
Submission Control No: 255984
_ACH-Quetiapine Fumarate XR (Quetiapine Fumarate Extended-Release
Tablets) _
_Page 2 of 85 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Musculoskeletal - Rhabdomyolysis
02/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
02/2022
7 WARNINGS AND PRECAUTIONS, Skin
02/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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