ACT VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Доступна с:

TEVA CANADA LIMITED

код АТС:

N06AX16

ИНН (Международная Имя):

VENLAFAXINE

дозировка:

150MG

Фармацевтическая форма:

CAPSULE (EXTENDED RELEASE)

состав:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 150MG

Администрация маршрут:

ORAL

Штук в упаковке:

15G/50G

Тип рецепта:

Prescription

Терапевтические области:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Обзор продуктов:

Active ingredient group (AIG) number: 0131294005; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2019-03-01

Характеристики продукта

ACT VENLAFAXINE XR
Page 1 of 87
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACT VENLAFAXINE XR
Venlafaxine Hydrochloride Extended Release Capsules
Extended Release Capsules, 37.5 mg, 75 mg, and 150 mg venlafaxine (as
venlafaxine
hydrochloride), Oral
Antidepressant / Anxiolytic
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
http://www.tevacanada.com
Submission Control Number: 274510
Date of Initial Authorization:
August 14, 2014
Date of Revision:
September 08, 2023
ACT VENLAFAXINE XR
Page 2 of 87
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
09/2023
7 Warnings and Precautions, 7.1 Special Populations, 7.1.1 Pregnant
Women
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
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
..............