ACT VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

MAH:

TEVA CANADA LIMITED

ATC_code:

N06AX16

INN:

VENLAFAXINE

dosage:

150MG

pharmaceutical_form:

CAPSULE (EXTENDED RELEASE)

composition:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 150MG

administration_route:

ORAL

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2019-03-01

SPC

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
..............