PMS-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Available from:

PHARMASCIENCE INC

ATC code:

N06AX16

INN (International Name):

VENLAFAXINE

Dosage:

150MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 150MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2007-08-17

Summary of Product characteristics

_pms-VENLAFAXINE XR (venlafaxine hydrochloride) _
_Page 1 of 84 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-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
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 270919
Date of Initial Authorization:
AUG 17, 2007
Date of Revision:
JAN 25, 2023
_pms-VENLAFAXINE XR (venlafaxine hydrochloride) _
_Page 2 of 84 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
01/2023
7 Warnings and Precautions, 7.1 Special Populations, 7.1.1 Pregnant
Women
06/2020
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 Adults
.