TEVA-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Disponible depuis:

TEVA CANADA LIMITED

Code ATC:

N06AX16

DCI (Dénomination commune internationale):

VENLAFAXINE

Dosage:

150MG

forme pharmaceutique:

CAPSULE (EXTENDED RELEASE)

Composition:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 150MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2006-10-06

Résumé des caractéristiques du produit

_TEVA-VENLAFAXINE XR Page 1 of 88 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-VENLAFAXINE XR
Venlafaxine Hydrochloride Extended Release Capsules
Extended Release Capsules, 37.5 mg, 75 mg and 150 mg
venlafaxine (as venlafaxine
hydrochloride), Oral
USP
Antidepressant / Anxiolytic
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
Submission Control Number: 274459
Date of Initial Authorization:
OCT 06, 2006
Date of Revision:
June 6, 2023
_TEVA-VENLAFAXINE XR Page 2 of 88 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
10/2022
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
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 6
4.4
Administration
............................................................................................................
9
4.5
Miss