RIVA-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

MAH:

LABORATOIRE RIVA INC.

ATC_code:

N06AX16

INN:

VENLAFAXINE

dosage:

37.5MG

pharmaceutical_form:

CAPSULE (EXTENDED RELEASE)

composition:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0131294002; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2019-11-08

SPC

_RIVA-VENLAFAXINE XR - Product Monograph _
_Page 1 of 71 _
PRODUCT MONOGRAPH
PR
RIVA-VENLAFAXINE XR
(venlafaxine hydrochloride extended release capsules)
venlafaxine (as venlafaxine hydrochloride)
USP
37.5 mg, 75 mg and 150 mg
Antidepressant / Anxiolytic
www.labriva.com
Submission Control No.: 240095
J7C 3V4
Blainville, Québec
660
Boul.
Industriel
LABORATOIRE RIVA INC.
July 8,
2020
Date of Revision:
_RIVA-VENLAFAXINE XR - Product Monograph _
_Page 2 of 71 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT
INFORMATION.........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
5
WARNINGS AND PRECAUTIONS
..................................................................................
6
ADVERSE REACTIONS
..................................................................................................
20
DRUG INTERACTIONS
..................................................................................................
37
DOSAGE AND ADMINISTRATION
..............................................................................
44
OVERDOSAGE
.................................................................................................................
48
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 49
STORAGE AND STABILITY
..........................................................................................
52
SPECIAL HANDLING INSTRUCTIONS
........................................................................
53
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................. 53
PART II: SCIENTIFIC INFORMATION
................................................................................
54
PHARMACEUTICAL INFORM