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:

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 PRE MARKET

authorization_date:

2015-10-16

SPC

PRODUCT MONOGRAPH
PR
VENLAFAXINE XR
(venlafaxine hydrochloride extended release capsules)
37.5 mg, 75 mg and 150 mg venlafaxine (as venlafaxine hydrochloride)
Antidepressant / Anxiolytic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 155222
Date of Preparation: May 11, 2012
_Page 2_
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..................................................................................................19
DRUG INTERACTIONS
..................................................................................................38
DOSAGE AND ADMINISTRATION
..............................................................................43
OVERDOSAGE.................................................................................................................47
ACTION AND CLINICAL
PHARMACOLOGY.............................................................49
STORAGE AND STABILITY
..........................................................................................52
SPECIAL HANDLING
INSTRUCTIONS........................................................................52
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................52
PART II: SCIENTIFIC INFORMATION
...............................................................................53
PHARMACEUTICAL
INFORMATION..........................................................................53
CLINICAL TRIALS
..............................................................