PMS-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Land: Canada

Taal: Engels

Bron: Health Canada

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25-01-2023

Werkstoffen:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Beschikbaar vanaf:

PHARMASCIENCE INC

ATC-code:

N06AX16

INN (Algemene Internationale Benaming):

VENLAFAXINE

Dosering:

150MG

farmaceutische vorm:

CAPSULE (EXTENDED RELEASE)

Samenstelling:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 150MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100/500

Prescription-type:

Prescription

Therapeutisch gebied:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2007-08-17

Productkenmerken

                                _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
.
                                
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