PMS-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

N06AX16

INN (nume internaţional):

VENLAFAXINE

Dozare:

150MG

Forma farmaceutică:

CAPSULE (EXTENDED RELEASE)

Compoziție:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 150MG

Calea de administrare:

ORAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2007-08-17

Caracteristicilor produsului

_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
.