PMS-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Dostupno od:

PHARMASCIENCE INC

ATC koda:

N06AX16

INN (International ime):

VENLAFAXINE

Doziranje:

75MG

Farmaceutski oblik:

CAPSULE (EXTENDED RELEASE)

Sastav:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 75MG

Administracija rute:

ORAL

Jedinice u paketu:

100/500

Tip recepta:

Prescription

Područje terapije:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Proizvod sažetak:

Active ingredient group (AIG) number: 0131294001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2007-08-17

Svojstava lijeka

_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
.