EFFEXOR XR CAPSULE (EXTENDED RELEASE)

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Fáanlegur frá:

BGP PHARMA ULC

ATC númer:

N06AX16

INN (Alþjóðlegt nafn):

VENLAFAXINE

Skammtar:

75MG

Lyfjaform:

CAPSULE (EXTENDED RELEASE)

Samsetning:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 75MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2003-03-04

Vara einkenni

_EFFEXOR XR (venlafaxine hydrochloride) _
_Page 1 of 71_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
EFFEXOR® XR
Venlafaxine Hydrochloride Extended Release Capsules
Extended Release Capsules, 37.5 mg, 75 mg and 150 mg venlafaxine (as
venlafaxine hydrochloride),
Oral
Mfr. Std.
Antidepressant/Anxiolytic
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
AUG 09, 2023
Date of Revision:
OCT 31, 2023
Submission Control Number: 276199
® Viatris Specialty LLC
_ _
_EFFEXOR XR (venlafaxine hydrochloride) _
_Page 2 of 71_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS
10/2023
4.9 Discontinuation
10/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............