RIVA-FLUVOX TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

FLUVOXAMINE MALEATE

Beschikbaar vanaf:

LABORATOIRE RIVA INC.

ATC-code:

N06AB08

INN (Algemene Internationale Benaming):

FLUVOXAMINE

Dosering:

50MG

farmaceutische vorm:

TABLET

Samenstelling:

FLUVOXAMINE MALEATE 50MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0122450002; AHFS:

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2021-05-14

Productkenmerken

_RIVA-FLUVOX – Product Monograph _
_ _
_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
RIVA-FLUVOX
(Fluvoxamine Maleate Tablets)
50 mg and 100 mg
Manufacturer Standard
Antidepressant /Antiobsessional Agent
LABORATOIRE RIVA INC.
660 Boul. Industriel,
Blainville, Québec
J7C 3V4
www.labriva.com
Date of Revision:
February 6, 2020
Control No.: 235581
_RIVA-FLUVOX – Product Monograph _
_ _
_Page 2 of 50 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE...............................................................................3
CONTRAINDICATIONS
....................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................25
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
.............................................................27
STORAGE AND STABILITY
..........................................................................................29
DOSAGE FORMS, COMPOSITION AND
PACKAGING..............................................29
PART II: SCIENTIFIC INFORMATION
................................................................................30
PHARMACEUTICAL INFORMATION
..........................................................................30
CLINICAL TRIALS
.......................................................................................