RIVA-FLUVOX TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

FLUVOXAMINE MALEATE

Boleh didapati daripada:

LABORATOIRE RIVA INC.

Kod ATC:

N06AB08

INN (Nama Antarabangsa):

FLUVOXAMINE

Dos:

50MG

Borang farmaseutikal:

TABLET

Komposisi:

FLUVOXAMINE MALEATE 50MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2021-05-14

Ciri produk

_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
.......................................................................................