PHL-FLUVOXAMINE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

FLUVOXAMINE MALEATE

Предлага се от:

PHARMEL INC

АТС код:

N06AB08

INN (Международно Name):

FLUVOXAMINE

дозиране:

50MG

Лекарствена форма:

TABLET

Композиция:

FLUVOXAMINE MALEATE 50MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2016-10-26

Данни за продукта

PRODUCT MONOGRAPH
Pr PHL-FLUVOXAMINE
Fluvoxamine Maleate Tablets, BP
50 mg & 100 mg
ANTIDEPRESSANT/ANTIOBSESSIONAL AGENT
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
Date of Revision:
October 07, 2016
Submission Control No.: 198571
_ _
_phl-FLUVOXAMINE Product Monograph _
_Page 2 of 52_
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
................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
............................................................28
STORAGE AND STABILITY
..........................................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
...............................................................................31
PHARMACEUTICAL INFORMATION
..........................................................................31
CLINICAL TRIALS
..........................................................................................................32
DETAILED PHARMACOLOGY
...........................................