FLUVOXAMINE TABLETS

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

FLUVOXAMINE MALEATE

Предлага се от:

TEVA CANADA LIMITED

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 PRE MARKET

Дата Оторизация:

2024-02-20

Данни за продукта

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_FLUVOXAMINE TABLETS _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FLUVOXAMINE TABLETS
fluvoxamine maleate tablets
Tablets, 50 mg and 100 mg fluvoxamine maleate, Oral
Teva Standard
Antidepressant, Antiobsessional Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
November 28, 2002
Date of Revision:
August 24, 2022
Submission Control Number: 266259
_ _
_FLUVOXAMINE TABLETS _
_Page 2 of 49_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic, Neurologic, Skin,
Reproductive Health: Female and Male Potential
06/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
06/2022
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
P
EDIATRICS
.......................................................................................................................................
4
1.2
G
ERIATRICS
......................................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................................4
4
DOSAGE AND ADMINISTRATION
.................................................................................................5
4.1
D
OSING
C
ONSIDERATIONS
............................................................................................