APO-FLUVOXAMINE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

FLUVOXAMINE MALEATE

Предлага се от:

APOTEX INC

АТС код:

N06AB08

INN (Международно Name):

FLUVOXAMINE

дозиране:

100MG

Лекарствена форма:

TABLET

Композиция:

FLUVOXAMINE MALEATE 100MG

Начин на приложение:

ORAL

Броя в опаковка:

100/250

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0122450001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

1997-05-12

Данни за продукта

Page 1 of 51
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
PR
APO-FLUVOXAMINE
Fluvoxamine Maleate Tablets
Tablets, 50 mg and 100 mg, Oral
BP
Antidepressant, Antiobsessional Agent SEP 21, 2022
_ _
CONTROL NUMBER:_ _266973_ _
_ _
_ _
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9 DATE OF INITIAL AUTHORIZATION:
MAY 12, 1997
DATE OF REVISION:
Page 2 of 51
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant
Women
09/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
09/2022
7 WARNINGS AND PRECAUTIONS,
Serotonin Toxicity/Neuroleptic Malignant
Syndrome
09/2022
7 WARNINGS AND PRECAUTIONS,
Reproductive Health: Male and Female Potential
09/2022
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 Pediatrics
.......................................................................................................................................
4
1.2 Geriatrics
.......................................................................................................................................
4
2 CONTRAINDICATIONS
..................................................................................................................4
4 DOSAGE AND ADMINISTRATION
..................................................................................................5
4.1 Dosing Considerations
......................................................................................