MINT-CITALOPRAM TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Предлага се от:

MINT PHARMACEUTICALS INC

АТС код:

N06AB04

INN (Международно Name):

CITALOPRAM

дозиране:

40MG

Лекарствена форма:

TABLET

Композиция:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0136243002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2014-09-05

Данни за продукта

_MINT-CITALOPRAM Product Monograph_
Page 1 of 45
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-CITALOPRAM
Citalopram Tablets
Tablets, 10 mg, 20 mg and 40 mg citalopram (as citalopram
hydrobromide), Oral
USP
Antidepressant
Mint Pharmaceuticals Inc.
Date of Initial Authorization:
6575 Davand Drive
September 5, 2014
Mississauga, Ontario
L5T 2M3
Date of Revision:
February 28, 2024
SUBMISSION CONTROL NUMBER: 279156
Page 2 of 45
_MINT-CITALOPRAM Product Monograph_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2024
7 WARNINGS AND PRECAUTIONS, Hematologic
07/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
07/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
07/2022
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
....................................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS
..................................................................................
5
4
DOSAGE AND ADMINISTRATION
.............................................................................................