IPG-CITALOPRAM TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Предлага се от:

MARCAN 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:

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:

2016-11-17

Данни за продукта

_IPG-CITALOPRAM (_
_citalopram hydrobromide) Product Monograph _
_Page 1 of 45 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
PR
IPG-CITALOPRAM
®
Citalopram tablets
Tablets, 10, 20 and 40 mg citalopram (as citalopram hydrobromide),
Oral
USP
Antidepressant
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, Ontario
Canada, K2E 1A2
Date of Initial Authorization:
NOV 17, 2016
Date of Revision:
July 29, 2022
Submission Control Number: 261614
_IPG-CITALOPRAM (_
_citalopram hydrobromide) Product Monograph _
_Page 2 of 45 _
RECENT MAJOR LABEL CHANGES
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 INFORM ATION
...................................................... 4
1
INDICATIONS
..........................................................................................................
4
1.1
Pediatrics
.........................................................................................................
4
1.2
Geriatrics
.........................................................................................................
4
2
CONTRAINDICATIONS
..........................................................................................
4
4
DOSAGE AND ADMINISTRATION
........................................................................
5
4.1
Dosing Considerations
....................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................. 6
4.4
Administration...................................