APO-CITALOPRAM TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Доступна с:

APOTEX INC

код АТС:

N06AB04

ИНН (Международная Имя):

CITALOPRAM

дозировка:

40MG

Фармацевтическая форма:

TABLET

состав:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Администрация маршрут:

ORAL

Штук в упаковке:

30/100

Тип рецепта:

Prescription

Терапевтические области:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Обзор продуктов:

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

Статус Авторизация:

APPROVED

Дата Авторизация:

2004-01-20

Характеристики продукта

_APO-CITALOPRAM (Citalopram tablets) _
_ _
_Page 1 of 51 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-CITALOPRAM
Citalopram Tablets
Tablets, 20 and 40 mg citalopram (as citalopram hydrobromide), Oral
USP
Antidepressant
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JAN 20, 2004
Date of Revision:
NOV 23, 2023
Submission Control Number: 278774
_APO-CITALOPRAM (Citalopram tablets) _
_ _
_Page 2 of 51_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
11/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
01/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
01/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
01/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5
4
DOSAGE AND ADMINISTRATION .......................................................................................
5
4.1
Dosing Considerations
.................................................................