TEVA-CITALOPRAM TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Доступна з:

TEVA CANADA LIMITED

Код атс:

N06AB04

ІПН (Міжнародна Ім'я):

CITALOPRAM

Дозування:

10MG

Фармацевтична форма:

TABLET

Склад:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 10MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Огляд продуктів:

Active ingredient group (AIG) number: 0136243003; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2010-11-02

Характеристики продукта

TEVA-CITALOPRAM_ _
_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CITALOPRAM
Citalopram Hydrobromide Tablets
Tablets, 10 mg, 20 mg and 40 mg citalopram (as citalopram
hydrobromide), Oral
Teva Standard
Antidepressant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control Number: 280059
Date of Initial Authorization:
October 24, 2008
Date of Revision:
February 26, 2024
TEVA-CITALOPRAM_ _
_Page 2 of 56 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS
02/2024
7 WARNINGS AND PRECAUTIONS, Hematologic
10/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
10/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2022
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
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX…………………………………………………………….5
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
...................................................