TEVA-CITALOPRAM TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

N06AB04

INN (Међународно име):

CITALOPRAM

Дозирање:

40MG

Фармацеутски облик:

TABLET

Састав:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Пут администрације:

ORAL

Јединице у пакету:

30/100

Тип рецептора:

Prescription

Терапеутска област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2010-11-02

Карактеристике производа

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
...................................................