TEVA-CITALOPRAM TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

MAH:

TEVA CANADA LIMITED

ATC_code:

N06AB04

INN:

CITALOPRAM

dosage:

20MG

pharmaceutical_form:

TABLET

composition:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

administration_route:

ORAL

units_in_package:

30/100/500

prescription_type:

Prescription

therapeutic_area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0136243001; AHFS:

authorization_status:

APPROVED

authorization_date:

2010-11-02

SPC

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