NATCO-CITALOPRAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Available from:

NATCO PHARMA (CANADA) INC

ATC code:

N06AB04

INN (International Name):

CITALOPRAM

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-10-11

Summary of Product characteristics

_NATCO-CITALOPRAM (Citalopram hydrobromide) Product Monograph _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NATCO-CITALOPRAM
Citalopram Tablets
Tablets, 10 mg, 20 mg and 40 mg citalopram (as citalopram
hydrobromide), Oral
USP
Antidepressant
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Initial Authorization:
SEP 11, 2015
Date of Revision:
MAR 26, 2024
Submission Control Number: 279906
_ _
_NATCO-CITALOPRAM (Citalopram hydrobromide) Product Monograph _
_Page 2 of 50_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
03/2024
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
......................................................................
5
1
INDICATIONS
...............................................................................................................
5
1.1
Pediatrics
................................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 6
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations