NATCO-CITALOPRAM TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Dostupné s:

NATCO PHARMA (CANADA) INC

ATC kód:

N06AB04

INN (Mezinárodní Name):

CITALOPRAM

Dávkování:

10MG

Léková forma:

TABLET

Složení:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 10MG

Podání:

ORAL

Jednotky v balení:

100/500

Druh předpisu:

Prescription

Terapeutické oblasti:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2022-10-11

Charakteristika produktu

_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