MINT-CITALOPRAM TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Disponibil de la:

MINT PHARMACEUTICALS INC

Codul ATC:

N06AB04

INN (nume internaţional):

CITALOPRAM

Dozare:

20MG

Forma farmaceutică:

TABLET

Compoziție:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Calea de administrare:

ORAL

Unități în pachet:

30/100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-09-05

Caracteristicilor produsului

_MINT-CITALOPRAM Product Monograph_
Page 1 of 45
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-CITALOPRAM
Citalopram Tablets
Tablets, 10 mg, 20 mg and 40 mg citalopram (as citalopram
hydrobromide), Oral
USP
Antidepressant
Mint Pharmaceuticals Inc.
Date of Initial Authorization:
6575 Davand Drive
September 5, 2014
Mississauga, Ontario
L5T 2M3
Date of Revision:
February 28, 2024
SUBMISSION CONTROL NUMBER: 279156
Page 2 of 45
_MINT-CITALOPRAM Product Monograph_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2024
7 WARNINGS AND PRECAUTIONS, Hematologic
07/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
07/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
07/2022
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
....................................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS
..................................................................................
5
4
DOSAGE AND ADMINISTRATION
.............................................................................................