AG-CITALOPRAM TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Disponible desde:

ANGITA PHARMA INC.

Código ATC:

N06AB04

Designación común internacional (DCI):

CITALOPRAM

Dosis:

40MG

formulario farmacéutico:

TABLET

Composición:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Vía de administración:

ORAL

Unidades en paquete:

30/100

tipo de receta:

Prescription

Área terapéutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2014-09-02

Ficha técnica

AG-Citalopram (Citalopram Tablets, USP) Page 1 of
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-CITALOPRAM
AG-Citalopram Tablets
Tablet, 10 mg, 20 mg and 40 mg citalopram (as citalopram
hydrobromide), Oral
USP
Antidepressant
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3 Canada
Date of Initial Authorisation :
FEB 10, 2010
Date of Revision:
JUL 10, 2023
Submission Control No: 276339
AG-Citalopram (Citalopram Tablets, USP) Page 2 of
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
07/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
07/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
07/2023
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
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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5
4.2 Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
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