APO-ESCITALOPRAM TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Disponible des:

APOTEX INC

Codi ATC:

N06AB10

Designació comuna internacional (DCI):

ESCITALOPRAM

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG

Vía de administración:

ORAL

Unidades en paquete:

30/100/500

tipo de receta:

Prescription

Área terapéutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0150435002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2014-09-10

Fitxa tècnica

_APO-ESCITALOPRAM (Escitalopram Oxalate) _
_ _
_Page 1 of 73 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ESCITALOPRAM
Escitalopram Tablets
Tablets, 10 mg and 20 mg escitalopram (as escitalopram oxalate), Oral
USP
Antidepressant / Anxiolytic / Antiobsessional
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
SEP 10, 2014
Date of Revision:
AUG 02, 2023
Submission Control Number: 272371
_APO-ESCITALOPRAM (Escitalopram Oxalate) _
_ _
_Page 2 of 73 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
08/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
08/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
08/2023
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
.................................................................................................................
4
1.1
Pediatrics
.......................................................................................................................
4
1.2
Geriatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
5
4
DOSAGE AND ADMINISTRATION
....................................................................................
6
4.1
Dosing Considerations
...................................................................................................
6
4.2
Recommended Dose and Dosage
Adjustment.........................................