TEVA-ESCITALOPRAM TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

MAH:

TEVA CANADA LIMITED

ATC_code:

N06AB10

INN:

ESCITALOPRAM

dosage:

10MG

pharmaceutical_form:

TABLET

composition:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG

administration_route:

ORAL

units_in_package:

30/100

prescription_type:

Prescription

therapeutic_area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2014-09-10

SPC

TEVA-ESCITALOPRAM (Escitalopram Oxalate Tablets) Page 1 of 63
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-ESCITALOPRAM
Escitalopram Oxalate Tablets
Tablets, 10 mg and 20 mg escitalopram (as escitalopram oxalate), Oral
Teva Standard
Antidepressant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
September 10, 2014
Date of Revision:
August 16, 2022
Submission Control Number: 264520
TEVA-ESCITALOPRAM (Escitalopram Oxalate Tablets) Page 2 of 63
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
08/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
08/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
08/2022
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
............................................................................................
4
4
DOSAGE AND ADMINISTRATION
............................................................................
5
4.1
Dosing Considerations
.........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
................................................... 6
4.4
Administration
....