TEVA-ESCITALOPRAM TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

N06AB10

INN (International Nazwa):

ESCITALOPRAM

Dawkowanie:

10MG

Forma farmaceutyczna:

TABLET

Skład:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2014-09-10

Charakterystyka produktu

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
....