APO-ESCITALOPRAM TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Saadav alates:

APOTEX INC

ATC kood:

N06AB10

INN (Rahvusvaheline Nimetus):

ESCITALOPRAM

Annus:

10MG

Ravimvorm:

TABLET

Koostis:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

30/100/500

Retsepti tüüp:

Prescription

Terapeutiline ala:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2014-09-10

Toote omadused

_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.........................................