PMS-ESCITALOPRAM TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Dostupno od:

PHARMASCIENCE INC

ATC koda:

N06AB10

INN (International ime):

ESCITALOPRAM

Doziranje:

20MG

Farmaceutski oblik:

TABLET

Sastav:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 20MG

Administracija rute:

ORAL

Jedinice u paketu:

30/100

Tip recepta:

Prescription

Područje terapije:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Proizvod sažetak:

Active ingredient group (AIG) number: 0150435004; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2017-10-25

Svojstava lijeka

_Pr_
_pms-ESCITALOPRAM – Product Monograph _
_Page 1 of 62 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATIO N
PR
PMS-ESCITALOPRAM
Escitalopram Tablets
Tablets, 10 mg and 20 mg escitalopram (as escitalopram oxalate), Oral
USP
Antidepressant / Anxiolytic / Antiobsessional
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
25 OCTOBER 2017
Date of Revision:
27 APRIL 2023
Submission Control No: 270921
_Pr_
_pms-ESCITALOPRAM – Product Monograph _
_Page 2 of 62 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
04/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
04/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
04/2023
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
....................................................................................................
4
4
DOSAGE AND ADMINISTRATION
...................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...