PMS-ESCITALOPRAM TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Tilgængelig fra:

PHARMASCIENCE INC

ATC-kode:

N06AB10

INN (International Name):

ESCITALOPRAM

Dosering:

20MG

Lægemiddelform:

TABLET

Sammensætning:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 20MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100

Recept type:

Prescription

Terapeutisk område:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2017-10-25

Produktets egenskaber

_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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...