MINT-ESCITALOPRAM TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Saatavilla:

MINT PHARMACEUTICALS INC

ATC-koodi:

N06AB10

INN (Kansainvälinen yleisnimi):

ESCITALOPRAM

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2015-01-16

Valmisteyhteenveto

MINT-ESCITALOPRAM (escitalopram oxalate) Product Monograph
Page 1 of 60
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATIO N
PR
MINT-ESCITALOPRAM
escitalopram oxalate (as escitalopram)
Tablets, 10, 15, 20 mg escitalopram (base), Oral
Antidepressant / Anxiolytic / Antiobsessional
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
Jan 16, 2015
Date of Revision:
MAR 15, 2024
Submission Control Number: 280949
MINT-ESCITALOPRAM (escitalopram oxalate) Product Monograph
Page 2 of 60
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
05/2024
1 INDICATIONS
08/2022
1 INDICATIONS, 1.2 Geriatrics
08/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
08/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
08/2022
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
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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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