MINT-ESCITALOPRAM TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Tilgængelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

N06AB10

INN (International Name):

ESCITALOPRAM

Dosering:

20MG

Lægemiddelform:

TABLET

Sammensætning:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 20MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2015-01-16

Produktets egenskaber

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
..........................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................................................
4
1
INDICATIONS
...........................................................................................................................
4
1.1
Pediatrics
............................................................................................................................
4
1.2
Geriatrics
............................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................