MINT-ESCITALOPRAM TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Dostupno od:

MINT PHARMACEUTICALS INC

ATC koda:

N06AB10

INN (International ime):

ESCITALOPRAM

Doziranje:

20MG

Farmaceutski oblik:

TABLET

Sastav:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 20MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2015-01-16

Svojstava lijeka

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
.....................................................................................