BIO-ESCITALOPRAM TABLET

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Fáanlegur frá:

BIOMED PHARMA

ATC númer:

N06AB10

INN (Alþjóðlegt nafn):

ESCITALOPRAM

Skammtar:

10MG

Lyfjaform:

TABLET

Samsetning:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

(3X10)/100/500

Gerð lyfseðils:

Prescription

Lækningarsvæði:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2018-09-25

Vara einkenni

_Bio-ESCITALOPRAM Product Monograph _
_Page 1 of 57_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATIO N PR
BIO-ESCITALOPRAM

Escitalopram Oxalate Tablets
Tablets, 5, 10, 15, 20 mg escitalopram (as escitalopram oxalate), Oral
Manufacturer’s standard
Antidepressant / Antiobsessional
Biomed Pharma
1B-9450 Boulevard Langelier
Saint-Léonard, Quebec
H1P 3H8
Date of Initial Authorization:
September 25, 2018
Date of Revision:
MAR 20, 2023
Submission Control Number: 272233
_Bio-ESCITALOPRAM Product Monograph _
_Page 2 of 57_
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
03/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
03/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
03/2023
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
...............................