BIO-ESCITALOPRAM TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Tersedia dari:

BIOMED PHARMA

Kode ATC:

N06AB10

INN (Nama Internasional):

ESCITALOPRAM

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 5MG

Rute administrasi :

ORAL

Unit dalam paket:

(3X10)/100/500

Jenis Resep:

Prescription

Area terapi:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0150435001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-09-25

Karakteristik produk

_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
...............................