BIO-ESCITALOPRAM TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Prieinama:

BIOMED PHARMA

ATC kodas:

N06AB10

INN (Tarptautinis Pavadinimas):

ESCITALOPRAM

Dozė:

5MG

Vaisto forma:

TABLET

Sudėtis:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 5MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

(3X10)/100/500

Recepto tipas:

Prescription

Gydymo sritis:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2018-09-25

Prekės savybės

_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
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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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4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
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