BIO-ESCITALOPRAM TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Dostępny od:

BIOMED PHARMA

Kod ATC:

N06AB10

INN (International Nazwa):

ESCITALOPRAM

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

(3X10)/100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2018-09-25

Charakterystyka produktu

_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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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
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
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