País: Canadá
Língua: inglês
Origem: Health Canada
ESCITALOPRAM (ESCITALOPRAM OXALATE)
BIOMED PHARMA
N06AB10
ESCITALOPRAM
10MG
TABLET
ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG
ORAL
(3X10)/100/500
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0150435002; AHFS:
APPROVED
2018-09-25
_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 ............................... Leia o documento completo