Država: Kanada
Jezik: angleščina
Source: Health Canada
ESCITALOPRAM (ESCITALOPRAM OXALATE)
TEVA CANADA LIMITED
N06AB10
ESCITALOPRAM
20MG
TABLET
ESCITALOPRAM (ESCITALOPRAM OXALATE) 20MG
ORAL
30/100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0150435004; AHFS:
APPROVED
2014-09-10
TEVA-ESCITALOPRAM (Escitalopram Oxalate Tablets) Page 1 of 63 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-ESCITALOPRAM Escitalopram Oxalate Tablets Tablets, 10 mg and 20 mg escitalopram (as escitalopram oxalate), Oral Teva Standard Antidepressant Teva Canada Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Canada www.tevacanada.com Date of Initial Authorization: September 10, 2014 Date of Revision: August 16, 2022 Submission Control Number: 264520 TEVA-ESCITALOPRAM (Escitalopram Oxalate Tablets) Page 2 of 63 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Hematologic 08/2022 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 08/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 08/2022 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 ................................................... 6 4.4 Administration .... Preberite celoten dokument