国家: 加拿大
语言: 英文
来源: Health Canada
ESCITALOPRAM (ESCITALOPRAM OXALATE)
PHARMASCIENCE INC
N06AB10
ESCITALOPRAM
10MG
TABLET
ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG
ORAL
30/100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0150435002; AHFS:
APPROVED
2017-10-25
_Pr_ _pms-ESCITALOPRAM – Product Monograph _ _Page 1 of 62 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATIO N PR PMS-ESCITALOPRAM Escitalopram Tablets Tablets, 10 mg and 20 mg escitalopram (as escitalopram oxalate), Oral USP Antidepressant / Anxiolytic / Antiobsessional PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com Date of Initial Authorization: 25 OCTOBER 2017 Date of Revision: 27 APRIL 2023 Submission Control No: 270921 _Pr_ _pms-ESCITALOPRAM – Product Monograph _ _Page 2 of 62 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Hematologic 04/2023 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 04/2023 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 04/2023 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 ... 阅读完整的文件