PMS-ESCITALOPRAM TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

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27-04-2023

有效成分:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

可用日期:

PHARMASCIENCE INC

ATC代码:

N06AB10

INN(国际名称):

ESCITALOPRAM

剂量:

10MG

药物剂型:

TABLET

组成:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG

给药途径:

ORAL

每包单位数:

30/100

处方类型:

Prescription

治疗领域:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0150435002; AHFS:

授权状态:

APPROVED

授权日期:

2017-10-25

产品特点

                                _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
...
                                
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