BIO-ESCITALOPRAM TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

제공처:

BIOMED PHARMA

ATC 코드:

N06AB10

INN (International Name):

ESCITALOPRAM

복용량:

20MG

약제 형태:

TABLET

구성:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 20MG

관리 경로:

ORAL

패키지 단위:

(3X10)/100/500

처방전 유형:

Prescription

치료 영역:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

제품 요약:

Active ingredient group (AIG) number: 0150435004; AHFS:

승인 상태:

APPROVED

승인 날짜:

2018-09-25

제품 특성 요약

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