TEVA-ESCITALOPRAM TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

제공처:

TEVA CANADA LIMITED

ATC 코드:

N06AB10

INN (International Name):

ESCITALOPRAM

복용량:

20MG

약제 형태:

TABLET

구성:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 20MG

관리 경로:

ORAL

패키지 단위:

30/100

처방전 유형:

Prescription

치료 영역:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2014-09-10

제품 특성 요약

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
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2
PART I:
HEALTH PROFESSIONAL INFORMATION
............................................................ 4
1
INDICATIONS
.........................................................................................................
4
1.1
Pediatrics
.............................................................................................................
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
................................................... 6
4.4
Administration
....