APO-SERTRALINE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-06-2023
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Active ingredient:
SERTRALINE (SERTRALINE HYDROCHLORIDE)
Available from:
APOTEX INC
ATC code:
N06AB06
INN (International Name):
SERTRALINE
Dosage:
50MG
Pharmaceutical form:
CAPSULE
Composition:
SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG
Administration route:
ORAL
Units in package:
100/250
Prescription type:
Prescription
Therapeutic area:
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0123417001; AHFS:
Authorization status:
APPROVED
Authorization date:
1999-09-01
Summary of Product characteristics
_APO-SERTRALINE (Sertraline hydrochloride Capsules)_
_Page 1 of 70 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-SERTRALINE
Sertraline Hydrochloride Capsules
Capsules, 25 mg, 50 mg and 100 mg sertraline (as sertraline
hydrochloride), Oral
Apotex Standard
Antidepressant / Antipanic / Antiobsessional Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
SEP 01, 1999
Date of Revision
JUN 23, 2023
Submission Control Number: 274621
_APO-SERTRALINE (Sertraline hydrochloride Capsules)_
_Page 2 of 70 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
06/2023
7.1.1 Pregnant Women
06/2023
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
1
INDICATIONS
.......................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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6
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
........................................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
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