APO-SERTRALINE CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Commercializzato da:

APOTEX INC

Codice ATC:

N06AB06

INN (Nome Internazionale):

SERTRALINE

Dosaggio:

50MG

Forma farmaceutica:

CAPSULE

Composizione:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG

Via di somministrazione:

ORAL

Confezione:

100/250

Tipo di ricetta:

Prescription

Area terapeutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Dettagli prodotto:

Active ingredient group (AIG) number: 0123417001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

1999-09-01

Scheda tecnica

_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
.............................................................................................................................
4
1.2
Geriatrics
.............................................................................................................................
5
2
CONTRAINDICATIONS
..........................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................................
6
4
DOSAGE AND ADMINISTRATION
..........................................................................................
6
4.1
Dosing Considerations
........................................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
..............................................................