SERTRALINE CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Dostępny od:

SANIS HEALTH INC

Kod ATC:

N06AB06

INN (International Nazwa):

SERTRALINE

Dawkowanie:

25MG

Forma farmaceutyczna:

CAPSULE

Skład:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0123417003; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2010-06-08

Charakterystyka produktu

_Page 1 of 62_
_SERTRALINE Product Monograph_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SERTRALINE
Sertraline Hydrochloride Capsules
Capsules, 25 mg, 50 mg and 100 mg sertraline (as sertraline
hydrochloride), Oral
Antidepressant / Antipanic / Antiobsessional Agent
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control Number: 274293
Date of Initial Authorization:
JUL 27, 2010
Date of Revision:
MAY 03, 2023
_SERTRALINE Product Monograph _
_Page 2 of 62_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
07/2022
7.1.1 Pregnant Women
07/2022
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
.............................................................................................................
2
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
.......................................................................................................................
5
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
............................................................. 6
4.4
Administration
.........................................................................