PRIVA-SERTRALINE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Disponible depuis:

NORA PHARMA INC

Code ATC:

N06AB06

DCI (Dénomination commune internationale):

SERTRALINE

Dosage:

25MG

forme pharmaceutique:

CAPSULE

Composition:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2022-07-26

Résumé des caractéristiques du produit

_ESCITALOPRAM Tablets _
_Page 1 of 53 _
PRODUCT MONOGRAPH
PR
ESCITALOPRAM TABLETS
Escitalopram Oxalate Tablets
10 and 20 mg escitalopram (as escitalopram oxalate)
Manufacturer’s Standard
ANTIDEPRESSANT / ANTIOBSESSIONAL
NORA PHARMA INC.
1565, Lionel-Boulet Boul.
Varennes, Québec
J3X 1P7
Control #: 263886
Date of
Preparation:
June 2,
2022
_ESCITALOPRAM Tablets _
_Page 2 of 53 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
10
DRUG
INTERACTIONS..........................................................................................................
23
DOSAGE AND
ADMINISTRATION......................................................................................
29
OVERDOSAGE
........................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
32
STORAGE AND STABILITY
.................................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 33
PART II: SCIENTIFIC INFORMATION
..........................................................................................
35
PHARMACEUTICAL INFORMATION
.................................................................................