PRIVA-SERTRALINE CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Saatavilla:

NORA PHARMA INC

ATC-koodi:

N06AB06

INN (Kansainvälinen yleisnimi):

SERTRALINE

Annos:

100MG

Lääkemuoto:

CAPSULE

Koostumus:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0123417002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2023-04-01

Valmisteyhteenveto

_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
.................................................................................