PRIVA-SERTRALINE CAPSULE

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Disponibbli minn:

NORA PHARMA INC

Kodiċi ATC:

N06AB06

INN (Isem Internazzjonali):

SERTRALINE

Dożaġġ:

100MG

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2023-04-01

Karatteristiċi tal-prodott

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