SANDOZ ESCITALOPRAM TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Mevcut itibaren:

SANDOZ CANADA INCORPORATED

ATC kodu:

N06AB10

INN (International Adı):

ESCITALOPRAM

Doz:

10MG

Farmasötik formu:

TABLET

Kompozisyon:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100

Reçete türü:

Prescription

Terapötik alanı:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0150435002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2014-09-10

Ürün özellikleri

_ _
_Sandoz Escitalopram _
_Page 1 of 61_
PRODUCT MONOGRAPH
PR SANDOZ ESCITALOPRAM
Escitalopram Oxalate Tablets
10, 20 mg as escitalopram
ANTIDEPRESSANT / ANXIOLYTIC / ANTIOBSESSIONAL
Sandoz Canada Inc.
Date of Revision: October 6, 2020
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Submission Control No: 240809
_ _
_Sandoz Escitalopram _
_Page 2 of 61_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
5
ADVERSE
REACTIONS
.........................................................................................................
11
DRUG
INTERACTIONS
.........................................................................................................
27
DOSAGE
AND
ADMINISTRATION
.....................................................................................
33
OVERDOSAGE
.......................................................................................................................
35
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
36
STORAGE
AND
STABILITY
.................................................................................................
38
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 38
PART II: SCIENTIFIC INFORMATION
...............................................................................
40
PHARMACEUTICAL
INFORMATION
.................................................................................
40
CLINICAL
TRIALS
...................................