ACT ESCITALOPRAM TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

N06AB10

INN (International Adı):

ESCITALOPRAM

Doz:

5MG

Farmasötik formu:

TABLET

Kompozisyon:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100/250/500

Reçete türü:

Prescription

Terapötik alanı:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0150435001; AHFS:

Yetkilendirme durumu:

CANCELLED PRE MARKET

Yetkilendirme tarihi:

2018-06-12

Ürün özellikleri

_ _
_ _
ACT ESCITALOPRAM_ _
_ _
_ _
_ _
_ Page 1 of 52_
PRODUCT MONOGRAPH
PR
ACT ESCITALOPRAM
Escitalopram Oxalate Tablets
5 mg, 10 mg & 20 mg escitalopram as escitalopram oxalate
Professed Standard
ANTIDEPRESSANT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision:
April 19, 2018 Control No.: 214495
_ _
ACT ESCITALOPRAM
_Page 2 of 52_
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
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
21
DOSAGE AND ADMINISTRATION
.............................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 30
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
34
DETAILED PHARMACOLOGY
....................................................................................
36
TOXICOLOGY
...............