ACT ESCITALOPRAM TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Dostupné z:

TEVA CANADA LIMITED

ATC kód:

N06AB10

INN (Medzinárodný Name):

ESCITALOPRAM

Dávkovanie:

5MG

Forma lieku:

TABLET

Zloženie:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 5MG

Spôsob podávania:

ORAL

Počet v balení:

30/100/250/500

Typ predpisu:

Prescription

Terapeutické oblasti:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Prehľad produktov:

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

Stav Autorizácia:

CANCELLED PRE MARKET

Dátum Autorizácia:

2018-06-12

Súhrn charakteristických

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ACT ESCITALOPRAM_ _
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_ 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
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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
...............