ACT ESCITALOPRAM ODT TABLET (ORALLY DISINTEGRATING)

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ESCITALOPRAM

Dostupné s:

TEVA CANADA LIMITED

ATC kód:

N06AB10

INN (Mezinárodní Name):

ESCITALOPRAM

Dávkování:

10MG

Léková forma:

TABLET (ORALLY DISINTEGRATING)

Složení:

ESCITALOPRAM 10MG

Podání:

ORAL

Jednotky v balení:

30

Druh předpisu:

Prescription

Terapeutické oblasti:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2020-05-01

Charakteristika produktu

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PRODUCT MONOGRAPH
PR
ACT ESCITALOPRAM ODT
Escitalopram Orodispersible Tablets
10 mg & 20 mg escitalopram
ANTIDEPRESSANT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
Date of Revision:
May 1, 2020
Submission Control No.: 238205
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ACT ESCITALOPRAM ODT
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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
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
21
DOSAGE AND ADMINISTRATION
.............................................................................
27
OVERDOSAGE
...............................................................................................................
29
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 30
STORAGE AND STABILITY
.........................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 33
PART II: SCIENTIFIC INFORMATION
..............................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.........................................................................................................
35
DETAILED PHARMACOLOGY
.........