ACT ESCITALOPRAM TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

N06AB10

INN (Nome Internazionale):

ESCITALOPRAM

Dosaggio:

10MG

Forma farmaceutica:

TABLET

Composizione:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG

Via di somministrazione:

ORAL

Confezione:

30/100/250/500

Tipo di ricetta:

Prescription

Area terapeutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2018-06-12

Scheda tecnica

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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
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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
.................................................................................
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
...............