TEVA-ESCITALOPRAM TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
23-09-2010
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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
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:
2015-10-16
Súhrn charakteristických
PRODUCT MONOGRAPH
PR
TEVA-ESCITALOPRAM
(escitalopram oxalate)
Tablets 5 mg, 10 mg, 15 mg and 20 mg escitalopram (as escitalopram
oxalate)
Antidepressant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No. 119039, 138252
Date of Preparation:
September 23, 2010
2
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...........................................................................................
10
DRUG INTERACTIONS
...........................................................................................
20
DOSAGE AND
ADMINISTRATION.......................................................................
26
OVERDOSAGE
.........................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
..................................................... 29
STORAGE AND
STABILITY...................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................... 31
PART II: SCIENTIFIC INFORMATION
........................................................................
32
PHARMACEUTICAL
INFORMATION...................................................................
32
CLINICAL
TRIALS...................................................................................................
34
DETAILED
PHARMACOLOGY..............................................................................
35
TOXICOLOGY
..................................................................
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