TEVA-ESCITALOPRAM TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
23-09-2010
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ESCITALOPRAM (ESCITALOPRAM OXALATE)
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
N06AB10
INN (Alþjóðlegt nafn):
ESCITALOPRAM
Skammtar:
5MG
Lyfjaform:
TABLET
Samsetning:
ESCITALOPRAM (ESCITALOPRAM OXALATE) 5MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0150435001; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2015-10-16
Vara einkenni
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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