CO MIRTAZAPINE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
12-10-2016
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Aktiv ingrediens:
MIRTAZAPINE
Tilgjengelig fra:
COBALT PHARMACEUTICALS COMPANY
ATC-kode:
N06AX11
INN (International Name):
MIRTAZAPINE
Dosering :
30MG
Legemiddelform:
TABLET
Sammensetning:
MIRTAZAPINE 30MG
Administreringsrute:
ORAL
Enheter i pakken:
100
Resept typen:
Prescription
Terapeutisk område:
MISCELLANEOUS ANTIDEPRESSANTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0143928002; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2013-07-19
Preparatomtale
PRODUCT MONOGRAPH
Pr
_CO_ MIRTAZAPINE
Mirtazapine Tablets USP
30 mg
Antidepressant
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, Ontario
L5N 2B8
CONTROL NUMBER: 093861
Date of Preparation:
December 7, 2005
Date of Revision:
-2-
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
SUMMARY PRODUCT INFORMATION . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 3
INDICATIONS AND CLINICAL USE . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 3
CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . 3
WARNINGS AND PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 4
ADVERSE REACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . 8
DRUG INTERACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . 13
DOSAGE AND ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . 14
OVERDOSAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 16
ACTION AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 17
STORAGE AND STABILITY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 19
DOSAGE FORMS, COMPOSITION AND PACKAGING . . . . . . . . . . . . . . .
. . . . . . . 19
PART II: SCIENTIFIC INFORMATION . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 21
PHARMACEUTICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 21
CLINICAL TRIALS . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 21
DETAILED PHARMACOLOGY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . 22
TOXICOLOGY . . . . . . . . . . . . . . . . . . . . . .
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