SANDOZ MIRTAZAPINE FC TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
21-04-2005
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Aktiv ingrediens:
MIRTAZAPINE
Tilgjengelig fra:
SANDOZ CANADA INCORPORATED
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:
2009-08-06
Preparatomtale
_Page 1 of 32_
PRODUCT MONOGRAPH
Pr
RHOXAL-MIRTAZAPINE FC
15 and 30 mg tablets
Antidepressant
Rhoxalpharma Inc.
DATE OF PREPARATION:
4600 Thimens boulevard
April 19, 2005
Saint-Laurent, Quebec
H4R 2B2
DATE OF REVISION:
Control #: 098116
_Page 2 of 32_
Table of Contents
PART I: HEALTH PROFESSIONAL
INFORMATION.........................................................3
SUMMARY PRODUCT
INFORMATION........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS...................................................................................................3
WARNINGS AND
PRECAUTIONS.................................................................................3
ADVERSE
REACTIONS...................................................................................................7
DRUG
INTERACTIONS..................................................................................................12
DOSAGE AND
ADMINISTRATION..............................................................................13
OVERDOSAGE................................................................................................................14
ACTION AND CLINICAL
PHARMACOLOGY............................................................15
STORAGE AND
STABILITY..........................................................................................18
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................18
PART II: SCIENTIFIC
INFORMATION................................................................................19
PHARMACEUTICAL
INFORMATION..........................................................................19
CLINICAL
TRIALS..........................................................................................................21
DETAILED
PHARMACOLOGY.....................................................................................22
TOXICOLOGY.......................
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