SANDOZ MIRTAZAPINE FC TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
21-04-2005
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Aktivní složka:
MIRTAZAPINE
Dostupné s:
SANDOZ CANADA INCORPORATED
ATC kód:
N06AX11
INN (Mezinárodní Name):
MIRTAZAPINE
Dávkování:
30MG
Léková forma:
TABLET
Složení:
MIRTAZAPINE 30MG
Podání:
ORAL
Jednotky v balení:
100
Druh předpisu:
Prescription
Terapeutické oblasti:
MISCELLANEOUS ANTIDEPRESSANTS
Přehled produktů:
Active ingredient group (AIG) number: 0143928002; AHFS:
Stav Autorizace:
CANCELLED POST MARKET
Datum autorizace:
2009-08-06
Charakteristika produktu
_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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