RATIO-MIRTAZAPINE TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
31-08-2005
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Aktívna zložka:
MIRTAZAPINE
Dostupné z:
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
ATC kód:
N06AX11
INN (Medzinárodný Name):
MIRTAZAPINE
Dávkovanie:
30MG
Forma lieku:
TABLET
Zloženie:
MIRTAZAPINE 30MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
MISCELLANEOUS ANTIDEPRESSANTS
Prehľad produktov:
Active ingredient group (AIG) number: 0143928002; AHFS:
Stav Autorizácia:
CANCELLED POST MARKET
Dátum Autorizácia:
2014-09-19
Súhrn charakteristických
_Page 1 of 31_
PRODUCT MONOGRAPH
Pr
ratio-MIRTAZAPINE
30 mg tablets
Antidepressant
ratiopharm inc.
DATE OF PREPARATION:
17 800 rue Lapointe
August 26, 2005
Mirabel, PQ
J7J 1P3
Control #: 100745
_Page 2 of 31_
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...................................................................14
STORAGE AND
STABILITY................................................................................................17
DOSAGE FORMS, COMPOSITION AND
PACKAGING...................................................17
PART II: SCIENTIFIC
INFORMATION......................................................................................18
PHARMACEUTICAL
INFORMATION................................................................................18
CLINICAL
TRIALS................................................................................................................20
DETAILED
PHARMACOLOGY........................................................................
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