SANDOZ MIRTAZAPINE FC TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

MIRTAZAPINE

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

N06AX11

INN (Kansainvälinen yleisnimi):

MIRTAZAPINE

Annos:

30MG

Lääkemuoto:

TABLET

Koostumus:

MIRTAZAPINE 30MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTIDEPRESSANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0143928002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2009-08-06

Valmisteyhteenveto

_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.......................