NU-MIRTAZAPINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Osta se nyt

Lataa Valmisteyhteenveto (SPC)
02-11-2009

Aktiivinen ainesosa:

MIRTAZAPINE

Saatavilla:

NU-PHARM INC

ATC-koodi:

N06AX11

INN (Kansainvälinen yleisnimi):

MIRTAZAPINE

Annos:

45MG

Lääkemuoto:

TABLET

Koostumus:

MIRTAZAPINE 45MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTIDEPRESSANTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0143928003; AHFS:

Valtuutuksen tilan:

CANCELLED (UNRETURNED ANNUAL)

Valtuutus päivämäärä:

2018-03-28

Valmisteyhteenveto

                                Page 1 of 32
PRODUCT MONOGRAPH
PR
NU-MIRTAZAPINE
Mirtazapine Tablets
USP
15 mg, 30 mg and 45 mg
Antidepressant
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural St., Units 1 & 2
October 14, 2009
Richmond Hill, Ontario
L4B 1E4
Control#: 133373
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
...................................................................................
12
OVERDOSAGE......................................................................................................................
14
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
14
STORAGE AND
STABILITY...............................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 17
PART II: SCIENTIFIC INFORMATION
.............................................................................
19
PHARMACEUTICAL
INFORMATION...............................................................................
19
CLINICAL TRIALS
...............................................................................................................
20
DETAILED PHARMACOLOGY
...................................
                                
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